ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES by ORATEC INTERVENTIONS, INC.

The Electrosurgical Probes are disposable electrosurgical devices intended to be used in general surgical procedures where electro-coagulation and cutting of soft tissues is desired. They are intended to be used with ORATEC Interventions ElectroThermal™ Generators.

Device Description

The ORATEC Interventions Electrosurgical Probes are single-use electrosurgical devices designed for use in minimally invasive procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radio-frequency energy in a controlled fashion. The modified probes consist of the following features:

a shaft with a radiofrequency-energized tip for minimally invasive access to . perform tissue coagulation and/or cutting;
different electrode tip configurations to provide optimal access to tissue; .
. handle and cable connection receptacle at the proximal end.

The modifications made from the predicate device are:

Adding alternate electrode tip materials; .
Adding alternate insulating materials on the probe shaft; .
Adding different tip configurations; .
Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. ●

AI/ML Overview

The provided text is a 510(k) Summary for a device modification, specifically for ORATEC TAC-S Monopolar Cautery Probe. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy through new performance studies akin to those for a novel device or software.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of, for example, an AI/ML algorithm or a new medical device's clinical performance.

Here's why and what information is provided:

Focus of a 510(k) for device modification: The primary goal of this Special 510(k) is to show that the modified device (ORATEC Electrosurgical Probes with altered materials, tip configurations, and dimensions) is as safe and effective as the existing, legally marketed predicate device (Electrosurgical Probes, K965007). It achieves this by highlighting similarities and explaining how differences do not raise new questions of safety or effectiveness.
Nature of the device: This is an electrosurgical device, not an AI/ML system. Performance is typically assessed through engineering design verification and validation, biocompatibility, electrical safety, electromagnetic compatibility, and potentially bench testing to confirm physical properties and functionality.
Lack of AI-specific or clinical study details: The document does not describe:
- Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
- Any study explicitly designed to "prove" the device meets such criteria using patient data, ground truth established by experts, or MRMC studies.

Based on the provided text, I cannot complete the table or answer most of the questions as they pertain to clinical performance studies, AI/ML models, or specific ground truth methodologies.

However, I can extract information relevant to the device modification and its comparison to the predicate:

Device Modifications and Comparison to Predicate:

Feature	Predicate Device (K965007)	Modified Device (ORATEC TAC-S Monopolar Cautery Probe)
Intended Use	Same	Same: general surgical procedures for electro-coagulation and cutting of soft tissues; used with ORATEC ElectroThermal™ Generators.
Operating Principle	Same	Same
Basic Probe Design	Same	Same
Shaft Material	Same	Same
Packaging/Sterilization	Same	Same
Electrode Tip Materials	Existing	Alternate electrode tip materials
Insulating Materials on Probe Shaft	Existing	Alternate insulating materials on probe shaft
Tip Configurations	Existing	Different tip configurations
Handle, Probe Shaft, and Electrode Dimensions	Existing	Decreased for smaller versions (smaller probe shaft dimensions and electrode surface areas)

Answers to Applicable Questions (based only on the provided text):

A table of acceptance criteria and the reported device performance: Not applicable in the traditional sense for a 510(k) device modification. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to the predicate device, meaning the modifications do not raise new questions of safety or effectiveness. The "performance" is implicitly deemed equivalent if substantial equivalence is established. No specific quantitative performance metrics (like accuracy, sensitivity) are presented for this type of device modification.
Sample size used for the test set and the data provenance: Not applicable. No clinical or comparative test set data from patients is described. The "test" for a device modification in a 510(k) is typically a review of engineering changes, material specifications, and comparison to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set of patient data is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a device modification of an electrosurgical probe, demonstrating substantial equivalence to a predicate. It does not contain the detailed performance study information typically requested for AI/ML devices or novel medical devices requiring extensive clinical data.

Summary

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JUL 30 1990

Image /page/0/Picture/1 description: The image is a black and white abstract design. It features a black background with white, curved lines that appear to be stylized representations of a human figure, possibly a back. The lines create a sense of movement and flow within the rectangular frame. A circled "R" symbol is visible in the lower right corner.

Special 510(k): Device Modification ORATEC TAC-S Monopolar Cautery Probe

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.

The assigned 510(k) number is:	K992408
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A. Submitter:
ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

(650) 369-9904 Telephone: (650) 369-9902 Fax:

Sheila Ramerman Contact: July 19, 1999 Date Prepared:

B. Device Names:

Classification Name:	Electrosurgical Device
Common/usual Name:	Electrosurgical Probes
Proprietary Name:	Electrosurgical Probes Family:Ligament Chisels™MicroLigament Chisels™Ablator™ Probes

Electrosurgical Probes, K965007 C. Predicate Device:
Device Description: D.

a shaft with a radiofrequency-energized tip for minimally invasive access to . perform tissue coagulation and/or cutting;
different electrode tip configurations to provide optimal access to tissue; .
. handle and cable connection receptacle at the proximal end.

3700 Haven Court Menlo Park, CA 94025

ORATEC

lnc.

Interventions,

Phone: (650) 369-9904 fax: (650) 369-9905

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Special 510(k): Device Modification ORATEC TAC-S Monopolar Cautery Probe

The modifications made from the predicate device are:

Adding alternate electrode tip materials; .
Adding alternate insulating materials on the probe shaft; .
Adding different tip configurations; .
Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. ●
Intended Use: E.

Comparison with the Predicate Device: F.
The Electrosurgical Probes and the modified Electrosurgical 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 Electrosurgical Probes and the modified Electrosurgical Probes differ in that the modified probes:

use alternate electrode tip materials; .
. use alternate insulating materials on the probe shaft;
use different tip configurations; ●
have smaller probe shaft dimensions and electrode surface areas. .

Based on the data and information presented here, the modified Electrosurgical Probes are substantially equivalent to the existing Electrosurgical 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

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

K992408 Re:

Trade Name: ORATEC Interventions Electrosurgical Probes Regulatory Class: II Product Code: GEI Dated: July 19, 1999 Received: July 20,1999

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 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,

P. Coello

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

510(k) Number (if known): _ K 992408

Device Name: _ORATEC Interventions Electrosurgical 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992408

Prescription Use X(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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(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.