(24 days)
Concerto™ Bipolar Needle Electrode
Not Found
No
The description focuses on the electrosurgical mechanism and hardware, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as an electrosurgical device used for thermal coagulation necrosis of soft tissues, including liver lesions, which directly indicates a therapeutic purpose.
No
The device is described as an electrosurgical device used for thermal coagulation necrosis of soft tissues, not for diagnosis. Its function is to ablate tissue, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a "disposable, electrosurgical device" consisting of a needle, arrays, cannula, and handle mechanism, all of which are physical hardware components.
Based on the provided information, the Concerto™ Bipolar Needle Electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The description details an electrosurgical device that delivers energy to tissue for heating and coagulation. This is a direct intervention on the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Concerto™ Bipolar Needle Electrode is a therapeutic device used for tissue ablation.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All data gathered demonstrate this device as the predicate device substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Concerto™ Bipolar Needle Electrode
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
| General
Information | Submitter: Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
508-683-4003 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Nicholas Condakes |
| General
Provisions | Trade Name: Concerto ™ Bipolar Needle Electrode |
| | Classification Name: Electrode, Electrosurgical |
| Name of
Predicate
Devices | Concerto ™ Bipolar Needle Electrode |
| Classification | Class II |
| Performance
Standards | 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. |
1
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.
Page 2 of 2
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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
3
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
4
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)
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| 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