The Dornier Medilas H 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, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

Device Description

The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.

AI/ML Overview

This document describes a 510(k) submission for the Dornier Medilas H Pulsed Laser. The provided text is a summary seeking clearance for the device, and as such, it does not detail a study proving the device meets specific performance acceptance criteria in the manner one might find for a diagnostic or AI-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, many of the requested elements regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a laser device demonstrating substantial equivalence, explicit "acceptance criteria" for a specific disease or diagnostic task are not provided in the same way they would be for a clinical diagnostic device.

The "performance" is primarily focused on demonstrating that the device operates safely and effectively within established laser standards and is technologically similar to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence: Similar principles of operation and technological characteristics to predicate devices.	The Medilas H has the same principles of operation and similar technological characteristics as previously cleared predicates, the Dornier Medilas Fibertome 5100 and Coherent's VersaPulse 2.1. Similarities include: photoelectric power meters, automatic calibration, 2-stage foot switch, watchdog monitored microprocessor, graphic display panel for operating parameters/status, adjustable pulse durations/continuous modes, 1 mW aiming beam power, and an identical cooling system to the Medilas 5100. Minor differences (e.g., Medilas H only has a Standard operating mode while predicates offer several) do not present new issues of safety or effectiveness.
Compliance with Safety Standards: Adherence to established laser safety and electrical safety standards.	Complies with class IV performance standards for light emitting products under the Radiation Control Health and Safety Act of 1968 (21 C.F.R. § 1040.10 and §1040.11). Complies with applicable requirements of voluntary standards: IEC-601, IEC 825NDE 0837/2.86.
Safety Features: Incorporation of mechanisms to prevent unintended laser emission or hazardous operation.	Features include a single rotating magnetic shutter controlled by two parallel running microprocessors; if microprocessors run differently, a "system fault" routinely is initiated, immediately halting laser production and release. Cooling system prevents operation at excessive temperatures.
Intended Use: Device performs as intended for specified indications.	Intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, colonoscopes) or in open surgery (contact or non-contact) for various specialties (Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, General Surgery). The submission asserts that the technological characteristics support these uses in a manner substantially equivalent to predicate devices.

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

This is not applicable. The submission does not describe a clinical study in the traditional sense involving a "test set" of patient data. It relies on technological comparison and compliance with standards rather than clinical performance data against a specific disease outcome.

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

This is not applicable. No ground truth for a test set was established as no such study is described.

4. Adjudication Method for the Test Set

This is not applicable. No test set requiring expert adjudication is described.

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 is not applicable. This is not an AI-assisted diagnostic device, but a surgical laser. No MRMC study was performed.

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

This is not applicable. This is a surgical laser, not an algorithm.

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

This is not applicable. The submission is based on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards for laser devices, not on a ground truth related to a specific disease diagnosis or outcome in a study. The closest concept to "ground truth" here would be the established safety and efficacy profiles of the predicate devices and the regulatory standards themselves.

8. The Sample Size for the Training Set

This is not applicable. This is not a machine learning device that requires a training set.

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

This is not applicable. As above, this is not a device requiring a training set with established ground truth.

Summary

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510(k) SUMMARY Dornier Surgical Products, Inc.'s MediLas H Pulsed Laser

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

Walter Payerl President 10027 South 51st Street Phoenix, AZ 85044

(770) 426-1315 Phone: (770) 514-6288 Facsimile:

Contact Person:

Carol Wernecke Director of Regulatory and Clinical Affairs 1155 Roberts Boulevard Kennesaw, GA 30144

May 14, 1998 Date Prepared:

Name of Device and Name/Address of Sponsor

Medilas H Pulsed Holmium YAG Laser .

Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144

Classification Name

HO: YAG lasers have not been specifically classified by FDA.

Predicate Devices

Dornier Medilas Fibertome Laser Model 5100 and Coherent's VersaPulse 2.1.

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Intended Use

Technological Characteristics and Substantial Equivalence

The Medilas H has the same principles of operation and similar technological characteristics as previously cleared predicates, the Dornier Medilas fibertome 5100 and Coherent's VersaPulse 2.1.

The Medilas H and the 5100 laser have photoelectric power meters and both are automatically calibrated. Both laser have a 2-stage, waterproof and explosionproof, foot switch and both laser incorporate a watchdog monitored microprocessor.

There are minor differences between the Medilas H and its predicate, none of which present new issues of safety or effectiveness. The Medilas H and the 5100 offers adiustable pulse durations, or continuous. The maximum power of both aiming beam at the aperture is 1 mW.

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

Whereas, its predicate devices offers several modes of operation to include the standard, the Medilas H offer only a software controlled Standard operating mode. -The Standard mode is used for non-contact coagulation and vaporization.

Like the 5100 laser, the Medilas H has a cooling system which includes an aircooled, temperature controlled internal closed circuit water system. The cooling system in the Medilas H is identical to the system included in the previously cleared 510(k) for the Medilas 5100 (K964760). In order to conduct away the

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heat produced by the laser pump lamp, the cooling circuit dissipates a maximum of approximately 1.5 kW of heat. This premits a maximum of approximately 15 minutes of uninterrupted operation at full laser power before the maximum permissible water temperature of 770 F (25oC) is reached.

As a safety feature, the Medilas H and the 5100 has a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutters. The Medilas H and the 5100 laser is based on a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiated a "system fault" routine. During any "system fault" laser production and release immediately halt.

Performance Data

While no performance standard have been established for HO: YAG lasers under Section 514 of the Federal Food, Drug and Cosmetic Act, the Dornier Medilas H laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control Health and Safety Act of 1968. See 21 C.F.R. § 1040.10 and §1040.11. the laser also complies with the applicable requirements of the following voluntary standards: IEC-601. IEC 825NDE 0837/2.86.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

Dornier Surgical Products, Inc. ·c/o Ms. Carol Wernecke Director of Regulatory and Clinical Affairs Dornier Medical Systems, Inc. 1155 Robert Boulevard Kennesaw, Georgia 30144

Re: K981718

Trade Name: Dornier Medilas H Laser System Regulatory Class: II Product Code: GEX Dated: May 14, 1998 Received: May 15, 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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Page 2 - Ms. Carol Wernecke

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

K981718 510(k) Number:

Device Name: Dornier Medilas H Laser

Indication For Use:

The Dornier Medilas H 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, colonoscopes, or for open surgery for contact or noncontact surgery with or without hand pieces for use in coagulation, incision/exiciions, ablation and vaporization of soft tissue. The laser is indicated for use in medicine and surgery, in the following specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	or	Over-the-Counter Use
------------------	-----------------------------------------	----	----------------------	--

Signature
(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K981718
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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.