(28 days)
No
The summary describes a standard electrosurgical device for thermal ablation and makes no mention of AI or ML capabilities.
Yes
The device is used for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions, which is a therapeutic intervention.
No
The device is used for thermal coagulation necrosis of soft tissues for treatment purposes (ablation), not for diagnosis.
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, the Concerto™ Bipolar Needle Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Concerto™ Bipolar Needle Electrode Function: The description clearly states that the Concerto™ Bipolar Needle Electrode is an electrosurgical device used for the thermal coagulation necrosis of soft tissues within the body. It directly interacts with and treats tissue, rather than analyzing a sample taken from the body.
- Intended Use: The intended use is for the ablation of soft tissues and liver lesions, which is a therapeutic procedure performed directly on the patient.
Therefore, the Concerto™ Bipolar Needle Electrode is a therapeutic device, not an in vitro diagnostic device.
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
GEI
Device Description
The Concerto™ Bipolar Needle Electrode is a dispossable, 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, including nonresectable liver lesions.
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
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
Not Found
Predicate Device(s)
Concerto™ Bipolar Needle Electrode K050301
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR i 4 2005
Summary of Safety and Effectiveness Page 1 of 2
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
K050361
| General Information | Submitter: Boston Scientific Corporation
100 Fairbanks Boulevard
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
Special 510(k) Modified Concerto™ Bipolar Needle Electrode February 11, 2005
Page 2 of 2
Concerto™ Bipolar Needle Electrode is intended to be used in conjunction Intended Use with a Boston Scientific radiofrequency (RF) generator for the thermal and Device with a Decree over wis of soft tissues, including partial or complete ablation of Description courcesectable liver lesions. The Concerto™ Bipolar Needle Electrode is a dispossable, 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.
Summary of Substantial Equivalence
The Concerto™ Bipolar Needle Electrode has been tested and compared to All data gathered demonstrate this device as the predicate device. substantially equivalent. No new issues of safety or efficacy have been raised.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 ¿ 2005
Mr. Nicholas Condakes Senior Regulatory Affairs Specialist Boston Scientific Corporation 100 Fairbanks Boulevard Marlborough, Massachusetts 01752
Re: K050361
K050301
Trade/Device Name: Concerto™ Bipolar Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Number. 21 CFR 876.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 11, 2005 Received: February 14, 2005
Dear Mr. Condakes:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and nave determined the arreed predicate devices marketed in interstate for use stated in the encrosule for legally manative provide (Device Amendments. Or to commerce prior to May 28, 1776, the endeminent with the provisions of the Federal Food. 12mg. devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a prevalisions of the Ac and Cosmetic Act (Act) that do not require approval controls) provisions of the Act. The
You may, therefore, market the device, subject to the generation, licium of You may, therefore, market the device, seejos, so the one of registration. Insting of general controls provisions of the Act morade read prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in If your device is classifica (seculture) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Existing may - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of I sates oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a business with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination that your atered by other Federal agencies. You must of any Federal statures and regulations daminding, but not limited to registration and listing ( 2 )
comply with all the Act's requirements, including, but not the requiremen comply with an the Act 3 requirements, morading, canufacturing practice requirements as set a CFK Part 607), labering (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party (21 CFR 1000 1050 form in the quality systems (QD) regalantin (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 5 (0(k) I his letter will anow you to begin manening your antial 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 Pair annovided If you desire specific advice for your as not the regulation of the regulation entitled. colliact the Office of Complaned (210) = 16 = 16 = 16 = 1 = 1 807.97). You may obtain Mission of Creation on your responsibilities under the Act from the Division of Small other gelleral information on your responsivenes at its toll-free number (800) 63-204) on (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Mulkerso
Miriam C. Provost, Ph.D. 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) | K050361 |
|---|---|
| Device Name: | Concerto™ Bipolar Needle Electrode |
| 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. | |
| Prescription Use | |
| (Per 21 CFR 801 Subpart D) | ✗ |
| OR | |
| Over-The Counter Use | |
| (21 CFR 807 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
| Confidential
| Boston Scientific Corporation | 510(k) Number K050361 000077 |
|---|---|
| ----------------------------------------------- | ------------------------------ |