The Cobra Cooled Surgical Probe is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Description

The Cobra Cooled Surgical Probe is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The text discusses a 510(k) submission for an electrosurgical probe and compares it to a predicate device, noting that "non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use." However, it does not provide details about:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm-only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of a Special 510(k) submission, confirming substantial equivalence to a predicate device, and outlining the intended use and device characteristics. It states that non-clinical tests were conducted and met design-input criteria, but it does not elaborate on the specifics of these tests, their methodology, or the results in sufficient detail to answer your questions.

Summary

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

510(k) Summary of Safety and Effectiveness 3.

General Information a.

Modified Device Information

Category:	Comments:
Sponsor:	Boston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134
Correspondent:	April I. MalmborgRegulatory Affairs Specialist IIBoston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134
Contact Information:	E-mail: malmbora@bsci.comPhone: (408) 895-3637Fax: (408) 895-2202
Device Common Name:	Electrosurgical Probe
Device Proprietary Name:	Cobra Cooled Surgical Probe (K032207)
Device Classification:	21 CFR §878.4400

Predicate Device Information

Predicate Device:	Cobra Cooled Surgical Probe (K023291)
Predicate Device Manufacturer:	Boston Scientific Corporation
Predicate Device Common Name	Electrosurgical Probe
Predicate Device Classification:	21 CFR §878.4400
Predicate Device Classification Number:	Class II

Boston Scientific Corporation Special 510(k) Submission

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

K032207
Page ② z Pac

SPECIAL 510(K) SUBMISSION Cobra Cooled Surgical Probe

b. Date Summary Prepared

August 18, 2003

Description of Device C.

d. Intended Use

The intended use for the Cobra Cooled Surgical Probes is as follows:

The Cobra Cooled Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.

Comparison to Predicate Device e.

See Table I- Comparison of Device Characteristics to Predicate on the following page.

000006

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

Device Manufacturer& Name	Cobra® Cooled Surgical Probe
Boston Scientific Corporation		Same
Device Description	Electrosurgical Probe	Same
510(k) Number	K023291	K032207
Regulatory Class	II	Same
Device Classification	21 CFR §878.4400	Same
Intended Use	Coagulation of Cardiac Tissueduring Cardiac surgery and SoftTissue during General OpenSurgical Procedures	Same
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Shaft Size	9F	Same
Tip Material	Polycarbonate	Same
Length (cm)	15-35	Same
Electrode Size (mm)	6 to 12.5 mm	Same
Electrode Number	2 to 7	Same

Table 1 - Comparison of Device Characteristics to Predicate

f. Summary of the Non-clinical Data

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. April I. Malmborg Regulatory Affairs Specialist II 2710 Orchard Parkway San Jose, CA 95134

Re: K032207

Trade/Device Name: Cobra Cooled Surgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: July 17, 2003 Received: July 22, 2003

Dear Ms. Malmborg:

This letter corrects our substantially equivalent letter of August 20, 2003.

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 (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 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.

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

Page 2 - Ms. April I. Malmborg

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.

This letter will allow you to continue 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

el. Mall

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SPECIAL 510(K) SUBMISSION Cobra Cooled Surgical Probe

K032207

4. Premarket Notification -Indication for Use Statement

Device Name: Cobra Cooled Surgical Probe

Indication for Use:

The intended use for Cobra Cooled Surgical Probe is as follows:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR (Per 21 CFR §801.109) Over-the-Counter Use_

Mark N. Mellema

f General, Restorative and Neurological Devic

510(k) Number.

Boston Scientific Corporation Special 510(k) Submission

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.