LESIONPOINT RF CANNULA by COSMAN MEDICAL, INC.

The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint 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 LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.

AI/ML Overview

The provided 510(k) summary for the LesionPoint RF Cannula does not contain acceptance criteria or detailed study information.

The summary states:

Non-Clinical Data: "Cosman Medical has done bench testing on the LesionPoint RF Cannula to confirm performance characteristics of this device."
Conclusion: "The comparison to the predicate device demonstrates that the LesionPoint RF Cannula is safe and effective and is substantially equivalent to the predicate devices."

This document is a marketing application for a medical device seeking substantial equivalence to existing predicate devices. For such applications, detailed performance metrics, acceptance criteria, and comprehensive study results like those requested are typically not included in this summary document. The FDA determines substantial equivalence based on the device's intended use, technological characteristics, and safety and effectiveness information compared to predicates, often relying on a combination of bench testing, comparisons to predicate devices, and sometimes (but not always for 510(k)s) clinical data.

Therefore, for the specific questions:

A table of acceptance criteria and the reported device performance: Not provided in the document. The document only mentions "bench testing...to confirm performance characteristics." No specific metrics or acceptance criteria are reported.
Sample size used for the test set and the data provenance: Not provided. The document only mentions "bench testing." No details on sample size or data provenance (e.g., country, retrospective/prospective) are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The document doesn't describe a test set requiring expert ground truth for performance evaluation of classification or diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 cannula, not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided. The device undergoes "bench testing," which typically involves engineering and physical property measurements rather than ground truth based on clinical or expert consensus.
The sample size for the training set: Not applicable/not provided. The document doesn't mention a training set, as it's not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided 510(k) documentation focuses on demonstrating substantial equivalence to predicate devices through physical and technical characteristic comparisons and general bench testing, rather than detailed performance studies with specific acceptance criteria as might be seen for novel diagnostic or AI-powered devices.

Summary

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K053415

I-25 & PROMENADE

510(k) Summary of Safety and Effectiveness Information

Company Information:	Cosman Medical, Inc.76 Cambridge St., Burlington MA 01803. USATel. 781-272-6561. Fax 781-272-6563Contact Name: Michael Arnold, Director of RA(781) 272-6561email: marnold@cosmancompany.comRegistration No.: 3004867882
Date Prepared:	April 21, 2006
Trade Name:	LesionPoint Cannula
Common Name:	Radiofrequency Lesion Probes
Classification:	CFR 882.4725, Radiofrequency Lesion Probe,Class II Neurology Devices, Product Code: GXI
Predicate Devices:	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)

Description: The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint 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 LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.

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

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

LesionPoint 510(k)

Page 1 of 2 - 4/21/2006

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K05-3415

Page 2 of 2

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

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

Very truly yours,

COSMAN MEDICAL, INC.

Michael Arnold

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

LesionPoint 510(k)

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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 eagle with three lines representing its body and wings. The eagle faces right and has its head slightly tilted upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ABS 2 5 2006

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

Re: K053415

Trade/Device Name: LesionPoint RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: April 11, 2006 Received: April 13, 2006

Dear Dr. 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 -- Michael A. Arnold, Ph.D.

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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Molkerson-ري Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K053415-

Indications for Use

510(k) Number (if known): K053415

Device Name: LesionPoint RF Cannula

Indications For Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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 ____________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off Division of Genera. Restorative, and Neurological Devices

: : : 115 D 510(k) Number_ Y (

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
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.(b)
Classification. Class II (performance standards).