(90 days)
The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.
Not Found
This document is a 510(k) summary for the Cosman G4 Radiofrequency Generator, which is a medical device. This type of document focuses on establishing substantial equivalence to existing devices rather than presenting a detailed clinical study demonstrating acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this filing.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria in the provided text. The document states that "Performance testing was done to validate the intended use of the Cosman device." However, specific quantitative acceptance criteria (e.g., "output power must be within X% of target") are not detailed.
- Reported Device Performance: Not detailed in this summary. The 510(k) summary asserts "The comparison and performance test results in this 510(k) notification show that the Cosman G4 Radiofrequency Generator is substantially equivalent to the predicated devices and is safe and effective for the intended use." This indicates that performance data was collected and reviewed by the FDA, but the actual data and specific performance metrics are not included in this high-level summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. Performance testing is mentioned, but details about the test set, its size, or provenance are absent. For a radiofrequency generator, performance testing typically involves bench testing or animal studies, not human data sets in the way AI/ML devices do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. For a device like a radiofrequency generator, "ground truth" would relate to its physical output and operational parameters rather than clinical diagnoses established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This concept is typically relevant for studies involving human interpretation (e.g., image analysis for AI devices).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a radiofrequency generator, not an AI-assisted diagnostic tool or an imaging device that requires human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device. Its performance is directly tied to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. For a physical device like this, "ground truth" for performance testing would likely involve objective measurements of electrical output (e.g., power, impedance, temperature at the probe tip) against specifications, using calibrated equipment.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning device.
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OCT 1 6 2008
K0 82051
Page 1 of ①
510(k) Summary
| Device Name: | Cosman G4 Radiofrequency Generator |
|---|---|
| Common Name: | G4 |
| Manufacturer: | Cosman Medical, Inc.76 Cambridge St., Burlington MA 01803. USATel. 781-272-6561. Fax 781-272-6563 |
| Contact Name: | Louis Falcone, Director of RA/QAemail: Ifalcone@cosmanmedical.com |
| Establishment Registration No.: | 3004867882 |
| Classification: | 882.4400, Radiofrequency Lesion Generator, Class IINeurology Devices, Product Code: GXD |
| Performance Standard: | No applicable performance standards have been issuedunder section 514 or under section 513(b) of the Food,Drug, and Cosmetic Act. |
| Predicate Devices: | Cosman RF Lesion Generator, model RFG-1A(FDA Substantial Equivalence, K050084) |
| NeuroTherm RF Pain Management Generator NT1000(FDA Substantial Equivalence, K052878) |
Statement of Intended Use: The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.
Device Substantial Equivalence: The Cosman G4 Radiofrequency Generator has been compared to previously 510(k) cleared devices with respect to intended use and tachnological characteristics. Performance testing was done to validate the intended use of the Cosminon device. The comparison and performance test results in this 510(k) notification show that the Cosman G4 Radiofrequency Generator is substantially equivalent to the predicated devices and is safe and effective for the intended use.
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Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The bird is facing to the right and has three stylized wing shapes.
OCT 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cosman Medical, Inc. % Mr. Louis Falcone Director, RA/QA 76 Cambridge Street Burlington, Massachusetts 01803
Rc: K082051
Trade/Device Name: Cosman G4 Radiofrequency Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator. Regulatory Class: II Product Code: GXD Dated: September 08, 2008 Received: September 26, 2008
Dear Mr. Falconc:
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. Louis Falcone
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 vours.
Mark N. Millerson
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 Statement
510(k) Number: (if Known)
0 82051
Device Name: Cosman G4 Radiofrequency Generator
Indications for Use Statement: The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.
Prescription Use X
Over-The Counter Use
(part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R. Oyler Forman
(Division Sign-6 Division of General, Restorative, and Neurological Devices
510(k) Number K082051
§ 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).