(63 days)
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.
Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes
Here's an analysis of the provided text regarding the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes:
Important Note: The provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than providing extensive de novo clinical trials to prove efficacy. Therefore, much of the requested information regarding detailed study design (like sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, and specific ground truth establishment methods) is often not explicitly present in these types of documents. The focus is on showing similarity in intended use, technological characteristics, and performance data sufficient to establish equivalence.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes' acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification. This means the primary "acceptance criterion" is substantial equivalence to existing predicate devices.
The text states: "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."
This implies that the "study" conducted was a comparison of the device's performance against the predicate devices to demonstrate that it operates safely and effectively in a similar manner. The document does not outline specific, quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance is based on the demonstration of equivalent performance characteristics to the identified predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, specific quantitative acceptance criteria in the format of a clinical trial endpoint are not explicitly listed. The "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" would encompass various engineering and functional tests designed to demonstrate this equivalence and ensure the device functions as intended.
| Acceptance Criterion (Implied by 510(k) Process) | Reported Device Performance (Summary from Text) |
|---|---|
| Substantial Equivalence to Predicate Devices | Performance testing was conducted to demonstrate safety and effectiveness for intended use, showing substantial equivalence to predicate devices (Radionics RFG-3C Plus, Radionics SMK Sluijter-Mehta Kit, Radionics Microelectrode Kit, Diros Technology URF-2AP, Diros Technology URP-2A). |
| Safety and Effectiveness for Intended Use | Demonstrated to be "safe and effective for their intended use" through performance testing and comparison to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. 510(k) submissions often rely on engineering and laboratory testing rather than large-scale human subject clinical trials for non-novel devices. If human data were used, the specifics are not detailed here.
- Data Provenance: Not explicitly stated. Given it's a device manufactured in the USA, it's likely testing was conducted domestically, but the text doesn't confirm this or specify whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Again, for a 510(k) of this type, the "ground truth" often relates to engineering specifications and performance benchmarks, not subjective expert assessment of medical images or diagnostic outputs.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. It is unlikely that a formal adjudication process (like 2+1 or 3+1) was used, as this is typically applied in studies involving expert interpretation of data (e.g., radiology reads), which isn't the primary focus of this type of 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted (or at least, not reported in this summary). This type of study is more common for diagnostic imaging devices where human interpretation is a key component and the goal is to show improved reader performance with AI assistance. The Cosman device is a therapeutic lesion generator, not a diagnostic tool with AI.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed and the device does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical instrument for generating lesions, not an algorithm. Its performance is inherent in its operation and interaction with human users, not in a "standalone algorithm" sense.
7. The Type of Ground Truth Used
Given the nature of the device (a lesion generator), the "ground truth" would likely involve:
- Engineering specifications and performance metrics (e.g., output power accuracy, temperature control, impedance measurement).
- Bench testing to verify the ability to create lesions of appropriate size and characteristics in controlled environments or simulated tissue.
- Potentially, non-clinical (e.g., animal) studies to demonstrate lesion creation and safety without specific clinical outcome data being the "ground truth" for this 510(k).
- Comparison to the established performance characteristics of the predicate devices.
The provided text does not specify the exact nature of this "ground truth."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Cosman RF Lesion Generator is not an AI/machine learning device that requires a training set in the conventional sense. Its design and validation rely on established engineering principles and performance testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the detailed clinical study information often associated with novel AI/software as a medical device (SaMD) clearances or PMAs. The "study" refers to the entire body of testing and comparison data submitted to the FDA to support the claim of substantial equivalence.
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MAR 1 7 2005
050084
| General Device Summary | |
|---|---|
| Device: | Cosman RF Lesion Generator, Model RFG-1A, andassociated Radiofrequency Lesion Probes |
| Proprietary Trade Name: | Cosman RF Lesion Generator, Model RFG-1ACosman Radiofrequency Lesion Probes |
| Manufacturer: | Cosman Medical, Inc.76 Cambridge St., Burlington MA 01803. USATel. 781-272-6561. Fax 781-272-6563 |
| Contact Name: | Michael Arnold, Director of RA/QAemail: 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 IINeurology Devices, Product Code: GXD882.4725, Radiofrequency Lesion Probe, Class IINeurology Devices, Product Code: GXI |
| Performance Standard: | No applicable performance standards have been issuedunder 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 RadiofrequencyProbes (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 (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
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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
§ 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).