(30 days)
Dornier Medilas H, Lumenis Versapulse Powersuite, convergent Omnipulse 30, Trimedyne Omnipulse
No
The provided text describes a laser system for surgical procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used in surgical procedures for various tissue modifications and stone breaking, which are therapeutic interventions.
No
The device description indicates its use in surgical procedures for treating various conditions (e.g., breaking up stones, cutting tissue), not for diagnosing them.
No
The device description explicitly states it is a "pulsed solid-state Holmium YAG-Laser System," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body (breaking up stones, cutting, ablation, etc.) using a laser.
- Device Description: The device description confirms it's a surgical laser system used for these procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
not presented
Key Metrics
Not Found
Predicate Device(s)
The AURIGA laser system is substantially equivalent to the Dornier Medilas H, Lumenis Versapulse Powersuite, convergent Omnipulse 30 or Trimedyne Omnipulse.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUN 3 0 2005
K051399 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for WaveLight. The logo consists of three horizontal wavy lines on the left, followed by the word "WaveLight" in a bold, sans-serif font. A small registered trademark symbol is located to the upper right of the word "WaveLight".
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, AG
Am Wolfsmantel 5
91058 Erlangen
Germany |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Alexander Popp
WaveLight Laser Technologie, AG
Am Wolfsmantel 5
91058 Erlangen
Germany |
| 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 :
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.
1
Image /page/1/Picture/0 description: The image shows the text "K051399 2 of 2" written in cursive. The text appears to be handwritten, with a slightly uneven and flowing style. The numbers are clearly distinguishable, and the phrase "2 of 2" indicates a sequence or series.
S WaveLight®
510(k) Summary of Safety and Effectiveness – AURIGA Device
5. Indications for Use
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.
6. Performance Data
not presented
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle head facing right, with three curved lines emanating from its neck, representing the department's mission to promote health and well-being. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
4
S WaveLight®
510 (k) Indications for Use
Indications for Use
KOSI39 510(k) Number (if known): N/A AURIGA Device Name:
Indications for Use:
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.
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 .