The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectorny with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

Device Description

The da Vinci Xi Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: da Vinci Xi Single-Site Instruments and Accessories. This document does not pertain to an AI/ML device, and therefore the acceptance criteria and study information outlined in the request (specifically regarding AI/ML performance metrics, ground truth, expert adjudication, MRMC studies, and training/test sets) are not applicable.

The document discusses the substantial equivalence of the new device to a predicate device (da Vinci Si Single-Site Instruments and Accessories) and outlines the design verification and validation processes conducted to ensure safety and effectiveness.

Here’s a breakdown of the information relevant to the device, formatted as requested where possible, but with clear indications where the requested AI/ML specific information is not available:

Device: da Vinci Xi Single-Site Instruments and Accessories

1. Table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way it might for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly tied to meeting design input requirements, ensuring safety and effectiveness, and demonstrating substantial equivalence to the predicate device.

The "Performance Data" section describes categories of testing performed, which serve as evidence of the device meeting its design requirements and thus implicitly its acceptance criteria.

Acceptance Criteria Category (Implicit)	Reported Device Performance (Summary of Testing)
Design Verification	Bench testing performed with an IS4000 da Vinci Surgical System covering: - Instruments: Physical specifications (size, weight, shape); Mechanical requirements (axes torques, loading, range of motion, accuracy, grip forces, needle handling, tip alignment); Electrical requirements; User interface; Equipment interfaces (cannula, sterile adapter, RFID, Universal Surgical Manipulator, Patient Side Manipulator). - Accessories: Physical specifications (size, shape, finish, materials); Mechanical requirements (forces, loading, insufflation, flow rate, cannula insertion, port insertion/removal); Compatibility (instruments, seals, cannulae); Markings; System Recognition (magnets). - Other: Software compatibility testing and instrument data verification testing to confirm intended function.
Design Validation	Validated general, functional, and interaction (compatibility) requirements. Assessed safety and efficacy in representative simulated clinical settings. Testing utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst-case clinical use. Representative tissue types were used as appropriate. The validation aimed to address how the features of each device meet user needs and intended use as documented in product requirements documents.
Substantial Equivalence	Demonstrated by showing the subject device has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device (da Vinci® SiTM Single-Site Instruments and Accessories in K122532). The distal tips (jaws, blades, cautery-tips, and clevis) are identical to the predicate. Modifications to the back ends were for compatibility with the IS4000 Surgical System. Performance data detailed above supported this claim.

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

Sample Size: Not explicitly stated in terms of a "test set" sample size for a quantitative performance metric. The validation involved using porcine (in vivo) and cadaveric tissue models. The number of such models or specific tests performed is not quantified.
Data Provenance: Not applicable as this is not a data-driven AI/ML study. The "data" comes from physical, mechanical, electrical, and simulated clinical performance testing, primarily bench tests and tissue model evaluations.

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. This device is not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from a test set of images or patient data. The "ground truth" for this device's performance would be engineering specifications and successful execution of surgical tasks on tissue models.

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

Not applicable. No expert adjudication method for a test set of data is mentioned, as this is not an AI/ML study.

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 is not an AI-assisted device in the context of diagnostic interpretation by human readers. It is a surgical instrument system.

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

Not applicable. This is not an algorithm, but a set of physical surgical instruments and accessories. Its performance is always "human-in-the-loop" as it's designed to be used by trained physicians.

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

The "ground truth" implicitly used for the design verification and validation testing would be adherence to engineering specifications, functional requirements, and successful simulated surgical outcomes on tissue models as determined by qualified engineers/testers and potentially surgeons participating in the validation. It is not expert consensus on medical images or pathology results.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of AI/ML. Its design and development would have involved iterative prototyping and testing, but these are not "training sets" in the AI sense.

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

Not applicable. As there is no AI/ML training set, there is no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of a human figure, represented by three profiles facing to the right, with a symbolic design above them that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2016

Intuitive Surgical, Inc. Ms. Melissa Gonzales Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, CA 94086

Re: K152448

Trade/Device Name: da Vinci Xi Single-Site Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: February 5, 2016 Received: February 8, 2016

Dear Ms. Gonzales:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

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 Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

da Vinci Xi Single-Site Instruments and Accessories

Indications for Use (Describe)

The Intuitive Surgical da Vinci Xi Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (154000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery, suction irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo ophorectory with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm and 10 mm straight cannulae, 8mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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FORM FDA 3881 (8/14)

INTUITIV

SURGICAL

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Melissa S. GonzalezRegulatory AffairsPhone Number: 408-523-8684Fax Number: 408-523-8907Email: melissa.gonzalez@intusurg.com
Date Summary Prepared:	August 26, 2015
Trade Name:	da Vinci® XiTM Single-Site Instruments and Accessories
Common Name:	Endoscope and accessories
Classification:	Class II - 21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY, GCJ
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	K122532 – da Vinci® SiTM Single-Site Instruments and Accessories

Device Description

Intended Use/Indications for Use:

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Substantial Equivalence:

The subject da Vinci Xi Single-Site Instruments and Accessories are very similar to the predicate devices (da Vinci® SiTM Single-Site Instruments and Accessories in K122532). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The basic architecture of the subject devices remains unchanged from the predicate; the distal tips (jaws, blades, cautery-tips, and clevis) of the da Vinci Xi Single-Site Instruments are identical to the predicate da Vinci Si Single-Site Instruments. However, the back ends of the instruments and accessories have been modified for compatibility with the IS4000 Surgical System, incorporating elements of both the predicate da Vinci Si Single-Site Instruments and Accessories and the referenced IS4000 8mm EndoWrist Instruments and related accessories. Several previously cleared accessories, used with both the subject and the predicate devices, are unchanged from the predicate da Vinci Si Single-Site Accessories (10mm accessory cannula and obturator and 5mm flexible blunt obturators).

Performance Data:

In accordance with Intuitive Surgical's Design Control process, risk analyses were conducted to evaluate the impact of modifications to the predicate instruments. Design verification and design validation testing were conducted on the subject instruments to confirm that the design outputs meet the design input requirements and that each instrument is safe and effective for its intended use.

Design Verification:

The bench testing with the subject da Vinci Xi Single-Site Instruments and Accessories was performed with an IS4000 da Vinci Surgical System. The general and device-specific design verification summarized in this submission verifies mechanical and labeling requirements for the subject device, such as:

. Instruments:
- Physical specifications (size, weight, shape); o
- Mechanical requirements (axes torques, loading, range of motion, accuracy, grip o forces, needle handling, tip alignment):
- Electrical requirements: o
- User interface; o
- Equipment interfaces (cannula, sterile adapter, RFID, Universal Surgical o Manipulator, Patient Side Manipulator).
Accessories: ●
- Physical specifications (size, shape, finish, materials); o
- Mechanical requirements (forces, loading, insufflation, flow rate, cannula O insertion, port insertion/removal);
- Compatibility (instruments, seals, cannulae) O
- Markings O
- System Recognition (magnets) O

Image /page/4/Picture/20 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in all caps, with the word "SURGICAL" in smaller letters below it. There is a yellow graphic above the word "INTUITIVE".

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Other verification included software compatibility testing and instrument data verification testing to confirm the subject da Vinci Xi Single-Site Instruments and Accessories function as intended.

Design Validation:

The design validation summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject da Vinci Xi Single-Site Instruments and Accessories. Design validations for each subject da Vinci Xi Single-Site Instrument and Accessory address how the features of each device meet the user needs and intended use as documented in the product requirements documents. The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Xi Single-Site Instruments and Accessories are substantially equivalent to the predicate da Vinci Si Single-Site Instruments and Accessories cleared in K122532.

Image /page/5/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in large, gray, sans-serif font. Below that, the word "SURGICAL" is in a smaller font. There is a yellow dot above the "I" in Intuitive.

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.