← Product Code [NAY](/productcode/NAY) · K080291 # INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER (K080291) _Intuitive Surgical, Inc. · NAY · Mar 19, 2008 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K080291 ## Device Facts - **Applicant:** Intuitive Surgical, Inc. - **Product Code:** [NAY](/productcode/NAY.md) - **Decision Date:** Mar 19, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic, Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K080291 · Mar 19, 2008 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER | Intuitive Surgical, Inc. | Clinical experience/routine clinical use data | The sponsor utilized clinical experience from real-world beating heart surgical procedures to demonstrate sufficient performance to warrant the removal of a warning label regarding beating heart procedures. | Labeling modification; Clinical experience; Beating heart surgery | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Clinical experience of the da Vinci S Surgical Systems in beating heart surgical procedures; Retrospective review of clinical experience; Study Period: Prior to January 2008 | Patients undergoing beating heart surgical procedures | Not applicable for this study | Performance in beating heart procedures | ## Indications for Use The Intuitive Surgical® Endoscopic Instrument Control System 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments. ## Device Story Robotic surgical system comprising surgeon console, patient-side cart, and stereo vision system; surgeon controls endoscopic instruments and camera via master tool manipulators; system relays commands to patient-side cart; stereo endoscope provides 3D visualization. EndoWrist instruments provide seven degrees of motion mimicking human hand dexterity; integrated electronic circuit tracks usage and expires instruments after pre-determined cycles. EndoWrist Stabilizer uses suction-based pods for epicardial stabilization during non-arrested heart surgery; includes irrigation and vacuum tubing assemblies. Used by trained physicians in operating rooms; system enhances precision in tissue manipulation, suturing, and dissection. Labeling modification removes previous warnings regarding beating heart procedures based on clinical experience. ## Clinical Evidence No new clinical testing performed. Substantial equivalence is based on clinical experience with the da Vinci S Surgical System in beating heart surgical procedures to date, which provided sufficient evidence to support the removal of previous labeling warnings. ## Technological Characteristics Robotic telemanipulation system; stereo vision (3D/2D); articulating instruments (7 degrees of freedom); electronic integrated circuits for instrument tracking/expiration. EndoWrist Stabilizer uses suction-based pods, irrigation, and vacuum tubing. System components: Surgeon Console, Patient Side Cart, Stereo View Endoscopic Vision System. ## Regulatory 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. ## Predicate Devices - Intuitive Surgical da Vinci Surgical System ([K040237](/device/K040237.md)) - da Vinci S Surgical System ([K050369](/device/K050369.md)) - EndoWrist Stabilizer ([K060391](/device/K060391.md)) ## Reference Devices - Octopus TE (Medtronic, Inc.) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Ko8u291 ## MAR 1 9 2008 #### 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | Applicant: | Intuitive Surgical, Inc.
950 Kifer Road
Sunnyvale, CA 94086
408.523.2100 | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturing/
Distribution Address: | Intuitive Surgical, Inc.
950 Kifer Road
Sunnyvale, CA 94086 | | Establishment Registration Number: 2955842 | | | Date submitted: | January 31, 2008 | | Proprietary Name: | Intuitive Surgical da Vinci Surgical System, the da Vinci S
Surgical System, and the EndoWrist Stabilizer | | Common Name: | Endoscopic Instruments, Control System and Accessories | | Classification Status: | Class II per 876.1500 - Endoscope and Accessories | | Product Codes: | NAY | | Predicate Devices: | Intuitive Surgical da Vinci Surgical System (K040237), the
Vinci S Surgical System (K050369), and the EndoWrist
Stabilizer (K060391) | #### Device Description: #### 1. The da Vinci Surgical System consists of three integrated sub-systems as follows: Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of the Surgeon Console (Model IS1200-SSC), Patient Side Cart (Model IS1200-PSC) and a Stereo View Endoscopic Vision System (Model VS1000) that includes a stereo endoscope that provides a 3-dimensional view of the surgical field. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon, through the use of Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart. The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon da {1}------------------------------------------------ Console are relayed to the Patient Side Cart, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the Patient Side Cart. Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, Model VS1000, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where, they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field. EndoWrist Instruments: A full range of endoscopic surgical instruments is available to support the surgeon for a wide range of surgical tasks such as tissue manipulation, suturing, cutting, coagulation and clamping. Most instruments have a unique articulating design at their distal tips known as a "wrist" and these instruments provide seven degrees of motion (wrist pitch, wrist yaw, grip, roll, insertion, arm pitch, and arm yaw) that mimic the dexterity of the human hand and wrist. Quick-release levers facilitate instrument changes during surgical procedures, and the instruments have an electronic integrated circuit in their housing that identifies the instrument on the system. The instruments are programmed for a limited number of uses to ensure reliability and consistent performance, and the integrated circuit "expires" the instrument after a pre-determined number of uses have been reached. Note: The da Vinci Surgical System (Model IS1200) cannot be used with the EndoWrist Stabilizer but can be used in conjunction with standard non-robotically operated stabilizers such as Octopus TE (Medtronic, Inc.). #### 2. The da Vinci S Surgical System consists of three integrated sub-systems as follows: Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of the Surgeon Console (Model IS2000-SSC), Patient Side Cart (Model IS2000-PSC) and a Stereo View Endoscopic Vision System (Model VS2000) that includes a stereo endoscope that provides a 3-dimensional view of the surgical field. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon, through the use of Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM). which are located on the Patient Side Cart. The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM. known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the Patient Side Cart, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the Patient Side Cart. Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System. Model VS1000, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides, The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where, they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field. {2}------------------------------------------------ EndoWrist Instruments: A full range of endoscopic surgical instruments is available to support the surgeon for a wide range of surgical tasks such as tissue manipulation, suturing. cutting, coagulation and clamping. Most instruments have a unique articulating design at their distal tips known as a "wrist" and these instruments provide seven degrees of motion (wrist pitch, wrist yaw, grip, roll, insertion, arm pitch, and arm yaw) that mimic the dexterity of the human hand and wrist. Quick-release levers facilitate instrument changes during surgical procedures, and the instruments have an electronic integrated circuit in their housing that identifies the instrument on the system. The instruments are programmed for a limited number of uses to ensure reliability and consistent performance, and the integrated circuit "expires" the instrument after a pre-determined number of uses have been reached. ## 3. The Intuitive Surgical EndoWrist Stabilizer The Intuitive Surgical EndoWrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vinci® STM Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the stabilizer instrument by tapping a foot pedal on the Surgeon Console. The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features: - The EndoWrist Stabilizer incorporates collapsible "pods" as grips that provide . suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port. - . A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue. - . A disposable, pre-packaged sterilized tubing assembly known as "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below. - . A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source. Note: The Intuitive Surgical EndoWrist Stabilizer can only be used with the da Vinci S Surgical System and operated in the same way as other Intuitive Surgical EndoWrist Instruments. The surgeon manipulates and positions the stabilizer using the MTMs, and can "lock" the stabilizer in place by switching MTM control away from the arm holding the stabilizer instrument by tapping a foot pedal on the Surgeon Console. {3}------------------------------------------------ ## Indication for Use: Device Name: Intuitive Surgical da Vinci and da Vinci S Endoscopic Instrument Control System and Endoscopic Instruments The Intuitive Surgical® Endoscopic Instrument Control System 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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. ## Indications for Use: Device Name: Intuitive Surgical Endowrist® Stabilizer For use with Intuitive Surgical Endoscopic Instrument Control System The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments. #### Substantial Equivalence Discussion: Intuitive Surgical has proposed a labeling modification for their da Vinci Surgical System (K040237), the da Vinci S Surgical System (K050369), and the EndoWrist Stabilizer (K060391) to remove the warning language regarding beating heart procedures. There is no change to the Indications for Use for any of the devices. Based on the clinical experience of the da Vinci S Surgical Systems in beating heart surgical procedures to date, Intuitive Surgical has determined that there is now sufficient evidence to establish the performance of the da Vinci Surgical System, the da Vinci S Surgical System and the EndoWrist Stabilizer in beating heart procedures, and the removal of warning from the labeling for all three devices is clearly warranted. A detailed justification for this labeling modification was provided. The modified da Vinci Surgical System (K040237), the da Vinci S Surgical System (K050369), and the EndoWrist Stabilizer (K060391) have the following similarities to those which previously received 510(k) clearance: - . has the same indicated use, - . uses the same operating principle. - . incorporates the same device design, - . incorporates the same materials. {4}------------------------------------------------ Performance Data: Since the subject devices are identical to the predicate devices and no design changes were implemented, performance testing was not required. #### Conclusion: The removal of the beating heart warning does not alter the fundamental scientific technology of the device because it does not change the devices' operating principles. The da Vinci Surgical System, the da Vinci S Surgical System, and the EndoWrist Stabilizer described in this submission are substantially equivalent to the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 1 9 2008 Intuitive Surgical, Inc. % Ms. Karen Uyesugi VP. Clinical & Regulatory Affairs 950 Kifer Road Sunnyvale, California 94086 Re: K080291 Trade/Device Name: Intuitive Surgical Endowrist® Stabilizer For use with Intuitive Surgical Endoscopic Instrument Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: January 31, 2008 Received: February 4, 2008 Dear Ms. Uyesugi: 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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Ms. Karen Uyesugi forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k080291 Device Name: Intuitive Surgical Endowrist® Stabilizer For use with Intuitive Surgical Endoscopic Instrument Control System ## Indications for Use: The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments. Prescription Use » (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Onetu (Division Sign-Off) Division of General Restorative Division of General, Restorative. and Neurological Devices **510(k) Number** K080291 --- **Source:** [https://fda-staging.innolitics.com/device/K080291](https://fda-staging.innolitics.com/device/K080291) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com