The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in coniunction 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 H Laser is indicated for use in medicine and surgery, in the following specialties: 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. The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718). The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibrated. They also have a 2-stage waterproof and explosion proof footswitch and both lasers incorporate a watchdog-monitored microprocessor. Both Lasers depict a graphic display panel which show the laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas H lasers provide a temperature controlled method for contact cutting and non-contact coagulation and vaporization with fibers made of quartz glass with a bare fiber tip. These fibers are available in diameters of 400 and 600 µm. The Medilas H lasers feature one mode of operation: Standard. The microprocessor controlled Dornier Medilas H lasers have been developed in accordance with the latest technical standards. The lasers have a cooling system that includes an air-cooled, temperature controlled, internal closed circuit water system. As a safety feature, both Medilas H lasers have a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutter. The Medilas H lasers contain a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiates a "system fault" routine. During any "system fault" laser production and release immediately halt.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dornier Medilas H Pulsed Laser:

Acceptance Criteria and Study Analysis for the Dornier Medilas H Pulsed Laser

Based on the provided 510(k) summary, the device is a modified version of an already cleared predicate device (K981718). The submission focuses on demonstrating substantial equivalence rather than presenting an entirely new device with novel performance curves. Therefore, the "acceptance criteria" here are framed around compliance with existing standards and the assertion that modifications do not impact safety or effectiveness.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Compliance with Class IV performance standards for light emitting products per Radiation Control Health and Safety Act of 1968 (21 C.F.R. § 1040.10 and §1040.11).	The Dornier Medilas H laser is in compliance with these class IV performance standards.
Compliance with applicable requirements of voluntary standards IEC-601, IEC 825/VDE 0837/2.86.	The laser also complies with these applicable requirements.
Modified aiming beam wavelength (635 nm) and power (1mW) compared to predicate (630 nm, 1mW) does not present new safety/effectiveness issues.	Stated that "These modifications do not present any new issues of safety or effectiveness of the device."
New housing dimensions do not present new safety/effectiveness issues.	Stated that "These modifications do not present any new issues of safety or effectiveness of the device."
Principle of operation and key technological characteristics (e.g., photoelectric power meters, automatic calibration, footswitch, watchdog-monitored microprocessor, graphic display, cooling system, single rotating magnetic shutter with two parallel running microprocessors) are the same or similar to the predicate device.	The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718). Specific features are listed as being identical or having minor, non-impactful differences.

Sample size used for the test set and the data provenance:
The document does not specify a numerical sample size for a test set. This submission relies on demonstrating compliance with existing regulatory and voluntary standards, and the assertion that minor modifications (aiming beam wavelength, housing) do not affect safety or effectiveness. There is no mention of a clinical or performance study with a distinct "test set" in the traditional sense of evaluating a diagnostic or interventional outcome on a set of patients or samples. The "data provenance" primarily consists of engineering specifications and compliance assessments against published standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. As there is no explicitly defined "test set" and ground truth establishment in a clinical or diagnostic context, expert involvement in such a capacity is not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
An adjudication method is not applicable and not mentioned. There is no clinical or performance study involving multiple reviewers of data for consensus.
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:
An MRMC comparative effectiveness study was not done. This device is a laser system, not an AI-assisted diagnostic tool, and the submission is not focused on evaluating human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance study in the context of an algorithm or AI is not applicable and was not done. The device is a medical laser. The "performance data" refers to compliance with safety standards for laser products.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the modifications, the "ground truth" used is essentially engineering verification and validation against known laser safety standards and the established performance of the predicate device. The assertion is that changes are minor and do not alter the already-cleared performance characteristics. There is no biological or clinical "ground truth" established for this specific submission beyond demonstrating compliance with existing laser safety regulations.
The sample size for the training set:
A "training set" is not applicable and not mentioned. This device is a laser system, not a machine learning model, so there is no concept of a training set as would be used for AI development.
How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.

Summary

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NOV 25 1998

983962

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 1155 Roberts Boulevard Kennesaw, GA 30144

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

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

Date Prepared: November 5, 1998

Name of Device and Name/Address of Sponsor

Medilas H Pulsed Holmium YAG Laser

Dornier Surgical Products, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144

Classification Name

HO: FDA has not specifically classified YAG lasers.

Predicate Devices

Unmodified Dornier Medilas H Laser

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Intended Use

Technological Characteristics and Substantial Equivalence

The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718).

The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibrated. They also have a 2-stage waterproof and explosion proof footswitch and both lasers incorporate a watchdog-monitored microprocessor.

Both Lasers depict a graphic display panel which show the laser operating parameters, application modes, time functions, system status and messages for the user.

The Medilas H lasers provide a temperature controlled method for contact cutting and non-contact coagulation and vaporization with fibers made of quartz glass with a bare fiber tip. These fibers are available in diameters of 400 and 600 µm.

The Medilas H lasers feature one mode of operation: Standard. The microprocessor controlled Dornier Medilas H lasers have been developed in accordance with the latest technical standards.

The lasers have a cooling system that includes an air-cooled, temperature controlled, internal closed circuit water system. The cooling systems are identical as concurred in 510(k) # K981718.

As a safety feature, both Medilas H lasers have a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutter. The Medilas H lasers contain a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser

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hardware initiates a "system fault" routine. During any "system fault" laser production and release immediately halt.

There are minor differences between the Medilas H laser, and the unmodified cleared Medilas H laser (K981718). The modified laser system aiming beam is 635 nm, maximum power at aperture 1mW and the unmodified cleared Medilas H laser aiming beam is 630 nm, maximum power at aperture 1mW. The modified Medilas H is contained in new housing. The dimensional specification is visually different from the predicate (unmodified Medilas H) laser system. These modifications do not present any new issues of safety or effectiveness of the device.

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 825/VDE 0837/2.86.

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/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 1998

Ms. Carol Wernecke Director Regulatory and Clinical Affairs Dornier Medical Systems, Inc 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K983963

Trade Name: Dornier Medilas H Laser (Modified) Regulatory Class: II Product Code: GEX Dated: November 05, 1998 Received: November 06, 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 531 through 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 yours,

foeele

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

	K9P 3963
510(k) Number:	K081718-Special 510(k): Device Modification
Device Name:	Modified Dornier Medilas H Laser

Indications for Use:

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, 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 H is indicated for use in medicine and surgery, in the following medical specialties:

◆ Urology
♦ Arthroscopy
◆ General Surgery
◆ Pulmonology
· Gynecology
· Gastroenterology
◆ ENT
◆ Lithotripsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
------------------	---

Over-the-Counter Use
----------------------	--

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	R983963

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.