(123 days)
Not Found
No
The summary describes a physical medical device (electrode) and its function (thermal ablation) without mentioning any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as being used for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions," which are therapeutic actions.
No
This device is described as an electrode for thermal coagulation necrosis and ablation of soft tissues, not for diagnosing conditions. It is used to treat, not to identify or monitor.
No
The device description clearly outlines physical components like a needle electrode, delivery cannula, handle mechanism, and connection to an RF generator, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the thermal coagulation necrosis of soft tissues within the body using radiofrequency energy. This is a therapeutic procedure performed directly on a patient.
- Device Description: The device is a needle electrode designed to be inserted into tissue and connected to an RF generator. This is a surgical or interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body to diagnose a condition. IVDs are used to perform tests on biological specimens.
Therefore, the LeVeen SuperSlim Needle Electrode is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LeVeen SuperSlim Needle Electrode is intended to be used in conjunction with a 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 description of the proposed modified LeVeen Needle Electrode is the same as the predicate devices. The LeVeen SuperSlim Needle Electrode consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, 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
Testing has been completed to demonstrate that the proposed changes do not result in any new issues of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
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
SECTION 5 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4178 Fax: 508-683-5939
Contact: Jennifer A. Kimball Director Regulatory Affairs Date Prepared: July 2, 2009
2. Device:
Trade Name: LeVeen SuperSlim Needle Electrode Common Name: Electrode, Electrosurgical Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's LeVeen Needle Electrode, K000032 Boston Scientific Corporation's LeVeen Needle Electrode, K982556
4. Device Description:
The description of the proposed modified LeVeen Needle Electrode is the same as the predicate devices. The LeVeen SuperSlim Needle Electrode consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
5. Intended Use:
The LeVeen SuperSlim Needle Electrode is intended to be used in conjunction with a radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
NOV - 6 2009
1
6. Technological Characteristics:
The technological characteristics are identical to the predicate device.
7. Performance Data:
Testing has been completed to demonstrate that the proposed changes do not result in any new issues of safety or effectiveness.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed changes do not raise any new issues of safety or effectiveness.
ﮨﮯ۔
000011
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 an abstract symbol resembling a stylized eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Ms. Jennifer Kimball Director Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01545
NOV - 6 2009
.Re: K092009
Trade Name: Modifications to: LeVeen SuperSlim Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Class: II Product Code: GEI Dated: October 8, 2009 Received: October 9, 2009
Dear Ms. Kimball:
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 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 cormly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 – Ms. Jennifer Kimball
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you doshe specific ad roo sor your your your contrices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation only the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
Puc Pailton m Ve
Des
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined
Device Name: LeVeen SuperSlim Needle Electrode
Indications For Use:
The LcVcen SupersSlim Needle Electrode is intended to be used in conjunction with a radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/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 Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | 1092009 |
Special Premarket Notification, LeVeen SuperSlim Needle Electrodes