(260 days)
Not Found
No
The document describes a laser photocoagulator and its intended uses, focusing on the laser technology and its equivalence to predicate devices. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for treating various eye conditions such as proliferative diabetic retinopathy, retinal detachments, glaucoma, and macular degeneration, all of which fall under the scope of therapeutic intent.
No
The device description and intended use clearly state that the "Supra Twin Ophthalmic Laser Photocoagulator" is for "photocoagulation" and "ablation" of ocular tissues to treat various eye diseases, not diagnose them.
No
The device description explicitly states it is a "laser" and mentions "Nd: YAG laser using a KTP crystal," which are hardware components. While it mentions software validation, the core device is a physical laser system.
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 Twin Ophthalmic Laser Photocoagulator is a therapeutic device that uses laser energy to treat diseases of the eye by photocoagulating ocular tissues. It directly interacts with the patient's body.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the patient. The device is used directly on the eye.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm 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.
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810nm is indicated for use for :
Phocoagulation or ablation of pigmented tissue within the eye,
Transcleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),
Limited and pan-retinal photocoagulation,
Transpupillary photocoagulation,
Endophotocoagulation.
Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choroidal neovasculature, and Age related macular degeneration (AMD) treatments.
Product codes
HQF
Device Description
The Quantel Supra Twin is a modification of the Quantel Supra (K070776) and the Quantel Viridis Twin (K023464). The SUPRA Twin 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 of itraocular endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at wavelengths of 532 nm. and 810 nm. Its basic improvement is the laser. Controls, indications, and methods of use are basically the me,
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular, Eye, Retinal, Ciliary Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: Supra Twin has been extensively validated, both the laser itself and the software.
Clinical tests: Clinical tests are not necessary, since Supra Twin uses the same technology as the predicate device.
Conclusions: Supra Twin is equivalent in safety and efficacy to the legally-marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 Twin Ophthalmic Laser
510(k) Summary K081946
(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: March 23, 2009
(2) Name of Device
Trade Name: Supra Twin Common Name: Ophthalmic Laser Classification name: Laser, ophthalmic
(3) Equivalent legally-marketed devices.
(4) Description
The Quantel Supra Twin is a modification of the Quantel Supra (K070776) and the Quantel Viridis Twin (K023464). The SUPRA Twin 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 of itraocular
1
endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at wavelengths of 532 nm. and 810 nm. Its basic improvement is the laser. Controls, indications, and methods of use are basically the me,
(5) Intended Use
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532mm is intended to 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 vitrectorny surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractig ral getinal 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.
810 nm Intended Use:
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810nm is intended to be used for :
Phocoagulation or ablation of pigmented tissue within the eye,
Transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),
Limited and pan-retinal photocoagulation.
Transpupillary photocoagulation,
Endophotocoagulation,
Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbentopations), transpupillary photocoagulation of choroidal neovasculature, and Age related macular desencerative (AMD) treatments.
(6) Performance Data
(a) Non-clinical tests
Supra Twin has been extensively validated, both the laser itself and the software.
(b) Clinical tests
Clinical tests are not necessary, since Supra Twin uses the same technology as the predicate device,
(c) Conclusions
2
Supra Twin is equivalent in safety and efficacy to the legally-marketed predicate devices.
.
.
. . . . . . .
;
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stars above it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2.5 2009
Quantel Medical c/o Mr. George Myers, Sc.D. Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K081946
Trade/Device Name: Supra Twin Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: February 27, 2009 Received: March 3, 2009
Dear Mr. 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.
4
Page 2 - Mr. George Myers, Sc.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Malvina B. Eggleston, wid
Malvina B. Evdelman. M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Supra Twin Ophthalmic Laser
532 nm Indications For Use:
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm 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.
810 nm Indications For Use:
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810mm is indicated for use for :
Phocoagulation or ablation of pigmented tissue within the eye,
Transcleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),
Limited and pan-retinal photocoagulation,
Transpupillary photocoagulation,
Endophotocoagulation.
Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choroidal neovasculature, and Age related macular degeneration (AMD) treatments.
Prescription Use X (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)
(1)
(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number K081946