K243582 · Intuitive Surgical, Inc. · NAY · Feb 28, 2025 · Gastroenterology, Urology
Device Facts
Record ID
K243582
Device Name
da Vinci SP Advanced Access Port Kit (432701)
Applicant
Intuitive Surgical, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
Feb 28, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
To assist in the accurate control of endoscopic instruments in minimally invasive surgery.
Device Story
The da Vinci SP Advanced Access Port Kit is a sterile, single-use accessory for the da Vinci SP Surgical System (SP1098). It provides a single-incision access point for robotic instruments, endoscopes, and manual assist instruments. The device features an integrated entry guide, a wound retractor, and a 12-6mm reducer to support 12mm instruments. It maintains insufflation during surgery. Operated by surgeons in an OR, it facilitates robotic-assisted minimally invasive procedures. The system uses a master/slave servomechanism to translate surgeon inputs into precise instrument movements. By enabling single-port access, it allows for complex surgical tasks while minimizing incision size, potentially reducing patient trauma and recovery time.
Clinical Evidence
No clinical trials were conducted. Evidence consists of bench verification (physical, mechanical, reliability, shelf-life, sterilization, packaging), cadaver studies for anatomical access/reach, and live animal models for safety/performance (hemostasis, tissue handling). Human factors validation included comparative task analysis, use-related risk analysis, and formative usability evaluations.
Technological Characteristics
Single-use, EO-sterilized accessory. Components: Advanced Access Port, 12-6mm reducer, wound retractor. Materials are biocompatible per ISO 10993-1. Features integrated entry guide with 32mm lumen, three chamber seals, and magnet-based system identification. Connectivity: Mechanical interface to SP1098 system. Dimensions: Supports incisions 2.9-7cm. No software/firmware; purely mechanical accessory.
Indications for Use
Indicated for use in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port. Intended for adult use by trained physicians in an operating room environment.
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.
da Vinci SP Surgical System, Model SP1098 (K242318)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2025
Intuitive Surgical, Inc. Manjunath Ramappa Bisalehalli Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K243582
Trade/Device Name: da Vinci SP Advanced Access Port Kit (432701) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: January 29, 2025 Received: January 29, 2025
Dear Manjunath Ramappa Bisalehalli:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include 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.
{1}------------------------------------------------
## K243582 - Manjunath Ramappa Bisalehalli
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-comprehensive-regulatory
{2}------------------------------------------------
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S - Date: 2025.02.28 14:52:36
-05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K243582
Device Name
da Vinci SP Advanced Access Port Kit (432701)
Indications for Use (Describe)
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
Type of Use (Select one or both, as applicable)
< Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart 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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
| 510(k) Owner | Intuitive Surgical, Inc. | |
|---------------------|---------------------------------------------------------|--|
| | 1266 Kifer Road | |
| | Sunnyvale, CA 94086 | |
| Contact | Manjunath Bisalehalli | |
| | Sr. Regulatory Affairs Specialist | |
| | Cell Phone Number: 412-298-4604 | |
| | Email: Manjun.RamappaBisalehalli(@intusurg.com | |
| Date Summary | November 19, 2024 | |
| Prepared | | |
| Trade Name | da Vinci SP Surgical System, Model SP1098, EndoWrist SP | |
| | Instruments, and Accessories | |
| | | |
| Common Name | Endoscope and accessories | |
| | | |
| Classification | Class II, | |
| | 21 CFR 876.1500, Endoscope and Accessories | |
| | | |
| Product Codes | NAY (System, Surgical, Computer Controlled Instrument) | |
| Review Panel | General and Plastic Surgery | |
| | | |
| Predicate Device(s) | da Vinci SP Access Port (K202571) | |
| | | |
## 510(k) Summary
# Device Description
The subject da Vinci SP Advanced Access Port Kit, Large Incision is a sterile, single-use, disposable accessory to the da Vinci SP Surgical System, Model SP1098, the predicate device is the cleared da Vinci SP Access Port Kit 510(k) #K202571). It provides surgical access for the SP1098 system during minimally invasive robotic surgery. The da Vinci SP Advanced Access Port Kit is compatible with the existing EndoWrist SP Instruments, SP Endoscope, and manual laparoscopic instruments (referred to as "assist instruments") and other compatible laparoscopic devices through a single incision while maintaining insufflation, which is identical to the predicate device. It is also compatible with Intuitive da Vinci SP 12mm Instruments, unlike the predicate device. The subject device enables superficial instrument articulation, like the predicate device. Figure 1 provides an image of the da Vinci SP Advanced Access Port and its components.
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image shows a medical device with a white and transparent body. The device has several components, including a handle, a transparent container, and a tube. The handle is located at the top of the device and is used to control the device. The transparent container is located in the middle of the device and is used to collect fluids. The tube is located at the bottom of the device and is used to drain fluids. There are also blue knobs on the side of the device.
Figure 1: da Vinci SP Advanced Access Port Kit
## Indications for Use:
da Vinci SP Advanced Access Port Kit
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
Image /page/5/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "I" in the word. The font is a simple sans-serif font. The background is white.
{6}------------------------------------------------
## Comparison of Technological Characteristics with the Predicate Device(s)
The subject device comprises of an Advanced Access Port, a removable 12-6mm Reducer, and a Large Wound Retractor. In addition to all the existing compatibilities with the predicate device, the subject device adds new compatibility with Intuitive da Vinci SP 12 mm instruments.
The key differences between the subject device and predicate device, da Vinci SP Access Port Kit (510(k) # K202571) are:
- New Entry Guide lumen configuration (with an increased diameter from 25mm . (predicate) to 32mm) to support Intuitive's 12mm instrument
- Non-removable Integrated Entry Guide with new seals ●
- . Introduction of a Reducer (12-6mm) to support use of a third 6mm instrument through the 12mm lumen
- New magnet configuration for system identification .
- . Two additional chamber seals
- . Reduced number of insufflation tubes and shortened tube length
Both the subject and predicate devices are single use, Ethylene Oxide (EO) sterilized devices.
## Table 1: Subject Devices and Predicate Device, da Vinci SP Accessories
| Subject Device SP Accessory | | Previously cleared SP Accessory<br>(Predicate device submission, K202571) | |
|---------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------|---------------------------------------|
| da Vinci SP Accessory | da Vinci SP Accessory<br>Model Number | da Vinci SP Accessory | da Vinci SP Accessory<br>Model Number |
| da Vinci SP Advanced Access Port Kit,<br>Large Incision | 432701 | da Vinci SP Access Port Kit, Large<br>Incision | 430075 |
Image /page/6/Picture/14 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "U" in the word. The font is sans-serif and the letters are evenly spaced.
{7}------------------------------------------------
For reference, Table 2 includes a comparison of the indications for use of the SP1098 System with the Subject Device (do Vinci SP Advanced Access Port Kit) and the previously cleared SP1098 System (K242318). The are no changes being made to the da Vinci SP® Surgical System, Model SP1098 as part of this 510(k) submission.
| Characteristic | SP1098 System | SP1098 System |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | (with subject device, da Vinci SP Advanced Access Port Kit) | (K242318) |
| Indications for Use | da Vinci SP® Surgical System, Model SP1098<br><br>The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical<br>System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical<br>EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical<br>procedures that are appropriate for a single port approach; and transoral otolaryngology<br>surgical procedures in the oropharynx restricted to benign tumors and malignant tumors<br>classified as T1 and T2. The system is indicated for adult use. It is intended for use by<br>trained physicians in an operating room environment in accordance with the<br>representative, specific procedures set forth in the Professional Instructions for Use.<br><br>EndoWrist SP Instruments<br><br>Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical<br>System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic<br>dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery<br>and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt<br>and sharp dissection, approximation, ligation, electrocautery, and suturing through a single<br>port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical<br>procedures that are appropriate for a single port approach; and transoral otolaryngology<br>surgical procedures in the oropharynx restricted to benign tumors and malignant tumors<br>classified as T1 and T2. The system is indicated for adult use. It is intended for use by<br>trained physicians in an operating room environment in accordance with the<br>representative, specific procedures set forth in the Professional. | IDENTICAL to the<br>subject device |
## Table 2. SP1098 System's Indications for Use Comparison
{8}------------------------------------------------
Table 3 includes a comparison of the Subject Device (da Vinci SP Advanced Access Port Kit) and the Predicate device (Predicate Device, da Vinci SP Access Port Kit cleared via K202571).
| Characteristic | Subject Device | Predicate Device | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | |
| General Information | | | |
| Manufacturer | Intuitive Surgical, Inc. | IDENTICAL to the subject device | |
| Trade Name | da Vinci SP Advanced Access Port | da Vinci SP Access Port | |
| Model # | da Vinci SP Advanced Access Port Kit, Large<br>Incision (432701) | da Vinci SP Access Port Kit, Large Incision<br>(430075) | |
| Common Name | Endoscope and accessories | IDENTICAL to the subject device | |
| Regulation Number | 21 CFR 876.1500 | IDENTICAL to the subject device | |
| Product Code | NAY, GCJ | IDENTICAL to the subject device | |
| Device Classification | Class II | | |
| | | IDENTICAL to the subject device | |
| Classification Advisory<br>Committee | General and Plastic Surgery | IDENTICAL to the subject device | |
| System Compatibility | Compatible with the SP1098 system | IDENTICAL to the subject device | |
| Principles of Operation | Facilitates accurate movement of surgical instruments and IDENTICAL to the subject device<br>an endoscope through a single surgical port by using a | | |
| Characteristic | Subject Device | Predicate Device | |
| | da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | |
| | master/slave servomechanism that incorporates servo<br>drive and system-level motor control. | | |
| Indications for Use | da Vinci SP® Advanced Access Port Kit | da Vinci SP® Access Port Kit | |
| | The SP Advanced Access Port Kit is intended to be used<br>in endoscopic surgery to provide access for da Vinci SP<br>instruments, a da Vinci SP Endoscope, and assist<br>instruments through a single port. | The SP Access Port Kit is intended to be used in<br>endoscopic surgery to provide access for da Vinci SP<br>instruments, a da Vinci SP Endoscope, and assist<br>instruments through a single port. | |
| Intended Use | To assist in the accurate control of endoscopic<br>instruments in minimally invasive surgery. | IDENTICAL to the subject device | |
| Prescription use | Prescription/Physician use only | IDENTICAL to the subject device | |
| Where used (hospital, home,<br>ambulance, etc.) | Hospital | IDENTICAL to the subject device | |
| | Design | | |
| Components | Advanced Access Port, Large Incision (with<br>●<br>integrated Entry Guide)<br>Wound Retractor<br>●<br>12-6mm Reducer<br>● | Access Port (small and large)<br>●<br>SP Short Entry Guide<br>●<br>Wound Retractor (small and large)<br>●<br>No Reducer Component | |
| Access Port | Flexible | | |
| | Transparent | IDENTICAL to the subject device | |
| | Spherical | | |
| Characteristic | Subject Device | Predicate Device | |
| | da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | |
| SP Entry Guide | Two 6 mm lumens One 12 mm lumen One endoscope lumen | Three 6 mm instrument lumens One endoscope lumen | |
| Incision Retraction | Wound Retractor | IDENTICAL to the subject device | |
| Ability to Use Instruments<br>Immediately Inside Incision | Yes | IDENTICAL to the subject device | |
| Size Accepted for Laparoscopic<br>Assist Instruments | Chamber Seal: 5 mm to 10 mm Rotating Access Port Seal: 5 mm to 12 mm | IDENTICAL to the subject device | |
| Number of Chamber Seals | Three (3) | One (1) | |
| Rotational Range of<br>Laparoscopic Assist Instrument<br>Insertion Around SP<br>Instrument Cluster | 270° | IDENTICAL to the subject device | |
| Incision Size Range | 2.9 cm - 7 cm (SP Advanced Access Port Kit, Large Incision, when not using SP 12mm Instrument. 3.5 cm - 7 cm (SP Advanced Access Port Kit, Large Incision, when using SP 12mm Instrument | Small Access Port Kit: 2.7 cm to 4 cm Large Access Port Kit: 2.7 cm to 7 cm | |
| Sterilization Method | Ethylene Oxide | IDENTICAL to the subject device | |
| Disposable or Reusable | Disposable | IDENTICAL to the subject device | |
| Biocompatibility | All patient-contacting materials are biocompatible per ISO 10993-1. For a comparison of the patient contacting | IDENTICAL to the subject device | |
| Characteristic | Subject Device | Predicate Device | |
| | da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | |
| | materials for the subject vs. the predicate, and a summary<br>of the biocompatibility testing, refer to Section 6. | | |
| Cleaning and Disinfection | Single Use Device - Not Applicable | IDENTICAL to the subject device | |
| Method | | | |
| Packaging | lid. The packaging configuration consists of six (6) da<br>Vinci SP Advanced Access Port Kits, packaged in<br>individual cartons, and sealed in a corrugate shipper box. | Thermoformed PETG tray, PETG retainer lid, and Tyvek Thermoformed PETG tray, PETG retainer lid, and Tyvek<br>lid. The packaging configuration consists of six (6) da<br>Vinci SP Access Port Kits, packaged in individual cartons,<br>and sealed in a corrugate shipper box. A layer of<br>polyurethane foam that is placed at two (2) opposite ends<br>of the shipper box. | |
## Table 3 Comparison – Subject Device and Predicate Device
{9}------------------------------------------------
# INTUITIVE
{10}------------------------------------------------
# INTUITIVE
{11}------------------------------------------------
# INTUITIVE
{12}------------------------------------------------
## Performance Data:
Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements.
## Bench Verifications
Testing was performed on the subject device, da Vinci SP Advanced Access Port Kit to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the bench verification testing for the subject device is described in Table 4.
## Table 4: Summary of the bench verification testing for the da Vinci SP Advanced Access Port Kit
| Subject Device | Testing |
|-----------------------------------------|--------------------------------------|
| da Vinci SP Advanced Access<br>Port Kit | 1. Physical specifications |
| | 2. Mechanical requirements |
| | 3. User Interface and Patient Safety |
| | 4. Reliability |
| | 5. Environmental requirements |
| | 6. Shelf-life and Sterilization |
| | 7. Shipping and Storage |
| | 8. Package and Labeling |
## Cadaver and Animal Validations
Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments using da Vinci SP Advanced Access Port Kit. Live animal models were used to assess safety and performance for da Vinci SP Advanced Access Port Kit in cases where a live tissue model was required. These models replicate factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensuring that appropriate hemostasis is achieved and maintained. Procedures were chosen on the basis of the types of surgical tasks that are performed, and which da Vinci SP Advanced Access Port Kit is needed for the tasks.
## Human Factors
Human Factors process conducted for the subject devices included the following activities:
- Known use-related issues for predicate devices and devices similar to the subject devices O were analyzed using post-market data and the MAUDE database. All identified userelated issues that are relevant to the use of the subject devices were documented in the risk analvsis.
{13}------------------------------------------------
- A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user- O device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for O each user task identified as New or Modified from the predicate in the CTA.
- Formative usability evaluations were conducted during the development process to O inform the device user interface design and confirm assessment of use-related risks.
# Summary:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device, da Vinci SP Advanced Access Port is substantially equivalent to its predicate device, da Vinci SP Access Port Kit (K202571).
Image /page/13/Picture/7 description: The image shows the word "INTUITIVE" in blue font with a small circle above the letter "U". Below the word, the number "10" is written in bold font. The text is centered and the background is white.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
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.
