COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;

K050084 · Cosman Medical, Inc. · GXI · Mar 17, 2005 · Neurology

Device Facts

• Record ID: K050084
• Device Name: COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT
• Applicant: Cosman Medical, Inc.
• Product Code: GXI · Neurology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Device Story

Device consists of RF lesion generator (Model RFG-1A) and associated RF lesion probes; used by clinicians to create thermal lesions in nerve tissue. System delivers radiofrequency energy to target tissue via probes to treat pain or perform functional neurosurgery. Device operates by generating RF current; energy application creates controlled lesions. Used in clinical settings by physicians. Output allows for precise nerve tissue ablation; facilitates pain relief and neurosurgical intervention.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiofrequency lesion generator and associated probes. System delivers RF energy for thermal tissue ablation. Non-sterile supply. Class II medical device (21 CFR 882.4400, 882.4725).

Indications for Use

Indicated for patients requiring radiofrequency lesioning for pain management or functional neurosurgical nerve tissue lesioning.

Regulatory Classification

Identification

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

Predicate Devices

• Radionics RFG-3C Plus Lesion Generator (K982489)
• Radionics SMK Sluijter-Mehta Kit (K870028, K963577, K980430)
• Radionics Microelectrode Kit (K991399)
• Diros Technology URF-2AP Lesion Generator (K021869)
• Diros Technology URP-2A and Associated Radiofrequency Probes (K010202)

Submission Summary (Full Text)

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MAR 1 7 2005

050084

| General Device Summary | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | Cosman RF Lesion Generator, Model RFG-1A, and<br>associated Radiofrequency Lesion Probes |
| Proprietary Trade Name: | Cosman RF Lesion Generator, Model RFG-1A<br>Cosman Radiofrequency Lesion Probes |
| Manufacturer: | Cosman Medical, Inc.<br>76 Cambridge St., Burlington MA 01803. USA<br>Tel. [phone]. Fax [phone] |
| Contact Name: | Michael Arnold, Director of RA/QA<br>email: [e-mail] |
| Establishment Registration No.: | Number not assigned |
| Sterilization Site Address: | No part of this device is supplied sterile. |
| Classification: | 882.4400, Radiofrequency Lesion Generator, Class II<br>Neurology Devices, Product Code: GXD<br><br>882.4725, Radiofrequency Lesion Probe, Class II<br>Neurology Devices, Product Code: GXI |
| Performance Standard: | No applicable performance standards have been issued<br>under section 514 or under section 513(b) of the Food,<br>Drug, and Cosmetic Act. |
| Predicate Devices: | Radionics RFG-3C Plus Lesion Generator (K982489)<br>Radionics SMK Sluijter-Mehta Kit (K870028,<br>K963577,K980430 and Preamendment Devices)<br>Radionics Microelectrode Kit (K991399)<br>Diros Technology URF-2AP Lesion Generator (K021869)<br>Diros Technology URP-2A and Associated Radiofrequency<br>Probes (K010202) |

Intended Use: The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Device Equivalence: The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes have been compared to previously 510(k) cleared devices with respect to intended use and technological characteristics. Performance testing was done to

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Page 2 of (2)

results in this 510(k) notification show that the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes are substantially equivalent to predicate devices and are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines.

MAR 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Mr. Michael Arnold Director of RA/QA Cosman Medical, Inc. 76 Cambridge Street Burlington, Massachusetts 01803

Re: K050084

K03008+
Trade/Device Name: Cosman RF Lesion Generator, Model RFG-1A Cosman Radiofrequency Lesion Probes Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: January 11, 2005 Received: January 13, 2005

Dear Mr. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the ievice We have reviewed your Section 9 ro(ts) premained in substantially equivalent (for the indications relerenced above and nave use are are are are are are and a severes marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Ameridae, or to commerce prior to May 20, 1770, the encordance with the provisions of the Federal Food. Drug. devices that have been icclassified in accerative while approval application (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (soc abore) als. Existing major regulations affecting your device can may be subject to saen adamons. Title 21, Parts 800 to 898. In addition. FDA may be found in the Code of Pouchal States oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease oc advised that I Dri 3 issuares vith other requirements of the requirements of the Act that FDA has made a determinations administered by other Federal agencies. You must of any I cacraf statutes and regalations and limited to: registration and listing (21 comply with an the Act STequirements, as see and manufacturing practice requirements as set CFK Fall 807), adoning (21 CFR Part 807), go are if applicable, the clectronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael Arnold

This letter will allow you to begin marketing your device as described in your Section 51 0(k) I his ietter will anow you to begin manitoting your and equivalence of your device to a legally premarket nothleadon. The PDA miams of cassification 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 If you desire specific advice for your ac not 240) 276-0115. Also, please note the regulation entitled.
Contact the Office of Compliance at [phone]. Also, please not contact the Office of Compunation is (21 trial Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204) or Manufacturers, International and Outsailters http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Gr Miriam C. Provost, Ph.D. Acting Director Division of General. Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K050084

Device Name: Cosman RF Lesion Generator, Model RFG-1A and associated Radiofrequency Lesion Probes

Indications For Use:

"The Cosman Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. "

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use X ___________________________________________________________________________________________________________________________________________________________ AND/OR

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of (Division Sign-Off) Division of General, Restorative,

and Neurological Devices

510(k) Number_KO500004