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 Description

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Appendectomy" under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, 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.

AI/ML Overview

This document, a 510(k) summary, details a labeling modification for the da Vinci Xi and X Surgical Systems to include "Appendectomy" under their cleared "general laparoscopic surgical procedures" indications for use. It is not a study demonstrating device performance or meeting acceptance criteria in the typical sense of a new device or a new algorithmic feature.

Therefore, many of the requested fields are not applicable in this context. This submission is for a procedural labeling change based on the existing safety and effectiveness of the device for similar procedures.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria or reported device performance in the form of metrics (e.g., accuracy, sensitivity, precision) because it's a labeling modification for an existing device. Instead, the "acceptance criteria" here relate to demonstrating that appendectomy is equivalent in safety and effectiveness to already cleared procedures for the device.

Acceptance Criteria (Demonstration Points)	Reported Device Performance (Argument presented in submission)
All procedural steps, surgical tasks, and instruments required to perform appendectomy are part of the umbrella procedure.	A comparison of surgical tasks performed with the da Vinci Systems for appendectomy shows no new surgical tasks are introduced compared to the colorectal umbrella procedure of Low Anterior Resection Total Mesorectal Excision (LAR/TME) and covered procedure Colectomy.
Appendectomy is less complex and less challenging than the umbrella procedure.	Explicitly stated as a condition met.
All anatomical structures encountered in appendectomy are encountered similarly in the umbrella procedure.	Explicitly stated as a condition met. (Appendectomy and LAR/TME / Colectomy employ the same surgical tasks in the same anatomical location of the abdomen).
Use of the device for appendectomy does not introduce any new issues of safety or effectiveness as compared to device usage in the cleared umbrella procedure.	The surgical risks associated with appendectomy (bleeding, infection, leak, stricture, bowel injury, injury to adjacent organs, perforation) are not different from those associated with LAR/TME and Colectomy. Therefore, the addition of appendectomy as a representative, specific procedure does not represent a change or modification in the device that could significantly affect the safety or effectiveness of the device, requiring no new clinical data or other validation/verification testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No new test set or data was used because this submission is for a labeling modification based on the substantial equivalence of the procedure to already cleared procedures. The submission argues that appendectomy is covered under existing cleared procedures (LAR/TME and Colectomy) for which the device has already demonstrated safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new ground truth was established for a test set. The claim is based on the inherent surgical similarities between procedures already approved for the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method was used as there was no new test set requiring expert review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC comparative effectiveness study was done. This device is a surgical system, not an AI-assisted diagnostic or interpretative tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical system that assists in controlling instruments. It is not an algorithm performing a task without human intervention. The submission focuses on the human surgeon using the device for a new procedure within its established capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth," in a conceptual sense for this submission, is the established surgical knowledge and practice regarding the equivalence of appendectomy to other laparoscopic procedures (LAR/TME and Colectomy) already cleared for the da Vinci systems. This is implicitly based on expert surgical opinion on procedural steps, required instruments, anatomical structures, and associated risks. No formal new "ground truth" for a study was established for this submission.

8. The sample size for the training set:

Not applicable. There is no training set in the context of this submission. The device itself has undergone extensive training (development and testing) prior to its initial clearance. This submission solely re-evaluates the scope of its cleared indications.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for this labeling modification, there is no ground truth established for it. The original "ground truth" for the device's development would have been established through a rigorous process of engineering, preclinical testing, and clinical trials for its initial clearance and prior modifications.

Summary

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May 12, 2023

Intuitive Surgical, Inc. Michael Prutton Regulatory Affairs Specialist 1266 Kifer Road Suunyvale, California 94086

Re: K231224

Trade/Device Name: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: April 27, 2023 Received: April 28, 2023

Dear Michael Prutton:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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-advice-comprehensive-regulatoryassistance/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,

Mark
Trumbore -S

Digitally signed by
Mark Trumbore -S
Date: 2023.05.12
09:25:59 -04'00'

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

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Indications for Use

Submission Number (if known)

Device Name

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

Indications for Use (Describe)

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 surqical procedures, gynecologic laparoscopic surqical 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 revasoularization. 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (21 CFR § 807.92)

I. Submitter Information
Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Michael PruttonRegulatory Affairs SpecialistMichael.Prutton@intusurg.com408-317-8653
Date Summary Prepared:	May 10, 2023

II. Subject Device Information

Device Trade Name:	da Vinci® Xi and X 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:	Special 510(k)

III. Predicate Device Information

Predicate Devices: Intuitive Surgical da Vinci Xi Surgical System, Model IS4000 (K131861) Intuitive Surgical da Vinci X Surgical System, Model IS4200 (K171294)

IV. Device Description

V. Indications for Use

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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.

VI. Comparison of Indications for Use

The indications for use are the same.

VII. Technological Comparison

This application is for a change to the labeling only. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, 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.

VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions

The appendix is a small, tube-like structure that is attached to the Cecum of the large intestine. The appendix is removed during an appendectomy procedure, commonly used to treat appendicitis. It is also removed en bloc with the specimen during a right colectomy procedure, which is a covered procedure under the umbrella procedure Low Anterior Resection Total Mesorectal Excision (LAR/TME) which was cleared under K171632. A comparison of the surgical tasks performed with the da Vinci Surgical Systems for appendectomy shows that there are no new surgical tasks introduced by the appendectomy as compared to the colorectal umbrella procedure of LAR/TME and covered procedure Colectomy. They employ the same surgical tasks in the same anatomical location of the abdomen.

The surgical risks associated with appendectomy are not different than those associated with Low Anterior Resection Total Mesorectal Excision (LAR/TME) and Colectomy. They include: 1) bleeding; 2) infection; 3) leak; 4) stricture; 5) bowel injury; 6) injury to adjacent organs; and 7) perforation.

Appendectomy is a covered procedure under the umbrella procedure of Low Anterior Resection Total Mesorectal Excision (LAR/TME) and covered procedure Colectomy based on the following:

1. All procedural steps, surgical tasks, and instruments required to perform appendectomy with the da Vinci Xi or X Surgical Systems are part of the umbrella procedure.
  CONFIDENTIAL

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Appendectomy is less complex and less challenging than the umbrella procedure. 2.
1. All anatomical structures encountered in appendectomy are encountered similarly in the umbrella procedure.
1. Use of the da Vinci Xi or X Surgical Systems to perform appendectomy does not introduce any new issues of safety or effectiveness as compared to device usage in the cleared umbrella procedure.

Appendectomy can be completed using the da Vinci Xi or X Surgical Systems without introducing any different issues of safety or effectiveness as compared to the representative, specific general laparoscopic surgical procedures previously cleared for the Xi and X systems. The addition of appendectomy as a representative, specific procedure does not represent a change or modification in the device that could significantly affect the safety or effectiveness of the device, thus requiring no new clinical data or other validation/verification testing to evaluate safety or effectiveness of the device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.