(90 days)
No
The summary describes a laser photocoagulator with different wavelengths and delivery systems, focusing on the physical properties and intended uses of the laser itself. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for medical treatments such as photocoagulation or ablation of pigmented tissue within the eye, for conditions like diabetic retinopathy, macular degeneration, and retinal detachment, directly performing therapeutic actions.
No
Explanation: The device is described as an "Ophthalmic Photocoagulator" used for "photocoagulation or ablation of pigmented tissue within the eye." This indicates a therapeutic or treatment-delivery function, not a diagnostic one. No diagnostic capabilities are mentioned in the provided text.
No
The device description explicitly states it is a "combination system consisting of a Nd:YAG frequency doubled laser" and a "diode laser," which are hardware components.
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 Viridis Twin laser is a therapeutic device that uses laser light to treat conditions within the eye. It directly interacts with and modifies tissue in the body.
- Intended Use: The intended use clearly describes photocoagulation and ablation of tissue within the eye for various ophthalmic conditions. This is a treatment, not a diagnostic test performed on a sample.
- Device Description: The description details a laser system and delivery systems used to deliver energy to the treatment site. This aligns with a therapeutic device, not a diagnostic one.
Therefore, the Viridis Twin laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.
The 532 nm wavelength is indicated for use for:
retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.
The 810 nm wavelength is indicated for use for:
photocoagulation 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 (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The Viridis Twin Ophthalmic Photocoagulator is a combination system consisting of a Nd:YAG frequency doubled laser which emits a beam of coherent light at 532 nm and a diode laser which emits a beam of coherent light 810 microns. The treatment beam is selected by the user, the delivery system is attached to the appropriate laser aperture, and the energy is delivered to the treatment 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
within the eye, ciliary body
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)
None required.
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.
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
§ 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.
0
SECTION 10
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Viridis Twin laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
Quantel Medical Applicant: QUANTEL MEDICAL Address: 21 rue Newton Z.I. du Br zet 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax) Contact Person: Mr. Jean Abascal Regulatory Affairs Manager (+33) 169 29 17 25 : (+33) 169 29 17 29 Preparation Date: September 2002 (of the Summary) Viridis Twin Ophthalmic Photocoagulator Device Name: Ophthalmic Laser, frequency doubled Nd: Y AG (532 nm) laser Common Name: Laser Surgical Instrument, frequency doubled Nd: Y AG (532 nm) laser Ophthalmic Laser, 810 nm diode laser Laser Surgical Instrument; 810 nm diode laser Classification Ophthalmic laser (see 21 CFR 886.4390) Name: Laser surgical instrument (see: 21 CFR 878.4810). Product Code: HQF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Viridis Laser (K960867); Novus Verdi Delivery Systems (K991258) -and the Viridis laser
1
IRIS Medical OcuLight SL/SLx (K020374); Nidek DC-3300 (K013760) The predicate lasers utilize several delivery systems, including slit lamp adapters, biomicroscopes, endoprobes, and indirect ophthalmoscopes to deliver the laser energy to the treatment sites.
The delivery systems used with the Viridis Twin Ophthalmic Photocoagulator are the same as or similar to delivery systems supplied with or used with other ophthalmic photocoagulators operating at 532 nm and/or 810 nm. These devices are independently marketed by their respective manufacturers which are responsible for complying with regulatory and marketing requirements. The cited models are compatible for use with the Viridis Twin Ophthalmic Photocoagulator.
- Device description: The Viridis Twin Ophthalmic Photocoagulator is a combination system consisting of a Nd:YAG frequency doubled laser which emits a beam of coherent light at 532 nm and a diode laser which emits a beam of coherent light 810 microns. The treatment beam is selected by the user, the delivery system is attached to the appropriate laser aperture, and the energy is delivered to the treatment site(s) via delivery systems/devices.
- Quantel Viridis Twin Ophthalmic Photocoagulator is indicated Indications: The for the photocoagulation or ablation of pigmented tissue within the eye.
The 532 nm wavelength is indicated for use for:
retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.
The 810 nm wavelength is indicated for use for:
photocoagulation 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,
2
endophotocoagulation,
treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients),
transpupillary photocoagulation of choriodal neovasculature, and
age-related macular degeneration (AMD) treatments.
Performance Data: None required.
- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Viridis Twin Ophthalmic Photocoagulator is substantially equivalent to the cited legally marketed predicates. 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.
Revised: January 2003
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Quantel Medical c/o Roger W. Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K023464
Trade/Device Name: Viridis Twin Ophthalmic Photocoagulator Regulation Number: 886.4390 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: October 9, 2002 Received: October 15, 2002
Dear Mr. Barnes:
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
4
Page 2 – Mr. Roger W. Barnes
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97): Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkinson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Viridis Twin laser
Indications for Use Statement:
The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.
The 532 nm wavelength is indicated for use for:
retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.
The 810 nm wavelength is indicated for use for:
photocoagulation 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),
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| Prescription Use | OR |
| (Per 21 CFR 801.109) |
Over-The Counter Use
6
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 choriodal neovasculature, and
age-related macular degeneration (AMD) treatments.
revised: January 2003