(91 days)
The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.
The Cosman RF Injection Electrodes are used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions of nerve tissue or for use in percutaneous nerve blocks.. The COSMAN CU, CUR, TCD and CCD are temperature sensing RF injection electrodes. The COSMAN CP, CR and CN are non-temperature sensing RF injection electrodes. The Cosman RF Injection Electrodes are available in a variety of lefegths and gauges. The Cosman RF Injection Electrodes are provided sterile packed and are labeled for Single Use Only.
The provided text is a 510(k) Summary for the Cosman RF Injection Electrodes. It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a clinical study for the Cosman RF Injection Electrodes. Instead, the basis for clearance is substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective | "The comparison to the predicate device demonstrates that the Cosman RF Injection Electrodes are safe and effective and are substantially equivalent to the predicate device." "The comparison and testing results in this 510(k) notification show the Cosman RF Injection Electrodes are substantially equivalent to predicate devices and are safe and effective for its intended use." |
| Substantially Equivalent | "The Cosman RF Injection Electrodes have similar physical and technical characteristics to the predicate devices." "The comparison and testing results in this 510(k) notification show the Cosman RF Injection Electrodes are substantially equivalent to predicate devices..." |
2. Sample size used for the test set and the data provenance
The document does not report on a test set sample size or data provenance from a study demonstrating the device's performance through direct human or animal trials. The clearance is based on comparison to predicate devices, which implies that the prior performance of those devices, not a new study, forms the basis of the safety and efficacy argument.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
5. 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. The Cosman RF Injection Electrodes are a medical device (electrode/probe), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As stated above, this is a medical device, not an algorithm.
7. The type of ground truth used
Not applicable. The safety and effectiveness are established through substantial equivalence to predicate devices, not through a study involving a defined ground truth like pathology or outcome data for this specific device.
8. The sample size for the training set
Not applicable. The document does not describe a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a study involving a training set for an algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a comparison study rather than an independent performance study with new human or animal subjects. The "study" referenced is the process of comparing the Cosman RF Injection Electrodes to legally marketed predicate devices.
- Methodology: The sponsor performed a detailed comparison of the Cosman RF Injection Electrodes' "physical and technical characteristics" and "intended use" to those of predicate devices (Technomed Europe RF Injection Needles (K04237), Cosman Medical TC Electrodes (K050084), and Cosman Medical RF Cannula (K060799)).
- Proof of Acceptance Criteria: The submission asserts that this comparison, along with "testing results" (though specific tests or data are not detailed in the summary), demonstrates that the Cosman RF Injection Electrodes are "substantially equivalent" to the predicates and are "safe and effective for its intended use."
The entire submission is focused on establishing substantial equivalence under the 510(k) pathway, which does not typically require new clinical performance data if substantial equivalence can be demonstrated through technological characteristics and intended use alongside existing predicate devices.
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510(k) Summary
| Applicant / Manufacturer: | Cosman Medical, Inc.76 Cambridge St., Burlington MA 01803. USATel. 781-272-6561, Fax 781-272-6563 |
|---|---|
| Contact Person: | Louis Falcone, Director of RA |
| Registration Number: | 3004867882 |
| Date Prepared: | July 11, 2008 |
| Trade Names: | Cosman RF Injection Electrodes |
| Common Name: | Radiofrequency Lesion Probe |
| Classification: | CFR 882.4725, Radiofrequency Lesion ProbeClass II Neurology Devices, Product Code: GXI |
| Predicate Devices: | Technomed Europe RF Injection Needles(K04237)Cosman Medical TC Electrodes (K050084)Cosman Medical RF Cannula (K060799) |
Device Description: The Cosman RF Injection Electrodes are used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions of nerve tissue or for use in percutaneous nerve blocks.. The COSMAN CU, CUR, TCD and CCD are temperature sensing RF injection electrodes. The COSMAN CP, CR and CN are non-temperature sensing RF injection electrodes. The Cosman RF Injection Electrodes are available in a variety of lefegths and gauges. The Cosman RF Injection Electrodes are provided sterile packed and are labeled for Single Use Only.
Intended Use: The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The neve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.
Comparison to Predicate:
The Cosman RF Injection Electrodes have been compared to previously 510(k) cleared devices with respect to intended use and technological characteristics. The Cosman RE Injection Electrodes have similar physical and technical characteristics to the predicate devices. The comparison and testing results in this 510(k) notification show the Cosman RF Injection Electrodes are substantially equivalent to predicate devices and are safe and effective for its intended use.
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Safety and Effectiveness: The comparison to the predicate device demonstrates that the Cosman RF Injection Electrodes are safe and effective and are substantially equivalent to the predicate device.
Submitted By:
Name: Louis Falcone
Lavi Iblue
Signature
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. 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
OCT 1 4 2008
Cosman Medical, Inc. % Mr. Louis Falcone Director of Regulatory Affairs 76 Cambridge Street Burlington, Massachusetts 01803
Rc: K082012
Trade/Device Name: Cosman RF Injection Electrodes Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: September 30, 2008 Received: October 3, 2008
Dear Mr. Falcone:
We have reviewed your Scction 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 adultcration.
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 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.
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Page 2 - Mr. Louis Falcone
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 levice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH 's Office of Surveillance and Riometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
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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Indications for Use
510(k) Number (if known):
Device Name: Cosman RF Injection Electrodes
Indications For Use:
" The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made. "
Prescription Use X Over-The-Counter Use 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 1 |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K082012 |
|---|---|
| --------------- | --------- |
:
§ 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).