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

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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 document is a 510(k) summary for the Dornier Medilas D Family Lasers. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel device proving its efficacy or accuracy.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, are not explicitly present in this type of regulatory submission. This document describes the device, its intended use, and its technological characteristics as compared to a predicate device, ultimately stating its compliance with established electrical and laser safety standards rather than clinical performance metrics.

Here is a summary of what can be extracted from the document, with explanations for the missing information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness through Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective.	The submission concludes that the Dornier Medilas D Family Lasers and the predicate device (Biolitec Ceralas Diode 100 W 980 nm Laser System K050824) are "substantially equivalent" from a clinical perspective and based on design specifications. "No significant differences exist between the proposed diode lasers and the predicate devices."
Compliance with Safety Standards: Compliance with relevant international electrical and laser safety standards.	The lasers are in compliance with Class IV performance standards for light-emitting products promulgated under the Radiation Control for Health and Safety Act of 1968 (21 C.F.R. §1040.10 and §1040.11). They also comply with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
Technological Characteristics Comparison: The new device's technological characteristics should not raise new issues of safety or effectiveness compared to the predicate device.	The "minor differences" between the Medilas D Family Lasers and its predicates "should not raise any concerns regarding the overall safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As this is a 510(k) for a laser system built on substantial equivalence to an existing device, it relies on design comparisons and compliance with safety standards rather than new clinical outcome data or a specific "test set" in the context of AI/diagnostic device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. This type of detail is relevant for diagnostic devices or those requiring expert interpretation for ground truth, which is not the primary focus of this laser system's 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. MRMC studies are typically for evaluating the impact of AI on human diagnostic performance, which is not applicable to a laser system device focused on tissue manipulation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided. This refers to AI algorithm performance and is not relevant for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not specified because the submission relies on the established safety and efficacy of the predicate device and compliance with general device standards, not on a new clinical study generating specific ground truth. The "ground truth" for this type of submission is essentially the proven safety record and performance of the predicate device and the adherence to recognized safety standards.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/provided. See point 8.

Summary

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K 083500

50 11

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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	FEB 12 2009
Contact Person:	Theron GoberQuality and Regulatory Manager
Phone Number:	770-514-6204
Fax Number:	770-514-6288
EstablishmentRegistration Number:	1037955
Date Prepared:	November 20, 2008
Device Trade Name(s):	Medilas D Family Lasers, including:• Medilas D Litebeam• Medilas D Litebeam +• Medilas D Urobeam• Medilas D Multibeam• Medilas D FlexiPulse• Medilas D MagnaPulse
Device Common Name:	Diode Laser System
Classification Name:	GEX - Laser Instrument, Surgical Powered
Predicate Device(s):	Biolitec Ceralas Diode 100 W 980 nm Laser System (Model D100) K050824
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.

Intended Use:

The Dornier Medilas D Family Lasers, specifically the Medilas

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

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam. "Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins with branch varicosities.

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Technological Characteristics:

Performance Data:

Conclusion:

From a clinical perspective and comparing design specifications, the Dornier Medilas D Family Lasers and the predicate device 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 laser should not raise any concerns regarding the overall safety or effectiveness.

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 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).

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 device 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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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dornier MedTech America, Inc. Theron Gober Quality and Regulatory Manager 1155 Roberts Blvd. Kennesaw, GA 30144

FEB 1 2 2009

Re: K083500

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: November 21, 2008 Received: November 25, 2008

Dear Mr. Gober:

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 probibitions against misbranding and a 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 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.

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Page 2 - Theron Gober

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

David Krone

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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Proprietary to Dornier MedTech America, Inc.

INDICATIONS FOR USE

510(k) Number (if known): K 083500

Device Name: Medilas D Family Lasers

Indications for Use

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

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, 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, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

David Krane
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K083500
---------------	---------

Dornier MedTech America, Inc.
Medilas D Family Lasers 510(k) Submission
2/12/2009Medilas D Family Lasers 510(K) Submission November 20, 2008

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.