The Side Firing Needle with Vent Sheath is intended for superficial or interstitial incision. excision, resection, ablation, vaporization, coagulation and hemostasis and may be used with any cleared Holmium laser that has a compatible connector.

Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.

Device Description

The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.

AI/ML Overview

The provided text describes a medical device, the Trimedyne Side Firing Needle with Vent Sheath, and its 510(k) submission to the FDA. It does not include information about acceptance criteria or a study using the device with acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which is typically found for AI/ML or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and nonclinical testing.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth, experts, and MRMC studies are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the provided text, indicating where information is present or absent:

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

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatible	The Side Firing Needle with Vent Sheath is biocompatible.
Performs as intended (superficial/interstitial incision, excision, etc. using Holmium laser)	Performs as intended (based on verification and validation tests).
Acceptable mechanical properties	Has acceptable mechanical properties (based on verification and validation tests).
Substantial equivalence to predicate devices (K992230, K010041, K990851)	"The Side Firing Needle with Vent Sheath differs... in the addition of a pointed tip, a silver reflector... and a vent sheath..." but is deemed substantially equivalent implying overall comparable safety and effectiveness.

Note: The acceptance criteria are inferred from the "Conclusions Drawn From Testing" and the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to previously cleared devices. Specific numerical performance targets are not provided.

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

Not Applicable. The submission states "No clinical tests were submitted in this Premarket Notification." The nonclinical data involved "verification and validation tests, including performance and tissue affect studies," but specific sample sizes or provenance for these tests are not detailed.

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 clinical data was submitted, and thus no expert-adjudicated ground truth for a test set is mentioned.

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

Not Applicable. No clinical data or test set requiring adjudication is described.

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 accessory, not an AI or diagnostic device that would involve human readers or an MRMC study.

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

Not Applicable. This is a hardware medical device, not an algorithm.

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

Not Applicable. Given the lack of clinical studies, no "ground truth" in the diagnostic sense was established. The nonclinical "tissue affect studies" would have relied on direct observation of the laser's interaction with tissue, but details are not provided.

8. The sample size for the training set

Not Applicable. As a physical device, there is no "training set" in the context of machine learning or AI models. The device was likely designed and optimized through engineering and bench testing.

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

Not Applicable. See point 8.

Summary

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K022655

Side Firing Needle with Vent Sheath

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.15091 Bake ParkwayIrvine, CA 92618949-559-5300
	Contact Person:	Glenn YeikExecutive Vice President

August 8, 2002 Summary Date:

ll. Device Name

Proprietary:	To be determined
Common:	Laser Fiber
Classification:	Accessory to Laser-Powered Instrument

III. Predicate Device

The predicate devices for the Side Firing Needle with Vent Sheath are:

Trimedyne Side Firing Switchable Tip with Suction/Irrigation cleared under K992230; .
SLT Diffuser™ Fiber cleared under K010041; and .
. Índigo Diffuser-Tip™ Fiberoptic cleared under K990851.

IV. Device Description

V. Intended Use

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Technological Characteristics VI.

The Side Firing Needle with Vent Sheath differs from the Side Firing Switchable Tip with Suction/Irrigation in the addition of a pointed tip, a silver reflector to minimize energy emission in other than the main beam direction, and a vent sheath to provide an exhaust path for fluid and vapor.

VII. Nonclinical Data

The Side Firing Needle with Vent Sheath was subjected to a series of verification and validation tests, including performance and tissue affect studies.

VIII. Clinical Data

No clinical tests were submitted in this Premarket Notification.

IX. Conclusions Drawn From Testing

The Side Firing Needle with Vent Sheath is biocompatible, performs as intended, and has acceptable mechanical properties when used in accordance with its labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Human Services USA. The logo is a circular emblem with the words "HUMAN SERVICES * USA" arranged around the top half of the circle. The bottom half of the circle contains the word "DEPARTMENT". In the center of the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2002 NOV

Trimedyne, Inc. Glenn D. Yeik Executive Vice President 15091 Bake Parkway Irvine, California 92618

Re: K022655

Trade/Device Name: Trimedyne Side Firing Needle with Vent Sheath Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 8, 2002 Received: August 9, 2002

Dear Mr. Yeik:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act. or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Glenn D. Yeik

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

. . . . .

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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Indications Page

Page 1 of 1

510(k) Number: 12022655

Device Name:

Trimedyne Side Firing Needle with Vent Sheath

Indications for Use:

Superficial and interstitial 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)

My Signature Of

(Division Sign Division of General, Restorative and Neurological Devices

510(k) Number K022455

Prescription Use _

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.