The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.

Device Description

The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.

AI/ML Overview

This document describes the Trimedyne® OmniTip™ Side Firing Switchable Tips with Suction/Irrigation, a laser fiber device. The primary focus of the provided text is the device's substantial equivalence to predicate devices and its intended use, rather than detailed acceptance criteria and a specific study proving those criteria.

Based on the provided information, the device is considered substantially equivalent for its intended use, which is with any pulsed Holmium:YAG 2.1 micrometer laser for incision, excision, ablation, vaporization, and coagulation.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify quantitative acceptance criteria with corresponding performance metrics in a tabular format. The conclusion states: "The device is biocompatible, performs as intended, and has acceptable mechanical properties when used according to its labeling." This is a general statement of compliance rather than a detailed breakdown of acceptance criteria.

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

Sample Size for Test Set: The document mentions "simulated clinical testing using heart tissue" but does not specify a sample size for this testing. It also references "a series of tests, including mechanical, biological, and performance studies," but again, no sample sizes are provided.
Data Provenance: Not specified. It's likely the testing occurred at the manufacturer's location in the USA (Trimedyne, Inc., Irvine, CA). Whether the data was retrospective or prospective is not mentioned.

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)

The document states: "A physician's feedback is also used to validate the use of the device in a clinical setting."

Number of Experts: "A physician" suggests one expert, but it's not explicitly stated.
Qualifications of Experts: The term "physician" is a general qualification; specific experience or specialty is not provided.

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

Not applicable. The clinical validation involved "a physician's feedback," which doesn't describe a formal adjudication process typically seen in studies involving multiple reviewers for ground truth establishment.

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 a laser fiber, not an AI diagnostic or assistance tool, so an MRMC study comparing human readers with and without AI assistance is not relevant. The document does not mention any MRMC study.

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

Not applicable. This is a physical medical device (laser fiber), not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

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

For the "simulated clinical testing," the ground truth was implicitly based on the observed performance during these tests and the "physician's feedback." This would likely involve visual assessment of the tissue effects (incision, ablation, coagulation) and mechanical function, but a formal "ground truth" definition (like pathology) is not explicitly stated.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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K992230 Attachment 4

510(k) Summary of Safety and Effectiveness Information

Trimedyne® OmniTip™ Side Firing Switchable Tips with Suction/Irrigation

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.

Submitter Information:	Trimedyne, Inc.P.O. Box 57001Irvine, CA 92619-7001(949) 559-5300(949) 559-1330
Contact person:	Susan H. GambleVice President, Regulatory Affairs and Quality
Summary Date:	July 1, 1999

II. Device Name

OmniTip™ Side Firing Switchable Tip with Suction/Irrigation Proprietary:

Common: Laser Fiber

Classification: Accessories to Laser-Powered Instrument (unclassified)

Predicate Device III.

The predicate devices are the Trimedyne OmniTip™ Switchable Tips and Tapertip™ Holmium Arthroscopic Handpieces.

IV. Device Description

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V. Intended Use

This device is intended for use with any Holmium laser (with a compatible connector) for its cleared applications.

VI. Technological Characteristics

The device differs from the predicate devices due mainly only to the incorporation of suction/irrigation channel and minor configuration changes.

VII. Nonclinical Tests

The device was subjected to a series of tests, including mechanical, biological, and performance studies.

VIII. Clinical Tests

The device was subjected to a simulated clinical testing using heart tissue. A physician's feedback is also used to validate the use of the device in a clinical setting.

IX. Conclusions Drawn from Testing

The device is biocompatible, performs as intended, and has acceptable mechanical properties when used according to its labeling.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 1999

Ms. Susan H. Gamble Vice President, Regulatory Affairs and Quality Trimedyne, Inc. 2801 Barranca Road P.O. Box 57001 Irvine, California 92619

K992230 Re:

Trade Name: OmniTip™ Side Firing Switchable Tip with Suction/Irrigation Regulatory Class: II Product Code: GEX, GCX, and GBX Dated: July 1, 1999 Received: July 2, 1999

Dear Ms. Gamble:

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. Susan H. Gamble

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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number	K992230
Device Name	OmniTip™ Side Firing Switchable Tip with Suction/Irrigation
Indications for Use	The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Signature
Title of General Representative

(Ax) Number	K992230	Page 28 of 32
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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.