(24 days)
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 able them 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 Concerto™ 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.
The provided text describes a Special 510(k) for a modified Concerto™ Bipolar Needle Electrode. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to the predicate device. It usually focuses on demonstrating that the modifications do not raise new issues of safety or effectiveness and often relies on performance standards rather than extensive clinical studies or AI algorithm performance evaluations.
Based on the provided text, the device is a hardware product (an electrosurgical needle electrode), not an AI/ML powered medical device. Therefore, much of the requested information regarding AI-specific criteria (like AI algorithm performance, test/training sets, experts for ground truth, MRMC studies) is not applicable.
Here's an analysis of the provided text with respect to the questions, focusing on what is available and noting what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance (as stated in submission) |
|---|---|
| Compliance with applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001. | "The modified Concerto Bipolar Needle 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." |
| Compliance with International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001. | "The modified Concerto Bipolar Needle 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." |
| Substantial Equivalence to the predicate device (Concerto™ Bipolar Needle Electrode). | "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." The text indicates the device "has been tested and compared to the predicate device." However, specific quantitative performance metrics comparing the modified device to the predicate are not provided in this summary. The stated performance is a qualitative declaration of substantial equivalence based on unspecified "data gathered" and comparison testing. |
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 given text. The filing is a Special 510(k), which focuses on design changes and compliance with performance standards for hardware, not typically on extensive clinical data or algorithm performance. The device is tested and compared to the predicate device, but details of this testing (sample sizes, prospective/retrospective nature, data provenance) are not included in the summary.
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 question is not applicable as the device is a hardware medical device (electrosurgical needle electrode), not an AI/ML powered device requiring expert-established ground truth for a test set in the traditional sense of image analysis or diagnostic AI. The "ground truth" for this device would refer to its performance against engineering specifications and its ability to achieve thermal coagulation necrosis as intended, assessed through engineering and possibly animal/cadaveric bench testing, rather than expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI/ML evaluations where there is a need to resolve discrepancies in expert interpretations or diagnoses.
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 question is not applicable. An MRMC study is relevant for evaluating the clinical utility of diagnostic aids, especially AI algorithms, on human reader performance. This device is an interventional electrosurgical tool, not a diagnostic imaging or AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an electrosurgical needle electrode, which is a physical tool operated by a clinician, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given this is a hardware device, the "ground truth" would likely refer to:
- Engineering specifications and measurements: Verifying electrical conductivity, insulation integrity, deployment mechanism, material properties, and dimensional accuracy.
- Bench testing: In vitro models to demonstrate coagulation zone formation and temperature profiles.
- Pre-clinical (animal/cadaveric) studies: To assess tissue effects, coagulation necrosis size, and safety.
The text states, "The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent." This implies that the ground truth for comparison was established through performance testing against the predicate and established standards, rather than expert consensus on diagnostic images or pathology reports with respect to an AI output.
8. The sample size for the training set
This question is not applicable. As a hardware medical device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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KO60419 Special 510(k) Modified Concerto™ Bipolar Needle Electrode February 16, 2006
MAR 1 3 2006
Page 1 of 2
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| GeneralInformation | Submitter: Boston Scientific Corporation100 Boston Scientific WayMarlborough, MA 01752508-683-4003 |
|---|---|
| Contact Person: Nicholas Condakes | |
| GeneralProvisions | Trade Name: Concerto ™ Bipolar Needle Electrode |
| Classification Name: Electrode, Electrosurgical | |
| Name ofPredicateDevices | Concerto ™ Bipolar Needle Electrode |
| Classification | Class II |
| PerformanceStandards | The modified Concerto Bipolar Needle Electrode has been designed tocomply with the applicable sections of ANSI/AAMI American Standard forElectrosurgical Devices HF-18/2001 and the International ElectrotechnicalCommission Standard for Electrosurgical Devices, IEC 60601-2-2/2001. |
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Intended Use Concerto™ Bipolar Needle Electrode is intended to be used in conjunction and Device with a Boston Scientific radiofrequency (RF) generator for the thermal Description 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 Concerto™ 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. The Concerto™ Bipolar Needle Electrode has been tested and compared to Summary of Substantial All data gathered demonstrate this device as the predicate device. Equivalence 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.
MAR 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corp c/o Mr. Nicholas Condakes Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K060419
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: February 28, 2006 Received: March 1, 2006
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 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
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Page 2 - Mr. Nicholas Condakes
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 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 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
ell. Mdl
-+1'11--
Mark N. Melkerson Acting 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
510(k) Number (if known):
Device Name: Concerto™ Bipolar Needle Electrode
Indications Concerto™ Bipolar Needle Electrode is intended to be used in conjunction for Use: with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete able them of nonresectable liver lesions.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(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 | |
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510(k) Number_ Ko60419
00126
§ 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.