These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

Device Description

The Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices. These devices consist of an optical fiber which may or may not be contained in a catheter tube, cannula, needle, handpiece or handle. The fibers range from 50 to 1000 microns core diameter and will be offered with various distal tip configurations.

AI/ML Overview

The provided documents are a 510(k) summary and FDA clearance letter for a medical device called "Resposable Holmium Bare Fibers". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through extensive clinical trials. Therefore, much of the requested information about acceptance criteria and clinical studies is explicitly stated as "Not Applicable" or "No nonclinical/clinical tests were submitted."

Here's a breakdown of the requested information based on the provided text:

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

Based on the provided documents, there are no specific acceptance criteria or reported performance metrics from a formal study described. The 510(k) summary states, "No nonclinical test data were submitted in this Premarket Notification." and "No clinical tests were submitted in this Premarket Notification." The basis for clearance is substantial equivalence to an existing predicate device (Trimedyne Disposable Holmium Bare Fibers) due to minor material and configuration changes allowing for sterilization/reuse.

Acceptance Criteria	Reported Device Performance
Not applicable (No specific acceptance criteria or performance metrics from a formal study are provided in the document.)	Not applicable (No performance data from a formal study are provided in the document.)

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

Sample Size: Not applicable. No test set was used for a study described in the provided documents.
Data Provenance: Not applicable. No study data provenance is mentioned as no tests were submitted.

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 by experts is mentioned as no test set or study was submitted.

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

Not applicable. No adjudication method is mentioned as no test set or study was submitted.

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. No MRMC comparative effectiveness study was done. This device is a laser fiber, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a laser fiber, not an algorithm. Therefore, no standalone algorithm performance was assessed.

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

Not applicable. No ground truth was established as no clinical or nonclinical tests were submitted for this 510(k). The assessment was based on substantial equivalence.

8. The sample size for the training set

Not applicable. No training set was used as no machine learning or AI component is part of this device or its evaluation in this submission.

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

Not applicable. No training set or ground truth for a training set was established for the reasons mentioned above.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Trimedyne" in a bold, sans-serif font. Below the word is a graphic of three stacked arrowheads pointing downwards. Above the word "Trimedyne" is the alphanumeric string "K973172".

EB - 3 1998

Summary of 510(k) Safety and Effectiveness Information

Resposable Holmium Bare Fibers

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.

1.	Submitter Information:	Trimedyne, Inc.P.O. Box 57001Irvine, CA 92619-7001714/559-5300714/559-1330
	Contact Person:	Susan H. GambleVice President, Regulatory Affairs & Quality Assurance
	Summary Date:	December 22, 1997
11.	Device Name
	Proprietary:	Resposable Holmium Bare Fibers
	Common:	Laser Fiber
	Classification:	Accessories to Laser-Powered Instruments

111. Predicate Device

The predicate devices are the Trimedyne Disposable Holmium Bare Fibers.

IV. Device Description

V. Intended Use

These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

Technological Characteristics VI.

The devices differ from their predicate devices due only to the incorporation of minor materials and configuration changes which allow for steam and EtO sterilization/reuse.

VII. Nonclinical Tests

No nonclinical test data were submitted in this Premarket Notification.

VIII. Clinical Tests

No clinical tests were submitted in this Premarket Notification.

Conclusions Drawn from Testing IX.

Not applicable.

TRIMEDYNE, INC. 2801 BARRANCA ROAD P.O. Box 57001, Irvine, CA 92619-7001 714 559-5300, FAX 714 559-1330, 800 733-5273

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan H. Gamble Vice President, Regulatory Affairs & Quality Assurance Trimedyne. Incorporated P.O. Box 57001 Irvine, California 92619-7001

FEB - 3 1998

K973172 Re:

Trade Name: Resposable Holmium Bare Fibers Regulatory Class: II Product Code: GEX Dated: December 22, 1997 Received: December 23, 1997 .....

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 requirements , 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

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Page 2 - Ms. Gamble

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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510(k) Number (if known): K973172

Device Name:

(

Resposable Holmium Bare Fibers

Indications for Use:

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QDE)

A. Oleks

Prescription Use	X
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Over-the-Counter Use _

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.