MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY by ORATEC INTERVENTIONS, INC.

The TAC-S™ Monopolar Cautery Probes are disposable electrosurgical devices intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are intended to be used with Oratec™ Interventions ElectroThermal™ Generators.

Device Description

The ORATEC Interventions TAC-S, MiniTAC-S, and MicroTAC-S Monopolar Cautery Probes are single-use electrosurgical devices designed for use in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radiofrequency energy in a controlled fashion. The modified probes consist of the following features:

. a shaft with a radiofrequency-energized tip for percutaneous or intraoperative access to perform tissue coagulation;
. a thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery;
handle and cable connection receptacle at the proximal end;
accessory connector cables which are designed to fit standard RF control units with temperature and impedance feedback.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the TAC-S™ Monopolar Cautery Probe Family. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies designed for that purpose. The "study" here is essentially the comparison to the predicate and the data supporting substantial equivalence.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, specific acceptance criteria beyond "intended use," etc.) are typically not found directly in a 510(k) summary focused on substantial equivalence for this type of device. The "acceptance criteria" for a 510(k) is primarily the FDA's determination of substantial equivalence based on the provided comparison.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of a 510(k) summary for these specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k) Submission): The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device (TAC-S™ Monopolar Cautery Probe, K963157) regarding safety and effectiveness for the stated intended use. This is achieved by showing that the modified devices (MiniTAC-S and MicroTAC-S) are as safe and effective as the predicate.

Reported Device Performance:
The document does not provide specific performance metrics in a quantitative sense (e.g., coagulation time, tissue impedance, temperature range achieved) against explicit numerical acceptance criteria. Instead, it asserts equivalence based on:

Aspect	Predicate Device (K963157)	Modified Devices (TAC-S, MiniTAC-S, MicroTAC-S)	Equivalence Claim / Performance Statement
Intended Use	Arthroscopic procedures where electro-coagulation of soft tissues is desired, with Oratec™ Interventions ElectroThermal™ Generators.	Arthroscopic procedures where electro-coagulation of soft tissues is desired, with Oratec™ Interventions ElectroThermal™ Generators.	Same indicated use.
Operating Principle	Electrosurgical device for tissue coagulation via RF energy.	Electrosurgical device for tissue coagulation via RF energy.	Same operating principle.
Basic Probe Design	Shaft with RF-energized tip, thermocouple, handle, cable connection.	Shaft with RF-energized tip, thermocouple, handle, cable connection.	Same basic probe design.
Shaft Material	Not explicitly stated for predicate in summary, but implied to be the same.	Implied similar to predicate (except for insulation).	Same shaft material (implies structural and biocompatibility equivalence).
Packaging & Sterilization	Not explicitly stated for predicate in summary.	Not explicitly stated for modified devices.	Packaged and sterilized in the same manner.
Insulating Material	Not explicitly stated, but implied to be different.	Teflon used on probe shaft.	Difference: Teflons an insulating material. This change would require testing to ensure safety/function.
Dimensions	Larger/standard dimensions.	Smaller handle, probe shaft, and electrode dimensions (for MiniTAC-S and MicroTAC-S).	Difference: Reduced dimensions. This change would require testing to ensure safety/function.

Summary of "Performance": The performance reported is that the modified devices are deemed "substantially equivalent" to the predicate, meaning they are expected to perform safely and effectively for their intended use despite minor design changes. The document does not provide a study with quantitative performance metrics against specific benchmarks, but rather a justification of equivalency.

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

The document does not describe a clinical "test set" in the context of a prospective study with human subjects. The evaluation is primarily a design comparison and likely bench/pre-clinical testing to support the modified features.

Sample Size for Test Set: Not applicable or not specified in this type of submission. There is no mention of a clinical trial or a "test set" from such a trial.
Data Provenance: The data provenance implicitly comes from the manufacturer's internal testing (likely bench testing for material changes and dimension checks) used to support the substantial equivalence claim. There is no mention of country of origin for clinical data, as no clinical data (in the sense of human trials) is presented. It is a retrospective comparison to an existing device.

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

This element is not applicable to this 510(k) submission. There is no mention of a specific "test set" requiring expert ground truthing, as this is not a diagnostic device or a device whose performance is assessed by expert interpretation of outputs.

4. Adjudication Method for the Test Set

This element is not applicable to this 510(k) submission. There is no mention of a "test set" requiring adjudication.

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

This element is not applicable to this 510(k) submission. This is an electrosurgical device, not a diagnostic imaging device with AI components. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

This element is not applicable to this 510(k) submission. This is a physical electrosurgical probe, not an algorithm or software-only device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a 510(k) submission of this nature, the "ground truth" is implicitly established by the predicate device's safety and effectiveness. The manufacturers typically demonstrate through engineering analysis, bench testing, and sometimes cadaveric or animal studies (if relevant) that the modified device performs comparably to the predicate for critical parameters. There's no mentioned independent "ground truth" derived from expert consensus, pathology, or outcomes data for a new clinical study.

8. The Sample Size for the Training Set

This element is not applicable to this 510(k) submission. There is no "training set" in the context of machine learning. The device is a physical instrument.

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

This element is not applicable to this 510(k) submission, as there is no "training set" or AI component.

Summary

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510(k) Summary

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.

K98418 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

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

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

Contact: Sheila Ramerman Date Prepared: November 18, 1998

B. Device Names:

Classification Name:	Electrosurgical Device
Common/usual Name:	Electrosurgical Accessory
Proprietary Name:	TAC-STM Monopolar Cautery Probe Family:TAC-S Monopolar Cautery ProbeMiniTACTM-S Monopolar Cautery ProbeMicroTAC-STM Monopolar Cautery Probe

C. Predicate Device: TAC-STM Monopolar Cautery Probe, K963157
D. Device Description:

. a shaft with a radiofrequency-energized tip for percutaneous or intraoperative access to perform tissue coagulation;
. a thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery;
� handle and cable connection receptacle at the proximal end;
� accessory connector cables which are designed to fit standard RF control units with temperature and impedance feedback.

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The only modifications made from the predicate device are:

. Using teflon as an insulating material on the probe shaft.
Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. .
E. Intended Use:

The TAC-STM Monopolar Cautery Probe is a disposable electrosurgical device intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. It is intended to be used with OratecTM Interventions ElectroThermal™ Generators.

Comparison with the Predicate Device: F.
The TAC-S Monopolar Cautery Probe and the modified TAC-S probes are similar in that they:
. have the same indicated use:
use the same operating principle: .
. use the same basic probe design:
. use the same shaft material;
. are packaged and sterilized in the same manner.

The TAC-S Monopolar Cautery Probe and the modified TAC-S probes differ in that the modified TAC-S probes:

use teflon as an insulating material on the probe shaft. .
have smaller probe shaft dimensions and electrode surface areas. .

Based on the data and information presented here, the modified TAC-S probes are substantially equivalent to the existing TAC-S probes manufactured and distributed by Oratec Interventions, 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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1998

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

Re: K984185

Trade Name: Mini TAC-STM Monopolar Cautery Probe and Micro TAC-STM Monopolar Cautery Probe Regulatory Class: II Product Code: GEI Dated: November 20, 1998 Received: November 23, 1998

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 (OS) 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

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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 tollfree 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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Page of

510(k) Number (if known): K984185

Device Name: Oratec™ Interventions TAC-STM Monopolar Cautery Probes

Indications 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	K984185
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Prescription Use ✓(Per 21 CFR 801.109)	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.