K Number
K964585
Device Name
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
Manufacturer
Date Cleared
1997-04-17

(153 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
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.
More Information

Not Found

Not Found

No
The summary describes a fiber optic energy delivery device and its mechanical properties. There is no mention of AI, ML, image processing, or any data-driven algorithms.

No

The device is described as an "energy delivery device" for use with a laser, and its performance studies highlight mechanical and biological properties, not therapeutic efficacy. There are no mentions of treating or diagnosing any medical condition.

No
The device description indicates it is a fiber optic energy delivery device, which is used for treatment, not diagnosis. The performance studies also do not mention diagnostic metrics.

No

The device description explicitly states it is a "fiber optic energy delivery device consisting of a nearcontact fixed laser fiber contained in a stainless steel shaft," indicating it is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as an energy delivery device for use with a holmium laser for its cleared applications. This indicates a therapeutic or surgical application, not a diagnostic test performed on samples outside the body.
  • Device Description: The description details a fiber optic energy delivery device used in conjunction with a handpiece. This aligns with a device used for delivering laser energy directly to tissue, not for analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
  • Performance Studies: The performance studies mentioned focus on sterilization, mechanical, biological, and performance aspects related to the device's function as an energy delivery tool, not on the accuracy or reliability of diagnostic results.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's description and intended use clearly fall outside of that definition.

N/A

Intended Use / Indications for Use

These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.

Product codes

Not Found

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The devices were subjected to a series of tests; these tests included sterilization, mechanical, biological, and performance studies. No clinical tests were submitted in this Premarket Notification. The devices are biocompatible, perform as intended, and have acceptable mechanical properties when used according to their labeling.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

The predicate devices are the Trimedyne Omni™ Switchtip System and Tapertip™ Endfiring Multiuse Handpieces.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 57001
Irvine, CA 92619-7001
714/559-5300
714/559-1330 |
|---------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Susan H. Gamble
Director, 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.

1

Clinical Tests /III.

יי

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.