(148 days)
Not Found
No
The document describes a physical medical device (needle electrode) and its function (thermal ablation using RF energy). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are bench tests of the physical components.
Yes
The device is intended for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions," indicating a direct therapeutic action on the body.
No.
The device is used for thermal coagulation necrosis of soft tissues, which is a treatment, not a diagnostic procedure. It aims to ablate tissue rather than provide information about a medical condition.
No
The device description clearly outlines a physical needle electrode, handle mechanism, and connection to an RF generator, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions." This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The description details a physical electrode array that delivers RF energy to the patient's tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes 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 diagnostic, monitoring, or compatibility purposes. This device's function is to treat tissue directly.
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 The description of the proposed inouthed Lovech Reetrode consists of a preshaped. multi-amed electrode array which is contained within a delivery cannula. The array is a revice is attached to a handle mechanism that deploys the array into targeted tissue. The device is attached 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
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)
Bench Testing has been performed on the proposed Leveen Superslim Needle Electrode device with PEEK insulation, which demonstrates that the PEEK insulation met the required specifications for the completed design verification, electrical tests and biocompatibility tests.
Bench Testing has been performed on the proposed, Leveen. Superslim Needle Electrode device with modified handle and cannula design, which demonstrates that the handle and cannula re-design met the required specifications for the completed design verification tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
MAR 1 5 2012
K 113090 PAGE 1 OF 2
SECTION 6 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4359 Fax: 508-683-5939
Contact: Ashley Pyle Director Regulatory Affairs Date Prepared: September 12, 2011
2. Device:
Trade Name: LeVeen SuperSlim Needle Electrode Common Name: Electrode, Electrosurgical, Common 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 Superslim Needle Electrode, K092009
4. Device Description:
The description of the proposed modified LeVeen Needle Electrode is the same as the The description of the proposed inouthed Lovech Reetrode consists of a preshaped. multi-amed electrode array which is contained within a delivery cannula. The array is a revice is attached to a handle mechanism that deploys the array into targeted tissue. The device is attached 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 The Leveen SuperSimmanoothe Drobe thermal coagulation nocrosis of soft tissues, .
radiofrequency (RF) generator for the thermal coagulation no coasing ma including partial or complete ablation of nonresectable liver lesions.
1
6. Technological Characteristics:
The proposed Leveen Superslim Needle Electrode device will have PEEK insulation. The currently cleared Levcen Superslim Needle Electrode insulation material is FEP (K092009).
The proposed Leveen Superslim Needle Electrode device has a modified handle and cannula The proposed to the currently cleared Leveen Superslim Needle Electrode (K092009).
7. Performance Data:
Bench Testing has been performed on the proposed Leveen Superslim Needle Electrode device with PEEK insulation, which demonstrates that the PEEK insulation met the required specifications for the completed design verification, electrical tests and biocompatibility tests.
Bench Testing has been performed on the proposed, Leveen. Superslim Needle Electrode device with modified handle and cannula design, which demonstrates that the handle and cannula re-design met the required specifications for the completed design verification tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Leveen Superslim Needle Electrode is substantially equivalent to the currently cleared Leveen Superslim Needle Electrode (K092009).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 5 2012
Boston Scientific Corporation % Ms. Ashley Pyle 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K113090
Trade/Device Name: LeVeen SuperSlim Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 02, 2012 Received: March 05, 2012
Dear Ms. Pyle:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Ms. Ashley Pyle
comply 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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 807.97). For questions regarding 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 5 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined
KII3090
Device Name: LeVeen SuperSlim Needle Electrode
Indications For Use:
The LeVeen SupersSlim Needle Electrode is intended to be used in conjunction with a
reers. The LeVeen Supersonin Needie Excertator the thermal coagulation necrosis of soft tissues,
radiofrequency (RF) generator for the thermal coagulation lissions factioneduction (101) generator romonresectable 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 | K113090 |
|---|---|
| --------------- | --------- |
Special Premarket Notification, LeVeen SuperSlim Needle Electrodes
000015