(63 days)
Not Found
No
The document describes a rigid gas permeable contact lens and its materials, intended use, and manufacturing process. There is no mention of AI or ML technology in the description of the device or its function.
No
The device corrects visual acuity in non-diseased eyes with myopia or hyperopia, which is a correction rather than a treatment for a disease or condition.
No
Explanation: The device is a contact lens indicated for the correction of visual acuity, which is a therapeutic rather than a diagnostic function. It does not identify or diagnose a disease or condition.
No
The device description clearly indicates it is a physical contact lens made from specific materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The OPTIMUM GP contact lens is a medical device that is placed on the human cornea to correct vision. It acts as a refracting medium and does not analyze any biological samples.
- Intended Use: The intended use is for the correction of visual acuity, not for diagnosing or monitoring a disease or condition based on in vitro analysis.
The description clearly indicates it's a contact lens for vision correction, which falls under the category of ophthalmic devices, not IVDs.
N/A
Intended Use / Indications for Use
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
HQD, HOD
Device Description
The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the human cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.
| Solution | Manufacturer |
|---|---|
| Boston Simplus | Bausch & Lomb |
| Unique Ph | Alcon |
| Optimum CDS | Lobob Laboratories |
The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.
The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners
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)
The document mentions a chart "depicts the dramatic reduction in the OPTIMUM GP contact lens wetting angle measurements post plasma surface treatment." and a bar graph showing "% Reduction in Contact Angle after Plasma Surface Treatment" for Optimum Classic (17% reduction), Optimum Comfort (28% reduction), Optimum Extra (20% reduction), and Optimum Extreme (38% reduction). No further study details are provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
SPECIAL 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K062548 | NOV | 1 2006 | ||||
|---|---|---|---|---|---|---|---|
| Applicant information: | |||||||
| Date Prepared: | August 28th, 2006 | ||||||
| Submittals Name: | CONTAMAC Ltd. | ||||||
| Bearwalden Business Park | |||||||
| Saffron Walden | |||||||
| Essex United Kingdom CB11 4JX | |||||||
| Contact Person: | |||||||
| Medvice Consulting, Inc. | |||||||
| Martin Dalsing, Consultant and U.S. Agent for Contamac Ltd. | |||||||
| 2214 Sanford Drive, B7 | |||||||
| Grand Junction, CO 81505 | |||||||
| (970) 243-5490 | |||||||
| Fax #: (970) 243-5501 | |||||||
| E-mail: marty@fdapproval.com | |||||||
| Device Information: | |||||||
| Device Classification: | Class II | ||||||
| Classification Number: | HQD | ||||||
| Classification Name: | Daily Wear Rigid Gas Permeable (RGP) Contact Lens | ||||||
| Trade Name: | OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses |
1
Device Description:
The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the (fuman cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.
| Solution | Manufacturer |
|---|---|
| Boston Simplus | Bausch & Lomb |
| Unique Ph | Alcon |
| Optimum CDS | Lobob Laboratories |
The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.
The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.
UV Blocker
In the OPTIMUM GP Contact Lens with UV Blocker, a Benzophenone UV blocker is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315nm and 95% in the UVA range of 316 -380mm.
2
Contamac Ltd. Special 510(k): Manufacturing Process Change, Premarket Notification
The following chart depicts the dramatic reduction in the OPTIMUM GP contact lens wetting angle measurements post plasma surface treatment.
Image /page/2/Figure/2 description: The image is a bar graph titled "% Reduction in Contact Angle after Plasma Surface Treatment". The x-axis shows four different categories: Optimum Classic, Optimum Comfort, Optimum Extra, and Optimum Extreme. The y-axis shows the percent reduction, ranging from 0% to 40%. The bar graph shows that Optimum Classic has a 17% reduction, Optimum Comfort has a 28% reduction, Optimum Extra has a 20% reduction, and Optimum Extreme has a 38% reduction.
Unmodified Predicate Devices:
The OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses is substantially equivalent to Contamac Ltd. own unmodified predicate devices:
-
- Optimum GP (roflufocon ) K033594, Contamac Ltd.
INDICATIONS FOR USE:
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
3
Technological Characteristics Comparison:
ﺒﻌﻪ
ु
| Technological
Characteristic
/Device | Optimum GP
(roflufocon) Gas
Permeable Contact
Lens.
Modified Device | Optimum GP
(roflufocon) Gas
Permeable Contact
Lens.
Un-Modified Device
K033594 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear
for the correction of
visual acuity in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or
hyperopia. | Indicated for daily wear
for the correction of
visual acuity in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or
hyperopia. |
| Functionality | After machining from
the optical blank, the
contact lenses act as a
refractive medium that
focus light rays from
near and distant objects
on the retina. | After machining from
the optical blank, the
contact lenses act as a
refractive medium that
focus light rays from
near and distant objects
on the retina. |
| Indication for
Use | Daily wear, Rigid Gas
Permeable RGP Contact
Lens | Daily wear, Rigid Gas
Permeable RGP Contact
Lens |
| Production
Method | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate |
| USAN name | roflufocon | roflufocon |
| Water Content |