(14 days)
No
The summary describes a laser device for photocoagulation and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is indicated for use in photocoagulation of various vascular and structural abnormalities of the retina and choroids, as well as procedures for glaucoma, all of which aim to treat medical conditions.
No
Explanation: The device is described as a laser indicated for photocoagulation to treat various conditions of the eye. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "semi conductor laser" which emits a beam of coherent light, indicating it 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 describes a laser used for photocoagulation procedures on the eye. This is a therapeutic intervention performed directly on the patient's tissue.
- Device Description: The device is described as a laser that emits a beam of light delivered via delivery systems. This aligns with a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such examination.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Supra 577. Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows:
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids including:
-
- Proliferative and nonproliferative diabetic retinopathy; "
-
- choroidal neovascularization;
-
- branch retinal vein occlusion;
-
- age-related macular degeneration;
-
- retinal tears and detachments;
-
- retinopathy of prematurity;
Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
Product codes
HOF
Device Description
The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retina, choroid, anterior and posterior segments of the eye
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)
Non clinical Conclusion:
Laboratory testing was conducted to validate and verify that the proposed device. SUPRA 577. Y met all design specifications and was substantially equivalent to the predicate device.
Clinical Conclusion: No Clinical information is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IRIDEX IQ 577 Laser (K071687)
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.
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SECTION 11
page 1/2
510(k) SUMMARY
K09158
I. General information
Applicant:
Address:
Quantel Medical QUANTEL MEDICAL 21 rue Newton
Z.1. du Brezel 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 ÷33 (0)473 745 700 (Fax)
Mr. Patrick QUERO Contact Person: Quality Manager & Regulatory Affairs (+33) 473 74 57 45 (+33) 473 74 57 00
Preparation Date: November 2008 (of the Summary)
II. Name
| Device Name: | SUPRA 577.Y Laser |
|---|---|
| Common Name: | SUPRA 577.Y Laser |
| Classification | |
| Name: | Ophthalmic laser (see 21CFR 886.4390) |
| Product Code: | HOF : Panel: 86 |
III. Predicate Device
IRIDEX IQ 577 Laser (K071687)
IV. Product Description
The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.
V. Indications for Use
The SUPRA 577.Y Laser is indicated for use in photocoagulation of both anterior and posterior segments including:
& Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of ▼ Retinal photocouraliation, paid iss of the retina and choroids including:
030
1
Page 2/2
- Proliferative and nonproliferative diabetic retinopathy, 1.
- choroidal neovascularization: ni
- branch retinal vein occlusion: าก
- age-related macular degeneration: র্ব
- retinal tears and detachments: 5.
- retinopathy of prematurity:
� Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
KO91581
VI. Device Technological Characteristics and comparison to Predicate Device
SUPRA 577. Y share the same indications for use and safety compliance. similar design features, Son to For . I mare the une are substantially equivalent to the predicate device , the IRIDEX 1Q 577 Laser (K071687). In addition a review of the predicate device demonstrate that the SUPRA 577. Y Laser is safe and effective as the predicate device as they share equivalent wavelengths, power, exposure time and are used to perform the same indicated surgical procedures.
VII. Performance Standard
SUPRA 577.Y is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC 60825-1:2007, Safety of laser products Part 1 : Equipment classification, requirements and . � user's quide.
- IEC 60601-2-22: 2007, Medical electrical Equipment -- Part 2 : Particular requirements for the safety .� of diagnostic and therapeutic laser equipment.
- IEC 60601-1: 1998 + A1:1991+A2:1995, Medical Electrical equipment Part 1 : general requirement . ● for safety.
- IEC 60601-1-2: 2001 +A1:2004. Medical Electrical equipment -- Part 1 : General requirements for . � safety-2, Collateral Standard : electromagnetic compatibility - requirements and tests.
The device also complies with European Medical Directive 93/42/EEC and the US Federal Performance The dovide and coulphen with (2) CFR 1040.10 and 21CFR1040.10 and 21CFR1040.11 for Class IV Laser Products with permissible deviations defined in Laser Notice 50, dated July 26, 2001.), Part 820 – Quality System Regulation, and have passed ISO 9001 and 13485 System Certification.
Non clinical Conclusion:
Laboratory testing was conducted to validate and verify that the proposed device. SUPRA 577. Y met all design specifications and was substantially equivalent to the predicate device.
Clinical Conclusion: No Clinical information is required.
VIII. Conclusion
Based on the information in this notification Quantel Medical concludes that the SUPRA 577. Y Laser is substantially equivalent (SE) to the cited legally marketed predicate. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who have the responsibility for complying with applicable regulations and marketing requirements.
Siège social et burnaux : 21 le Bréat - 6303 Clemont-Ferrand Ceda: 2 - Frans» - Tél. +33 (0) 73.745.70 - email : contact@gardel-médial.fr
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quantel Medical c/o Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Rd. Newton, CT 06470
JUN 1 6 2009
Re: K091581
Trade/Device Name: SUPRA 577.Y LASER Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HOF Dated: May 28, 2009 Received : June 2 2009
Dear Mr. Borsai:
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 reclassified 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, 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 (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 FDA'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) (21 CFR 803); good manufacturing practice requirements as set 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Keria Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): __ K_ 69 / 58 /
Device Name: Supra 577.Y
Indications for Use Statement:
The Supra 577. Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows:
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including: ◆ Retinal photocoagulation, panretinal photocoagulation and intravitreal
endophotocoagulation of vascular and structural abnormalities of the retina and choroids . including:
-
- Proliferative and nonproliferative diabetic retinopathy; "
-
- choroidal neovascularization;
-
- branch retinal vein occlusion;
-
- age-related macular degeneration;
-
- retinal tears and detachments;
-
- retinopathy of prematurity;
- Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use X (Per 21 CFR 801.109) OR
Over-The Counter Use
Rb
(Division/Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
025
510(k) Number K091581