The Spinecath Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

Device Description

The proposed Intradiscal Catheter System, consisting of the Spinecath Intradiscal Catheter and the Acutherm Decompression Catheter, is used as part of the Intradiscal Electrothermal Therapy (IDET) and Targeted Disc Decompression (TDD) procedures. The procedures require the use of an introducer needle and the ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine Generator. The introducer needle transects the disc annulus and assists the surgeon in the placement of the catheters in the intradiscal space. The ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine System delivers radiofrequency energy to the catheters where the energy is converted to thermal energy.

AI/ML Overview

The provided text describes the Smith & Nephew Intradiscal Catheter System (K073466). However, it does not contain details about specific acceptance criteria or an analytical study with performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way typically expected for a detailed AI/ML device submission.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing, implying that if it performs comparably, it meets the inherent "acceptance criteria" of the predicate.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document. The submission focuses on demonstrating identical performance to predicate devices (K013622 and K993967) rather than providing specific quantitative acceptance criteria for parameters like accuracy, sensitivity, specificity, or precision, which are common for AI/ML devices.

The document states: "Performance testing of the proposed Intradiscal Catheter System demonstrates that it performs identically to the predicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967)." This implies that the 'acceptance criteria' are met by showing functional equivalence to the established predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The type of testing mentioned is "performance testing" and "biocompatibility testing," which are typically laboratory or bench tests, not clinical studies with patient data in the context of AI/ML evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The document describes a medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this type of device would relate to its physical and functional performance (e.g., coagulation capabilities, decompression effectiveness, material properties), which are evaluated through engineering and biological tests, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain diagnoses, which is not the type of study described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable/provided. MRMC studies are used to evaluate the impact of a device (often AI/ML) on human readers' performance, typically in diagnostic tasks. This submission is for a surgical catheter system, not a diagnostic imaging device with AI assistance.

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

This information is not applicable/provided. This device is a surgical tool used by a human, not an algorithm operating independently.

7. The Type of Ground Truth Used

The ground truth used for performance validation would likely be based on engineering specifications and pre-defined functional outcomes for the catheters (e.g., precise temperature delivery, effective tissue coagulation, successful decompression in a controlled environment). For biocompatibility, the ground truth is established by validated toxicology and material science standards. No pathology or outcomes data are mentioned in this summary in the context of device performance testing.

8. The Sample Size for the Training Set

This information is not applicable/provided. This is a hardware medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

Summary of what the document does state about the study:

The study described is focused on demonstrating substantial equivalence to previously cleared predicate devices (Nucleotomy Catheter K013622 and Spinecath Intradiscal Catheter K993967).

Study Type: Performance testing (implied bench testing or in-vitro studies) and biocompatibility testing.
Purpose: To show that the "proposed Intradiscal Catheter System performs identically" to the predicate devices and that it "does not pose a substantial biocompatibility risk."
Results: The results of "all performance and biocompatibility testing are enclosed" (referring to the full 510(k) submission, not this summary document). The summary states these tests demonstrate identical performance and no substantial biocompatibility risk.

Summary

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K073466

Orthopaedics Smith & Nephew, Inc. 1450 Brooks Bd. Memphis, TN 38116 U.S.A. 901-396-212 800-821-5700 www.smith-nephew.com

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We are smith&nephew

FEB 22 200

510(k) Summary of Safety and Effectiveness Smith & Nephew Intradiscal Catheter System

Submitted By:	Smith & Nephew, Inc., Orthopaedic Division
	1450 East Brooks Road
	Memphis, TN 38116
Date:	12/7/2007
Contact Person:	Mason W. Robbins, Regulatory Affairs Specialist
	Tel: (901) 399-6021
	Fax: (901) 399-1557
Proprietary Name:	Smith & Nephew Intradiscal Catheter System
Common Name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Name and Reference:	21 CFR 888.4400, Electrosurgical cutting and coagulation device and accessories
Device Product Code and Panel Code:	GEI/ Orthopedics / 87

Device Description:

Intended Use:

The Spinecath Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

Technological Characteristics:

The proposed Intradiscal Catheter System is identical to the oredicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967) w

Substantial Equivalence Information:

Performance testing of the proposed Intradiscal Catheter System demonstrates that it performs identically to the predicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967). Biocompatibility testing of the proposed device demonstrates that like the predicate devices, the proposed Intradiscal Catheter System does not pose a substantial biocompatibility risk to patients who undergo an IDET or a TDD procedure. The results of all performance and biocompatibility testing are enclosed.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. Mason W. Robbins Regulatory Affairs Specialist 1450 East Brooks Road Memphis. Tennessee 38116

K073466 Re: Trade/Device Name: Smith & Nephew Intradiscal Catheter System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 04, 2008 Received: February 05, 2008

Dear Mr. Robbins:

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 - Mr. Mason W. Robbins

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric'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. Millerson

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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L073466

p. l of i

Premarket Notification Indications for Use Statement

510(k) Number (if known): _

Device Name: Smith & Nephew Intradiscal Catheter System

Indications for Use:

The Spinecath Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

Mark A. Millkern

(Division Sigu-Oi Division of General, Restorative, and Neurological Devices

510(k) Number K073466

Prescription Use X (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.