The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, 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/2 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

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device (Dornier Medilas H/2 Laser) and does not contain the kind of study information (acceptance criteria, sample sizes, expert qualifications, ground truth, etc.) that you are asking for.

The 510(k) summary focuses on establishing "substantial equivalence" of the new device to a predicate device already on the market, rather than presenting a performance study with detailed acceptance criteria and study data. It primarily discusses:

Device Name, Submitter, and Contact Information: Basic identification details.
Classification Name and Predicate Devices: How the device is categorized and which existing device(s) it is compared to for regulatory purposes.
Intended Use and Indications for Use: What the device is designed to do and for which medical conditions/procedures. In this case, it's for cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties.
Technological Characteristics and Substantial Equivalence: The core of a 510(k), where the manufacturer argues that their new device is similar enough to an already legally marketed device (the predicate) that it does not raise new questions of safety or effectiveness. The key point here is that the only minor difference mentioned is the replacement of a contraindication with a precaution statement regarding kidney and bladder stone fragmentation.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically include detailed performance data, acceptance criteria, and study methodologies.

Summary

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Mar-23-99 04:31P

K 984591

510(k) SUMMARY Dornier Surgical Products, Inc's Medilas H/2 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: March 23, 1999

Name of Device and Name/Address of Sponsor

Medilas H/2 Laser

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

Classification Name

FDA has not specifically classified Ho:YAG lasers.

Predicate Devices

Dornier Medilas H Laser System (K983963)

Intended Use

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. #11 #1

Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier Medilas H/2 Laser and the predicate devices are substantially equivalent and have the same intended use. The minor difference between the two laser systems is the replacement of a contraindication with a precaution statement regarding its use in fragmentation of kidney and bladder stones. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the Dornier Medilas H/2 and the predicate devices: the Dornier Medilas H (K983963).

Dornier Surgical Products, Inc believes the minor differences of the Dornier Medilas H/2 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 26 1999

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

K984591 Re: Trade Name: Dornier Medilas H/2 Laser Regulatory Class: II Product Code: GEX Dated: December 22, 1998 Received: December 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 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 (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/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

510(k) Number:

K 984591

Dornier Medilas H/2 Laser Device Name:

Indications for Use:

The Dornier Medilas H/2 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

Over-the-Counter Use Prescription Use or

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.