The Dornier Medilas D 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, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties:

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

Device Description

The Dornier Medilas D laser is a 50 W diode laser that emits laser radiation in the invisible range of 940 nm. It offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps, and offers adjustable pulse duration. It has software controlled operating modes including Standard, Fibertom, LITT and LPS. It uses a 0.1mW Diode laser aiming beam with a wavelength of 645 nm. It incorporates a graphic display showing laser operating parameters, application modes, time functions, system status and messages for the user. It has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system. It is based on a single shutter with two parallel running microprocessors.

AI/ML Overview

The provided text describes a 510(k) submission for the Dornier Medilas D Laser, which asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study.

Therefore, most of the requested information regarding acceptance criteria, study details, and data provenance cannot be extracted from this document, as such a study was not conducted or reported for this 510(k) submission.

Here's what can be inferred for the relevant points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics from a dedicated study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The reported "performance" is a comparison of technological characteristics to those predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Comparison to Predicates)
Intended Use Equivalence: The intended use of the Medilas D Laser must be the same as the predicate devices.	The Dornier Medilas D Laser has the same intended use as the Dornier 5100 Laser and Indigo's 830e Laser: cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties (Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery).
Technological Characteristics Equivalence: The Medilas D Laser must have similar principles of operation and technological characteristics to the predicate devices, with any differences not raising new safety or effectiveness concerns.	Principles of Operation: Same as Dornier 5100 (continuous-wave laser). Wavelength: 940 nm (Medilas D) vs. 1064 nm (5100). Both invisible ranges. Power Output: 0-50 W (Medilas D) vs. 2-100 W (5100). Both adjustable in 1 W steps. Pulse Duration: Adjustable (same as 5100). Calibration: Medilas D calibrated during manufacturing and service calls (end-user does not calibrate fibers). 5100 has automatic calibration with photoelectric power meter. Safety Features: Both have 2-stage waterproof/explosion-proof switch and watchdog-monitored microprocessor. Aiming Beam: Medilas D: 0.1mW Diode, 645 nm. 5100: 2 mW Diode, 630 nm. Max power for both at aperture is 1 mW. Differences do not affect tissue. Graphic Display: Both incorporate graphic displays for operating parameters, modes, time, status, and messages. Operating Modes: Medilas D shares "Standard, Fibertom, LITT and LPS" modes with 5100. 5100 has additional modes not on Medilas D. Cooling System: Both have air-cooled, temperature-controlled internal closed circuit water system. Microprocessor Control: Both use a single shutter with two parallel running microprocessors; "system fault" routine for discrepancies. Laser Medium: Medilas D is a diode laser, similar to Indigo's 830e (diode laser). 5100 is an Nd:YAG laser (though not explicitly stated, implied by 1064 nm wavelength). Differences in laser medium (diode vs. Nd:YAG) are acknowledged but deemed not to raise new safety/effectiveness issues, especially by referencing the Indigo 830e.
Safety and Effectiveness: Any minor differences from predicate devices should not present new issues of safety or effectiveness.	The submitter states: "There are minor differences between the Medilas D laser and the predicate 5100 laser, none of which present new issues of safety or effectiveness." and "The minor differences in the aiming beam, software controlled operating modes, do not present new issues of 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)

Not applicable. No "test set" or clinical study data were provided in this 510(k) submission to demonstrate performance against specific criteria. The submission relies on a comparison of technological characteristics to already cleared devices.

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)

Not applicable. No "ground truth" establishment by experts was detailed as no specific performance study was presented.

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

Not applicable. No "adjudication method" was detailed as no specific performance study was presented.

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

Not applicable. This device is a laser for surgical procedures, not an AI-assisted diagnostic tool, and no MRMC study was conducted or described.

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

Not applicable. This device is a laser, not an algorithm, and performance was established by demonstrating substantial equivalence to predicate devices, not through standalone algorithm performance.

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

Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate devices as previously determined by the FDA. The Medilas D Laser's "performance" is its similarity in function and safety profile to these established devices.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this 510(k) is not for an AI algorithm or a device requiring a training phase from data.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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982629

SEP 1 1 1998

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Medilas D Laser

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Dornier Medilas D Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Dornier 5100 Laser (K964760) and Indigo's 830e (K955758).

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

Dornier Surgical Products, Inc.	Phone:	770-426-1315
10027 South 51st Street	Facsimile:	770-514-6288
Phoenix, AZ 85044
Contact Person: Carol Wernecke	Date Prepared:	July 21, 1998

Name of Device and Name/Address of Sponsor

Dornier Medilas D Laser Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix, AZ 85044

Classification Name

Diode lasers have not been specifically classified by FDA.

Predicate Devices

Dornier Medilas Fibertome Laser Model 5100 and Indigo's 830e Laser

Intended Use

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The Dornier Medilas D Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

Technological Characteristics and Substantial Equivalence

The Dornier Medilas D laser and its predicate device, the Dornier 5100 has the same intended use. Both lasers 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 in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand pieces). Both devices are indicated for use in medicine and surgery.

The Dornier Medilas D laser has the same principles of operation and similar technological characteristics as the previously cleared predicates, Dornier 5100 laser. The Medilas D is a 50 W laser while the 5100 laser is a 100 W laser. Both devices are continuous-wave, emitting laser radiation in the invisible ranges of 940 nm (Medilas D) and 1064 nm (5100). The Medilas D offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps. The 5100 offers laser power of 2-100 W at the distal tip of the light quide, adjustable in 1 W steps. Both laser offers adjustable pulse duration. The Medilas D and the 5100 laser offers the same software controlled operating modes with exception to the Medilas D, it does not have the same number of operating modes as the 5100 laser.

The Medilas D is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The 5100 laser has a photoelectric power meter and is automatically calibrated. Both lasers have a 2-stage waterproof and explosion-proof switch and both laser incorporates a watchdog-monitored microprocessor.

There are minor differences between the Medilas D laser and the predicate 5100 laser, none of which present new issues of safety or effectiveness. The minor differences are discussed in detail below.

The Medilas D and the 5100 laser use very similar aiming beams. The Medilas D uses a 0.1mW Diode laser aiming bean with a wavelength of 645 nm. The 5100 laser uses a 2 mW Diode laser aiming beam with a

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wavelength of 630 nm. The maximum power of both aiming beams at the aperture is 1 mW. The minor differences in wavelengths between the treatment beams do not raise new issues of safety or effectiveness since the aiming beam does not affect the tissue. The aiming beams merely provide visual indication of the location at which the treatment beam will strike the tissue.

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

Like its predicated device, the Medilas D laser offers several software controlled operating modes. Most of the operating modes are identical to those offered in the predicate device, the 5100 laser. Both lasers include the following operating modes: Standard, Fibertom, LITT and LPS. The 5100 contain several other modes of operation that are not available on the Medilas D.

The Medilas D and the 5100 laser has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system.

Both the Medilas D and the 5100 laser are based on a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the 5100 laser hardware initiates a "system fault" routine. During any "system fault," laser production and release immediately halt.

The Medilas D is not an Nd:YAG laser." The Medilas D is a diode laser. The comparison to the laser medium (diode) for the second predicate. Indigo's 830e (K955758) is to provide information to establish the Medilas D substantial equivalency determination in today's marketplace.

The Dornier Medilas D laser has the same principles of operation and similar technological characteristics as the previously cleared predicates, Dornier 5100 (K964760) and Indigo's 830e (K955758). As explained above, the minor differences in the aiming beam, software controlled operating modes, do not present new issues of safety or effectiveness.

From a clinical perspective and comparing design specifications, the Dornier Medilas D laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the

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Dornier Medilas D and the predicate devices, Dornier 5100 and Indigo's 830e lasers.

Dornier Surgical Products, Inc. believes the minor differences of the Dornier Medilas D and its predicate laser devices should not raise any concerns regarding the overall safety or effectiveness.

Advisory:

This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Ms. Carol Wernecke Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix, Arizona 85044

Re: K982629

Trade Name: Dornier Medilas D Laser Regulatory Class: II Product Code: GEX Dated: July 27, 1998 Received: July 28, 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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carol Wernecke

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.

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/dsma/dsmamain.html".

Sincerely vours.

Acosta

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

510(k) Number:	K922629
Device Name:	Dornier Medilas D Laser

Indications for Use:

The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties:

Urology �
Plastic Surgery �
General Surgery �
Dermatology �
Gynecology �
Pulmonary Surgery �
Gastroenterology �
ENT ﻬ
Radiology .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

Pooch
(Division Sign-Off)

Division of Scheral Rest 510(k) Number

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.