(80 days)
Not Found
No
The summary describes a physical electrode device and its mechanism of action (RF energy for thermal coagulation). There is no mention of software, algorithms, or data processing that would indicate the use of 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 tissue, including partial or complete ablation of nonresectable liver lesions," which are therapeutic treatments.
No
The device is described as an electrode used for thermal coagulation necrosis and ablation of tissue, which is a therapeutic function, not a diagnostic one. It is used to treat conditions, not to identify or characterize them.
No
The device description clearly outlines physical components such as an electrode array, delivery cannula, handle mechanism, introducer sheath/stylet assembly, and connection to an RF generator. This indicates a hardware-based medical 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 "thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions." This describes a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is an electrode array used to deliver radiofrequency energy to heat and destroy tissue. This is a treatment device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, 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 is used for direct therapeutic intervention.
N/A
Intended Use / Indications for Use
The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
Product codes
GEI, JOS
Device Description
The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF 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 tissue, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
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
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
OCT 1 1 2001
510(k) Summary of Safety and Effectiveness KD12315
| Trade Name | LeVeen™ Electrode |
|---|---|
| Common/Classification | |
| Name | Electrosurgical Electrode |
| Classification | Class II |
| Summary of Substantial | |
| Equivalence | The modified LeVeen™ Electrode is substantially |
| equivalent to the previously cleared LeVeen™ Electrode | |
| Device Description | The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array. |
| Intended Use | The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions. |
;
July 20, 2001
RadioTherapeutics Corporation
1308 Borregas Avenue, Sunnyvale, CA 94089 (408) 745-3200 • Fax (408) 745-9848
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing the wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2001
Ms. Kirsten Valley Vice President, Regulatory RadioTherapeutics Incorporated 1308 Borregas Avenue Sunnyvale, California 94089
Re: K012315
Trade/Device Name: LeVeen™ Electrode Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: July 20, 2001 Received: July 23, 2001
Dear Ms. Valley :
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 complies 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 CFR 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.
2
Page 2 - Ms. Kirsten Valley
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 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 Part 801 and additionally 21 CFR Part 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, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walk, my
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
3
510(k) Number (if known): Unifer (in humber
012315
Device Name: The LeVeen™ Electrode
Indications for Use: The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, 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)
SN
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number Kot 2315
Prescription Use
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
OR