Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures
Gastroenterological/Gastrointestinal Surgery
General Surgery of soft tissue
Genitourinary Surgery/Urology
Gynecological Surgery during open and endoscopic procedures
Lithotripsy and Percutaneous Urinary Lithotripsy
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue
Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy

Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstitial applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.

Device Description

The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).

AI/ML Overview

The provided document is a 510(k) summary for the Trimedyne OmniPulse™ Mini, Model 2120, a Holmium:Yttrium Aluminum Garnet (Ho:YAG) Laser System. It outlines the device's technical characteristics, intended use, and its substantial equivalence to predicate devices. However, this document clearly states that "No nonclinical data was submitted in this Premarket Notification" and "No clinical data was submitted in this Premarket Notification."

Therefore, based on the provided information, there is no study detailed that proves the device meets specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems) based on similar technological characteristics and intended use.

Consequently, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as no such studies were submitted or referenced.

Here's a breakdown of what can and cannot be stated based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as this was a substantial equivalence submission relying on predicate devices, not a de novo clearance requiring novel performance thresholds.
Reported Device Performance: No performance data from new studies are reported in this document. The device's technological characteristics such as wavelength, pulse width, pulse energy range, and pulse repetition rates are described, but these are specifications, not performance metrics against acceptance criteria from a study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable, as no test set or clinical study was submitted.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Experts and Qualifications: Not applicable, as no test set requiring ground truth establishment was submitted.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no test set was submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No MRMC comparative effectiveness study was mentioned or submitted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance Study: Not applicable, as this is a laser device, not an AI algorithm. No standalone performance study was mentioned or submitted.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable, as no studies requiring ground truth were submitted.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable, as this is a laser device, not a machine learning model requiring a training set. No study involving a training set was mentioned or submitted.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary of what can be extracted:

The submission for the OmniPulse™ Mini, Model 2120, based its clearance on demonstrated substantial equivalence to existing predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems). This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

The document describes the technological characteristics of the OmniPulse™ Mini, including:

Wavelength: 2.1 µm
Nominal Pulse Width: 350 microseconds
Pulse Frequencies: 7, 10, 15, and 20 Hz
Pulse Energies: 0.2 to 2.0 Joules (range depends on frequency)
Exposure Modes: Continuous, single burst, or repetitive burst

Its intended use covers a broad range of applications in various surgical specialties, identical to the predicate devices. The key argument for acceptance was that "All of the characteristics of the OmniPulse Mini fall with the previously cleared ranges for the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating that the new device's specifications and capabilities were within the established safe and effective parameters of the predicate devices, rather than through new performance studies specific to this device model.

Summary

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Ko43012 11/2

1/2

NOV 17 2004 OmniPulse™ Mini, Model 2120

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 92618949-951-3800
Contact Person:	Glenn YeikPresident and COO
Summary Date:	27 September 2004

11. Device Name

Proprietary:	OmniPulse™ Mini, Model 2120
Common:	Holmium:Yttrium Aluminum Garnet (Ho:YAG) Laser System
Classification:	Various Medical Lasers

lll. Predicate Device

The predicate devices for the OmniPulse™ Mini are the Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems.

IV. Device Description

V. Intended Use

The OmniPulse™ Mini is designed for use in conjunction with Trimedyne's various arthroscopic handpieces and optical fiber delivery devices. As with the other cleared Trimedyne Ho:YAG laser systems, applications for this laser system include superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

. "

General Surgery of Soft Tissues .
. Genitourinary Surgery/Urology
. Otorhinolanryngology (ENT) Surgery
Gynecological Surgery .
Lithotripsy and Percutaneous Urinary Lithotripsy ◆

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Orthopedic Surgery .
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression/Discectomy

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Therapeutic Dermatological, Therapeutic Plastic, and Aesthetic Surgical . Procedures
Gastroenterological/Gastrointestinal Surgery .

When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, this laser system may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.

VI. Technological Characteristics

The laser is driven by a flash lamp and emits one pulse of laser radiation each time the flash lamp is fired. The laser pulse refers to the pulse waveform - each laser pulse consists of large numbers of overlapping spikes that have a duration of about one microsecond. These spikes compose the pulse waveform with nominal pulse duration of 350 microseconds. Laser pulses are generated at the frequency chosen by the operator. Pulse frequencies of 7, 10, 15 and 20 Hz are available.

In general, the operator may request pulse energies from 0.2 to 2.0 Joules. The range of pulse energies available depends on the pulse frequency. Not all energies are available at all pulse frequencies. The number of pulses emitted from the laser system can be controlled by the operator through the choice of one of three exposure modes.

VII. Nonclinical Data

No nonclinical data was submitted in this Premarket Notification.

VIII. Clinical Data

No clinical data was submitted in this Premarket Notification.

. IX. Conclusions

All of the characteristics of the OmniPulse Mini fall with the previously cleared ranges for the predicate devices. Therefore, the OmniPulse Mini Model 2120 is substantially equivalent to the Trimedyne OmniPulse™-MAX and OmniPulse Jr. ™ laser systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines forming the body and stylized curves representing the head and tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2004

Trimedyne, Inc. c/o Ms. Elizabeth Drew Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169

Re: K043012 K043012
Trade/Device Name: Trimedyne OnmiPulse™ Mini 20 Watt Ho:YAG Laser System, Model 2120 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 20, 2004 Received: November 2, 2004

Dear Ms. Drew:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conime.co proc to may 20, 2017) 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). and Cosmeter for (100) and the device, subject to the general controls provisions of the Act. The r ou may, dicrerere, mains 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 rr your device 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 r reade o a . made a determination that your device complies with other requirements of the Act that I Dr Has Inters and regulations administered by other Federal agencies. You must or unly 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 - Ms. Elizabeth Drew

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo solvet notification. The FDA finding of substantial equivalence of your device to a legally premaince 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mass facturers, 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,

Miriam C. Provost

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 for Use

Koy3012 510(k) Number:

Device Name: Trimedyne OmniPulseTM Mini 20 watt Ho:YAG Laser System, Model 2120

Indications for Use:

Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in 】. therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including:
- scars
- tattoo removal
- vascular lesions (including port wine stains,
- hemangioma, telangiectasia [facial, leg], and rosacea) ー
- corns
- papillomas
basal cell carcinomas
lesions of skin and subcutaneous tissue
plantar warts
periungual and subungual warts
debridement of decubitus ulcer
skin tag vaporization

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. -

Miriam C. Provost

eneral. Restorative. and Neurological Devices

510(k) Number_

Page 1 of 4

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Indications - continued

Gastroenterological/Gastrointestinal Surgery, including: 2.

cholecystectomy + lysis of adhesions �
appendectomy
biopsy
pylorostenotomy ﻬ
benign and malignant lesions .
rectal polyps of sigmoid colon
gall bladder calculi ◆
biliary/bile duct calculi �
benign and malignant neoplasm ◆
polyps ◆
colitis ↓
ulcers ◆
angiodysplasia .
hemorrhoids
varices esophagitis
esophageal ulcer
Mallory-Weiss tear
gastric ulcer
duodenal ulcer
non-bleeding ulcer
gastric erosions
colorectal cancer
gastritis
bleeding tumors
pancreatitis
vascular malformations
telangiectasias
telangiectasias of the Osler-Weber-Rendu disease

3. General Surgery of soft tissue, including:

skin incision �
tissue dissection
excision of external tumors and lesions ◆
complete or partial resection of internal organs ◆
tumors and lesions �
tissue ablation .
mastectomy �
hepatectomy �
pancreatectomy : � .
splenectomy �
thyroidectomy .
parathyroidectomy
hemiorrhaphy
tonsillectomy
lymphadenectomy +
partial nephrectomy �
pilonidal cystectomy �
resection of lipoma +
pelvic adhesiolysis �
debridement of decubitus ulcer
hemorrhoids
pilodidal cyst removal and repair
debridement of statis ulcer
biopsy

Genitourinary Surgery/Urology, including: 4.

superficial urinary bladder tumors �
invasive bladder carcinoma +
urethral strictures �
lesions of the external genitalia
bladder
urethral and ureteral tumors
condylomas
urethral and penile hemangioma ◆
bladder neck obstructions �
holmium laser incision, excision, resection, � ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)

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Indications - continued

Gynecological Surgery during open and endoscopic procedures, including: 5. .
- condyloma acuminata +

Lithotripsy and Percutaneous Urinary Lithotripsy, including: 6.

fragmentation of urinary calculi .
fragmentation of urethral calculi
fragmentation of kidney calculi .
treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed

Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, 7. including:

knee meniscectomy �
: ..
knee synovectomy +
chondromalacia and tears ﺑ
loose body debridement ◆
lateral retinacular release +
debridement of the degenerative knee .
plica removal +
ligament and tendon release
contouring and sculpting of articular surfaces
debridement of inflamed synovial tissue
capsulectomy in the knee
chondroplasty in the knee
chondromalacia ablation
1. Qtorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:
- endosinus surgery •
- functional endoscopic sinus surgery ◆
- turbinate procedures (e.g., turbinectomy) �
- dacryocystorhinostomy (DCR) +
- ethmoidectomy -�
polypectomy
maxillary antrostomy �
frontal sinusotomy 4
sphenoidotomy

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Indications - continued

Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: 9. Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following:
- Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, including: .
  - foraminoplasty -
- Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: ●
  - uncomplicated ruptured or herniated discs
  - neck pain with radiation down the arm - ". .
  - symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep . tendon reflexes
  - MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and – symptoms
    - positive electromyography and/or nerve conduction studies
    - no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
- Percutaneous Thoracic Disc Decompression/Discectomy in soft tissue, in patients with:
  - uncomplicated ruptured or herniated discs -
  - thoracic and intercostal intractable pain -
  - paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myelography
  - MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
  - no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

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.