The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues 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

The provided text describes a 510(k) summary for the Cobra® Cooled Surgical Probe, a general electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might expect for an AI/ML medical device.

Therefore, many of the requested sections about acceptance criteria, device performance, ground truth, and sample sizes for AI/ML studies are not applicable or cannot be extracted from this document. The document describes traditional medical device testing.

Here's an attempt to answer the questions based only on the provided text, noting when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for AI/ML device performance (e.g., sensitivity, specificity thresholds). Instead, it describes general non-clinical tests designed to ensure safety and functionality. The "reported device performance" is essentially that these tests were conducted and the device performed adequately to meet the safety and effectiveness requirements for substantial equivalence.

Requirement/Test Category	Acceptance Criteria (Not explicitly stated as numeric thresholds)	Reported Device Performance (Implied Pass)
Fluid Path Integrity	(Implicit: no leaks, maintains integrity)	Testing conducted, conformed to requirements.
Bond Joint Tensile Strength	(Implicit: meets specified strength requirements)	Testing conducted, conformed to requirements.
Bond Joint Torsional Strength	(Implicit: meets specified strength requirements)	Testing conducted, conformed to requirements.
Distal Section Fatigue	(Implicit: withstands expected fatigue)	Testing conducted, conformed to requirements.
Shaft to Handle Tensile Strength	(Implicit: meets specified strength requirements)	Testing conducted, conformed to requirements.
Biocompatibility	(Implicit: non-toxic, non-irritating)	Testing conducted, conformed to requirements.
In vivo performance (acute)	(Implicit: safe and effective coagulation in acute setting)	Testing conducted, conformed to requirements (for coagulation of soft tissues/hemostasis).
In vivo performance (chronic)	(Implicit: safe and effective coagulation in chronic setting)	Testing conducted, conformed to requirements (for coagulation of soft tissues/hemostasis).
Good Laboratory Practices (GLP)	Conformance to 21 CFR Part 58	Testing conformed to 21 CFR Part 58.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided. The "non-clinical data" refers to device engineering and biological testing, not a clinical study with a "test set" of patients/samples in the AI/ML sense. The provenance of the data is that it was generated from testing within Boston Scientific Corporation or their designated labs, conforming to GLP.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. "Ground truth" in the context of expert consensus for a test set is specific to performance studies involving human interpretation or pathology, which is not the type of testing described here.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where multiple human readers assess cases, which is not the focus of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes non-clinical engineering and biocompatibility testing, along with in vivo performance testing. It does not refer to an MRMC study comparing human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No. This device is an electrosurgical probe, which is a physical instrument, not an algorithm. Therefore, a "standalone" algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For the in vivo performance testing, the "ground truth" would implicitly be the observed physiological effect (e.g., successful coagulation, hemostasis, lack of adverse tissue effects) as assessed by the researchers or histopathology following the animal studies. For engineering tests, the ground truth is against a specific engineering specification or standard. The document does not specify how this was established (e.g., specific pathology reports, outcome data, etc.) but states "In vivo performance" was tested.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (electrosurgical probe), not a machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning algorithm, this information is not relevant to this device submission.

Summary

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APR 1 6 2002

Attachment 4510(k) Summary	K021046 1/2
Category:	Comments
Sponsor:	Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134
Correspondent:	Susan R. PoolManager, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134
Contact Information:	E-mail: pools@bsci.comPhone: 408.895.3608Fax: 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
Predicate Device Classification(s)	21 CFR § 878.4400, product code GEI

Date Summary Was Prepared:

March 28, 2002

Description of the Device:

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K021046 2/2

Intended Use:

Comparison to Predicate Device:

	Predicate Device	Modified Device
510(k) Reference	K981981; K010956	Current Submission
Intended Use	Coagulation of tissue	Same
DeviceDescription	Electrosurgical Probe	Same
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Manufacturer	Boston Scientific Corporation/EPTechnologies, Inc.	Same
DeviceClassification	Class II, 21 CFR §878.4400, codeGEI	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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of a human figure, with three abstract shapes forming the body and head, symbolizing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2002

Ms. Susan Pool Regulatory Manager Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re: K021046

Trade/Device Name: Cobra Cooled Surgical Probe, Model 1596X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 28, 2002 Received: April 1, 2002

Dear Ms. Pool:

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. Susan Pool

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse of substantial equivalence of your device to a legally promatics notification: "The Pressification 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 and If you desire specific ad roo for your witten diagnostic devices), please contact the Office of additionally 21 OF IC For 659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1007 - 1007 - 1001) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I cither general information on your responsibilities under the Act may be obtained from the Other general mionmator thernational 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

Cor Celia 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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Attachment 2 Intended Use Statement

KO21046 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Cobra® Cooled Surgical Probe Device Name:

Indication for Use:

The Probe is intended for use only under direct visual control of the physician The I robe is incended for ass base of a coagulate soft tissues. The Probe during open, general bargical produce blood and soft tissues to produce hemostasis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR §801.109)

Over-

Over-the-Counter Use_

Muriam C. Provost

ion of General, Restorative Neurological Device

510(k) Number K021046

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.