DORNIER MEDILAS D

K982629 · Dornier Surgical Products, Inc. · GEX · Sep 14, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982629
• Device Name: DORNIER MEDILAS D
• Applicant: Dornier Surgical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece). The Dornier Medilas D Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

Device Story

Dornier Medilas D Laser is a diode laser system for soft tissue surgery; emits continuous-wave laser radiation at 940 nm. Input: user-selected power (0-50 W) and pulse duration via graphic display panel. Operation: laser energy delivered through light guide to distal tip for contact or non-contact tissue interaction; includes 645 nm diode aiming beam. Used in OR/clinic by physicians; supports endoscopic (laparoscopes, etc.) and open surgery. Safety features: watchdog-monitored dual-microprocessor architecture; system fault routine halts laser production if microprocessors mismatch; air-cooled internal closed-circuit water cooling system. Output: thermal energy for incision, excision, vaporization, ablation, or coagulation. Benefits: precise tissue management across multiple surgical specialties.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design specifications.

Technological Characteristics

Diode laser; 940 nm wavelength; 0-50 W power output; continuous-wave operation. Features: 645 nm diode aiming beam; air-cooled, temperature-controlled internal closed-circuit water cooling system; graphic display panel. Control system: dual-microprocessor architecture with watchdog monitoring. Software-controlled operating modes (Standard, Fibertom, LITT, LPS).

Indications for Use

Indicated for soft tissue cutting, vaporization, ablation, and coagulation in patients undergoing endoscopic or open surgical procedures. Applicable across specialties: Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

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

• Dornier Medilas Fibertome Laser Model 5100 (K964760)
• Indigo's 830e Laser (K955758)

Submission Summary (Full Text)

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982629

SEP 1 1 1998

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Medilas D Laser

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Dornier Medilas D Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Dornier 5100 Laser (K964760) and Indigo's 830e (K955758).

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Dornier Surgical Products, Inc. | Phone: | 770-426-1315 |
|---------------------------------|----------------|---------------|
| 10027 South 51st Street | Facsimile: | 770-514-6288 |
| Phoenix, AZ 85044 | | |
| Contact Person: Carol Wernecke | Date Prepared: | July 21, 1998 |

#### Name of Device and Name/Address of Sponsor

Dornier Medilas D Laser Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix, AZ 85044

#### Classification Name

Diode lasers have not been specifically classified by FDA.

#### Predicate Devices

Dornier Medilas Fibertome Laser Model 5100 and Indigo's 830e Laser

#### Intended Use

The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

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The Dornier Medilas D Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

### Technological Characteristics and Substantial Equivalence

The Dornier Medilas D laser and its predicate device, the Dornier 5100 has the same intended use. Both lasers are intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand pieces). Both devices are indicated for use in medicine and surgery.

The Dornier Medilas D laser has the same principles of operation and similar technological characteristics as the previously cleared predicates, Dornier 5100 laser. The Medilas D is a 50 W laser while the 5100 laser is a 100 W laser. Both devices are continuous-wave, emitting laser radiation in the invisible ranges of 940 nm (Medilas D) and 1064 nm (5100). The Medilas D offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps. The 5100 offers laser power of 2-100 W at the distal tip of the light quide, adjustable in 1 W steps. Both laser offers adjustable pulse duration. The Medilas D and the 5100 laser offers the same software controlled operating modes with exception to the Medilas D, it does not have the same number of operating modes as the 5100 laser.

The Medilas D is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The 5100 laser has a photoelectric power meter and is automatically calibrated. Both lasers have a 2-stage waterproof and explosion-proof switch and both laser incorporates a watchdog-monitored microprocessor.

There are minor differences between the Medilas D laser and the predicate 5100 laser, none of which present new issues of safety or effectiveness. The minor differences are discussed in detail below.

The Medilas D and the 5100 laser use very similar aiming beams. The Medilas D uses a 0.1mW Diode laser aiming bean with a wavelength of 645 nm. The 5100 laser uses a 2 mW Diode laser aiming beam with a

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wavelength of 630 nm. The maximum power of both aiming beams at the aperture is 1 mW. The minor differences in wavelengths between the treatment beams do not raise new issues of safety or effectiveness since the aiming beam does not affect the tissue. The aiming beams merely provide visual indication of the location at which the treatment beam will strike the tissue.

Both the Medilas D and the 5100 laser incorporate a graphic display The graphic display shows laser operating parameters, panel. application modes, time functions, system status and messages for the user.

Like its predicated device, the Medilas D laser offers several software controlled operating modes. Most of the operating modes are identical to those offered in the predicate device, the 5100 laser. Both lasers include the following operating modes: Standard, Fibertom, LITT and LPS. The 5100 contain several other modes of operation that are not available on the Medilas D.

The Medilas D and the 5100 laser has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system.

Both the Medilas D and the 5100 laser are based on a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the 5100 laser hardware initiates a "system fault" routine. During any "system fault," laser production and release immediately halt.

The Medilas D is not an Nd:YAG laser." The Medilas D is a diode laser. The comparison to the laser medium (diode) for the second predicate. Indigo's 830e (K955758) is to provide information to establish the Medilas D substantial equivalency determination in today's marketplace.

The Dornier Medilas D laser has the same principles of operation and similar technological characteristics as the previously cleared predicates, Dornier 5100 (K964760) and Indigo's 830e (K955758). As explained above, the minor differences in the aiming beam, software controlled operating modes, do not present new issues of safety or effectiveness.

From a clinical perspective and comparing design specifications, the Dornier Medilas D laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the

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Dornier Medilas D and the predicate devices, Dornier 5100 and Indigo's 830e lasers.

Dornier Surgical Products, Inc. believes the minor differences of the Dornier Medilas D and its predicate laser devices should not raise any concerns regarding the overall safety or effectiveness.

### Advisory:

This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Ms. Carol Wernecke Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix, Arizona 85044

Re: K982629

Trade Name: Dornier Medilas D Laser Regulatory Class: II Product Code: GEX Dated: July 27, 1998 Received: July 28, 1998

Dear Ms. Wernecke:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carol Wernecke

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/dsma/dsmamain.html".

Sincerely vours.

Acosta

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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## PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

| 510(k) Number: | k922629 |
|----------------|-------------------------|
| Device Name: | Dornier Medilas D Laser |

Indications for Use:

The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties:

- Urology �
- Plastic Surgery �
- General Surgery �
- Dermatology �
- Gynecology �
- Pulmonary Surgery �
- Gastroenterology �
- ENT ﻬ
- Radiology .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use

Pooch
(Division Sign-Off)

Division of Scheral Rest 510(k) Number