(14 days)
No
The submission is for a labeling modification only, and explicitly states there are no changes to the technological characteristics of the cleared devices. There is no mention of AI or ML in the provided text.
Yes.
The device is intended to assist in various surgical procedures, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, which are direct interventions for treating tissue and disease.
No
The device is described as an "Endoscopic Instrument Control System" intended to "assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for surgical procedures ("grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories"). Its primary function is to facilitate surgical manipulation, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the da Vinci Surgical Systems are "software-controlled, electro-mechanical systems" and consist of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist surgeons in performing various surgical procedures by controlling endoscopic instruments. This involves direct manipulation of tissue within the body.
- Device Description: The device is described as a software-controlled, electro-mechanical system consisting of consoles and carts used with instruments and an endoscope for minimally invasive surgery.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The da Vinci Surgical System is a surgical robot, not an IVD.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Product codes
NAY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The submission is for a labeling modification only, specifically to include "Appendectomy" under the cleared "general laparoscopic surgical procedures" Indications for Use. There are no changes to the technological characteristics of the device. The justification for this modification is based on a comparison of surgical tasks and risks between appendectomy and previously cleared procedures (Low Anterior Resection Total Mesorectal Excision (LAR/TME) and Colectomy).
Key results:
- Appendectomy employs the same surgical tasks in the same anatomical location of the abdomen as the colorectal umbrella procedure of LAR/TME and covered procedure Colectomy.
- The surgical risks associated with appendectomy are not different from those associated with LAR/TME and Colectomy.
- All procedural steps, surgical tasks, and instruments required for appendectomy with the da Vinci Xi or X Surgical Systems are part of the umbrella procedure.
- Appendectomy is considered less complex and less challenging than the umbrella procedure.
- All anatomical structures encountered in appendectomy are encountered similarly in the umbrella procedure.
- 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.
- 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.
Key Metrics
Not Found
Predicate Device(s)
Intuitive Surgical da Vinci Xi Surgical System, Model IS4000 (K131861), Intuitive Surgical da Vinci X Surgical System, Model IS4200 (K171294)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 Road | |
| Sunnyvale, CA 94086 | |
| Contact: | Michael Prutton |
| Regulatory Affairs Specialist | |
| Michael.Prutton@intusurg.com | |
| 408-317-8653 | |
| 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
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.
V. Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including
4
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:
-
- 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
- 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.
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- Appendectomy is less complex and less challenging than the umbrella procedure. 2.
-
- All anatomical structures encountered in appendectomy are encountered similarly in the umbrella procedure.
-
- 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.