The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The ConcertoTM Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the tissue surrounding and in between the arrays. No grounding pads are required due to the device's Bipolar technology.

AI/ML Overview

This document does not contain the detailed information necessary to complete all sections of your request. It is a 510(k) summary for a medical device (Concerto™ Bipolar Needle Electrode) seeking substantial equivalence to a predicate device, not a study report detailing specific acceptance criteria and performance data.

Here's what can be extracted and what cannot:

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

The document states: "The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent." and that the device "has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001."

However, specific numerical acceptance criteria (e.g., minimum power output, maximum temperature, lesion size, etc.) and the precise reported performance values against these criteria are not provided in this summary. It only states that the device was found substantially equivalent.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This device is an electrosurgical needle electrode, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers/AI assistance is not applicable and not mentioned.

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

This refers to AI performance. Since this is a physical medical device (electrode),
"standalone" algorithm performance is not applicable.

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

This information is not provided in the document. For a physical device like this, ground truth would likely involve measurements of ablation size, temperature profiles, impedance, and other physical parameters, rather than expert consensus on images or pathology as seen in diagnostic AI.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of available information:

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

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Compliance with ANSI/AAMI Standard HF-18/2001	Achieved
Compliance with IEC Standard 60601-2-2/2001	Achieved
Substantial equivalence to predicate device (Reflect Bipolar/Monopolar Needle Electrode)	Achieved; "All data gathered demonstrate this device as substantially equivalent."

Missing Information: Specific numerical acceptance criteria, detailed performance metrics (e.g., precise ablation volumes, temperature maximums, power delivery characteristics) for both the predicate and the new device are not disclosed in this 510(k) summary.

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

Sample Size: Not provided.
Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not provided as the ground truth for a physical device like this would typically be based on physical measurements and engineering tests, not expert interpretation of outputs.

4. Adjudication method for the test set:

Not applicable/Not provided.

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 type of study is not applicable to this device, which is an electrosurgical electrode and not an AI-based diagnostic tool.

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

No, this is not applicable to a physical electrosurgical device.

7. The type of ground truth used:

This would likely involve various engineering and preclinical measurements related to the device's technical specifications and tissue ablation characteristics (e.g., power output, temperature distribution, lesion size in ex vivo/in vivo models). However, the specific types of ground truth used are not detailed in this summary.

8. The sample size for the training set:

Not applicable/Not provided.

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

Not applicable/Not provided.

Summary

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APR 2 8 2004

Special 510(k) Concerto™ Bipolar Needle Electrode

March 26, 2004

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Summary of Safety and Effectiveness

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

K040785

General Information	Submitter: Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760508-652-5003
	Contact Person: Nicholas Condakes
General Provisions
Trade Name:	Concerto™ Bipolar Needle Electrode
Classification Name:	Electrode, Electrosurgical
Name of Predicate Devices	Reflect Bipolar/Monopolar Needle Electrode
Classification	Class II
Performance Standards	The Concerto Bipolar Electrode has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001.

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Concerto™ Bipolar Needle Electrode March 26, 2004

Intended Use and Device Description

Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The ConcertoTM Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the No grounding pads are tissue surrounding and in between the arrays. required due to the device's Bipolar technology.

Summary of Substantial Equivalence

The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2004

Mr. Nicholas Condakes Regulatory Specialist II Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760

Re: K040785

Trade/Device Name: Concerto™ Bipolar Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 26, 2004 Received: March 29, 2004

Dear Mr. Condakes:

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 complics 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 CHR 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 - Mr. Nicholas Condakes

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 premaince hoticated 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 If you desire of Compliance at (301) 594-4659. 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 other Economics, 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/cdrb/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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Indications For Use KO40785 510(k) Number (if known) Concerto™ Bipolar Needle Electrode Device Name: Concerto™ Bipolar Needle Electrode is intended to be used in conjunction Indications with a Boston Scientific radiofrequency (RF) generator for the thermal for Use coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

(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 Subpart D)	Miriam C. Provost
	(Division Sign-Off)
	Over-The-Counter Use (21 CFR 807 Subpart C)
	Division of General, Restorative, and Neurological Devices
	ConfidentialBoston Scientific Corporation	000067
510(k) Number	K040785

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.