MEDILAS D FAMILY LASERS by DORNIER MEDTECH AMERICA, INC.

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

Device Description

The Dornier Medilas D Family Lasers are continuous-wave diode laser emitting laser radiation in the invisible range of 940 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D Family Lasers incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D Family Lasers feature several operating modes, including Standard, Fibertom, LITT and LPS. The lasers can be used in contact or non-contact open surgery with or without handpieces.

AI/ML Overview

The provided text describes the 510(k) summary for the Dornier Medilas D Family Lasers. It outlines the device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond regulatory compliance.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, a common pathway for medical device clearance in the US.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study for Dornier Medilas D Family Lasers

This submission for the Dornier Medilas D Family Lasers (including Medilas D Litebeam, Medilas D Litebeam +, Medilas D Urobeam, Medilas D Multibeam, and Medilas D FlexiPulse) relies on demonstrating substantial equivalence to predicate devices rather than independent performance studies with specific acceptance criteria. Therefore, a table of acceptance criteria and reported device performance, in the typical sense of quantitative clinical or analytical performance, cannot be extracted directly from this document.

The "acceptance criteria" can be inferred as compliance with existing regulatory standards and the demonstration of equivalent technological characteristics and overall performance to the identified predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred from Submission)
Regulatory Compliance	Complies with Class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11). Complies with voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
Technological Characteristics	"From a clinical perspective and comparing design specifications, the Dornier Medilas D Family Lasers and the predicate devices are substantially equivalent." Minor differences exist that "should not raise any concerns regarding the overall safety or effectiveness."
Overall Performance	"Based on the technological characteristics and overall performance of the devices... no significant differences exist between the proposed diode lasers and the predicate devices." Implied performance is equivalent to predicate devices for stated indications.
Safety and Effectiveness	Believed to be "substantially equivalent" to predicate devices, and differences "do not raise new issues of safety or effectiveness."

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

The document does not describe a specific "test set" for a performance study as it relies on substantial equivalence. It does not mention any sample sizes for tests, nor does it specify data provenance in terms terms of country of origin or retrospective/prospective nature. The assessment is based on a comparison of design specifications and regulatory compliance.

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

This information is not provided as there is no described test set or ground truth establishment relevant to the performance metrics of an AI/algorithm-based device. The submission focuses on the engineering and regulatory equivalence of a laser system.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or reported for this device, as it is a laser hardware system, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study, as understood for AI/algorithmic devices, was not conducted or reported. The device is an energy-based surgical tool. Its performance is assessed through compliance with electrical, laser radiation, and medical device safety standards, and by demonstrating equivalence in its operational specifications to previously cleared devices.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI image analysis or diagnostic algorithms is not relevant or discussed in this 510(k) submission. The "truth" in this context is the fulfillment of regulatory standards and the demonstration that the device's technical specifications and intended uses are analogous to legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable and not provided as this submission is for a laser surgical instrument, not an algorithm that requires a training set.

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

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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Proprietary to Dornier MedTech America, Inc.

070536

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.

Submitter Name andAddress:	Dornier MedTech America, Inc.1155 Roberts Blvd.Kennesaw, GA 30144
Contact Person:	Tim Thomas, Vice PresidentRegulatory/ Quality/ Clinical
Phone Number:	770-514-6163
Fax Number:	770-514-6288
EstablishmentRegistration Number:	1037955
Date Prepared:	February 23, 2007MAY 21 2007
Device Trade Name(s):	Medilas D Family Lasers, including:- Medilas D Litebeam- Medilas D Litebeam +- Medilas D Urobeam- Medilas D Multibeam- Medilas D FlexiPulse
Device Common Name:	Diode Laser System
Classification Name:	GEX - Laser Instrument, Surgical Powered
Predicate Device(s):	Medilas D Compact (K982629, K003993)Medilas D fibertom (K982629, K003993, K021724)Medilas D SkinPulse (K000072, K020339, K021724)Medilas D SkinPulse S / D940 (K003993, K020339, K021724)
General DeviceDescription:	The Dornier Medilas D Family Lasers are continuous-wavediode laser emitting laser radiation in the invisible range of940 nm. Each is calibrated during the manufacturing processand during service calls. The end-user does not calibratefibers for this system. The Medilas D Family Lasersincorporate a graphic display panel, which shows laseroperating parameters, application modes, time functions,system status and messages for the user. The Medilas DFamily Lasers feature several operating modes, includingStandard, Fibertom, LITT and LPS. The lasers can be usedin contact or non-contact open surgery with or withouthandpieces.

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Intended Use:

Technological From a clinical perspective and comparing design Characteristics: specifications, the Dornier Medilas D Family Lasers and the predicate devices are substantially equivalent. Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the proposed diode lasers and the predicate devices.

Dornier MedTech America, Inc. believes the minor differences of the Medilas D Family Lasers ant its predicates lasers should not raise any concerns regarding the overall safety or effectiveness.

Performance Data: While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light

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emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).

Conclusion:

Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that the Medilas D Family Lasers and the predicate devices selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 2 1 2007

Re: K070536 Trade/Device Name: Medilas D Family Lasers 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: February 23, 2007 Received: February 27, 2007

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 be 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 (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.

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 you

Mark N. Melker 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Medilas D Family Lasers

Indications for Use:

. Urology
Plastic Surgerv .
. General Surgery
. Dermatology
. Gynecology
. Pulmonary Surgery
. Gastroenterology
ENT .
Radiology .

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Division of General, Restorative, and Neurological Devices

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510(k) Number	L603531
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Concurrence of CDRH, Office of Device Evaluation (ODE)

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