(139 days)
No
The device description and intended use describe a simple RF cannula used for delivering energy, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for use in RF heat lesion procedures for the relief of pain, which is a therapeutic intervention.
No
The device is used to create heat lesions for pain relief, which is a treatment, not a diagnostic procedure.
No
The device description explicitly states the LesionPoint RF Cannula is a physical, stainless steel cannula with an insulated shaft and exposed tip, which is a hardware component.
Based on the provided information, the LesionPoint RF Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in RF heat lesion procedures for the relief of pain." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The device is a cannula used to deliver RF energy to tissue within the body. This is consistent with an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LesionPoint RF Cannula's function is to deliver energy for therapeutic lesion creation, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
"The LesionPoint RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain."
Product codes
GXI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Data: Cosman Medical has done bench testing on the LesionPoint RF Cannula to confirm performance characteristics of this device.
Key Metrics
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
I-25 & PROMENADE
510(k) Summary of Safety and Effectiveness Information
| Company Information: | Cosman Medical, Inc.
76 Cambridge St., Burlington MA 01803. USA
Tel. 781-272-6561. Fax 781-272-6563
Contact Name: Michael Arnold, Director of RA
(781) 272-6561
email: marnold@cosmancompany.com
Registration 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)
2
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
3
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,
2
Mark N. Molkerson-ري Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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 (