(34 days)
Not Found
No
The document describes a laser photocoagulator with increased power compared to its predicate device. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The performance studies focus on the laser's safety and efficacy based on equivalence to the predicate device, not on the performance of any AI/ML algorithm.
Yes
The device is used to treat various eye conditions such as proliferative diabetic retinopathy and retinal detachments, indicating its therapeutic purpose.
No
Explanation: The device is described as a photocoagulator, intended for treatment (retinal photocoagulation) rather than diagnosis.
No
The device description clearly states it is a laser photocoagulator, which is a hardware device that delivers laser energy. While it mentions software validation, the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Supra Ophthalmic Laser Photocoagulator is a therapeutic device that uses laser energy to treat ocular tissues. It directly interacts with the patient's eye to perform a medical procedure (photocoagulation).
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device's function is to deliver energy to the eye, not to analyze a sample.
Therefore, the Supra Ophthalmic Laser Photocoagulator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Supra Ophthalmic Laser Photocoagulator is intended to be used for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not for the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitroretinopathy, proliferative diabetic retinopathy.
With a slit lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal. detachments.
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Quantel Supra is a modification of the Quantel Vitra, (K043236). The SUPRA laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at a wavelength of 532 nm. Its basic improvement is the increase of laser power. Controls, indications, and methods of use are basically the same. The two lasers have the same screens and functions, and differ only in that the Supra has two output ports and more output power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular/Eye, Retina
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 tests: Supra has been extensively validated, both the laser itself and the software.
Clinical tests: Clinical tests are not necessary, since Supra uses the same technology as the predicate device.
Conclusions: Supra is equivalent in safety and efficacy to the legally-marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Quantel Medical · Special 510(k) Supra Ophthalmic Laser
510(k) Summary
APR 2 4 2007
(1) Submitter Information
Name: Quantel Medical
Address:
21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France
Telephone Number: 33-1-69-29-17-00
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: February 20, 2007
(2) Name of Device
Trade Name: Supra Common Name: Ophthalmic Laser Classification name: Laser, ophthalmic Product Code: HQF Regulation: 886.4390 Classification: Class II.
(3) Equivalent legally-marketed devices.
- Quantel VITRA, K043236
(4) Description
1
The Quantel Supra is a modification of the Quantel Vitra, (K043236). The SUPRA laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at a wavelength of 532 nm. Its basic improvement is the increase of laser power. Controls, indications, and methods of use are basically the same. The two lasers have the same screens and functions, and differ only in that the Supra has two output ports and more output power.
(5) Intended Use
The Supra Ophthalmic Laser Photocoagulator is intended to be used for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not for the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitroretinopathy, proliferative diabetic retinopathy.
With a slit lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal. detachments.
(6) Performance Data
(a) Non-clinical tests
Supra has been extensively validated, both the laser itself and the software.
(b) Clinical tests
Clinical tests are not necessary, since Supra uses the same technology as the predicate device.
(c) Conclusions
Supra is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three overlapping lines forming a stylized image of an eagle. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2007
Quantel Medical c/o Dr. George Myers Medsys Inc. 377 Route 17 S. Hasbrouck Heights, NJ 07604
Re: K070776
Trade/Device Name: Supra Ophthalmic Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Codes: HQF Dated: March 19, 2007 Received: March 27, 2007
Dear Dr. Myers:
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 such 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); 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
Page 2 - Dr. George Myers
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
M.B. Eichelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Supra Ophthalmic Laser
Indications For Use:
The Supra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DeXuder 4/20/2007
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K070276
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