(624 days)
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No
The summary describes a needle electrode for thermal ablation and does not mention any AI or ML components or functions.
Yes
The device is intended for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions," which describes a therapeutic intervention.
No
The LeVeen Needle Electrode is used for thermal coagulation necrosis and ablation of soft tissues, which is a therapeutic function, not a diagnostic one. It treats conditions rather than identifying or characterizing them.
No
The device description and intended use clearly describe a physical needle electrode used for thermal coagulation, indicating it is a hardware device, not software-only.
Based on the provided information, the LeVeen Needle Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions." This is a therapeutic procedure performed in vivo (within the body) to treat tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on sample analysis.
The LeVeen Needle Electrode is a therapeutic device used for tissue ablation, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation 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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissues, liver
Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/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 an eagle or bird with three curved lines representing its wings or body.
Public Health Service
APR 6 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Colin Nichols Official Correspondent RadioTherapeutics Corporation 1308 Borregas Avenue Sunnyvale, California 94089
Re: K982556 Trade Name: Leveen Needle Electrode Regulatory Class: II Product Code: GEI Dated: January 12, 2000 Received: January 13, 2000
Dear Mr. Nichols:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
Although this device is substantially equivalent to other devices used for ablation of soft tissue, we are concerned that users may overestimate the capability of the device. It is on this basis that we are requesting that you include the following statement in the precautions section of the labeling:
The effectiveness of this device for use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Colin Nichols
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he I DA Inding of sabbianian tquir device and permits your device to proceed to the device results in a classification for your device as described in your 510(k) market notification if the limitation statement above is added to your labeling, as described.
If you desire specific information about the application of other labeling requirements to your 11 you don't 500 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, advertising or your dovice, preference to preference to premarket notification'(21 CFR please note the regaration on your responsibilities under the Act may be obtained from 001.777). Oner Echeral Manufacturers 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 yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological IIcalth
Enclosure
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LeVeen Needle Electrode
Indications for Use Statement
The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
ω
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982556 |
|---|---|
| Prescription Use (per 21 CRF 801.109) | |
| OR Over-the-counter Use |
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