The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 154000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and shap 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, grnecologic 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 pediatic use. It is intended to be used by trained physicians in an operating room enviroument in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Device Description

The subject IS4000 da Vinci EndoWrist Instruments are to be used with the IS4000 da Vinci Surgical System. The EndoWrist Instruments consist of the housing, shaft, wrist, and tip. The housing contains the connection mechanism to the IS4000 da Vinci Surgical System arm. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. These instruments are reusable and provided non-sterile.

AI/ML Overview

This document describes K150284 for the IS4000 da Vinci EndoWrist® Instruments. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device. Therefore, a full clinical study with acceptance criteria, sample sizes for test and training sets, expert qualifications, and MRMC studies, as typically seen for novel high-risk devices, is not required nor provided in this summary.

The summary focuses on design verification and validation to demonstrate that the modified instruments are as safe and effective as the predicate device.

Here's the information extracted from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for modified instruments claiming substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or AUC) are not provided. Instead, the "acceptance criteria" are implied by successful completion of design verification and validation testing, confirming that the new instruments meet design input requirements and perform comparably to the predicate.

Acceptance Criteria (Implied by Verification/Validation)	Reported Device Performance
Instrument reliability and durability	Verified through bench testing.
Leakage	Verified through bench testing.
Roll, pitch, and yaw range of motion	Verified through bench testing.
Jaw close and open positions	Verified through bench testing.
Friction	Verified through bench testing.
Torque	Verified through bench testing.
Instrument insertion	Verified through bench testing.
Adequacy of labeling	Verified through bench testing.
Software compatibility with IS4000 System software	Verified through software compatibility testing.
Instrument data verification with IS4000 System software	Verified through instrument data verification testing.
Features meet user needs and intended use (as documented in product requirements)	Validated in representative simulated clinical settings (porcine in vivo and cadaveric tissue models).
Safety and efficacy in normal and expected worst-case clinical use	Assessed in representative simulated clinical settings (porcine in vivo and cadaveric tissue models).

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state "sample sizes" in terms of number of cases or patients for a test set in a traditional clinical study sense. The testing involved "representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models." The number of porcine or cadaveric models used is not specified.

Data Provence:

Country of origin: Not specified.
Retrospective or prospective: The design verification and validation testing are prospective, performed specifically for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of "experts" to establish a ground truth in a clinical study context. The validation involved assessing safety and efficacy in simulated clinical settings, which would likely have involved qualified personnel (e.g., engineers, medical professionals familiar with the product) but not specifically "experts" establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study with a test set requiring adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence through non-clinical performance data (bench testing, simulated use).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a surgical instrument, not an AI algorithm. Its performance is always with a human-in-the-loop (the surgeon).

7. The Type of Ground Truth Used

For the design validation, the "ground truth" was established by the expected functional performance of the instruments in simulated clinical settings (e.g., successful grasping, cutting, suturing, demonstrating intended interaction with tissue) and meeting documented product requirements. This is based on functional performance in controlled, simulated environments rather than diagnostic pathology or long-term clinical outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument, not an AI system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble a bird or a wing.

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

May 15, 2015

Intuitive Surgical Incorporated Ms. Sarah Rizk Senior Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, Califiornia 94086

Re: K150284

Trade/Device Name: IS4000 da Vinci EndoWrist® Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: April 14, 2015 Received: April 15, 2015

Dear Ms. Rizk:

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 -S

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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Form Annroved: OMB No 0910-0120

Expiration Date: January 31, 2017

e PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150284

Device Name

IS4000 da Vinci EndoWrist® Instruments

Indications for Use (Describe)

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.

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publiching Survious (301) 443-6740

Image /page/2/Picture/22 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL" which is in a smaller font. There is a yellow dot above the "I" in Intuitive.

Prairie Partie

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Sarah RizkRegulatory AffairsPhone Number: 408-523-6906Fax Number: 408-523-8907Email: sarah.rizk@intusurg.com
Date Summary Prepared:	Feb 4, 2015
Trade Name:	IS4000 da Vinci EndoWrist® Instruments
Common Name:	Endoscope and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY, GCJ
Classification Advisory Committee:	General and Plastic Surgery
Predicate Device:	K131861 – IS4000 da Vinci Surgical System

Device Description

Name	Part No.
Needle Drivers
8 mm Mega Needle Driver	470194
8 mm Large SutureCut Needle Driver	470296
Graspers
8 mm Cadiere Forceps	470049

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Name	Part No.
8 mm Cobra Grasper	470190
8 mm DeBakey Forceps	470036
Scissors
8mm Round Tip Scissors	470007

Intended Use/Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 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.

Substantial Equivalence:

The subject IS4000 da Vinci EndoWrist Instruments are very similar to the predicate devices (IS4000 da Vinci EndoWrist Instruments in K131861). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. Modifications consist of geometrical changes to instrument tips to provide an assortment of distal tips and offer more options for grasping, dissecting, manipulating, and transecting tissue for surgeon preference.

Performance Data:

In accordance with the Design Control process, risk analysis was 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 design input requirements and that each instrument is safe and effective for its intended use.

Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "U" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray. To the right of the word "SURGICAL" is a registered trademark symbol.

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Design Verification:

The bench testing with the subject EndoWrist Instruments was performed on an IS4000 da Vinci Surgical System. The general and instrument-specific design verification summarized in this submission verifies mechanical and labeling requirements for the subject instruments, such as:

instrument reliability and durability,
leakage,
roll, pitch, and yaw range of motion, ●
jaw close and open positions,
friction,
torque,
instrument insertion ●
adequacy of labeling. ●

Other verification performed includes software compatibility testing and instrument data verification testing to confirm the subject EndoWrist instruments function as intended with the current production IS4000 System software.

Design Validation:

The design validation summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject EndoWrist Instruments. Design validations for each subject EndoWrist Instrument address how the features of the instrument 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 IS4000 da Vinci EndoWrist Instruments are substantially equivalent to the predicate IS4000 da Vinci EndoWrist Instruments cleared in K131861.

Image /page/5/Picture/17 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray.

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.