OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A

K992574 · Trimedyne, Inc. · GEX · Oct 29, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992574
• Device Name: OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trimedyne Holmium:YAG Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.

Device Story

Trimedyne Holmium Laser System (Models 1210, 1210-VHP, 1500-A) is a Class IV, pulsed, solid-state Holmium:YAG laser; delivers 2.1 um infrared energy; pulsewidth up to 350 microseconds. System features menu-driven controls for pulse repetition rate, output energy, and lasing duration. Used in OR or clinical settings by physicians for multispecialty surgical applications including lithotripsy, ENT, and general surgery. Laser energy interacts with target tissue to perform incision, excision, resection, ablation, vaporization, coagulation, or hemostasis. Output allows precise tissue management; benefits include minimally invasive surgical capability and effective stone fragmentation. Healthcare providers operate the system via console controls to achieve desired clinical outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Holmium:YAG laser; 2.1 um wavelength; max pulsewidth 350 microseconds; max power 100 watts. Class IV, pulsed, solid-state laser. Menu-driven control interface for pulse repetition rate, output energy, and duration.

Indications for Use

Indicated for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in patients requiring surgical intervention in gastroenterological/GI, dermatology/plastic surgery, general surgery, genitourinary, gynecological, lithotripsy, orthopedic, ENT, and percutaneous lumbar discectomy procedures. Applicable to soft, mucosal, fatty, cartilaginous, and bony tissues, including specific conditions like urinary calculi, tumors, lesions, and various joint/sinus pathologies.

Regulatory Classification

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.

Predicate Devices

• Coherent VersaPulse Select Dual Wavelength Surgical Laser
• Trimedyne Optilase® Model 1000-100 Nd: YAG Laser System
• Nortech Autolith Lithotriptor Electro-Hydraulic System

Submission Summary (Full Text)

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OCT 2 9 1999

K992574

# 510(k) Summary of Safety and Effectiveness Information

# Trimedyne® Holmium Laser System

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.<br>P.O. Box 57001<br>Irvine, CA 92619-7001 |
|----|------------------------|-------------------------------------------------------------------|
| | Contact person: | Susan H. Gamble<br>Vice President, Regulatory Affairs and Quality |
| | Summary Date: | July 29, 1999 |

#### II. Device Name

Trimedyne Holmium Laser System, including: Proprietary:

- Trimedyne OmniPulse™ Holmium Laser System (Model 1210) +
- Trimedyne OmniPulseTM-MAX Holmium Laser System (Model 1210-VHP) ◆
- Model 1500-A Holmium Laser System �

Holmium: Yttrium Aluminum Garnet (Holmium: YAG) Laser Common:

Classification: Laser-Powered Instrument

## III. Predicate Device

The predicate devices are:

- Coherent VersaPulse Select Dual Wavelength Surgical Laser. 1.
- Trimedyne Optilase® Model 1000-100 Nd: YAG Laser System. 2.
- Nortech Autolith Lithotriptor Electro-Hydraulic System. 3.

## IV. Device Description

The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and up to 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.

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#### V. Intended Use

The Trimedyne Holmium:YAG Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.

#### VI. Technological Characteristics

The laser system is a Holmium: YAG laser which emits light at a wavelength of 2.1 um (near infrared) and a maximum pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.

### VII. Conclusions Drawn from Testing

The Trimedyne Holmium: YAG Laser System can be used for the proposed indications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Ms. Susan H. Gamble Vice President, Regulatory Affairs and Quality Trimedyne, Inc. 2801 Barranca Road P.O. Box 57001 Irvine, California 92619

Re: K992574

> Trade Name: Omni Pulse™ Holmium Laser System, Model 1210 Omni Pulse™ MAX Holmium Laser System, Model 1210-VHP Model 1500-A Holmium Laser System

Regulatory Class: II Product Code: GEX Dated: July 29, 1999 Received: August 2, 1999

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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# Page 2 – Ms. Susan H. Gamble

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Munell H. Sager

Sur 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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9925'74

Page 1 of 2 (revised)

| 510(k) Number (if known): | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Trimedyne Holmium Laser System, including: |
| | OmniPulse™ Holmium Laser System, Model 1210 |
| | OmniPulse™-MAX Holmium Laser System, Model 1210-VHP |
| | Model 1500-A Holmium Laser System |
| Indications for Use: | Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/ Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall blader 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, and telangiectasias of the Osler-Weber-Rendu disease. |
| | 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, with or without an endoscope, 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), corns, papillomas, and basal cell carcinomas. |
| | General Surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation. |
| | (Continued on page 2) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-the-Counter Use |
|------------------|----|----------------------|
|------------------|----|----------------------|

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ____________________________________________________________________________________________________

. .

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## Indications - continued

Genitourinary Surgery, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.

Gynecological Surgery during open and endoscopic procedures.

Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.

Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectorny, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, and debridement of the degenerative knee.

Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).

Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.