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 .

Device Description

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.

AI/ML Overview

This document is a 510(k) summary for the Dornier Medilas H 20 Laser and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices to establish substantial equivalence under the 510(k) pathway, which typically does not require new clinical performance studies with specific acceptance criteria in the same way a PMA or de novo submission might.

Here's what can be inferred from the document regarding the "study" for this submission:

Type of "Study": This is a predicatibility study (comparison to predicate devices), not a performance study with acceptance criteria. The "study" here involves demonstrating that the Dornier Medilas H 20 Laser is "substantially equivalent" to already approved devices.
Proof of Meeting "Acceptance Criteria": The "acceptance criteria" for a 510(k) submission are met when the FDA determines the new device is substantially equivalent to a predicate device. This is primarily done by showing it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Specific points from the document that relate to the comparison:

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)
Comparative Technological Characteristics (used for showing equivalence, not acceptance criteria for performance):
- Principles of Operation: Same basic operational features for Holmium YAG lasers with flash lamp emission.
- Laser Type: Solid State Holmium HO:YAG lasers (equivalent).
- Maximum Radiant Power: 20 Watts (equivalent to predicates).
- Wavelength: 2080nm (new device) vs. 2100nm (predicates) - deemed equivalent.
- Energy Output: 1.8J to 2.5J (equivalent to predicates).
- Pulse Duration: 350us (new device) vs. 250us (predicates) - deemed equivalent.
- Cooling Method: Integrated water cooling system with water/air exchangers (equivalent).
- Operational Modes: Continuous and pulse modes (equivalent).
- Delivery Systems: Ethylene oxide sterilized fiber optic delivery systems with SMA 905 connector (equivalent).
Intended Use: The Dornier Medilas H 20 Laser has the same indications for use as the predicate device Dornier Medilas H Laser (K981718), and the same general indications for use as the other two predicates.
Safety and Effectiveness Information: The document states that "Safety and effectiveness information was provided in the Premarket Notification to demonstrate that the Dornier Medilas H 20 Laser is safe and effective..." However, the nature of this information (e.g., specific test results, clinical data) is not detailed in this summary. It's typical for 510(k)s to rely on non-clinical (bench) testing and comparison to predicates rather than extensive human clinical trials to demonstrate safety and effectiveness for substantial equivalence.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research study with performance-based acceptance criteria.

Summary

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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.1155 Roberts BoulevardKennesaw, Georgia 30144 U.S.A.
Contact Person:	Tim Thomas
Contact Phone Number:	(770) 514-6163
Contact Fax Number:	(770) 514-6288
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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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 (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 Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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:

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

5.1

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.