The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Description

The Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.

AI/ML Overview

This submission describes the Cobra Bipolar System, an electrosurgical probe intended for the coagulation of soft tissue and blood to produce hemostasis during general surgery. The submission is a 510(k) premarket notification, indicating the applicant is seeking to demonstrate substantial equivalence to a predicate device rather than undergoing a full clinical trial for safety and effectiveness.

Therefore, the provided text does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, as is typical for 510(k) submissions. There is no mention of specific performance metrics (e.g., coagulation time, temperature control accuracy), ground truth establishment, expert adjudication, or sample sizes related to a performance study.

Here's a breakdown of why the requested information cannot be provided from the given text:

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

Not present. The document does not define specific performance acceptance criteria (e.g., a target coagulation depth, a maximum tissue temperature) for the Cobra Bipolar System. Instead, the "Modified Device" column in the comparison table states "Same" for "Intended Use" and "Device Description" as the "Predicate Device," implying that its performance is expected to be equivalent to the predicate, rather than measured against new, specific criteria.

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

Not present. There is no mention of any test set, participants, or data provenance as this is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not present. Establishing ground truth for device performance typically requires specific experiments or clinical data reviewed by experts. This document is not a report of such an activity.

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

Not present. No test set or adjudication method is described.

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 device is an electrosurgical probe, not an imaging or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This device is a surgical instrument and does not involve algorithms or AI in the sense of a standalone diagnostic or assistive system.

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

Not present. Ground truth is not discussed as no performance study is described. The "ground truth" for a 510(k) submission is typically the performance characteristics and safety profile of the predicate device, which the new device aims to match.

8. The sample size for the training set:

Not applicable. There is no training set for this type of device.

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

Not applicable. There is no training set mentioned.

Summary based on the provided text:

The submission focuses on establishing substantial equivalence of the Cobra Bipolar System to a legally marketed predicate device (Cobra Electrosurgical Probe, K013783). This is achieved by demonstrating that the new device has the same intended use, device description, and classification, and is similar in principle of operation. The FDA's letter confirms that the device is "substantially equivalent" to the predicate, allowing it to proceed to market under the general controls provisions of the Medical Device Amendments. This process generally relies on comparison to a predicate, and often involves engineering verification and validation testing to ensure the device performs as intended, but these details are typically presented in separate technical documents, not in the public 510(k) summary itself.

Summary

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510(K) SUMMARY

Category:	Comments
Sponsor:	Boston Scientific Corporation/EP Technologies, Inc.2710 Orchard ParkwaySan Jose, CA 95134
Correspondent:	April MalmborgSpecialist II, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134
Contact Numbers:	Phone: 408.895.3637Fax: 408.895.2202Email: malmbora@bsci.com
Device Common Name	Electrosurgical Probe
Device Proprietary Name	Cobra Bipolar System
Device Classification	21 CFR 878.4400; Class II
Predicate Device	Cobra Electrosurgical Probe
Predicate Device Manufacturer(s)	BSC/ EP Technologies, Inc.
Predicate Device Proprietary Name(s)	Eelectrosurgical Probes
Predicate Device Classification(s)	21 CFR 8778.4400; Class II

Date Summary Was Prepared:

April 3, 2003

Description of the Device:

Intended Use:

The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Comparison to Predicate Devices:

CONFIDENTIAL

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K023288 – Response to FDA Questions - April 2, 2003
Cobra Bipolar System

	Predicate Device	Modified Device
510(k) Reference	K013783	K023288
Intended Use	Coagulation of soft tissues	Same
Device Description	Electrosurgical Probe	Same
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Manufacturer	BSC/ EP Technologies	Same
DeviceClassification	Class II, GEI; 21 CFR §878.4400	Same

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected and form a continuous, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the design.

APR - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. April Malmborg Regulatory Affairs Specialist II Boston Scientific 2710 Orchard Parkway San Jose, California 95134

Re: K023288

Trade/Device Name: Cobra Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 30, 2002 Received: January 2, 2003

Dear Ms. Malmborg:

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 such 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); 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.

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Page 2 - Ms. April Malmborg

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

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K023288 - Response to FDA Questions - April 2, 2003 Cobra Bipolar System

INTENDED USE STATEMENT

510(k) Number: K023288

Device Name: Cobra Bipolar System

Indication for Use:

្រុះបា

The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the Counter Use_ (Per 21 CFR $801.109)

Miriam C. Provost

Division of General, Restorative and Neurologica! Devices

510(k) Number K023288

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.