The Dornier Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing.

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

Dermatology
Plastic Surgery
General Surgery
Urology
Gynecology
Pulmonary Surgery
Gastroenterology
ENT
Thoracic Surgery
Oral & Maxillofacial Surgery
Ophthalmology
Podiatry

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) Summary for the Dornier Medilas E Laser, dated July 20, 1998. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through clinical studies in the way a new medical algorithm would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. The 510(k) process for this device focused on technological characteristics and intended use in comparison to existing, legally marketed lasers.

Instead of a table of acceptance criteria and reported performance, the document states:
"The safety and effectiveness of the Dornier Medilas E 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: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K9971404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648)."

And further:
"From a clinical perspective and comparing design specifications, the Dornier Medilas E 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 Dornier Medilas E and the predicate devices, SEO CRL 2940 Erbium CrystaLase and the Sharplan Model 4020 Erbium YAG laser."

Summary of unavailable information from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable/not provided. The document focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for a novel device.
Sample sized used for the test set and the data provenance: Not applicable/not provided. There is no mention of a test set or data from a clinical study to assess performance.
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/not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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/not provided. This device is a laser, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to its evaluation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not provided. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
The sample size for the training set: Not applicable/not provided.
How the ground truth for the training set was established: Not applicable/not provided.

The document is a regulatory submission demonstrating substantial equivalence of a physical medical device (a laser) to existing predicate devices, rather than a clinical study report for an algorithm or a device requiring specific performance metrics against acceptance criteria.

Summary

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JUL 20 1998

K981438

DornierMedTech

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Medilas E 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 E 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: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K971404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648).

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

Dornier Surgical Products, Inc.10027 South 51st StreetPhoenix, AZ 85044	Phone:Facsimile:	770-426-1315770-514-6288
Contact Person: Carol Wernecke		Date Prepared: April 3, 1998

Name of Device and Name/Address of Sponsor

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

Classification Name

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

Predicate Devices

Schwartz Electro-Optics, Inc. CRL2940 Erbium CR Laser (K971404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971848).

Intended Use

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and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing. The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties: Dermatology, Plastic Surgery, General Surgery, Urology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophthalmology & Podiatry.

Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier Medilas E 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 Dornier Medilas E and the predicate devices, SEO CRL 2940 Erbium CrystaLase and the Sharplan Model 4020 Erbium YAG laser.

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

This information was prepared for the sole purpose of compliance Advisory: 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

JUL 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K981438 Re: Trade Name: Dornier Medilas E Laser Regulatory Class: II Product Code: GEX Dated: April 3, 1998 Received: April 21, 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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inh INV, 4 4044200113

INDICATIONS FOR USE STATEMENT

CAA/LA

VAGA 190------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------REAL MILL LINES------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A COLL COLLECTION

Device Name: Domier Medilas E Laser

Indications for Use:

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

Dermatology �
Plastic Surgery
General Surgery �
Urology
Gynecology
Pulmonary Surgery
Gastroenterology �
- ENT
Thoracic Surgery ◆
Oral & Maxillofacial Surgery
Ophthalmology �
Podiatry

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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.