DORNIER MEDILAS H 20 LASER

K061455 · Dornier Medtech America, Inc. · GEX · Aug 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061455
• Device Name: DORNIER MEDILAS H 20 LASER
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Medilas H 20 Laser is 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 for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Dornier Medilas H 20 Laser is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery.

Device Story

Pulsed solid-state Holmium:YAG laser system; emits 2080 nm radiation; absorbed by water; 0.4mm penetration depth. Operator controls pulse energy, frequency, and mode (continuous, repetitive burst, control panel burst) via touch screen display. Laser light transmitted to site via sterile fiber optic delivery systems with SMA 905 connector. Used in OR/clinic settings by physicians for endoscopic or open surgery. Output enables tissue incision, excision, vaporization, ablation, and coagulation. Benefits include precise soft tissue management across multiple surgical specialties.

Clinical Evidence

No clinical data provided. Substantial equivalence established through bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Solid-state Ho:YAG laser; 2080nm wavelength; 20W max radiant power; 1.8J-2.5J energy output; 350us pulse duration. Integrated water/air cooling system. Fiber optic delivery via SMA 905 connector. Sterilization via ethylene oxide. Touch screen interface for parameter control.

Indications for Use

Indicated for patients requiring soft tissue cutting, vaporization, ablation, or coagulation in arthroscopy, urology, lithotripsy, pulmonology, gastroenterology, gynecology, ENT, and general surgery. Used via endoscopic or open surgical procedures.

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 H Laser (K981718)
• Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012)
• Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703)

Submission Summary (Full Text)

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# KOP1422

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medilas H 20 Laser

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

#### 1. General Information

| Submitter Information: | Dornier MedTech America, Inc.<br>1155 Roberts Boulevard<br>Kennesaw, Georgia 30144 U.S.A. |
|---------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas |
| Contact Phone Number: | [phone] |
| Contact Fax Number: | [phone] |
| Summary Preparation Date: | May 19, 2006 |

#### 2. Device Name Proprietary Name: Dornier Medilas H 20 Laser Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System Common Name: Classification Name: Laser Instrument, Surgical, Powered (Product Code GEX)

#### 3. Predicate Devices

- . Dornier Medilas H Laser (K981718)
- . Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012)
- Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with I Accessories (K011703)

#### 4. Device Description

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The Dornier Medilas H 20 Laser is a pulsed solid-state Holmium:YAG laser system. The Dornier Medilas H 20 Laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400pm (0.4mm). The Dornier Medilas H 20 Laser incorporates a graphic display panel with touch screen capabilities allowing the operator to control the functions and laser parameters of the laser pulse control panel regulates the pulse energy, pulse frequency, pulse mode (continuous mode, pedalcontrolled repetitive burst mode and control panel bursts mode), pilot brightness, and various Menu functions. The Dornier Medilas H 20 Laser light emission is transmitted to the application site by a sterile fiber optic delivery systems or fiber optic cables with a SMA 905 connector.

#### 5. Intended Use

The Dornier Medilas H 20 Laser is designed for use in conjunction with various fiber optic cables as a laser system. The modified Dornier Medilas H 20 Laser and currently marketed Dornier Medilas H Laser 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 for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Dornier Medilas H 20 Laser is indicated for use in medicine and surgery, in the following medical specialties:

- . Arthroscopy
- . Urology
- Lithotripsy .
- . Pulmonology
- Gastroenterology .
- . Gynecology
- ENT .
- General Surgery .

#### 6. Technological Characteristics

The proposed Dornier Medilas H 20 Laser is substantially equivalent to the predicate devices Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012) and Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703) in device design, technology characteristics, and operational characteristics as provided in the Premarket Notification. Some of the Technology characteristics described include:

Principles of Operation: The Dornier Medilas H 20 Laser and all predicate lasers have same basic operational features for Holmium YAG lasers with flash lamp emission.

Laser Type: The Dornier Medilas H 20 Laser and all predicate lasers are Solid State Holmium HO:YAG lasers which are equivalent.

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Maximum Radiant Power: The Dornier Medilas H 20 Laser and all predicate lasers have a maximum of 20 Watts radiant power wattage which are equivalent.

Wavelength: The Dornier Medilas H 20 Laser has a wavelength of 2080nm and all predicate lasers operate at 2100nm which are equivalent.

Energy Output: The Dornier Medilas H 20 Laser and all predicate lasers have energy outputs between 1.8J to 2.5J which are equivalent.

Pulse Duration: The Dornier Medilas H 20 Laser has a pulse duration of 350us and all predicate lasers have pulse durations between 250us which are equivalent.

Cooling Method: The Dornier Medilas H 20 Laser has an integrated water cooling system with water/air exchangers and all predicate lasers have integrated water cooling system with water/air exchangers which are equivalent.

Operational Modes: The Dornier Medilas H 20 Laser and all predicate lasers have continuous and pulse modes which are equivalent.

Delivery Systems: The Dornier Medilas H 20 Laser and all predicate lasers use equivalent ethylene oxide sterilized fiber optic delivery systems with a SMA 905 connector that are used in conjunction with endoscopes for target visualization.

#### 7. Rational for Substantial Equivalence

The Dornier Medilas H 20 Laser has the same indications for uses as the predicate device Dornier Medilas H Laser (K981718). The Dornier Medilas H 20 Laser has the same general indications for uses as the predicate devices Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012) and Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703). There is no safety of efficacy concerns with the indications for use statements as presented.

#### 8. Safety and Effectiveness Information

Safety and effectiveness information was provided in the Premarket Notification to demonstrate that the Dornier Medilas H 20 Laser is safe and effective, when indicated for use for general and specific applications in the medical specialties of Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

#### 9. Conclusion

The Dornier Medilas H 20 Laser was determined to be substantially equivalent to similar current marketed and predicate surgical lasers. The Dornier Medilas H 20 Laser has the same indications for uses as the predicate device Dornier Medilas H Laser (K981718). The Dornier Medilas H 20 Laser has the same general indications for uses as the predicate devices Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012) and Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 1 2006

Dornier MedTech America, Inc. % Mr. Tim Thomas Vice President of Quality, Regulatory & Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K061455

Trade/Device Name: Dornier Medilas H 20 Laser 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: May 19, 2006 Received: July 1. 2006

Dear Mr. Thomas:

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 he 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

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Page 2 - Mr. Tim Thomas

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Office of Compliance at [phone]. 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 Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Leuner

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

Enclosure

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Dornier MedTech America, Inc. Dornier Medilas H 20 Laser System

# INDICATIONS FOR USE

510(k) Number (if known): __ كـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Device Name: Dornier Medilas H 20 Laser

### Indications for Use:

The Dornier Medilas H 20 Laser is 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 for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coaqulation of soft tissue. The Dornier Medilas H 20 Laser is indicated for use in medicine and surgery, in the following medical specialties:

- Arthroscopy .
- Urology .
- Lithotripsy .
- Pulmonology .
- Gastroenterology .
- Gynecology �
- ENT .
- General Surgery .

Prescription Use AND/OR Over-The-Counter Use × (Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off)
Division of General, Restorative,

and Neurological Devices

Page 1 of 1

Dornier MedTech America, Inc.) Number K061455
Dornier Medilas H 20 Laser 510(k) Submission
May 19, 2006

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