5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 by INTUITIVE SURGICAL, INC.

The Flared Cannuiae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.

Device Description

The Intuitive Surgical Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an Integral receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-Pin grounding connector

AI/ML Overview

The provided text describes the 510(k) summary for the Intuitive Surgical 5 mm and 8 mm Flared Cannulas (K101743). This document is for a medical device that serves as a port of entry during surgical procedures, not an AI/ML-driven device for diagnostic or predictive purposes. Therefore, most of the requested information regarding acceptance criteria for AI models, sample sizes for test/training sets, expert consensus, adjudication methods, and MRMC studies are not applicable.

However, I can extract information related to the device's performance claims and how they were substantiated for this specific medical device submission.

Here's the relevant information based on the provided text, acknowledging that most questions about AI model validation don't apply:

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

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	The device must demonstrate substantial equivalence to the predicate device (Intuitive Surgical, Inc. da Vinci Endoscopic Instrument Control System (Model IS1000) and Endoscopic Instruments K990144) in intended use, design, and technology.	The subject device is equivalent in Intended use, design, and technology as compared to the predicate device.
Safety and Efficacy	Performance testing must demonstrate that the device is substantially equivalent to the predicate device in terms of safety and efficacy and that the design output meets the design input requirements without raising any new issues of safety or efficacy.	"Performance tests (bench and animal lab tests) were conducted to demonstrate that the device Is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new Issues of safety or efficacy." "Based on the technical characteristics, Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal lab tests," but details on the number of tests performed or animals used are not provided.
Data Provenance: Not explicitly stated. Assuming tests were conducted by Intuitive Surgical, Inc., based in Sunnyvale, California, USA, the data likely originates from internal testing. It would be prospective testing as it relates to the development and validation of the new device.

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

This question is not applicable as the device is a physical surgical instrument, not an AI/ML model requiring expert-established ground truth for diagnostic accuracy. The validation is physical and functional, not clinical interpretation.

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

This question is not applicable as the device is a physical surgical instrument and does not involve clinical interpretation requiring adjudication.

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

This question is not applicable as the device is a physical surgical instrument, not an AI/ML system, and therefore does not involve human readers interpreting images with or without AI assistance.

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

This question is not applicable as the device is a physical surgical instrument, not an algorithm.

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

For this type of physical device, the "ground truth" would be established by engineering specifications, material standards, and surgical functional requirements. The tests ("bench and animal lab tests") would verify that the device performs according to these pre-defined physical and functional standards, ensuring it is safe and effective for its intended use (acting as a port of entry without maintaining insufflation). There is no "pathology" or "outcomes data" in the sense of diagnostic accuracy for this device.

8. The sample size for the training set

This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.

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

This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.

Summary

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

FEB - 4 2011

510(k) Summary

(As Required by 21 CFR 807.92(c))

Date:	09/10/2010
Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Meghna SridharanSr. Regulatory EngineerPh: (408) 523- 2487Fax: (408) 523-1390Meghna.sridharan@intusurg.com
Trade Name:	Intuitive Surgical Flared Cannula• Model # 420262: 5mm Flared Cannula• Model # 420319: 8mm Flared Cannula
Common Name:	Endoscopic Instrument and Accessories
Classification:	Endoscope and Accessories,21 CFR 876.1500, NAY(LFL)
Predicate Device:	Intuitive Surgical, Inc.K990144, da Vinci Endoscopic InstrumentControl System (Model IS1000) and EndoscopicInstruments
Device Description:	The Intuitive Surgical Flared Cannula consists ofa tapered hollow tubular shaft with a flareddistal tip and a bowl with an Integralreceptacle. The hollow shaft serves as the portof entry, the bowl is used to attach thecannula to the da Vinci Surgical System andthe receptacle allows for attachment ofcommercially available dispersive electrodegrounding pad via a 2-Pin groundingconnector
Intended Use:	The Flared Cannulae are Intended to be usedwith the da Vinci Surgical System (da Vinci S(Model IS2000) or da Vinci SI (Model IS3000)) toserve as a port of entry during da Vinci
Intuitive Surgical, Inc.	Confidential	Page 3-2

P. 1 of 2

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

procedures that do not require maintenance of Insufflation.

Technological Characteristics: The subject device is equivalent in Intended use, design and technology as compared to the predicate device.

Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the device Is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new Issues of safety or efficacy.

Summary: on the technical characteristics, Based Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device.

Intuitive Surgical, inc.

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Public Health Service

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

Intuitive Surgical, Inc. % Ms. Meghna Sridharan Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

FEB - 4 2011

Re: K101743

Trade/Device Name: Intuitive Surgical® Flared Cannula Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: January 27, 2011 Received: January 28, 2011

Dear Ms. Sridharan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially_equivalent.(for the_indications_ for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Meghna Sridharan

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

AZ
VS
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

Indications for Use

510(k) Number if known: K101743

Device Name: Intuitive Surgical Flared Cannula

INDICATION FOR USE:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use _ (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Osdoba for mkm

Division Sign-O (Division Sign of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101743

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.