(71 days)
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No
The summary describes a laser photocoagulation system with different delivery methods. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for "retinal photocoagulation for the treatment of ophthalmic conditions" such as "Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment," which are medical treatments.
No
The device is used for treatment (retinal photocoagulation) and does not mention any diagnostic capabilities.
No
The device description clearly outlines hardware components such as a laser source (Nd: YAG Slab, Laser Diode, KTP crystal), a treatment beam delivery system, and aiming laser (Red Laser Diode), along with various physical adaptors (slit lamp, indirect ophthalmoscope, endocular probe). This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The provided description clearly states the device is a laser system used for retinal photocoagulation. This is a therapeutic procedure performed directly on the patient's eye to treat ophthalmic conditions. It does not involve testing samples taken from the body.
The device is a therapeutic laser system, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
86HOF
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Retinal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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.
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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).
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§ 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.
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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.
K960867 Page 1 / 3
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 | VIRIDIS | |
or | |||
EVERGREEN 532 | EMERALD | ||
Same Intended Use | Retinal Photocoagulation for the treatment of Ophthalmic | ||
conditions. | |||
Same type of | |||
Delivery systems | 1°) Slit Lamp adaptor with Zoom | ||
2°) Indirect Ophthalmoscope adaptor | |||
3°) Endocular Probe | |||
Lasing medium | Argon | ND:YAG | ND:YAG |
Pumping system | High Voltage | Diode Laser | |
810 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 liquid | ||
cooled | Solid state cooling | Internally liquid | |
cooled | |||
Exposure Selections ( t ) | 0.01s to | ||
continuous | 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 |