(72 days)
Not Found
No
The summary describes a standard RF denervation system with probes and cannulae, and there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is indicated for use in "RF heat lesion procedures for the relief of pain," which is a therapeutic purpose.
No
The device is described as an electrode and cannulae used in RF heat lesion procedures for pain relief, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "temperature sensing electrode" and "disposable RF Cannulae," which are physical hardware components used in a medical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "RF heat lesion procedures for the relief of pain." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "temperature sensing electrode" and "RF Cannulae" used in "radiofrequency lesion procedures." These are instruments used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver radiofrequency energy for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Product codes
GXI
Device Description
The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Smith & Nephew Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUL 2 0 2007
Ko7/300
Endoscopy Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810
w.smith-nephew.com
We are smith&nephew
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew RF Denervation Probes & RF Cannulae Traditional 510(k)
Date Prepared: May 8, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover. MA 01810
B. Company Contact:
Kathy Reddig Regulatory Affairs Specialist Phone: 978-749-1321 Fax: 978-749-1443
C. Device Name
| Trade Name: | Smith & Nephew RF Denervation Probe & RF Cannulae |
|---|---|
| Common Name: | Probe, Radiofrequency Lesion |
| Classification Name: | Radiofrequency Lesion Probe |
D. Predicate Devices
The Smith & Nephew RF Denervation Probe is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew RF Denervation Probes & RF Cannulae (K034012).
E. Description of Device
The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.
1
71300
F. Intended Use
Page 2 of 2
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
G. Comparison of Technological Characteristics
The Smith and Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution:
- Smith & Nephew RF Denervation Probes and RF Cannulae -- K034012
H. Summary Performance Data
The Smith & Nephew Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
2
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-like symbol with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2007
Smith & Nephew, Inc. % Ms. Kathy Reddig, RAC Regulatory Consultant 150 Minuteman Road Andover, Massachusetts 01810
Re: K071300
Trade/Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: July 2, 2007 Received: July 3, 2007
Dear Reddig:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Kathy Reddig, RAC
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milburn
Mark N. Melkerson 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):
Ko. 7/300
Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae
Indications For Use:
Smith & Nephew RF Denervation Probes and RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Mark N Milferson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Prescription Use ________x (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)