(108 days)
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No
The document describes a standard rigid gas permeable contact lens and its clinical performance. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
Yes
The "Intended Use / Indications for Use" states that the device is for "correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia)", which indicates a therapeutic purpose.
No
This device is a contact lens intended for correcting refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia), not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of a specific material (wilofocon A) and is a hemispherical shell. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive ametropia (vision problems) in the eye. This is a direct interaction with the body for a therapeutic or corrective purpose.
- Device Description: The device is a contact lens, which is a physical object placed on the surface of the eye.
- Anatomical Site: The anatomical site is the eyes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic testing performed outside of the body (in vitro).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
Flosi rigid gas permeable contact lenses are indicated for daily wear correction of visual acuity In aphakic and not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic), presbyopic or who have corneal astigmatism.
FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell of the following dimensions:
•Diameter 6.5 to 11.5 mm
•Center Thickness for Low Minus Lens: 0.05 to 0.30 mm for Plus Lens: 0.10 to 0.70 mm
•Base Curve 6.50 to 9.00 mm
•Powers -20.00 to +20.00 Diopters
•Aspheric Lens Eccentricity -1.5 to 1.5 Oblate to Prolate
Peripheral Curves 0.1 to 10 mm. Flatter or Steeper than Base Curve
•Toric Lens Axis 1 to 180 degrees in 1 degree steps Cylinder power 0.50 to 4.00 Diopters
The physical/optical properties of the lens are:
•Specific Gravity 1.25
•Refractive index (589 nm at 25°C) 1.44
•Light Transmittance Clear (370-760 nm) 93% Tinted (D & C Green No. 6) (380-780 nm) 87%
•Surface Character Hydrophobic
•Wetting Angle (CLMA Method) 23.0 ± 2
•Water Content (Gravimetric method at 22°C) 1.00 diopter had no change in 20/20 visual acuity.
Refraction:
- 99.1% of eyes showed no change to 1.00 diopters change.
- Average change: near zero.
- Generally low changes attributed to better fitting lens or measurement variation.
- Three eyes with changes of 1.50 diopters had no change in 20/20 visual acuity.
Visual Acuity: - No patients experienced a drop in visual acuity greater than one line.
- Visual acuity results were within expected ranges.
Average wearing time: 14.9 hours at the end of the study.
Overall Conclusion: No eyes experienced adverse reactions, SLFs requiring treatment, or SPCs requiring treatment. The FLOSI rigid gas permeable contact lens was shown to be worn safely by all patients in the study.
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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§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
K 974636
ﺍﯾﮏ ﮐﮯ ﮐﺎ ﺭﻗﺒﮧ 197
ുക്കും.
അവലംബം
MAR 30 1998
COMPREHENSIVE SUMMARY III.
1
NAME AND USE OF DEVICE
:
| Device Generic Name: | wilofocon A |
|---|---|
| Device Trade Name: | Flosi rigid gas permeable contact lens |
| Indications: | Flosi rigid gas permeable contact lenses are |
| Indicated for daily wear correction of visual | |
| acuity In aphakic and not-aphakic persons | |
| with non-diseased eyes who are nearsighted | |
| (myopic), farsighted (hyperopic), presbyopic | |
| or who have corneal astigmatism. | |
| Alrperm Ranges: | Chord diameter 6.5 to 11.5 mm |
| Center thickness 0.05 to 0.70 mm | |
| Base Curve 6.50 to 9.00 mm | |
| Powers -20.00 to +20.00 diopters | |
| Cleaning and Disinfection: | The Fiosi rigid gas permeable contact lens |
| must be disinfected using only a chemical (not | |
| heat) disinfection system as recommended. |
2
K97463k
VI. DEVICE CHARACTERISTICS
The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell of the following dimensions:
LENS PARAMETERS AVAILABLE
| •Diameter | 6.5 to 11.5 mm |
|---|---|
| •Center Thickness | |
| for Low Minus Lens: | 0.05 to 0.30 mm |
| for Plus Lens: | 0.10 to 0.70 mm |
| •Base Curve | 6.50 to 9.00 mm |
| •Powers | -20.00 to +20.00 Diopters |
| •Aspheric Lens Eccentricity | -1.5 to 1.5 |
| Oblate to Prolate | |
| Feripheral Curves | 0.1 to 10 mm. Flatter or Steeper than |
| Base Curve | |
| •Toric Lens | |
| Axis | 1 to 180 degrees in 1 degree steps |
| Cylinder power | 0.50 to 4.00 Diopters |
| The physical/optical properties of the lens are: | |
| •Specific Gravity | 1.25 |
| •Refractive index (589 nm at 25°C) | 1.44 |
| •Light Transmittance | |
| Clear (370-760 nm) | 93% |
| Tinted (D & C Green No. 6) (380-780 nm) | 87% |
| •Surface Character | Hydrophobic |
| •Wetting Angle (CLMA Method) | 23.0 ± 2 |
| •Water Content (Gravimetric method at 22°C) | Trade Name: Flosi (Wilofocon A) Rigid Gas Permeable Contact Lenses for Daily Wear (Spherical, Aspheric, Toric and Bifocal) Clear and Tinted (with D&C Green #6) Regulatory Class: II |
Product Code: 86 HQD Dated: March 11, 1998 Received: March 12, 1998
Dear Dr. Platt:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
7
Page 2 - Dr. William Platt
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number: K974636
Application Number:
Device Name: FLOSI (wilotocon A) Rigld Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses
Indications for use:
FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K974636 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Par 21 CFR 801.109) | (Optional Format 1.2.96) |