ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES by ORATEC INTERVENTIONS, INC.

The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

Device Description

The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.

Accessories provided with the Vulcan EAS include:

AC power cord .
Probe extension cable .
Dual-pedal footswitch control .

Each generator is also accompanied by Instructions for Use and a warranty registration card.

AI/ML Overview

This document is a 510(k) summary for the ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance against acceptance criteria from a study.

Therefore, many of the requested sections about acceptance criteria, study details, and ground truth cannot be fully addressed from the provided text.

Here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study. The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the ValleyLab Force FX Electrosurgical Generator. This means the "acceptance criteria" are implicitly met if the device is shown to be as safe and effective as the predicate.

Key points of comparison (which serve as the basis for "performance" as presented here):

Feature/Aspect	ORATEC Vulcan EAS	ValleyLab Force FX (Predicate)	Substantial Equivalence Status
Intended Use	General surgical, orthopedic/arthroscopic, coagulation, ablation, hemostasis of soft tissues.	Similar (general electrosurgical purposes implied by comparison)	Equivalent
Applications	Coagulation (fulguration), cutting, ablation (dessication) of tissues.	Coagulation (fulguration), cutting, ablation (dessication) of tissues.	Equivalent
Electrosurgical Device Compatibility	Monopolar and bipolar electrosurgical devices.	Monopolar and bipolar electrosurgical devices.	Equivalent
Impedance Measurement for Power Control	Measures impedance (resistance) to control power output.	Measures impedance (resistance) to control power output.	Equivalent
Preset Temperature/Power Combinations	Offers preset temperature and power combinations.	Offers preset temperature and power combinations.	Equivalent
Neutral Electrode Monitoring Circuits	Offers neutral electrode monitoring circuits.	Offers neutral electrode monitoring circuits.	Equivalent
Software-Controlled RF Generator	Software-controlled RF generator.	Software-controlled RF generator.	Equivalent
Temperature Control	Offers temperature control.	Does not offer temperature control.	Difference
Auto Probe Recognition	Offers auto probe recognition.	Does not offer auto probe recognition.	Difference
Remote Control of Generator Settings	Offers remote control of generator settings.	Does not offer remote control of generator settings.	Difference
Remote Display of Generator Settings	Offers remote display of generator settings.	Does not offer remote display of generator settings.	Difference
Auxiliary Thermocouple Accommodation	Can accommodate an auxiliary thermocouple.	Cannot accommodate an auxiliary thermocouple.	Difference
Ultrasonic Surgery Capability	Designed for electrosurgery only.	Also capable of ultrasonic surgery.	Difference

The differences highlighted are presented as features that the Vulcan EAS has and the Force FX does not, or vice-versa, but are argued not to raise new questions of safety or effectiveness, thus maintaining substantial equivalence.

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 clinical study with a "test set" in the context of validating algorithm performance. This is a 510(k) for an electrosurgical generator, and the information provided focuses on the device's design, intended use, and comparison to a predicate, not performance derived from a diagnostic algorithm or image analysis. Therefore, there is no mention of sample size or data provenance for such a test set.

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. This is not a study involving expert-established ground truth for a test set.

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

Not applicable.

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 is not a diagnostic AI device.

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. The "ground truth" for a 510(k) substantial equivalence submission for an electrosurgical generator is based on the functional and technical characteristics of the device being compared to a known safe and effective predicate, and potentially bench testing demonstrating its functionality as described. Specific clinical "ground truth" in the diagnostic sense is not typically used here.

8. The sample size for the training set:

Not applicable. This document does not describe an AI/ML device that requires a training set.

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

Not applicable.

Summary

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OCT 2 5 1999

Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a stylized representation of a human torso, with curved lines suggesting the contours of the body. Below the torso image, there is text that appears to be part of the brand name, although the full name is not visible in the image. The overall design is simple and modern.

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.
510(k) Summary

K991140 The assigned 510(k) number is:

A. Submitter: ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
Phone: (650) 369-9904 (650) 369-9902 Fax:

Sheila Ramerman Contact: Date Prepared: October 7, 1999

B. Device Names: ORATEC Interventions, Inc., VULCANTM EASTM Proprietary Name: ElectroThermal Arthroscopy System and Accessories Common Name: Electrosurgical generator and accessories Electrosurgical and Coagulation Unit and Accessories Classification Name:
C. Legally Marketed Device:

The ORATEC Vulcan EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator (K944602), currently manufactured and distributed by ValleyLab Inc.

D. Device Description:
The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.

Accessories provided with the Vulcan EAS include:

AC power cord .
Probe extension cable .
Dual-pedal footswitch control .

Phone: Each generator is also accompanied by Instructions for Use and a warranty registration card. (650) 369-9904 fax: (650) 369-9905

ORATEC Interventions, Inc.

3700 Haven Court Menlo Park, CA 94025

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Vulcan EAS Premarket Notification 510(k) Summary of Safety & Effectiveness Page 2

E. Intended Use:
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

F. Comparison with the Predicate Device:
The Vulcan EAS and the ValleyLab Force FX are similar in that:
Both can be used for coagulation (fulguration), cutting, or ablation (dessication) of . tissues
. Both can be used with monopolar and bipolar electrosurgical devices;
Both measure impedance (resistance) to control power output; .
. Both offer preset temperature and power combinations;
. Both offer neutral electrode monitoring circuits;
Both are software-controlled RF generators. .

The Vulcan EAS and the ValleyLab Force FX differ in that:

The Vulcan offers temperature control, whereas the Force FX does not .
The Vulcan offers auto probe recognition, whereas the Force FX does not; .
The Vulcan offers a remote control of generator settings, whereas the Force FX does . not:
. The Vulcan offers a remote display of generator settings, whereas the Force FX does not:
. The Vulcan can accommodate an auxiliary thermocouple, whereas the Force FX cannot;
. The Vulcan is designed for electrosurgery only, whereas the Force FX is also capable of ultrasonic surgery.

Based on the data and information presented here, the ORATEC VULCAN EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator manufactured and distributed by Valley Lab Inc.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 1999

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

Re: K991140

Trade Name: VULCAN™ EASTM ElectroThermal Arthroscopy System and Accessories Regulatory Class: II Product Code: GEI Dated: July 26, 1999 Received: July 27, 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 (OS) 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 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,

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

Enclosure

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K991140 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

[Signature]

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	991140

Prescription Use
(Per 21 CFR 801.109) X

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.