The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes. blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection 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 (except for transoral otolaryngology robotic surgical procedures). 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

The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System or IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument 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. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

However, I can extract information related to the device description, testing methods, and the general statement of equivalence.

Here's a breakdown of what can be inferred and what is missing:

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

The document does not provide a table with quantitative acceptance criteria and specific numerical performance results. Instead, it lists the types of tests performed to ensure the device meets design requirements.

Inferred "Acceptance Criteria" (based on tests performed):

Acceptance Criteria Type	Reported Device Performance (as inferred from tests)
Instrument Reliability	Verified through Design Verification tests
Instrument Durability	Verified through Design Verification tests
Leakage	Verified through Design Verification tests
Range of Motion (Roll, Pitch, Yaw)	Verified through Design Verification tests
Jaw Close and Open Positions	Verified through Design Verification tests
Friction	Verified through Design Verification tests
Electrical Safety	Verified through Design Verification tests
Instrument Labeling	Verified through Design Verification tests
Compatibility with Tip Cover Accessory	Verified through Design Verification tests
Compatibility with System Software	Verified through Design Verification tests
Functional Requirements	Validated through Design Validation tests in simulated clinical settings (porcine model)
Interaction (Compatibility) Requirements	Validated through Design Validation tests in simulated clinical settings (porcine model)
Safety	Assessed in representative simulated clinical settings (porcine model)
Efficacy	Assessed in representative simulated clinical settings (porcine model)

2. Sample sized used for the test set and the data provenance

Sample size used for the test set: Not explicitly stated. The document mentions "Design verification and design validation testing were conducted on the subject device." It does not specify the number of units tested.
Data provenance: The tests were conducted internally by Intuitive Surgical, Inc. on a "porcine model" for design validation. This suggests a prospective assessment of the device's performance in a controlled, simulated clinical environment. The country of origin is not specified but the company is based in Sunnyvale, California.

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

Not applicable. This device is a surgical instrument, not an AI/diagnostic tool requiring expert-established ground truth for its performance evaluation in this context. Its evaluation focuses on mechanical, electrical, and functional performance.

4. Adjudication method for the test set

Not applicable. See point 3.

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 diagnostic device, but a surgical instrument. An MRMC study is not relevant here.

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

Not applicable. This is a surgical instrument that is always used with a human-in-the-loop (a trained physician). Standalone performance of an algorithm is irrelevant.

7. The type of ground truth used

For the design validation, the "ground truth" was established by the physical and functional outcomes observed in a porcine model under "normal and expected worst case clinical use" scenarios. The evaluation aimed to confirm that "the features of the instrument meet the user needs and intended use."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

Summary of available information from the document:

The 8mm Monopolar Curved Scissors is a reusable surgical instrument used with the Intuitive Surgical da Vinci S and Si Surgical Systems. It performs cutting, cauterizing, coagulation, manipulation, and blunt dissection of tissue.

To demonstrate substantial equivalence to its predicate device, Intuitive Surgical performed:

Design Verification: Bench testing on an IS3000 da Vinci Si Surgical System to verify mechanical and labeling requirements, including reliability, durability, leakage, range of motion, jaw positions, friction, electrical safety, labeling, and compatibility with accessories and software.
Design Validation: Testing in representative simulated clinical settings utilizing a porcine model to evaluate functional and interaction requirements, as well as the safety and efficacy of the instrument under normal and worst-case clinical use. This ensured the instrument met user needs and intended use.

The document concludes that based on the intended use, indications for use, technological characteristics, and performance data from these tests, the device is substantially equivalent to the predicate device.

Summary

{0}------------------------------------------------

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.

April 6, 2018

Intuitive Surgical, Inc. Ms. Gayle Perry Senior Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K180033

Trade/Device Name: 8mm Monopolar Curved Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: March 9, 2018 Received: March 12, 2018

Dear Ms. Perry:

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, 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 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);

{1}------------------------------------------------

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 -S3 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Expiration Date: 06/30/2020 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known)

K180033

Device Name 8mm Monopolar Curved Scissors

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) X 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740

{3}------------------------------------------------

510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Gayle PerrySenior Regulatory Affairs EngineerPhone Number: 408-523-7252Fax Number: 408-523-8907Email: gayle.perry@intusurg.com
Date Summary Prepared:	January 3, 2018
Trade Name:	8mm Monopolar Curved Scissors
Common Name:	Endoscope and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	K050369 (use with the IS2000 system), with additional indicationsunder K081137 (use with the IS3000 system), K123329 (updatedTORS indication) and updated reprocessing instructions underK170644

Device Description

Intended Use/Indications for Use:

EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

Image /page/3/Picture/8 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 the registered trademark symbol next to it.

{4}------------------------------------------------

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection 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 (except for transoral otolaryngology surgical procedures). 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.

Technological Characteristics:

The subject 8mm Monopolar Curved Scissors is very similar to its predicate device originally cleared under K050369 for use with the IS2000 da Vinci S System, and subsequently cleared under K081137 for use with the IS3000 da Vinci Si System, with additional indications cleared under K123329 and reprocessing instructions under K170644. It has the same intended use. same fundamental scientific technology, and similar technological characteristics as the predicate device. Modifications consist of:

. material changes to the main tube and the extension tube,
addition of an adhesive between the main tube and extension tube,
geometrical changes to the main tube/extension tube interface.

Performance Data:

In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications to the predicate device. Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use.

Design Verification:

The bench testing with the subject device was performed on an IS3000 da Vinci Si Surgical System. The design verification summarized in this submission verifies mechanical and labeling requirements for the subject instrument, such as:

instrument reliability and durability, ●
leakage,

Image /page/4/Picture/14 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 light gray, with a registered trademark symbol to the right of the word.

{5}------------------------------------------------

roll, pitch, and yaw range of motion,
jaw close and open positions. ●
friction,
electrical safety, ●
instrument labeling,
compatibility with the tip cover accessory,
compatibility with system software.

Design Validation:

The design validation summarized in this submission validates functional and interaction (compatibility) requirements for the subject device. Design validation addresses how the features of the instrument meet the user needs and intended use as documented in the product requirements document. The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized a porcine model 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 8mm Monopolar Curved Scissors is substantially equivalent to the predicate device.

Image /page/5/Picture/13 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 light gray, with the registered trademark symbol next to it. Above the word "INTUITIVE" is a small yellow dot.

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.