(63 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use are focused on a radiofrequency lesion generator, which is a traditional medical device technology.
Yes
The device is indicated for creating radiofrequency lesions for the treatment of pain and for lesioning nerve tissue for functional neurosurgical procedures, which are therapeutic interventions.
No
The device is indicated for creating radiofrequency lesions to treat pain or for lesioning nerve tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly mentions a "Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures." This describes a therapeutic intervention performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The description of a "Lesion Generator" and "Lesion Probes" aligns with a device used for surgical or therapeutic procedures, not diagnostic testing of samples.
Therefore, the Cosman Radiofrequency Lesion Generator, Model RFG-1A, is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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. "
Product codes
GXD, GXI
Device Description
Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerve tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was done to 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982489, K870028, K963577, K980430, K991399, K021869, 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
MAR 1 7 2005
050084
| General Device Summary | |
|---|---|
| Device: | Cosman RF Lesion Generator, Model RFG-1A, and |
| associated Radiofrequency Lesion Probes | |
| Proprietary Trade Name: | Cosman RF Lesion Generator, Model RFG-1A |
| Cosman Radiofrequency Lesion Probes | |
| Manufacturer: | 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/QA |
| email: marnold@cosmancompany.com | |
| 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 |
| Neurology Devices, Product Code: GXD |
882.4725, Radiofrequency Lesion Probe, Class II
Neurology Devices, Product Code: GXI |
| Performance Standard: | No applicable performance standards have been issued
under section 514 or under section 513(b) of the Food,
Drug, and Cosmetic Act. |
| Predicate Devices: | Radionics RFG-3C Plus Lesion Generator (K982489)
Radionics SMK Sluijter-Mehta Kit (K870028,
K963577,K980430 and Preamendment Devices)
Radionics Microelectrode Kit (K991399)
Diros Technology URF-2AP Lesion Generator (K021869)
Diros Technology URP-2A and Associated Radiofrequency
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
1
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.
2
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.
3
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 (240) 276-0115. 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
4
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