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. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

Device Description

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

AI/ML Overview

This 510(k) summary provides limited information regarding the specific studies performed. Here's what can be extracted and reported, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance
"Safety and Performance" of device modification	Not explicitly stated as acceptance criteria, but generally implied for device changes.
Compliance to 21 CFR 820.30 Design Control requirements	Certified compliance.
Performance testing (validation testing) for the modification	Results provided (details not specified in this summary).
Substantial equivalence to predicate device	Determined to be substantially equivalent based on indications for use, fundamental scientific technology characteristics, and comparison.

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum temperature reached) or the detailed quantitative results of the "performance testing (validation testing)."

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

This information is not provided in the document. The summary only mentions "results of validation testing (performance testing)" without detailing the test set size, type of data (e.g., in-vitro, ex-vivo, animal, human), or its provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. This type of device (intradiscal catheter) does not typically involve image interpretation, so "ground truth" as it relates to expert review of images is not applicable here. The "ground truth" for this device would relate to engineering specifications and biological outcomes, which would be established through technical standards and clinical studies, respectively.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of medical device testing (e.g., mechanical, electrical, biocompatibility), adjudication is typically not performed in the same way as in diagnostic AI studies. Test results are usually compared against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The ORATEC SpineCATH™ Intradiscal Catheter is a medical device (catheter) used in a physical intervention, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established through a combination of:

Engineering Specifications: For mechanical properties, electrical safety, material compatibility, and function.
Biocompatibility Testing: To ensure the materials are safe for use in the human body.
Performance Data: Demonstrating the ability of the catheter to achieve its intended function (e.g., coagulation and decompression) in relevant models (e.g., ex-vivo tissue, animal models, and ultimately, human clinical data from the predicate device and potentially limited clinical data for the modified device if applicable, though not detailed here).
Clinical Outcomes Data: For the predicate device, showing its effectiveness in treating symptomatic patients. For the modified device, the "ground truth" for substantial equivalence relies on demonstrating that the modifications do not negatively impact the clinical outcomes or safety established for the predicate.

The document states that "performance testing (validation testing)" was done, implying that the device was tested against these types of established standards and expected performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process, validated through testing.

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

This information is not applicable and not provided. As explained above, this device is not an AI algorithm.

Summary

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510(k) Summary DEC 1 7 1999 ORATEC® SpineCATH™ Intradiscal Catheters

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:	K993967
Submitter:	ORATEC® Interventions, Inc.
	3700 Haven Court
	Menlo Park, CA 94025
	Establishment Registration # 2953127
Contact:	Jennifer Brennan
	Regulatory Affairs Associate
	Telephone: (650) 369-9904
	Fax: (650) 369-9902
Date Prepared:	November 22, 1999
Device Names:
Classification Name:	Electrosurgical device
Common/usual Name:	Electrosurgical accessory
Proprietary Name:	ORATEC® SpineCATH™ Intradiscal Catheter

Predicate Device: SpineCATH™ Intradiscal Catheter, K974664

Device Description:

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

Intended Use:

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. The ORATEC SpineCATH™ Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

Safety and Performance:

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This submission is a Special 510(k): Device Modification as described in FDA's Guidance document "The New S10(k) Paradigm- Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. " In support of this 510(k), ORATEC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification.

Conclusion:

Based on the indications for use, fundamental scientific technology characteristics, performance, and comparison to the predicate device, the modified SpineCATH Intradiscal Catheter is substantially equivalent to the predicate SpineCATH Intradiscal Catheter under the Federal, Food, Drug and Cosmetic Act. The SpineCATH Intradiscal Catheter is manufactured and distributed by ORATEC Interventions, Inc.

Proprietary information: This document and the information contained herein may not be reproduced, used, or disclosed without prior written consent of Oratec Interventions, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 1999

Ms. Jennifer Brennan Regulatory Affairs Associate ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

K993967 Re:

Trade Name: ORATEC® Spine CATH™ Intradiscal Catheter Regulatory Class: II Product Code: GEI Dated: November 22, 1999 Received: November 23, 1999

Dear Ms. Brennan:

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 Regulation (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 action. In addition, FDA may publish further announcements 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 - Ms. Jennifer Brennan

This letter will allow you to begin marketing your device as described in your 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 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,

Hamelin Laja

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

Device Name: ORATEC® SpineCATH™ Intradiscal Catheters

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rune/i/iyan

(Division Sign-Off)
Div. General Restorative Devices
510(K) Number 455 3467

Prescription Use
(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.