COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA

K060799 · Cosman Medical, Inc. · GXI · May 2, 2006 · Neurology

Device Facts

• Record ID: K060799
• Device Name: COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
• Applicant: Cosman Medical, Inc.
• Product Code: GXI · Neurology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

Device Story

Cosman RF Cannula is a sterile, single-use, disposable stainless steel cannula with an insulated shaft and exposed tip. Used in conjunction with a compatible RF generator (e.g., Cosman RF Generator K050084) to deliver radiofrequency energy to tissue. Operated by clinicians in a clinical setting to create RF heat lesions for pain relief. The device functions by conducting RF energy from the generator to the target tissue via the uninsulated tip. The clinician monitors the procedure via the generator interface to control lesion creation, aiming to provide therapeutic pain relief.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel cannula with insulated shaft and exposed tip. Sterile, single-use, disposable. Available in various lengths and gauges. Operates as a passive delivery component for RF energy from an external generator.

Indications for Use

Indicated for patients requiring RF heat lesion procedures for pain relief.

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

• LesionPoint RF Cannula (K053415)
• Neurotherm RF Cannula (K994344)
• Technomed Europe SMK Cannula (K042375)
• Cosman Medical RF Cannula & TC Electrodes (K050084)
• Smith & Nephew RF Cannula (K034012)
• Diros Facet Rhizotomy Electrode & Cannula (K010202)

Submission Summary (Full Text)

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060799

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## 510(k) Summary of Safety and Effectiveness Information

## MAY 2 2006

| Company Information: | Cosman Medical, Inc.<br>76 Cambridge St., Burlington MA 01803. USA<br>Tel. [phone]. Fax [phone]<br>Contact Name: Michael Arnold, Director of RA<br>[phone]<br>email: [e-mail]<br>Registration No.: 3004867882 |
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| Date Prepared: | April 28, 2006 |
| Trade Names: | Cosman CSK RF Cannula<br>Cosman RFK RF Cannula |
| Common Name: | Radiofrequency Lesion Probes |
| Classification: | CFR 882.4725, Radiofrequency Lesion Probe,<br>Class II Neurology Devices, Product Code: GXI |
| Predicate Devices: | LesionPoint RF Cannula (K053415)<br>Neurotherm RF Cannula (K994344)<br>Technomed Europe SMK Cannula (K042375)<br>Cosman Medical RF Cannula & TC Electrodes<br>(K050084)<br>Smith & Nephew RF Cannula (K034012)<br>Diros Facet Rhizotomy Electrode & Cannula<br>(K010202) |

Description: The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.

Intended Use: The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

Comparison to Predicate: The Cosman RF Cannula has similar physical and technical characteristics to the predicate devices.

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K060799

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Non-Clinical Data: Cosman Medical has done bench testing on the Cosman RF Cannula to confirm performance characteristics of this device.

Conclusion: The comparison to the predicate device demonstrates that the Cosman RF Cannula is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

COSMAN MEDICAL, INC.

Michael Arnold

Michael A. Arnold, PhD Director of Regulatory Affairs and Quality Assurance

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2006

Cosman Medical, Inc. c/o Mr. Michael Arnold Director of Regulatory Affairs 76 Cambridge Street Burlington, Massachusetts 01803

Re: K060799

Trade/Device Name: Cosman RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: March 22, 2006 Received: March 24, 2006

Dear Mr. Arnold:

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

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Page 2 - Mr. Michael Arnold

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. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

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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Ko60799

## Indications for Use

510(k) Number (if known):

Device Name: Cosman RF Cannula

Indications For Use:

" The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain. "

Prescription Use _ X AND/OR 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)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_Kolorifi

Cosman RF Cannula 510(k)