(71 days)
Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP).
The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm).
The 3 possible delivery systems are the followirig :
-
Slit lamp adaptor
-
Indirect ophthalmoscope adaptor
-
Endocular probe adaptor
Output power of all these delivery systems have a maximum of 1.5 Watts.
This document describes an ophthalmic laser device ("VIRIDIS" or "EVERGREEN 532") and compares it to predicate devices to demonstrate substantial equivalence. No acceptance criteria, device performance numbers, or details of a study proving the device meets acceptance criteria are provided in the extracted text. The document focuses on device description, intended use, and a comparison table of technical specifications with predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and the associated study. The provided text is a 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed predicate devices rather than presenting detailed performance studies against pre-defined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for BIOVISION. The logo consists of the letters "BVI" in large, bold, black font, stacked on top of four horizontal black lines. Below the lines, the word "BIOVISION" is written in a smaller, bold, black font.
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510(k) Summary of Safety and Effectiveness
The following information is submitted in accordance with the requirements of 21 CFR 807.92 :
Submitted by :
Zhatta
Jean Abascal B. V. International 89, Boulevard Etienne CLEMENTEL 63100 Clermont-Ferrand FRANCE
Contact person :
Jean Abascal
(33) 73 25 62 27
(33) 73 25 54 11
Telephone number : FAX number :
Date Prepared :
February 21st_1996
Device Name :
Classification Name : Ophthalmic Laser
Common / Usual Name : Ophthalmic Laser Photocoagulator
VIRIDIS Proprietary Name : Frequency Doubled Nd:YAG Photocoagulator
Other Proprietary Name : EVERGREEN 532 Frequency Doubled Nd:YAG Photocoagulator
Classification :
Devices Classification Panel : Ophthalmic Product code : 86HOF Ophthalmic lasers are Class II medical devices in accordance with 21 CFR § 886.4390.
"VIRIDIS" and "EVERGREEN 532" are identical. Note : Only the housing is different.
B.V.INTERNATIONAL : 89, Boulevard Etienne Clémentel - 63100 Clermont-Ferrand -Tel : 73 25 62 27 FRANCE Fax : 73 25 54 11
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Image /page/1/Picture/1 description: The image shows the logo for BIOVISION. The logo consists of the letters "BVI" in large, bold, black font, stacked on top of four horizontal black lines. Below the lines, the word "BIOVISION" is written in a smaller, black font with rounded letterforms.
510(k) Summary of Safety and Effectiveness
Predicate Devices :
- An other Frequency Doubled Nd:YAG Photocoagulator :
The EMERALD from Crystal Focus
- A Continuous-wave Argon Laser .:
The NOVUS 2000 from Coherent
Device Description
The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP).
The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm).
The 3 possible delivery systems are the followirig :
-
Slit lamp adaptor
-
Indirect ophthalmoscope adaptor
-
Endocular probe adaptor
Output power of all these delivery systems have a maximum of 1.5 Watts.
Intended Use :
Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
Predicate Comparison :
A chart comparing the VIRIDIS (or EVERGREEN 532) with the 2 predicate devices, demonstrating substantial equivalence, is attached.
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Image /page/2/Picture/0 description: The image shows a logo for "BVI BIOVISION". The logo is in black and white. The letters "BVI" are in large, bold font, with three horizontal lines underneath. Below the lines, the word "BIOVISION" is written in a smaller, but still bold, font.
510(k) Summary of Safety and Effectiveness
Device Comparison
| Manufacturer | Coherent Medical | B.V.International | Crystal Focus |
|---|---|---|---|
| Model | NOVUS 2000 | VIRIDISorEVERGREEN 532 | EMERALD |
| Same Intended Use | Retinal Photocoagulation for the treatment of Ophthalmicconditions. | ||
| Same type ofDelivery systems | 1°) Slit Lamp adaptor with Zoom2°) Indirect Ophthalmoscope adaptor3°) Endocular Probe | ||
| Lasing medium | Argon | ND:YAG | ND:YAG |
| Pumping system | High Voltage | Diode Laser810 nm | Flash |
| Doubling Frequency Crystal | --- | KTP | KTP |
| Output Wavelength | 488 - 514 nm | 532 nm | 532 nm |
| Pulsing system | Continuous | Pseudo-Continuous | Pulsed |
| Pulse Duration | --- | 25 micro sec. | 1 micro sec. |
| Average Power | 2.5 W | 1.5 W | 2 W |
| Pulse Repetition Rate | Continuous | 12 000 Hz | 10 000 Hz |
| Mini. Focal Spot Size :Diameter | 50 micro meters | 50 micro meters | 50 micro meters |
| Aiming beam : | Coaxial with treatment beam | ||
| Aiming beam : type | He-Ne laser | Diode Laser | He-Ne laser |
| Aiming beam : Wavelength | 632 nm | 670 nm | 632 nm |
| Cooling method | Internally liquidcooled | Solid state cooling | Internally liquidcooled |
| Exposure Selections ( t ) | 0.01s tocontinuous | 0.01 -0.02 -0.05 -0.07 -0.1 -0.2 -0.3 -0.4 -0.5-0.7 -1.0 -2.0 -3.0 sec. | 0.01- 0.02- 0.05- 0.1-0.2- 0.3- 0.4 -0.5 -0.7-1.0 and 3.0 sec. |
| Power requirements : Voltage | 208 - 240 Vac | 100 to 240 Vac | 208 - 240 Vac |
| Power requirements : Current | 45 A | 5 A | 13 A |
§ 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.