(120 days)
Not Found
No
The device description and performance studies focus on the laser technology and its physical parameters, with no mention of AI or ML.
Yes
The device is described as a laser for Selective Laser Trabeculoplasty (SLT), which is a medical procedure used to treat glaucoma, making it a therapeutic device.
No
The device description indicates it is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Selective Laser Trabeculoplasty (SLT), which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a laser system, which is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Selective Laser Trabeculoplasty (SLT)". This is a therapeutic procedure performed directly on a patient's eye to treat glaucoma.
- Device Description: The device is a laser system designed to deliver energy to the eye tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The SOLUTIS Laser is indicated for use in: Selective Laser Trabeculoplasty (SLT)
Product codes
GEX, HQF
Device Description
SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
510(k) Summary for the Quantel Medical SOLUTIS
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Quantel Medical
11 Rue du Bois Joli - CS 40015
63808 Cournon D'Auvergne Cedex
FRANCE
33-473 745 745
33-473 745 700 (Fax) |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-824-2541 |
| ----------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
AUG 0 2 2013Summary Preparation Date: July 18, 2013
-
- Names
Device Trade Name:
- Names
Common Namc:
Ophthalmic Laser
SOLUTIS
Laser Instrument, Surgical, Powered and Laser, Classification Names: Ophthalmic Product Code: GEX (21 CFR 878.4810) and HQF (21 CFR 886.4390) Panel: General & Plastic Surgery and Ophthalmology
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3. Predicate Devices
- Lumenis Selecta Duct (K021550) -
- Lumenis Family of Ophthalmic laser Systems, Model : Selecta SLT (K081704) -
4. Device Description
SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.
5. Indications for Use
The SOLUTIS Laser is indicated for use in:
- · Selective Laser Trabeculoplasty (SLT)
6. Substantial Equivalence
The SOLUTIS Laser shares the same intended use and technological characteristics as the predicate devices, the Lumenis Selecta Duet (K021550) and the Lumenis Family of Ophthalmic Laser Systems, Model SELECTA SLT (K081704) and therefore is substantially equivalent to the predicate devices. The SOLUTIS and the predicate devices are Q-switched, frequency doubled Nd: Y AG laser systems providing a wavelength of 532 nm. The maximum energy, repetition rate, pulse duration and other key technological characteristics are identical between the SOLUTIS and the predicate devices. No new questions of safety or effectiveness are raised. Therefore, the SOLUTIS is substantially equivalent to the predicate devices.
7. Performance Data
Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its back, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
Quantel Medical % Ms. Maureen O'Connell President/Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
Re: K130933
Trade/Device Name: SOLUTIS Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: June 28, 2013 Received: July 05, 2013
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassilied in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,
Please be advised that I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) { } CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Maureen O'Connell
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K130933
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name: SOLUTIS
Indications for Use:
Selective Laser Trabeculoplasty (SLT)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Joshua C. Nipper -S
(Division Sign-Off)
Division of Surgical Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________