The Oratec 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.

Device Description

The SpineCATH Intradiscal Catheter is a single use electrothermal device utilizing a flexible shaft design and thermally activated tip. The entire length of the shaft is fully insulated and when activated, only the tip delivers thermal energy. In addition, a thermocouple is located at the tip of the catheter to monitor temperature. The SpineCATH Intradiscal Catheter is for use only with the Oratec generator.

AI/ML Overview

The provided text is a 510(k) summary for the SpineCATH Intradiscal Catheter. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way modern AI/ML device submissions do.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not available in the provided document. The document describes a traditional medical device submission where equivalence is demonstrated through design, materials, and intended use, rather than through a performance study against predefined metrics.

Here's a breakdown of what is available based on the request:

1. A table of acceptance criteria and the reported device performance

Not applicable / Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific quantitative performance acceptance criteria in the way a diagnostic or AI/ML device would.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. There is no mention of a "test set" in the context of device performance evaluation in this document. The submission relies on demonstrating substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth establishment is not relevant for this type of submission, which focuses on device design and intended use equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided.

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. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. No ground truth in the context of performance metrics is established or used.

8. The sample size for the training set

Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.

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

Not applicable / Not provided.

Summary of Device and Substantial Equivalence:

Device Name: SpineCATH Intradiscal Catheter
Intended Use: For the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
Product Description: Single-use electrothermal device with a flexible shaft, thermally activated tip, fully insulated shaft, and a thermocouple at the tip for temperature monitoring. It is for use only with the Oratec generator.
Basis for Substantial Equivalence: The SpineCATH Intradiscal Catheter is claimed to be substantially equivalent in design to the Oratec EndoTAC Monopolar Cautery Probe (K972358). Its intended use (decompression of intervertebral discs) is considered substantially equivalent to currently available mechanical and laser devices, specifically mentioning Surgical Dynamics' Nucleotomes (K931109, K942987) and Laserscope's KTP/532 and KTP/Y AG Laser Systems (K896183, K913758).
Biocompatibility: Meets the requirements of ISO 10993 for External Communicating Devices, Tissue/Bone/Dentin Limited Contact, Communicating.

The FDA's letter concurs with the finding of substantial equivalence, allowing the device to be marketed.

Summary

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510(k) Summary of Safety and Effectiveness MAR 1 9 1998 SpineCATH Intradiscal Catheter

This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR §807.92.

K974464

General Information

Manufacturer:	Oratec Interventions, Inc.3700 Haven CourtMenlo Park, CA 94025Phone: (650) 369-9904
Contact Person:	Michael Kwan, Ph.D.Oratec Interventions, Inc.
Date Prepared:	December 1, 1997

Device Information

Classification:	Class II
Trade Name:	SpineCATH Intradiscal Catheter
Classification Name:	Electrosurgical Device and Accessories(878.4400)

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.

Product Description

Substantial Equivalence

The SpineCATH Intradiscal Catheter is substantially equivalent in design to the Oratec EndoTAC Monopolar Cautery Probe (K972358). The intended use of the SpineCATH Intradiscal Catheter, decompression of intervertebral discs, is substantially equivalent to currently available mechanical and laser devices,

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Dynamics' Nucleotomes (K931109, K942987) and including Surgical Laserscope's KTP/532 and KTPY AG Laser Systems (K896183, K913758).

Biocompatibility

The SpineCATH Intradiscal Catheter meets the requirements of ISO 10993 for External Communicating Devices, Tissue/Bone/Dentin Limited Contact, Communicating.

Summary

Based upon the information described in this submission, the Oratec SpineCATH Intradiscal Catheter has been shown to be substantially equivalent to the Oratec EndoTAC Monopolar Cautery Probe, Surgical Dynamics' Nucleotomes and Laserscope's KTP/532 and KTP/Y AG Laser Systems.

Molhael Kuan
Michael Kwan

Michael Kwan

Oratec Interventions, Inc. November 26, 1997

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

Dr. Michael Kwan Oratec Interventions, Incorporated 3700 Haven Court 94025 Menlo Park, California

K974464 Re: Oratec SpineCATH Intradiscal Catheter Trade Name: Regulatory Class: II Product Code: GEI February 4, 1998 Dated: February 5, 1998 Received:

Dear Dr. Kwan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS), for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Kwan

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

L. Stephen Phoebe

elia M. Witten, Ph.D., M.D. irector Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known):

Cavice Name: Oratec SpineCATH Intradiscal Catheter

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stetson Rhodes

of General Restorative Devi 长974464

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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.