The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

Device Description

The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

AI/ML Overview

The provided document is a 510(k) summary for the AURIGA Holmium Laser System. It focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use. Crucially, the document explicitly states "Performance Data not presented" and does not include any studies proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only provides the following:

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

No acceptance criteria or reported device performance are presented in the document. The document states "Performance Data not presented."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. No test set data or provenance is mentioned.

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 provided. No information on ground truth establishment for a test set is present.

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

Not provided. No adjudication method for a test set is mentioned.

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:

No MRMC study was done or reported. This device is a surgical laser, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.

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

Not applicable. This device is a surgical laser, not an algorithm.

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

Not provided. No ground truth information is available as no performance data or studies are presented.

8. The sample size for the training set:

Not provided. No training set is mentioned as no algorithm or AI is discussed.

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

Not provided. No training set or ground truth establishment for it is mentioned.

Summary

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JUN 3 0 2005

K051399 1 of 2

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510(k) Summary of Safety and Effectiveness - AURIGA Device

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	WaveLight Laser Technologie, AGAm Wolfsmantel 591058 ErlangenGermany
Contact Person:	Alexander PoppWaveLight Laser Technologie, AGAm Wolfsmantel 591058 ErlangenGermany
Summary Preparation Date:	November 8, 2004
Names:
Device Name:	AURIGA

Classification Name: Laser Instrument, Surgical Powered Product Code: GEX Panel: Dermatology and Plastic Surgerv

3. Predicate Devices

The AURIGA laser system is substantially equivalent to the Dornier Medilas H, Lumenis Versapulse Powersuite, convergent Omnipulse 30 or Trimedyne Omnipulse.

4. Device Description

Device Description AURIGA :

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S WaveLight®

510(k) Summary of Safety and Effectiveness – AURIGA Device

5. Indications for Use

6. Performance Data

not presented

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2005

Wavelight Laser Technologie AG c/o Mr. Jeffrey D. Rongero 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K051399 Trade/Device Name: Auriga Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 15, 2005 Received: June 17, 2005

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreaty 78 the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Ac. (1101) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, thance of the Act include requirements for annual registration, listing of general controls provisions of wastice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo are roy als. Existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTP issualles as our device complies with other requirements of the Act that I DA has made a actorimiations administered by other Federal agencies. You must of ally I coleral statutes und regarantents, including, but not limited to: registration and listing (21 Configure and the Free STequirements, only good manufacturing practice requirements as set CFN Fall 807), laocing (21 OF RT art 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeffrey D. Rongero

This letter will allow you to begin marketing your device as described in your Section 510(k) This iction with anow yourse of substantial equivalence of your device to a legally prematicated predicated. The 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), please If you desire specific as not any and (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Crain to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S WaveLight®

510 (k) Indications for Use

Indications for Use

KOSI39 510(k) Number (if known): N/A AURIGA Device Name:

Indications for Use:

Over-The-Counter Use Prescription Use × N/A AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

n (1319

Page 1 of 1 (indication for use only

Vision Sign-Off) ( Vision of General, Restorative Ad Neurological Devices

Off) 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.