(50 days)
Not Found
No
The summary describes a standard radiofrequency ablation system for nerve tissue, with no mention of AI or ML capabilities in its function, intended use, or performance studies.
Yes
The device is intended to create heat lesions in nerve tissue to inhibit nerve function, which is a therapeutic intervention.
No
The device is intended to create radiofrequency (RF) heat lesions in nerve tissue to inhibit nerve function, which is a therapeutic rather than a diagnostic purpose. While it can stimulate the nerve for locating the probe correctly, its primary function described is ablative, not diagnostic.
No
The device description explicitly mentions a "Generator and probe" which are hardware components used to deliver RF energy and create lesions. The system is described as a combination of hardware (Generator and probe) and likely software to control these components, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create radiofrequency (RF) heat lesions in nerve tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a "minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve." This involves applying energy to tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health. This device does not process or analyze biological specimens.
The device is a therapeutic device used for nerve ablation, which is a medical procedure performed on a patient.
N/A
Intended Use / Indications for Use
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
Product codes
GXI, GXD
Device Description
The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians in a hospital or clinical setting.
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)
Device integrity and functionality were verified and/or validated using samples produced under routine manufacturing conditions.
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
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).
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Appendix 1-F: Special 510(k) Summary of Safety and Effectiveness
1. Applicant
BioForm Medical, Inc. 4133 Courtnev Road, Suite 10 Franksville, WI 53126 Ph: 262-835-3300 Fax: 262-835-3330
Contact: Lori Hays
2. Date Prepared
June 16, 2008
3. Device Name
Trade Name: GFX Nerve Ablation System
Common Name: Lesion Probe and Generator System
Classification Name(s): Radiofrequency Lesion Probe (21 CFR 882.4725; GXI) Radiofrequency Lesion Generator (21 CFR 882.4400; GXD)
3. Indications for Use
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
Product Description 4.
The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.
5. Substantial Equivalence
The following are the predicate devices that are substantially equivalent to the GFX Nerve Ablation System:
510(k) Number: K063753 Device: GFX Nerve Ablation System BioForm Medical (formerly ACI) 4133 Courtney Rd., Ste. 10 Franksville, WI 53126
510(k) Number: K965182 Device: Radionics RFG-3CF Radionics, Inc. 22 Terry Avenue Burlington, MA 01803
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2081724
b
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6. Summary of Testing
·
Device integrity and functionality were verified and/or validated using samples produced under routine manufacturing conditions.
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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
BioForm Medical, Inc. % Ms. Lori Hays, MT, RAC Director, Regulatory Affairs 4133 Courtney Road, Suite 10 Franksville, Wisconsin 53126
Re: K081729
Trade/Device Name: GFX Nerve Ablation System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: July 28, 2008 Received: July 30, 2008
Dear Ms. Hays:
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.
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Page 2 - Ms. Lori Hays, MT, RAC
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mulhern
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 1-E: Statement of Indications for Use
510(k) Number (if known):
Device Name: GFX Nerve Ablation System
Indications for Use:
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat Iesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
ﺎﺳﻢ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1081729 510(k) Number_