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

Device Description

The Cobra Adhere Surgical System 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 procedures.

AI/ML Overview

This looks like a 510(k) submission for a medical device without an AI/ML component. The information provided heavily emphasizes hardware characteristics and intended use for electrosurgical probes, not software or algorithmic performance.

Therefore, many of the requested categories related to AI/ML device performance and testing (such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this document.

The document states: "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 specific acceptance criteria or detailed study results for these non-clinical tests.

Here's a breakdown of the requested information, highlighting what is available and what is not applicable:

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

Acceptance Criteria: Not explicitly stated in the provided document. The document generally refers to "design-input criteria" but does not detail what these criteria were.
Reported Device Performance: The document states 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, no specific performance metrics (e.g., coagulation time, temperature achieved, lesion size, safety endpoints) or quantitative results from these tests are provided.

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

Not applicable for an AI/ML device. This document describes an electrosurgical probe, not an AI/ML system that processes data. The "non-clinical tests" likely involved bench testing and potentially animal models, but no details on sample size or provenance are given.

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 applicable for an AI/ML device. Ground truth, in the context of AI/ML, refers to validated labels for data used to train and test algorithms. This device does not use ground truth in that sense.

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

Not applicable for an AI/ML device. Adjudication relates to resolving discrepancies in ground truth labeling for AI/ML data.

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 not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance would have been conducted or is relevant.

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

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

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

Not applicable for an AI/ML device. See point 3.

8. The sample size for the training set

Not applicable for an AI/ML device. This device is hardware; it does not have a "training set" in the context of machine learning.

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

Not applicable for an AI/ML device. See point 8.

Summary

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SPECIAL 510(K) SUBMISSION Cobra Adhere Surgical System

Page ① of ②

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. MalmborgSenior Specialist, Regulatory AffairsBoston 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 Adhere Surgical System
Device Classification:		21 CFR §878.4400

Predicate Device Information

Predicate Device:	Cobra Cooled Surgical Probe (K032207)
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

Confidential

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Page ② of ③

b. Date Summary Prepared

January 16, 2004

Description of Device c.

d. Intended Use

The intended use for the Cobra Adhere Surgical System is as follows:

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

e. Comparison to Predicate Device

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

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Page ③ 8 ③

	Cobra® Cooled SurgicalProbe	Cobra AdhereSurgical Probe
Device Manufacturer& Name	Boston Scientific Corporation	Same
Device Description	Electrosurgical Probe	Same
510(k) Number	K032207	Same
Regulatory Class	II	Same
Device Classification	21 CFR §878.4400	Same
Intended Use	Coagulation of Cardiac Tissueduring Cardiac surgery andSoft Tissue during GeneralOpen Surgical Procedures	Same
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Shaft Size	9F	Same
Mandrel-Length and	6.5 inches	11.73 inches;
Distal tip OD	0.036 inches	0.035 inches
Tip Material	Polycarbonate	Same
Length	15-35 cm	15-37 cm
Electrode Size	6 to 12.5 mm	Same
9F Hypotube Length	12 inches	8 inches
Electrode Number	2 to 7	Same

Table 1 - Comparison of Device Characteristics to Predicate

Summary of the Non-clinical Data f.

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.

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040104

Trade/Device Name: Cobra Adhere Surgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL. GEI Dated: January 16, 2004 Received: January 20, 2004

FEB 2 1 2008

Dear Ms. Malmborg:

This letter corrects our substantially equivalent letter of February 18, 2004.

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. 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 (OS) 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 vours.

Elmelli

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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K040104

4. Premarket Notification -Indication for Use Statement

Cobra Adhere Surgical System Device Name:

Indication for Use:

The intended use for Cobra Adhere Surgical System 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) Overathe-Counter Use

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

510(k) Number K040104

Boston Scientific Corporation Special 510(k) Submission

Confidential

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.