The Cobra® Cardiac 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.

Device Description

The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device, specifically an Electrosurgical Probe. The provided text focuses on the device description, intended use, comparison to a predicate device, and the FDA's substantial equivalence determination.

However, the document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the format requested. The "Summary of the Non-clinical Data" section merely lists types of tests performed (e.g., Fluid Path Integrity, Biocompatibility, In vivo performance) but does not provide:

Specific acceptance criteria values.
Reported device performance values against those criteria.
Details of the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

The 510(k) notification process primarily aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that a device meets specific, quantitative acceptance criteria through a detailed clinical or performance study report in the way you've outlined for AI/ML devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer what can be inferred or directly stated from the text, with explicit notes about what is missing:

Acceptance Criteria and Study for Cobra® Cooled Surgical Probe

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)	Comments / Missing Information
Mechanical Integrity	(Not specified quantitatively)	(Not specified quantitatively)	The document states "Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength" tests were conducted. However, no specific pass/fail criteria or quantitative results are provided.
Biocompatibility	(Not specified quantitatively)	(Not specified quantitatively)	The document states "Biocompatibility" tests were conducted. No specific criteria or results are provided.
In Vivo Performance	(Not specified quantitatively)	(Not specified quantitatively)	The document states "acute and chronic, In vivo performance" tests were conducted. No specific criteria or results are provided beyond the general statement that it "conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP))" where appropriate.
Sterilization	EO Sterilized (implied method)	Yes (implied met)	From comparison to predicate.
Single Use	Single Use (implied characteristic)	Yes (implied met)	From comparison to predicate.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified. The document mentions "non-clinical tests" and "In vivo performance" but does not provide any sample sizes for these tests.
Data Provenance: Not explicitly stated, but the tests were conducted by Boston Scientific Corporation/EP Technologies, Inc. It can be assumed these were internal company tests or contracted to a GLP-compliant lab. Country of origin and retrospective/prospective nature are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. For a physical electrosurgical probe, "ground truth" as it relates to expert consensus for image/data interpretation (like in AI studies) is not typically established. Performance is measured against engineering specifications, biocompatibility standards, and in-vivo physiological responses. The document does not refer to experts establishing a "ground truth" in this context.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for interpreting ambiguous data (e.g., medical images). This document describes performance testing of a physical device, where results are typically objective measurements or observations (e.g., tensile strength, integrity, tissue effect).

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:

No. This is a filing for an electrosurgical probe, not an AI/ML diagnostic or assistive device. Therefore, MRMC studies are not relevant or performed in this context.

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

No. This is a physical electrosurgical probe, not an algorithm.

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

For the "non-clinical data," the ground truth would typically be established by engineering specifications, regulatory standards (e.g., ISO, ASTM for materials and devices), and physiological outcomes observed in in vivo models or animal studies. The document does not elaborate on the specific "ground truth" for each test, but mentions GLP compliance.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. (See point 8).

Summary

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Category:		Comments
Sponsor:		Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134
Correspondent:		Andrea L. Ruth, RACSenior Associate, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134
Contact Information:		E-mail: rutha@bsci.comPhone: 408.895.3625Fax: 408.895.2202
Device Common Name		Electrosurgical Probe
Device Proprietary Name		Cobra® Cooled Surgical Probe
Device Classification		21 CFR § 878.4400, class II, product code GEI
Predicate Device		Electrosurgical Probe
Predicate Device Manufacturer(s)		Boston Scientific Corporation/EPTechnologies, Inc.
Predicate Device Proprietary Name(s)		Cobra® Surgical Probe
Predicate Device Classification Number		Class II

Date Summary Was Prepared:

September 20, 2002

Description of the Device:

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Intended Use:

Comparison to Predicate Device:

	Predicate Device	Modified Device
510(k) Reference	K981981; K010956	Current Submission
Intended Use	Coagulation of tissue	Same
Device Description	Electrosurgical Probe	Same
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Manufacturer	Boston Scientific Corporation/EP Technologies, Inc.	Same
Device Classification	Class II, 21 CFR §878.4400, code GEI	Same

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 included Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength, Biocompatibility and, both acute and chronic, In vivo performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134

Re: K023291

Trade/Device Name: Cobra® Cooled Cardiac Surgical Probe, Model 1596X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical probe Regulatory Class: Class II (two) Product Code: OCL, GEI Dated: October 1, 2002 Received: October 2, 2002

Dear Ms. Ruth:

This letter corrects our substantially equivalent letter of October 17, 2002.

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.

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Page 2 - Ms. Andrea L. Ruth

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,
Q. Mall.

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

Enclosure

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Attachment 2 Intended Use Statement

510(k) Number (if known):_

Cobra® Cooled Surgical Probe Device Name:

Indication for Use:

・

(023291

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices

510(k) Number	K023291
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Prescription Use		OR	Over-the-Counter Use
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(Per 21 CFR §801.109)

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.