Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

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. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use.

AI/ML Overview

The provided text describes the regulatory clearance for the Smith & Nephew RF Cannulae. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance. Instead, it focuses on the device's substantial equivalence to a predicate device and its compliance with electrical safety standards.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety Standards (UL 60601-1 and IEC 60601-1)	Meets 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.
Substantial Equivalence to Predicate Device	Determined by FDA to be substantially equivalent to Smith & Nephew RF Probe and Cannulae (K034012) in design, materials, function, and intended use.

2. Sample size used for the test set and the data provenance:

Not applicable. The document describes a regulatory submission based on substantial equivalence and compliance with safety standards, not a performance study on a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No such test set or ground truth establishment by experts is mentioned in the provided text.

4. Adjudication method for the test set:

Not applicable. No adjudication method is described as there is no performance study or test set using patient data.

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:

No. An MRMC study was not done, and the device is a medical cannulae, not an AI-assisted diagnostic tool. Therefore, there's no mention of human reader improvement with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. The device is a physical medical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The type of ground truth used:

Not applicable. The "ground truth" in this context is the existing predicate device and established electrical safety standards, not clinical outcomes data or pathology from a study. The device's "performance" is primarily assessed against these regulatory and technical benchmarks.

8. The sample size for the training set:

Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a medical device (RF Cannulae) seeking regulatory clearance. It focuses on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant electrical safety standards. It does not describe a clinical study with performance metrics, patient data, or expert-established ground truth in the way one would expect for an AI-enabled diagnostic or prognostic device. The "study" mentioned is the evaluation of the device against standards and comparison to an existing device, rather than a prospective clinical performance trial.

Summary

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Endoscopy Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810

smith-nephew.com

We are smith&nephew

Page 1 of 2

K063467

2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION a 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 Cannulae

Date Prepared: October 20, 2006

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Minnie Mildwoff Regulatory Affairs Specialist 978-7491538 (phone), 978-7491443 (fax)

C. Device Name

Trade Name:	Smith & Nephew RF Cannulae
Common Name:	Probe, Radiofrequency Lesion
Classification Name:	Radiofrequency Lesion Probe

D. Predicate Devices

The Smith & Nephew RF Cannulae is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew RF Probe and Cannulae (K034012).

E. Description of Device

F. Intended Use

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K 063 467

Image /page/1/Picture/1 description: The image shows the text "Page 2 of 2" in a handwritten style. Below the page number is the text "We are smith&nephew" in a bold font. There is a star-like symbol to the left of the text "We are smith&nephew".

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 device cleared for commercial distribution:

ﮯ۔ Smith & Nephew RF Probes and Cannulae - K034012

H. Summary Performance Data

The Smith & Nephew RF Denervation Probes & RF Canulae 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.

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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 is a circular seal with the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Minnie Mildwoff, RAC Regulator Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

NOV 2 1 2006

Re: K063467

Trade/Device Name: Smith and Nephew RF Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: October 23, 2006 Received: October 24, 2006

Dear Ms. Mildwoff:

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.

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Page 2 - Ms. Minnie Mildwoff, 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 responsibilitics 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,

Rola Palph

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):
K063467

Device Name: Smith and Nephew RF Cannulae

Indications For Use: Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

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)

Pto Rhen

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12063467
5106

510/k Vir

Smith & Nephew, Inc RF Cannulae Page 15 of 67

Regulation Number and Section

§ 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).