(30 days)
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Not Found
No
The summary describes a physical electrosurgical device and its intended use with an RF generator. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is described as an electrosurgical device used for thermal coagulation necrosis of soft tissues, which targets and treats non-resectable liver lesions, indicating a therapeutic purpose.
No
The device is described as an electrosurgical device used for thermal coagulation necrosis and ablation of soft tissues, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states it is a disposable, electrosurgical device consisting of a needle, arrays, handle mechanism, and delivery cannula, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description: The description details a surgical device used to deliver energy to tissue for ablation. It's a tool for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, 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 the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Concerto™ Bipolar Needle Electrode is a therapeutic device used for treatment.
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 ablation 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissues, including partial or complete ablation of nonresectable liver lesions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Reflect Bipolar/Monopolar 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.
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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
APR 2 8 2004
Special 510(k) Concerto™ Bipolar Needle Electrode
March 26, 2004
న్న
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.
| General Information | Submitter: Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760
508-652-5003 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
1
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.
2
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.
3
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 | ||
| Confidential | ||
| Boston Scientific Corporation | 000067 | |
| 510(k) Number | K040785 |