The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

Device Description

The Monopolar and Bipolar Cautery Cords have been designed as an accessory to electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments include scissors, forceps, and dissectors. The cord connects to the electrosurgical generator on one end and the active instrument on the other end. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generatormating connector on the other end.

AI/ML Overview

This is an electrosurgical cord, not an AI device. Therefore, the questions related to AI/algorithm performance, training sets, and expert adjudication are not applicable. The provided text describes a traditional medical device (Monopolar and Bipolar Cautery Cord) for which the acceptance criteria and performance evaluation are based on engineering and safety standards rather than diagnostic accuracy determined by AI.

Here's the relevant information based on the provided text for a traditional medical device:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance	Study Type
Material Equivalence	Substantially equivalent to predicate device in terms of design, materials, technological characteristics.	Comparative Analysis
Functional Verification	Meets design input requirements and demonstrates substantial equivalence to predicate.	Performance Testing (Functional, Mechanical, Electrical Safety, Simulated Procedures)
Dimensional Measurements	Conducted	Performance Testing
Mechanical Performance	Conducted	Performance Testing
Electrical Safety	Conducted	Performance Testing
Use in Simulated Surgical Procedures	Conducted	Performance Testing

Sample size used for the test set and the data provenance: Not applicable. This device is an accessory to an electrosurgical unit, and the performance testing described is engineering-based (dimensional, mechanical, electrical safety, simulated use), not based on a "test set" of patient data or clinical images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., diagnosis, segmentation) is not relevant for this electrosurgical cord. Performance was evaluated against engineering specifications and predicate device equivalence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies, which is not relevant here.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and functional equivalence to a legally marketed predicate device. This is determined through objective measurements and tests rather than clinical diagnoses or outcomes data.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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2014 JAN - 7

510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.
	1266 Kifer Road
	Sunnyvale, CA 94086

Contact:

Brandon Hansen Project Manager, Regulatory Affairs Phone Number: 408-523-7485 Fax Number: 408-523-8907 Email: Brandon.Hansen@intusurg.com

Date Summary Prepared: September 27, 2013

Trade Name:	Monopolar and Bipolar Cautery Cord
Common Name:	Monopolar/Bipolar Electrosurgical Cord
Classification:	Class II
	21 CFR 878.4400, Electrosurgical Cutting and CoagulationDevice and Accessories
Product Codes:	GEI
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	Olsen Medical Electrosurgical Cables/Adapters (K111262)

Page 1

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Device Description

Intended Use:

To connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.

Indications for Use:

Technological Characteristics:

The Monopolar and Bipolar Cautery Cords are substantially equivalent to the predicate devices. Olsen Medical Electrosurgical Cables/Adapters (K11262) in terms of design, materials, technological characteristics, and intended use.

Performance Data:

Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and use in simulated surgical procedures.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, Monopolar and Bipolar Cautery Cords are substantially equivalent to the predicate devices, the Olsen Medical Electrosurgical Cables/Adapters

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a sans-serif typeface, and the overall impression is one of official documentation or signage.

Public Health Service

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

January 7, 2014

Intuitive Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K133167

Trade/Device Name: Monopolar and Bipolar Cautery Cords Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2013 Received: November 7, 2013

Dear Mr. Hansen:

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 or any 1 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

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Page 2 - Mr. Brandon Hansen

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number if known: K133167

Device Name: Monopolar and Bipolar Cautery Cords

INDICATION FOR USE:

for connecting The Monopolar and Bipolar Cautery Cords are intended monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

Prescription Use _ X_

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(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)

Long H. Chen -A

for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number: K133167

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.