ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES by ORATEC INTERVENTIONS, INC.

The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Description

The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes.

Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.

AI/ML Overview

The provided text describes a 510(k) submission for the ORATEC Interventions ORA-50 ElectroThermal System and Accessories. The submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria, test results, or detailed performance metrics.

Therefore, many of the requested details about acceptance criteria and study methodology are not available in the given document. The document primarily details the device's intended use, description, and comparison to a predicate device to argue for substantial equivalence.

Here's an analysis based on the provided text, highlighting what is and is not available:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative performance metrics for a new study. The primary "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device.	The document states: "Based on the data and information presented here, the modified ORA-50 System and Accessories are substantially equivalent to the ORA-50 ElectroThermal System and Accessories currently manufactured and distributed by ORATEC Interventions, Inc." This indicates the device met the substantial equivalence requirement.
For an electrothermal system, typical performance aspects might include power output accuracy, temperature control precision, impedance monitoring accuracy, and safety features. However, specific thresholds or measured values for these are not provided in this summary.	No specific quantitative performance data (e.g., actual power output, temperature ranges maintained, impedance accuracy) is reported in this 510(k) summary for the new device or in comparison to the predicate.

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

The document does not describe a test set or clinical study with a sample size. The filing is for substantial equivalence based on hardware and software modifications.

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. No ground truth establishment for a test set is described.

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

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This device is an electrosurgical system, not an AI diagnostic tool. No MRMC study was conducted or is relevant.

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

Not applicable. This device is an electrosurgical system, not an algorithm.

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

Not applicable. The submission is based on engineering principles and comparison to a legally marketed predicate device, not on establishing ground truth for a clinical condition.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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JAN | 8 2000

510(k) Summary

Image /page/0/Picture/2 description: The image shows a black and white logo. The logo features a stylized depiction of a human back with curved lines suggesting muscles or contours. Below the image is partial text that appears to be the beginning of a word, with the letters 'O R A T E C' visible.

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: K994333

Submitter: A.

Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

phone: (650) 369-9904 (650) 369-9902 fax:

Contact: Sheila Ramerman

Date Prepared: December 16, 1999

B. Device Names:
Classification name Common/usual name Proprietary name

Electrosurgical and Coagulation Unit and Accessories Electrosurgical generator and accessories ORA-50 ElectroThermal System and Accessories

C. Predicate Device: Model ORA-50 ElectroThermal Generator, K964071
Device Description: D.

ORATEC Interventions, lnc.

3700 Haven Court Mento Park. (A 94025

Phone (650) 369-9904 fax: (650) 369-9902

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Intended Use: E.

Contraindications for Use: The ORA-50 ElectroThermal System and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

F. Comparison with the Predicate Device:

The ORA-50 System is a hardware and software modification of the Model ORA-50 Generator (K964071). The ORA-50 System and the Model ORA-50 ElectroThermal Generator have the same intended use and use the same operating principle.

Based on the data and information presented here, the modified ORA-50 System and Accessories are substantially equivalent to the ORA-50 ElectroThermal System and Accessories currently manufactured and distributed by ORATEC Interventions, Inc.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

JAN 18 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

K994333 Re: Trade Name: ORA-50 ElectroThermal System and Accessories Regulatory Class: II Product Code: HRX and GEI Dated: December 20, 1999 Received: December 23, 1999

Dear Ms. Ramerman:

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. Sheila Ramerman

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 vour 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.

Stipts Charles

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 of

510(k) number (if known): K994333

Device Name: ORATEC Interventions ORA-50 ElectroThermal System and Accessories

Indications for Use:

The ORA-50 ElectroThermal System ("ORA-50") and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical generators.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Stigh Plody

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K994333

Prescription Use	or	Over-The-Counter Use (Optional format 1-2-96)
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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.