(153 days)
These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
The Multiuse Switchable Tip is a fiber optic energy delivery device consisting of a nearcontact fixed laser fiber contained in a stainless steel shaft; it attaches to the Omni'10 Multiuse Handpiece through a quick-connect mechanism.
This document is a 510(k) summary for a medical device (Trimedyne Multiuse Switchable Tips). It explicitly states that "No clinical tests were submitted in this Premarket Notification." This means there is no study described within this document that proves the device meets specific acceptance criteria based on clinical performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies cannot be provided from the given text.
The only "tests" mentioned are "Nonclinical Tests" which included sterilization, mechanical, biological, and performance studies. However, the document does not elaborate on specific acceptance criteria for these nonclinical tests, nor does it provide detailed results or methodologies for these tests beyond their general categories.
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Image /page/0/Picture/0 description: The image shows the logo for "Trimedyne" on the left side of the image. On the right side of the image, the text "K 964585" is present at the top. Below this text, the date "APR 17 1997" is written.
Summary of 510(k) Safety and Effectiveness Information
Trimedyne® Multiuse Switchable Tips
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.
| I. Submitter Information: | Trimedyne, Inc.P.O. Box 57001Irvine, CA 92619-7001714/559-5300714/559-1330 |
|---|---|
| Contact Person: | Susan H. GambleDirector, Regulatory Affairs & Quality Assurance |
Summary Date: November 14, 1996
II. Device Name
Resposable OmniTip™ Switchable Tips Proprietary:
Common: Laser Fibers
Classification: Accessories to Laser-Powered Instrument (unclassified)
III. Predicate Device
The predicate devices are the Trimedyne Omni™ Switchtip System and Tapertip™ Endfiring Multiuse Handpieces.
IV. Device Description
The Multiuse Switchable Tip is a fiber optic energy delivery device consisting of a nearcontact fixed laser fiber contained in a stainless steel shaft; it attaches to the Omni'10 Multiuse Handpiece through a quick-connect mechanism.
V. Intended Use
These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
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 sterilization/reuse.
VII. Nonclinical Tests
The devices were subjected to a series of tests; these tests included sterilization, mechanical, biological, and performance studies.
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Clinical Tests /III.
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No clinical tests were submitted in this Premarket Notification.
Conclusions Drawn from Testing IX.
The devices are biocompatible, perform as intended, and have acceptable mechanical properties when used according to their labeling.
특
§ 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.