The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci Surgical System to transect soft tissues during endoscopic surgical procedures.

Device Description

The Intuitive Surgical® Bipolar Forceps is an endoscopic instrument with a grasping end effector to be used in conjunction with the Intuitive Surgical® Endoscopic Instrument Control System and a standard external electrosurgical generator unit (ESU). It is a resposable instrument connected to the ESU via a bipolar electrosurgical cable. The ESU, which is activated by a foot pedal on the generator itself, controls the coagulation current. The surgeon controls the grasping end effector (or grips) of the device. A coagulation current passes from the ESU between the two closely spaced grip electrodes then back to the generator, allowing for precise tissue coagulation. The device is similar in size and function to other Intuitive Surgical® Endowrist™ Endoscopic Instruments.

AI/ML Overview

This document is a 510(k) premarket notification for the Intuitive Surgical Endowrist™ Bipolar Forceps. However, it does not contain the detailed information required to fill out a table of acceptance criteria, reported device performance, or details about specific studies like sample sizes, expert qualifications, or ground truth establishment.

Here's why and what information can be extracted:

Missing Information:

The document primarily focuses on establishing substantial equivalence to a predicate device (Dexide Bipolar Forceps II, K991859 and da Vinci Surgical System, K990144). It states that the device is "essentially identical in terms of size, function, and materials."

Crucially, this type of 510(k) submission (especially for a device like this from 2001) often relies on design analysis and comparison and in vitro testing to demonstrate substantial equivalence, rather than extensive clinical studies with specified acceptance criteria and measured performance in humans.

Specifically, the document does not provide:

A table of explicit acceptance criteria (e.g., specific force measurements, coagulation times, tissue effects, or clinical outcomes).
Reported device performance against such criteria.
Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
Information about MRMC comparative effectiveness studies or standalone algorithm performance, as this is a surgical instrument, not an AI/software device.
Explicit descriptions of the ground truth used for any testing (beyond general statements about "functional characteristics").
Sample size for training sets, or how ground truth for training was established, as this is not an AI/ML device.

Information that can be extracted or inferred:

Category	Information from Document
1. Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that "in vitro testing confirm that basic functional characteristics and safety are substantially equivalent to the predicate device cited." Reported Performance: Similarly, no specific performance metrics are reported. The conclusion is that the device is "substantially equivalent."
2. Sample size (test set) & Data Provenance	Not provided. The term "in vitro testing" is used, implying laboratory-based tests rather than human subject data.
3. Number & Qualifications of Experts	Not provided.
4. Adjudication method	Not applicable/Not provided.
5. MRMC Comparative Effectiveness Study	Not applicable. This is a surgical instrument, not an AI/software product requiring MRMC studies for reader improvement.
6. Standalone Algorithm Performance	Not applicable. This is a surgical instrument, not an AI/software algorithm.
7. Type of Ground Truth used	Implied: For the "in vitro testing", the ground truth would likely be established physical and electrical properties, and functional characteristics (e.g., cutting, coagulation efficiency) compared to the known performance of the predicate device. This would not involve expert consensus, pathology, or outcomes data in the sense of clinical trials.
8. Sample size (training set)	Not applicable. This is a physical medical device, not a machine learning model.
9. Ground truth for training set	Not applicable. This is a physical medical device.

Summary of what the document suggests:

The Intuitive Surgical Endowrist™ Bipolar Forceps demonstrated its safety and effectiveness by showing "substantial equivalence" to existing, legally marketed predicate devices. This equivalence was established through:

Design analysis and comparison: Primarily focusing on the device's size, function, and materials.
In vitro testing: Laboratory tests to confirm basic functional characteristics and safety.

The 510(k) process in this context primarily aims to demonstrate that the new device is as safe and effective as a legally marketed predicate, rather than meeting specific quantifiable performance criteria through large-scale clinical trials, especially for a device of this nature and submission date.

Summary

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

Section II

NOV 1 6 2001

510(k) SUMMARY

012833

This summary of 510(k) safety and effectiveness information is submitted in accordance Tiffs summary of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

August 21, 2001 Date Prepared:

Applicant Information:

Name:	Intuitive Surgical, Inc.
Address:	1340 W. Middlefield RoadMountain View, California 94043

Establishment Registration Number: 2955842

Contact Person:	Michael Yramategui
Phone Number:	(415) 237-7048
Facsimile Number:	(415) 526-2060
E-mail:	mike_yramategui@intusurg.com

Device Information:

Classification Name:	Electrosurgical cutting and coagulation device andaccessories (21 CFR §878.4400)
Trade Name:	Intuitive Surgical® Endowrist™ Bipolar Forceps
Common Name:	Bipolar Forceps
Predicate Device(s):

United States Surgical	Dexide Bipolar Forceps	K991859
Intuitive Surgical	da Vinci Surgical System	K990144

Device Description:

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

current passes from the ESU between the two closely spaced grip electrodes then back to current passes non the 200 beine tissue coagulation. The device is similar in size and the generator, anowing for pressil Endowrist™ Endoscopic Instruments

Intended Use:

The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vincipal The Internet of Surgical "Dipolar Forcept to as a transect soft tissues during endoscopic surgical procedures.

Comparison to Predicate Device:

The Intuitive Surgical® Bipolar Forceps is essentially identical in terms of size, function, I he intentive Surgical "Dipolar Forespons costing instrument cited Dexide Bipolar Forceps II, K991859). The primary differences between the subject and Bibliate devices are the following: 1) the subject device is resposable and 2) the surgeon
predicate devices are the following: 1) the subject device is responsible and consi predicate devices and positions the subject device using the Intuitive Surgical® Endoscopic Instrument Control System while the predicate device is handheld.

In Vitro Test Data:

Design analysis and comparison as well as in vitro testing confirm that basic functional Design and your and betantially equivalent to the predicate device cited.

Summary:

Based upon the product technical information provided, intended use, and performance Dason apon the provided in this pre-market notification, the Intuitive Surgical® Bipolar Information provided in this pro hauntially equivalent to a currently marketed predicate device.

Intuitive™ and Intuitive Surgical® is a registered trademark of Intuitive Surgical, Inc.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Yramategui Director, Regulatory and Quality Affairs Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View, California 94043

Re: K012833

: KV12633
Trade/Device Name: Intuitive Surgical Endowrist™ Bipolar Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: August 21, 2001 Received: August 23, 2001

Dear Mr. Yramategui:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premained is substantially equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regally marketed producal Device Americal Device America Andress, or to commerce prior to May 26, 1970, the chariners and the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a proval application of the Act. Th and Cosmetic Act (Act) that to not require approvate of the general controls of the Act. The Act. The
You may, therefore, market the device, subject to the general magate You may, therefore, market the device, secject to since of manual registration, listing of general controls provisions of the Act mercise requirement and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
can If your device is classified (see above) into chair case regulations affecting your device can
may be subject to such additional controls. Title Co., In addition, FDA may may be subject to such additional controlis. Existing mays 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Peacharter regarming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a successful other requirements of the Act
that FDA has made a determination that your device and only . Every and that FDA has made a decermination that your cover Federal agencies: "You must or any Federal statutes and regulations administered of online to: registration and listing (21)
comply with all the Act's requirements, including, but not institus mosting m comply with all the Act Stequirements, monumations practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the ollectronic CFR Part 807); labelling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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

Page 2 -- Mr. Michael Yramategui

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice tor your covices devices), please contact the Office of additionally 21 CFK Fall 809.10 for in the underions on the promotion and advertising of Compliance at (301) 594-4037. Tidationally to qualier at (301) 594-4639. Also, please note the your device, prease comace the Orited on oremarket notification" (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21 and from t regulation entitled, "Misoranumig by referents to pr pr may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 2011 fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark N Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

NQV 1 6 2001

Section III

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device name: Intuitive Surgical® Bipolar Forceps

Indications for Use:

The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vincito Surgical I he intuitive Surgical - Dipolar Fereops to transect soft tissues during endoscopic surgical procedures.

Mark N. Millerson

0000

Restorative

510(k) Number K012833

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use

(per 21 CFR §801.109

(Optional Format 1-2-96)

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.