Published clinical literature (retrospective comparative cohort studies, prospective comparative cohort studies, meta-analyses, systematic reviews, and large database studies)
Published clinical data were used to support the expansion of representative, specific procedures (LAR/TME and ISR) under the cleared 'general laparoscopic surgical procedures' indication. Findings from these 'umbrella' procedures were extrapolated to support additional covered procedures.
LAR/TME; Intersphincteric Resection; Comparative effectiveness; General laparoscopic surgery
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Literature review of 11 publications (Midura, Liao, Somashekhar, Lee, Lin, Memon, Sun Y, Sun Z, Trastulli, Xiong, Yang); Meta-analyses, systematic reviews, and large database comparative studies
Patients undergoing Low Anterior Resection/Total Mesorectal Excision (LAR/TME); Sample Size: Varies by study (e.g., da Vinci cohorts ranging from 25 to 1217 patients)
Open and laparoscopic surgical procedures
Mortality, transfusion rates, length of stay, complications, surgical margins, anastomotic leak, erectile dysfunction, operative time, urologic function
Literature review of 2 publications (Park, Kim); Retrospective comparative cohort study and prospective comparative cohort study; Follow-up/Duration: Up to 12 months
Mortality, transfusion rates, length of stay, complications, surgical margins, anastomotic leak, erectile dysfunction, fecal incontinence, operative time, urologic function
Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Device Story
da Vinci Xi/X (IS4000/IS4200) are software-controlled, electro-mechanical surgical systems; consist of surgeon console, patient side cart, and vision side cart. Surgeon operates console to control endoscopic instruments (EndoWrist) and endoscopes; system translates hand movements into precise instrument motion. Used in OR by trained physicians for minimally invasive procedures (urologic, laparoscopic, gynecologic, thoracoscopic). Provides high-definition visualization and ergonomic control; facilitates complex tasks like suturing and dissection. Output is real-time surgical visualization and mechanical tissue manipulation. Benefits include potential for reduced blood loss, shorter hospital stays, and comparable clinical outcomes to open/laparoscopic surgery. Labeling expansion adds specific procedures: colectomy (right, left, transverse, total, hemi, sigmoidectomy), small bowel resection, rectopexy, intersphincteric resection (ISR), low anterior resection/total mesorectal excision (LAR/TME), and abdominoperineal resection (APR).
Clinical Evidence
Clinical evidence provided via published literature (prospective RCTs, meta-analyses, systematic reviews, and comparative cohort studies). Data focused on 'umbrella' procedures (LAR/TME and ISR) to support expansion to related procedures. Results show da Vinci-assisted procedures have comparable mortality, complication rates, surgical margins, and anastomotic leak rates vs. open/laparoscopic surgery. Some studies indicate lower blood loss and shorter hospital stays, with increased operative times. Urologic and sexual function outcomes were comparable or better than comparators.
Technological Characteristics
Software-controlled, electro-mechanical system. Components: Surgeon Console, Patient Side Cart, Vision Side Cart. Uses rigid endoscopes and EndoWrist instruments. Connectivity: Networked system. Sterilization: Compatible with standard surgical sterilization protocols. Software: Proprietary control software. No changes to technological characteristics from predicate.
Indications for Use
Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Used for tissue manipulation (grasping, cutting, dissection, approximation, ligation, suturing) and delivery of ablation probes.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/2 description: This image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
September 19, 2017
Intuitive Surgical, Inc. % Ms. Cindy Domecus Principal, Domecus Consulting Services, LLC & Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K171632
Trade/Device Name: da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 11, 2017 Received: August 15, 2017
Dear Ms. Domecus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black and appears to be the focus of the image. In the background, there is a faint, light blue watermark of the letters "FDA" repeated across the image.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
#### 510(k) Number (if known)
K171632
#### Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories
#### Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System. Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparossopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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# 510(k) Summary (21 CFR § 807.92(c))
#### I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus, R.A.C. (US & EU)<br>Principal, Domecus Consulting Services LLC<br>Chief Regulatory Advisor to Intuitive Surgical<br>Telephone: 650.343.4813<br>Fax: 650.343.7822<br>Email: domecusconsulting@comcast.net |
| Date Summary Prepared: | September 19, 2017 |
#### II. SUBJECT DEVICE INFORMATION
| Device Trade Name: | da Vinci® Surgical Systems, Model IS4000 and Model IS4200 |
|----------------------|-----------------------------------------------------------|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) |
| Regulatory Class: | II |
| Product Code: | NAY |
| Submission Type: | Traditional 510(k) |
## III. PREDICATE DEVICE INFORMATION:
Intuitive Surgical da Vinci Surgical Systems, Models IS4000 and IS4200 Predicate Device: (K131861, K152578, K153276, K161178, K170713, K171294) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
## IV. DEVICE DESCRIPTION:
This 510(k) is for expansion of the representative, specific procedures via labeling modification, to include the following additional representative, specific procedures under the previously cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861) and the da Vinci X Surgical System (K171294) : Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy);- Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
<sup>ี &</sup>quot;Colectomy" is already a cleared, representative, specific procedure under K131861. This application requests a revision to the labeling to specify "Right, Left, Transverse, Total, Hemi and Sigmoidectomy" colectomy procedures.
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## V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
## Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (IS4000 and IS4200) proposed in this submission.
## VII. PERFORMANCE DATA
## Pre-Clinical Animal Study Data
Animal performance data were provided in this premarket notification, including the results from seven (7) evaluations in a total of 32 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Nissen Fundoplication, Colectomy, Mitral Valve Repair and Small Bowel Anastomosis. These data were previously submitted in support of the da Vinci Xi Surgical System (K131861), the da Vinci Xi Stapler 45 (K140553) and the da Vinci Xi labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures indication (K153276); and urologic surgical procedures general indication (K161178). These data also support inclusion of the additional representative, specific procedures.
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## Clinical Study Data
Published clinical data support use of the da Vinci Xi and X Surgical Systems in the subject representative, specific procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the most complex/highest risk representative, specific procedures of Low Anterior Resection / Total Mesorectal Excision "LAR/TME" and Intersphincteric Resection "ISR" (referred to as the "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.
## Umbrella Procedures
Umbrella Procedure 1: Low Anterior Resection/Total Mesorectal Excision
Published clinical data were provided for the "Low Anterior Resection/Total Mesorectal Excision" umbrella procedure. Eleven (11) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included a prospective randomized controlled trial, meta-analyses, systematic reviews and large database comparative studies. A detailed summary of the published clinical data on this procedure is provided in Tables 1A and 1B below.
The findings from the LAR/TME publications show that da Vinci-assisted procedures are:
- Mortality: associated with comparable mortality rates,
- Transfusions: comparable or lower blood transfusion rates and EBL volumes,
- Length of Stay: comparable or shorter lengths of hospital stay,
- Complications: comparable or lower complication rates,
- Surgical Margins: comparable rates of positive surgical margins
- Anastomotic Leak: comparable anastomotic leak rates; and,
- ED: comparable or lower erectile dysfunction ED rates as compared to both open and ● laparoscopic surgical procedures.
- . Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- . Urologic Function: Additionally, these publications reported comparable urologic function and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Umbrella Procedure 2: Intersphincteric Resection
Published clinical data were provided for the "Intersphincteric Resection" umbrella procedure. Two (2) publications provided ISR data. One (1) publication reported the results from a retrospective comparative cohort study and one (1) publication reported the results from a prospective comparative
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cohort study. A summary of the published clinical data on this procedure is provided in Tables 2A and 2B below.
The findings from the ISR publications show that da Vinci-assisted procedures are associated with:
- Mortality: comparable mortality rates,
- Transfusions: comparable blood transfusion rates and EBL volumes,
- Length of Stay: comparable lengths of hospital stay,
- Complications: comparable complication rates,
- Surgical Margins: comparable rates of positive surgical margins,
- Anastomotic Leak: comparable anastomotic leak rates,
- ED: lower erectile dysfunction ED rates; and,
- Continence: comparable or higher fecal continence rates? as compared to both open and laparoscopic surgical procedures.
- . Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- Urologic Function: Additionally, these publications reported comparable urologic function and comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
## Covered Procedures
The published data on the above cited LAR/TME and ISR umbrella procedures were extrapolated to support clearance of the following covered procedures:
- . Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy),4
- . Small Bowel Resection,
- Rectopexy, and
- Abdominoperineal Resection (APR).
## VIII. CONCLUSION
Based on the information provided in this premarket notification for expansion of the representative, specific procedures, the inclusion of the following additional representative, specific procedures under the da Vinci Xi and X Surgical Systems "general laparoscopic surgical procedure" indication is substantially equivalent to the predicate devices (da Vinci Xi and X Surgical Systems): Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy); \$ Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR).
<sup>4 &</sup>quot;Colectomy" is already a cleared, representative, specific procedure under K131861. This application requests a revision to the labeling to specify "Right, Left, Transverse, Total, Hemi and Sigmoidectomy" colectomy procedures.
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| Publications | Sample Size (N) | | Operative Time<br>(minutes) | Estimated Blood<br>Loss "EBL" (ml) | Length of Stay<br>(days) | PostOp<br>Complications (%) | IntraOp<br>Complications (%) | Mortality Rate<br>(%) | Transfusion Rate<br>(%) | Publications | | Sample Size (N) | PSM Rate (%) | Urologic<br>Function | Conversion<br>Rate (%) | No. of Lymph<br>Nodes Harvested | CRM /<br>Positive CRM<br>Rate (%) | DRM /<br>Positive DRM<br>Rate (%) | Anastomotic<br>Leak Rate (%) | Erectile<br>Dysfunction | |
|--------------------------|-----------------|------|-----------------------------|------------------------------------|--------------------------|-----------------------------|------------------------------|-----------------------|-------------------------|----------------|----------|-----------------|--------------|-------------------------------------------------------|------------------------|---------------------------------|-----------------------------------|-----------------------------------|------------------------------|-----------------------------------|--------------|
| 1. Midura<br>(2015) | da Vinci | 331 | Not Reported | Not Reported | 5 | Not Reported | Not Reported | 1.20 | Not Reported | 1. Midura | da Vinci | 331 | 4.30 | | | 71.6% ≥12 | | | | | |
| | Open | 4403 | | | 6 | | | 1.70 | | (2015) | Open | 4403 | 6.10 | Not Reported | Not<br>Reported | 66.3% ≥12 | Not Reported | Not Reported | Not Reported | Not Reported | |
| | Lap | 5935 | | | 5 | | | 1.20 | | | Lap | 5935 | 4.70 | | | 68.7% ≥12 | | | | | |
| 2. Liao<br>(2016) | da Vinci | 498 | 191 - 337.9 | 0 – 187.51 | 6 – 10.8 | 25.7 | Not Reported | 1.1 | 4.6 | 2. Liao | da Vinci | 498 | | | Not<br>Reported | 17.4 | 8.41 | 2.08 | 6.63 | | |
| | Open | 576 | 124 - 273.8 | 120 – 275.481 | 7 - 16 | 26.6 | | 1.5 | 7.9 | (2016) | Open | 576 | Not Reported | Not Reported | | 16.5 | 8.62 | 2.02 | 4.51 | Not Reported | |
| 3. Somashekhar<br>(2015) | da Vinci | 25 | 310.3 | 165.14 | 7.52 | 0/02 | 4 | 0 | Not Reported | 3. Somashakher | da Vinci | 25 | 0 | | 0 | 16.88 | 0 | 3.6 cm / 0% | 0 | 18%1 | |
| | Open | 25 | 246.3 | 406.04 | 13.24 | 16/42 | 0 | 0 | | (2015) | Open | 25 | 0 | Not Reported | N/A | 15.2 | 0 | 2.4 cm / 0% | 4 | 26%1 | |
| 4. Lee<br>(2015) | da Vinci | 1043 | 202 – 396.5 | 45.7 – 188.8 | 2.9 – 11.9 | Not Reported | Not Reported | Not Reported | Not Reported | 4. Lee | da Vinci | 1043 | | 3mo:3.6 - 8.364<br>6mo: 3.5 - 84<br>12mo: 3.53 - 64 | 1.19 | 10.3 - 20 | Not Reported | Not Reported | 0 - 20 | 3mo:3.8 – 8.02<br>6mo:2.4 – 4.52 | |
| | Lap | 1181 | 158.1 - 298.8 | 59.2 - 229.2 | 3.9 - 13.5 | | | | | (2015) | Lap | 1181 | Not Reported | 3mo: 5.5 - 11.74<br>6mo: 3.2 - 8.24<br>12mo: 4.2 - 84 | 6.50 | 11.07 - 17.4 | | | 2.7 - 14 | 3mo: 5.9 – 132<br>6mo: 4.5 – 6.82 | |
| 5. Lin<br>(2011) | da Vinci | 268 | 202 – 232.6 | 100 – 137.40 | 6.9 – 11.9 | 22.01 | Not Reported | Not Reported | Not Reported | 5. Lin | da Vinci | 268 | | | 1.87 | 15.3 | 1.69% | 2.8 | | | |
| | Lap | 393 | 158.10 - 208 | 127 – 150 | 8.7 – 9.8 | 19.34 | | | | (2011) | Lap | 393 | Not Reported | Not Reported | 7.63 | 13.8 | 3.17% | 3.6 | Not Reported | Not Reported | |
| 6. Memon<br>(2012) | da Vinci | 353 | 190.1 - 385.3 | Not Reported | 5.7 - 11.9 | 10.7 – 32.2 | Not Reported | Not Reported | Not Reported | Not Reported | 6. Memon | da Vinci | 353 | | | 1.42 | MD5:-0.9 | 3.1 | 2.0 - 4.0 | | |
| | Lap | 401 | 168.6 - 315.0 | | 6 - 14.4 | 18.9 – 27.1 | | | | | (2012) | Lap | 401 | Not Reported | Not Reported | 7.73 | [-1.94, 1.80] | 3.2 | 2.0 - 4.5 | Not Reported | Not Reported |
| 7. Sun Y<br>(2016) | da Vinci | 1217 | Not Reported | Not Reported | 5 | 16 | Not Reported | 0.40 | Not Reported | 7. Sun Y | da Vinci | 1217 | 7 | | 8.22 | 16.8 | 4.76 | 3.5% | | | |
| | Lap | 4700 | | | 5 | 19.1 | | 0.76 | | (2016) | Lap | 4700 | 7 | Not Reported | 15.76 | 16.4 | 9.3 | 4% | Not Reported | Not Reported | |
| 8. Sun Z<br>(2015) | da Vinci | 324 | 190.1 - 325.5 | | 4 - 8 | Not Reported | Not Reported | Not Reported | Not Reported | 8. Sun Z | da Vinci | 324 | Not Reported | Not Reported | 0 | 15 | 5 | Not Reported | Not Reported | Not Reported | |
| | Lap | 268 | 190 - 280 | Not Reported | 3.6 - 10 | | | | | (2015) | Lap | 268 | | | 7.94 | 14 | 5 | | | | |
| 9. Trastulli<br>(2012) | da Vinci | 125 | 190.1 - 385.3 | | 5.7 - 11.9 | 29.30 | Not Reported | 0 | Not Reported | 9. Trastulli | da Vinci | 125 | | | 2.8 | 13.1 - 19.4 | 2.8 | 2 - 3.6 | 8 | | |
| | Lap | 156 | 158.1 - 297.3 | Not Reported | 6.6 - 14.4 | 23.10 | | 0 | | (2012) | Lap | 156 | Not Reported | Not Reported | 6.7 | 15.9 - 17 | 4.0 | 2 – 3.8 | 6.3 | Not Reported | |
| 10. Xiong<br>(2014) | da Vinci | 554 | 202 - 309.7 | 100 – 200 | 6.5 - 11.9 | 10 – 32.4 | Not Reported | 0 | Not Reported | 10. Xiong | da Vinci | 554 | | | 1.08 | 10.3 - 19.4 | 2.74 | 1.9 - 2.8 | 4 - 11 | 3.3 – 5.53 | |
| | Lap | 675 | 158.1 - 315 | 126.2 - 300 | 6 - 13.5 | 12.2 – 27.9 | | 0 | | (2015) | Lap | 675 | Not Reported | Not Reported | 5.19 | 11.1 - 17 | 5.78 | 2 - 4.5 | 2.7 - 14 | 16.6 – 43.33 | |
| 11. Yang<br>(2012) | da Vinci | 300 | 190.1 - 296 | 100 – 200 | 5.7 - 11.9 | 10.7 – 32.2 | Not Reported | Not Reported | Not Reported | 11. Yang | da Vinci | 300 | | Not Reported | 1.67 | 10.3 - 20 | 0 - 7.1 | 2 - 4 | 1.8 - 13.6 | | |
| | Lap | 426 | 158.1 - 315 | 127 - 300 | 6 – 9.8 | 12.2 – 27.1 | | | | (2012) | Lap | 426 | Not Reported | | 7.98 | 11.1 - 21 | 0 - 8.8 | 2 – 4.5 | 2.7 – 10.2 | Not Reported | |
#### TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Low Anterior Resection/Total Mesorectal Excision
1 Intraoperative Transfusions were also reported (robotic cohort: 1.9 - 5.4%, open cohort: 0 – 12.4%)
2Minor and Major Complications Reported
{8}------------------------------------------------
#### TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Low Anterior Resection/Total Mesorectal Excision
" Erectle dysfunction and retrograde ejaculation were patients during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C38. A total of 18 % of male patients in the RA group had sexual dysfunction features.
2 Publications utilized IIEF Questionnaires
3 One publication used a non-standardized questionnaire to assess ED and the IIEF Questionnaire
4Publication reported the IPSS score for Urologic function.
5 Mean difference reported with 95% confidence interval.
°PSM = Positive Surgical Margin
7CRM = Circumferential Resection Margin
ೆDRM = Distal Resection Margin
{9}------------------------------------------------
{10}------------------------------------------------
#### TABLE 2A: da Vinci vs. Open vs. Laparoscopic Intersphincteric Resection (ISR)
| Publications | Sample Size (N) | Operative Time<br>(minutes) | Estimated Blood<br>Loss "EBL" (ml) | Length of Stay<br>(days) | PostOp<br>Complications (%) | IntraOp<br>Complications (%) | Mortality Rate<br>(%) | Transfusion Rate<br>(%) |
|----------------|-------------------------|-----------------------------|------------------------------------|--------------------------|-----------------------------|------------------------------|-----------------------|-------------------------|
| 1. Park (2012) | <i>da Vinci</i><br>Lap | 235.5<br>185.4 | 45.7<br>59.2 | 10.6<br>11.3 | 15<br>12.5 | Not Reported | 0<br>0 | 0<br>0 |
| 2. Kim (2014) | <i>da Vinci</i><br>Open | 191<br>124 | Not Reported | 7<br>7.6 | 22.2<br>17.5 | 1.9<br>4.4 | 0<br>0 | 4.6<br>7.0 |
#### TABLE 2B: da Vinci vs. Open vs. Laparoscopic Intersphincteric Resection (ISR)
| Publications | Sample Size (N) | PSM Rate (%) | Urologic Function | Conversion Rate (%) | No. of Lymph Nodes Retrieved | CRM (cm) | DRM (cm) | Anastomotic Leak Rate (%) | Erectile Dysfunction | Fecal Incontinence |
|----------------|---------------------|--------------|-------------------|---------------------|------------------------------|----------|----------|---------------------------|----------------------|--------------------|
| 1. Park (2012) | <i>da Vinci</i> 40 | Not Reported | 3.6/3.51 | 0 | 12.9 | 6.2 mm | 1.4 | 7.5 | 11.6/13.0* | 8.2/7.82 |
| | Lap 40 | Reported | 5.5/3.21 | 0 | 13.3 | 6.9 mm | 1.3 | 5 | 7.6/9.0* | 11.2/8.42 |
| 2. Kim (2014) | <i>da Vinci</i> 108 | Not Reported | | 0 | 18.6 | 0.9%4 | 1.4 | 4.6 | 12.53 | 12.5/7.75 |
| | Open 114 | | | N/A | 16.7 | 0%4 | 1.2 | 4.4 | 34.13 | 14.2/10.35 |
*IIEF-5 at 3 and 6 months
4 IPSS at 3 and 6 months
² Wexner Scores at 3 and 6 months
ි Sewal dysfunction represented >1,3 functional in ejaculatory potency in male patients aged ≤ 65 years. These parameters were assessed in 40 patients (R group) and 44 patients (open group), respectively, at 6 months after surgery or chemoradiotherapy.
4CRM involvement, ≤1 mm
్ Assessed at 6 and 12 months
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
