(183 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on a comparison to predicate devices and bench testing to demonstrate substantial equivalence.
| Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|
| Technological Substantial Equivalence to Predicate Devices: | |
| - Indications For Use | Substantially equivalent |
| - RF Energy Output Type (Frequency, Power, Wave Type) | Substantially equivalent |
| - Treatment Time | Substantially equivalent |
| - Functions (stimulation and ablation) | Substantially equivalent |
| - Safety Monitoring Systems (Temperature, Impedance, Power Output) | Substantially equivalent |
| - Probe Type (single use) | Substantially equivalent |
| Biocompatibility: | Meets ISO 10993-1, AAMI/ISO 10993-7 |
| Sterilization: | Meets ISO 11135 |
| Packaging: | Validated and 100% visual verification for integrity |
| Device Integrity and Functionality: | Qualified/validated using routine manufacturing samples; meets ACI Inc.'s in-house requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense, such as a cohort of patients for an effectiveness or safety study. The "test set" from a regulatory perspective here refers to:
- Bench Testing Samples: Devices produced under routine manufacturing conditions. The exact quantity of samples is not specified.
- Biocompatibility Testing Samples: Not specified, but implied to be sufficient for meeting ISO standards.
- Sterilization Validation Batches: Not specified, but implied to be sufficient for meeting ISO standards.
The data provenance for these tests is internal to ACI Inc. and would be considered retrospective in the sense that they are internal validation tests, not a forward-looking clinical trial. There is no mention of country of origin for any human data, as no human data is presented for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided in the document. No clinical test set with human data requiring expert ground truth establishment for a diagnostic or AI-assisted system is described. The device is a direct treatment tool, and its "performance" is assessed through engineering and bench testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
This is not applicable or provided. There is no clinical test set requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done and is not described in this document. The device is a therapeutic radiofrequency ablation system, not an imaging or diagnostic aid that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The GFX Nerve Ablation System is a physical device (generator and probe) that creates heat lesions. It is not an algorithm, software, or AI system that operates in a "standalone" or "human-in-the-loop" capacity in the way an AI diagnostic tool would. Its performance is evaluated based on its physical and electrical characteristics and ability to produce lesions, as demonstrated through bench testing and comparison to predicate devices.
7. The Type of Ground Truth Used
For the bench testing and validation, the ground truth would be based on:
- Engineering specifications and standards: For RF energy output, temperature control, impedance monitoring, etc. (e.g., meeting specific voltage, current, and temperature targets).
- Biocompatibility standards: (ISO 10993 series for material safety).
- Sterilization efficacy standards: (ISO 11135 for sterility assurance).
- Physical integrity standards: For packaging and device robustness.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device submission's performance evaluation.
8. The Sample Size for the Training Set
This is not applicable. The GFX Nerve Ablation System is not an AI or machine learning device. It does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an algorithm.
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510(K) SUMMARY 11063753
DATE: 1/16/07
SUBMITTER INFORMATION
| A. Company Name: | ACI Inc. | JUN 2 0 2002 |
|---|---|---|
| B. Company Address: | 10940 Parker Road, Suite 513Parker, Colorado 80134 | |
| C. Company Phone: | (303) 790-7109 | |
| D. Company Facsimile: | (303) 790-1029 | |
| E. Company Contact: | W. Michael JanssenPresident / CTO |
DEVICE IDENTIFICATION
| A. Device Trade Name: | Lesion Probe and Generator System |
|---|---|
| B. Device Common Name: | GFX Nerve Ablation System consisting of;GFX Nerve Ablation Generator Model RFG-100 andGFX Nerve Ablation Probe Model PB-100T |
| C. Classification Name: | Radiofrequency Lesion Generator |
| D. Device Class: | Class II |
| E. Device Code: | GXD (proposed) (21 CFR 882.4400) |
PREDICATE DEVICES
Trade Name: Radionics RFG-3CF 510(k) Number: K965182
Trade Name: Mercury Medical Disposable RF Cannula 510(k) Number: K000073
DEVICE DESCRIPTION
GFX Nerve Ablation System (generator and probe):
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.
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INTENDED 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.
COMPARISON TO PREDICATE DEVICES
The GFX Nerve Ablation System is substantially equivalent in the following technological ways to the identified predicate devices;
- Indications For Use -
- RF Energy Output Type
- o Frequency
- o Power
- o Wave Type (pseudo-sinusoidal)
- Treatment Time o
- Functions (stimulation and ablation)
- Safety Monitoring Systems
- Temperature o
- Impedance o
- o Power Output
- Temperature o
- Safety Monitoring Systems
- Probe Type (single use) -
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
ACI Inc. conducts and maintains valid ethylene oxide sterilization processes in accordance with ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity for the sterile probe is initially validated and, in addition, 100% of ACI Inc. devices undergo packaging visual verification prior to transfer to finished goods inventory.
Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All Lesion Probes and Generators meet ACI Inc.'s in-house requirements, and requirements listed in ISO 10993-1, Biological Evaluation of Medical Devices and AAMI/ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues.
CONCLUSION
ﺳ
The GFX Nerve Ablation System (Generator and Probe) are substantially equivalent in technological characteristics and intended use to the predicate devices identified in this summary.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ACI Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
JUN 2 0 2007
Re: K063753
Trade/Device Name: GFX Nerve Ablation System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD, GXI Dated: June 4, 2007 Received: June 5, 2007
Dear Mr. Anselmo:
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 – Mr. Clay Anselmo
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
s,
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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Indications For Use
510(k) Number (if known): K063753
Device Name: GFX Nerve Ablation System
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Concurrence of CDRH, Office of Device Evalu
Over-The-Counter Use (21 CFR 801 Subpart C)
Division of General, Restorative,
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(Division Sign-Off)
510(k) Number
and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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§ 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).