The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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.

The EndoWrist Mercury Bipolar Grasper is intended to be used with compatible systems for endoscopic manipulation of tissue, including dissection, grasping, retraction, and bipolar coagulation of tissue.

Device Description

The EndoWrist Mercury Bipolar Grasper is a multiple-use, electrosurgical endoscopic instrument with a grasping tip to be used in conjunction with the da Vinci Xi (IS4000) and da Vinci X (IS4200) Systems and an external electrosurgical unit (ESU). Similar to the predicate device, the EndoWrist Mercury Bipolar Grasper consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. In addition, the subject Mercury Bipolar Grasper allows a user to select between two grip strength modes, DEFAULT and STRONG.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "EndoWrist Mercury Bipolar Grasper" by Intuitive Surgical, Inc. It establishes substantial equivalence by comparing the new device to a predicate device ("EndoWrist Fenestrated Bipolar Forceps," K131861).

The document does not contain information about a study that proves the device meets specific quantitative acceptance criteria related to its performance in a clinical or AI-assisted setting, as would be expected for a product involving AI or requiring performance metrics beyond basic functional validation. The approval is based on demonstrating substantial equivalence to a predicate device through design verification and validation, focusing on physical, mechanical, electrical, user interface, and software specifications, as well as functional testing in animal and cadaver models.

Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and human reader studies cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The primary acceptance criterion here is "substantial equivalence" to the predicate device. This is a regulatory standard for 510(k) submissions, meaning the device is as safe and effective as a legally marketed predicate device. Specific quantitative performance acceptance criteria are not detailed in this summary. The summary mentions that "design outputs meet the design inputs" and "the device performs as intended."
Reported Device Performance: The document generally states that the device was evaluated through "Design Verification and Validation" to show that "the design outputs meet the design inputs and the device performs as intended." It specifies:
- Bench tests: "confirmation that the device meets the physical, mechanical, electrical, user interface and software specifications."
- Animal and Cadaver Tests: "confirm that the subject device functions in accordance with its intended use."
No specific quantitative performance values (e.g., accuracy, sensitivity, specificity, or performance metrics related to a specific clinical task) are provided.

2. Sample size used for the test set and the data provenance:

Test Set (for performance validation): The document refers to "a series of bench tests" and "Tests with an animal model and a cadaver."
- Sample Size: Not specified quantitatively (e.g., number of animals, number of cadavers, or number of tests performed).
- Data Provenance: The document implies in-house testing ("Design Verification and Validation were performed on the subject Mercury Bipolar Grasper"). No information on geographical origin (country) or whether the data was retrospective or prospective is given, beyond indicating it was part of a design validation process. This type of testing is typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not required for this type of device (surgical instrument without AI component) or this type of regulatory submission (510(k) based on substantial equivalence to a predicate device, focusing on mechanical, electrical, and functional performance, rather than diagnostic accuracy requiring expert consensus). The "ground truth" for a surgical instrument's function is typically its ability to perform its intended mechanical and electrical actions without failure under various conditions.

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

Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies assessing diagnostic or prognostic performance, often involving multiple readers.

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. This device is a surgical instrument, not an AI diagnostic/assistive tool, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a surgical instrument that requires human operation (with robotic assistance), not a standalone algorithm.

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

The "ground truth" for this device's performance validation is its ability to meet engineering specifications (physical, mechanical, electrical, user interface, software) and to function as intended in simulated surgical environments (animal and cadaver models). This is a functional and safety "ground truth" rather than a clinical diagnostic "ground truth."

8. The sample size for the training set:

Not applicable. This document is about a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as it's not an AI device.

In summary, the provided document is a 510(k) clearance letter for a surgical instrument, focusing on its substantial equivalence to a predicate device through engineering design verification and validation. It does not involve AI performance evaluation, clinical outcome studies, or expert consensus-based ground truth typical of AI/diagnostic device submissions.

Summary

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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 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.

August 7, 2018

Intuitive Surgical, Inc. Mr. Vishal Kanani Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K180351

Trade/Device Name: EndoWrist Mercury Bipolar Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: June 29, 2018 Received: July 2, 2018

Dear Mr. Kanani:

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/ofdocs/ofpmn.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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use
	See PRA Statement below.
510(k) Number (if known)	K180351
Device Name	EndoWrist Mercury Bipolar Grasper
Indications for Use (Describe)	The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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.
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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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."

Image /page/2/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol next to it.

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020
	Indications for Use	See PRA Statement below.
510(k) Number (if known)	K180351
Device Name	EndoWrist Mercury Bipolar Grasper
Indications for Use (Describe)	The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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 laparoscopie 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.
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."

Image /page/3/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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510(k) Summary 6

[As Required by 21 CFR 807.92(c)]

March 1, 2018

Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
Official Contact: Vishal Kanani Sr. Regulatory Affairs Specialist Ph: 408-523-2035 Fax: 408-523-8907
Trade Name: EndoWrist® Mercury Bipolar Grasper
Common Name: Endoscopic instrument control system, endoscopic instruments and accessories
Endoscope and accessories, 21 CFR 876.1500, NAY Classification:

Predicate Device: EndoWrist® Fenestrated Bipolar Forceps (K131861)

Device Description:

Intended Use:

Image /page/4/Picture/15 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with a registered trademark symbol next to it.

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Indications for Use:

da Vinci Xi (IS4000) System:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) 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.

da Vinci X (IS4200) System:

Technological Characteristics:

The subject Mercury Bipolar Grasper is equivalent to its predicate, Fenestrated Bipolar Grasper in terms of its indications for use, intended use, design, technology, and performance specifications. Modifications from the predicate device include providing a user the ability to

Image /page/5/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with a registered trademark symbol to the right.

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select from two grip modes, DEFAULT and STRONG, and minor changes in the jaw design. These modifications do not affect the intended use or the fundamental technology of the device.

Performance Data:

Design Verification and Validation were performed on the subject Mercury Bipolar Grasper to demonstrate that the design outputs meet the design inputs and the device performs as intended.

Design Verification: The subject device was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the physical, mechanical, electrical, user interface and software specifications.

Design Validation:

The design validation testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model and a cadaver were performed to confirm that the subject device functions in accordance with its intended use.

Summary:

Based on the intended use, technical characteristics, and performance data, the subject Mercury Bipolar Grasper is equivalent to the predicate device in terms of safety, effectiveness, and performance.

Image /page/6/Picture/10 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in all caps, with a small yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in smaller, all-caps letters with a trademark symbol.

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.