(83 days)
Not Found
No
The summary describes a standard RF denervation probe and cannulae, focusing on electrical safety and compatibility with a generator. There is no mention of AI, ML, or any features that would suggest their use.
Yes
This device is designed for “RF heat lesion procedures for the relief of pain,” which is a therapeutic purpose.
No
Explanation: The device is described as being used for "RF heat lesion procedures for the relief of pain," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly details physical components (probes and cannulae) and their intended use in a physical procedure (RF heat lesion procedures). It also mentions electrical safety standards for hardware.
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 "cannula" used in "radiofrequency lesion procedures." These are instruments used for a medical intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for a therapeutic purpose.
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, GXD
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 Cannula. The Smith & Nephew RF Denervation Probe is packaged non-sterile for reuse. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae 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
The Smith & Nephew RF Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when use in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
Key Metrics
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
MAR 1 6 2004
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
978 749 1000 978 749 1599 Fax www.smith-nephew.com We are smith&nephew
Page ① of 2
SECTION IN
K 034012
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.
Date Prepared: December 23, 2003
A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road
Andover, MA 01810
| B. Company Contact: | |
|---|---|
| Karen Provencher | |
| Regulatory Affairs Specialist | |
| Phone: | 978-749-1365 |
| Fax: | 978-749-1443 |
- C. Device Name
| Trade Name: | Smith & Nephew RF Denervation Probes
Smith & Nephew RF Cannulae |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Probe, Radiofrequency Lesion |
| Classification Name: | Radiofrequency Lesion Probe |
D. Predicate Devices
The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution: Radionics Racz-Finch Electrode and RFK Needles (K870028 and K980430).
1
Page ② of ②
-
Description of Device ப்
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 Cannula. The Smith & Nephew RF Denervation Probe is packaged non-sterile for reuse. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use. -
Intended Use F.
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 & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following devices cleared for commercial distribution: -
Radionics Racz-Finch Electrode K870028 .
-
Radionics Disposable RF Cannulae K980430 .
-
H. Summary Performance Data
The Smith & Nephew RF Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when use in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.
MAR 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K034012
Trade/Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae Regulation Number: 21 CFR 882.4725; 21 CFR 882.4400 Regulation Name: Radicfrequency lesion probe, Radiofrequency lesion generator Regulatory Class: II Product Code: GXI, GXD Dated: December 23, 2003 Received: December 24, 2003
Dear Ms. Provencher:
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 (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.
3
Page 2 - Ms. Karen Provencher
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 (301) 594-4659. 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.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K034012 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Smith & Nephew RF Denervation Probes & RF Cannulae Device Name: _________________________________________________________________________________________________________________________________________________________________
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.
Prescription Use __ X_ (Per 21 CFR 801 Subpar! D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart Cl
(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_ /