The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing.

The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System.

No new indications are being requested.

Device Description

AI/ML Overview

This looks like a 510(k) summary for a medical device submitted to the FDA, rather than a study report detailing acceptance criteria and performance data.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and multi-reader multi-case studies cannot be extracted from the provided text.

The document states that the safety and effectiveness of the Dornier Scanner is based on "substantial equivalence" to predicate devices (Dornier VarioSpot 90 handpiece and Coherent's Computerized Pattern Generator). It does not describe a new study with explicit acceptance criteria and performance metrics for the Dornier Scanner itself.

Here's a breakdown of why the requested information is not present based on the provided text:

Acceptance Criteria and Device Performance Table: Not provided. The document makes a claim of "substantial equivalence" rather than presenting specific performance metrics against pre-defined acceptance criteria.
Sample Size and Data Provenance: Not applicable, as no new study is described where data was collected. The comparison is based on the characteristics of existing predicate devices.
Number and Qualifications of Experts for Ground Truth: Not applicable. Ground truth typically refers to validated outcomes in a clinical study; since no such study for the Dornier Scanner is described, no experts were needed to establish ground truth.
Adjudication Method: Not applicable for the same reasons as above.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned and not applicable. This type of study involves human readers interpreting data, often with AI assistance, which is not relevant to a laser handpiece accessory.
Standalone Performance Study: Not mentioned and not applicable. "Standalone" performance usually refers to an algorithm's performance without human intervention, which again, is not relevant to a laser handpiece.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided text is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" of a new device (Dornier Scanner) to existing predicate devices, rather than presenting a detailed study report of the new device's performance against specific acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Dornier MedTech. The logo consists of a stylized figure of a person with outstretched arms, followed by the company name in a bold, sans-serif font. The text is black, and the figure is also black.

K 99314 6

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Scanner for 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 Scanner 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 VarioSpot 90 handpiece (K981438) and Coherent's Computerized Pattern Generator (CPG) (K946304) scanner.

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

Dornier Surgical Products, Inc.10027 South 51st StreetPhoenix, AZ 85044	Phone: 770-693-5793Facsimile: 770-693-5770Date Prepared: September 13, 1999
Contact Person: Carol Wernecke	Phone: 770-426-1315Fax: 770-514-6288

Name of Device and Name/Address of Sponsor

Dornier Scanner Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix, AZ 85044

Classification Name

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

Predicate Devices

Dornier VarioSpot 90 handpiece (K981438) Coherent's Computerized Pattern Generator (CPG) (K946304) scanner

Intended Use

The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, and coagulation of soft

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tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing.

No new indications are being requested.

Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier Scanner 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 Scanner and the predicate devices. Dornier VarioSpot 90 handpiece (K981438) and Coherent's Computerized Pattern Generator (CPG) (K946304) scanner.

Dornier Surgical Products, Inc. believes the minor differences of the Dornier Scanner 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three overlapping human figures, representing the department's focus on people. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 1999

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

Re: K993146 Trade Name: Dornier Scanner Handpiece Regulatory Class: II Product Code: GEX Dated: September 15, 1999 Received: September 20, 1999

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 Ouality System Regulation (OS) 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.

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

1993146 510(k) Number:

Device Name:

Dornier Scanner

Indications for Use:

No new indications are being requested.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-the-Counter Use

(Division Sign-Off)
ion of General Restorative Devices K993146

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.