(127 days)
Not Found
No
The description focuses on the material composition, design variations, and clinical performance of rigid gas permeable contact lenses. There is no mention of any computational algorithms, data processing, or learning capabilities that would indicate the use of AI/ML.
Yes
The device is indicated for the correction of visual acuity in patients with myopia, hyperopia, and/or astigmatism, including for keratoconus management. These indications address medical conditions related to vision.
No
This device is a contact lens intended for correcting vision (myopia, hyperopia, astigmatism, presbyopia, keratoconus management), not for diagnosing medical conditions.
No
The device description clearly states it is a series of contact lenses fabricated from specific materials, which are physical hardware components. The intended use also describes the function of these physical lenses.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in non-diseased eyes with various refractive errors (myopia, hyperopia, astigmatism, presbyopia) and for keratoconus management. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens that acts as a refracting medium to focus light rays on the retina. This is a physical correction of vision, not a test performed on a sample from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a biological sample (like blood, urine, tissue, etc.) to provide diagnostic information.
Therefore, the OPTIMUM GP contact lens is a medical device, but it falls under the category of a corrective or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric 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 and/or possesses refractive astigmatism not exceeding 10.00 diopters. 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Multifocal 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 and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring presbyopic addition. 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. 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
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 place on the eye, the contact lens acts as a refracting medium to focus light rays upon the retina.
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 Methacryloxypropyl Methyl methacrylate, 1,1,1,3,3,3 - Hexandovosoprops inc. L. 3,3-tectakis(trimethyl siloxy)disiloxane, 2Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropy))-1,1,3,3-tec Tris(trimethylslloxy) shalle, 1,3-bls(includer).com/propy.com/props/inked 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.
In the OPTIMUM GP Contact Lens, the UV Blocker is 2,2 - Dihydroxy-4,4 "dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.
The physical properties of the OPTIMUM GP Contact Lens are:
Refractive Index: 1.4527 (roflufocon A), 1.4454 (roflufocon B), 1.4406 (roflufocon C), 1.4333 (roflufocon D), 1.4332 (roflufocon E)
Light Transmission (clear): >97% for all materials
Light Transmission (tinted): >90% for all materials
Wetting Angle (Dynamic contact receding angle): 12° (roflufocon A), 13° (roflufocon B), 6° (roflufocon C), 3° (roflufocon D), 6° (roflufocon E)
Specific Gravity: 1.189 (roflufocon A), 1.181 (roflufocon B), 1.178 (roflufocon C), 1.166 (roflufocon D), 1.155 (roflufocon E)
Oxygen Permeability (Dk) ISO/FATT Method: 26 x 10^-11 (roflufocon A), 46 x 10^-11 (roflufocon B), 65 x 10^-11 (roflufocon C), 100 x 10^-11 (roflufocon D), 125 x 10^-11 (roflufocon E) (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
Visitint lenses contain one or more of the following color additives and conform to: 21 CFR Part 73 & 74, Subpart D: D & C Green No. 6, FD & C Red No. 17 CI Solvent Yellow 18 for all materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
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)
Clinical Testing: The study was carried out to evaluate the safety and efficacy of the OPTIMUM GP Rigid Gas Permeable Contact Lens material when used as a daily wear contact lens for the correction of visual acuity.
Sample Size: A total of 272 eyes (136 patients) were entered into the study by 10 investigators. 246 eyes (123 patients) completed the study.
Safety measures: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes.
Efficacy measures: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time.
Key results: The sponsor concludes that OPTIMUM Rigid Gas Permeable Contact Lens material is equivalent in safety and efficacy to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970698, K000795, K002025, K940277, K990264
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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: | K033594 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
| Date Prepared: | November 16, 2003 |
|---|---|
| Name: | CONTAMAC Ltd. |
| Address | Bearwalden Business Park |
| Saffron Walden | |
| Essex England CB11 4JX | |
| Contact Person: | Robert McGregor |
| Phone number: | 44-1799 542 000 |
| US Agent: | Medvice Consulting, Inc. |
| Martin Dalsing | |
| Phone number | (970) 243-5490 |
| Fax number | (970) 243-5501 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | OPTIMUM GP (Oxygen Permeable) Daily Wear Contact |
| Lenses. |
1
Equivalent Devices:
The OPTIMUM GP (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon I), & (rollufocon to the following The OPTIMUM GP (follulocoll A), (romatoodl D), (ronaloour of), (ronaloour of the following predicate devices.
| | Predicate devices:
Predicate device manufacturer: | Device name: |
|-----|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Polymer Technology
1400 North Goodman Street
Rochester, NY 14603 | Boston ES Multifocal, Daily Wear
510(k) #: K970698 |
| 2.) | Polymer Technology
1400 North Goodman Street
Rochester, NY 14603 | Boston XO, Daily Wear
510(k) #: K000795 |
| 3.) | Paragon Vision Sciences
947 E. Impala Avenue
Mewa, AZ 85204 | BOSTON XO, EO, ES, 7 RXD, Daily Wear
510(k) #: K002025 (wet shipped lenses)
FluoroPerm 30, 510(k) #: K940277
FluoroPerm 60, 510(k) #: K940277
FluoroPerm 90, 510(k) #: K940277
FluoroPerm 151, 510(k) #:K940277
FluoroPerm HDS, P87024-S36 |
| 4.) | Metro Optics, Inc.
15802 Vision Drive
Pflugerville, TX 78660 | ComfortKone, Daily Wear
510(k) #: K990264 (Keratoconus Contact Lens Design) |
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 place on the (formocon A), (fondiocon DJ, (romatocer en) (1911). "The sess act as a refracting medium to focus light rays upon the retina.
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.
2
The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of I he OPT IMUM GF Collact Letts for Dany Women at Methacrylaxypropyl Methyl methacrylate, 1,1,1,3,3,3 - Hexandovosoprops inc. L. 3,3-tectakis(trimethyl siloxy)disiloxane, 2Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropy))-1,1,3,3-tec Tris(trimethylslloxy) shalle, 1,3-bls(includer).com/propy.com/props/inked with Ethylene Glycol Dimethacrylate.
Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more The OPTIMUM GP Contact Lenses contain one or more of the following color additives: D&C Green
visible for handling. The tinted lenses contain one of the following color addit No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.
UV Blocker
O v Blocker
In the OPTIMUM GP Contact Least Collections of All Justhershappenhenene . The JV to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 "dimethoxybenzophenone. The UV
to block UV radiation. The UV Blocker is 2,2 - Dibydroxy-4,4 "dimethoxy" (21 for to block UV radiation. The UV Blocker is 2,2 -Darydoxy ", Fennances - 1, 1 - 1
blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.
The physical properties of the OPTIMUM GP Contact Lens are:
| (roflufocon A) | (roflufocon B) | (roflufocon C) | (roflufocon d) | (roflufocon e) | |
|---|---|---|---|---|---|
| Refractive Index | 1.4527 | 1.4454 | 1.4406 | 1.4333 | 1.4332 |
| Light Transmission | |||||
| (clear) | >97% | >97% | >97% | >97% | >97% |
| Light Transmission | |||||
| (tinted) | >90% | >90% | >90% | >90% | >90% |
| Wetting Angle | |||||
| (Dynamic contact | |||||
| receding angle) | 12° | 13° | 6° | 3° | 6° |
| Specific Gravity | 1.189 | 1.181 | 1.178 | 1.166 | 1.155 |
| Oxygen | |||||
| Permeability (Dk) | |||||
| ISO/FATT Method | $26 x 10^{-11}$ | ||||
| (cm²/sec) (ml O₂/ml x | |||||
| mm Hg @ 35°C) | $46 x 10^{-11}$ | ||||
| (cm²/sec) (ml O₂/ml x | |||||
| mm Hg @ 35°C) | $65 x 10^{-11}$ | ||||
| (cm²/sec) (ml O₂/ml x | |||||
| mm Hg @ 35°C) | $100 x 10^{-11}$ | ||||
| (cm²/sec) (ml O₂/ml | |||||
| x mm Hg @ 35°C) | $125 x 10^{-11}$ | ||||
| (cm²/sec) (ml O₂/ml x | |||||
| mm Hg @ 35°C) | |||||
| Visitint lenses | |||||
| contain one or more | |||||
| of the following | |||||
| color additives and | |||||
| conform to: | |||||
| 21 CFR Part 73 & | |||||
| 74, Subpart D | D & C Green No. | ||||
| 6, FD & C Red | |||||
| No. 17 CI Solvent | |||||
| Yellow 18 | D & C Green No. | ||||
| 6, FD & C Red | |||||
| No. 17 CI Solvent | |||||
| Yellow 18 | D & C Green No. | ||||
| 6, FD & C Red | |||||
| No. 17 CI Solvent | |||||
| Yellow 18 | D & C Green | ||||
| No. 6, FD & C | |||||
| Red No. 17 CI | |||||
| Solvent Yellow | |||||
| 18 | D & C Green No. | ||||
| 6, FD & C Red | |||||
| No. 17 CI Solvent | |||||
| Yellow 18 |
3
Intended Uses:
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, roflufocon D, and rother competition I he OPT I MUM GF (fonulocon A, ronaloon D, ronis is indicated for daily wear for the correction of Spherical Rigid Cas Femicable (NOF) Connect roll it in in-diseased eyes with myopia of hyperopia. The lens may be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual 1 orie Rigid Gas Penneable (KOT) Condict Dons is insectives with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and rother man the the The OF I Invitified Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the Munitional Mitocal Night Oas I cimically (1627) okic persons with non-diseased eyes with myopia or correction of visual actiry in apliatio and now tipm not exceeding 4 diopters and are presbyopic requiring liyferopia antivor possesses retraorre antegramar be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) The OF TIMOM Of (Romatooon 14, romalovon act Lens is indicated for daily wear for promoted by atten Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the Correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only.
4
Description of Safety:
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the OPTIMUM GP Rigid Gas Permeable Contact Lens material. The results of all testing demonstrated that Of TIMOM Of Trigit Ous I entreaste Coanable Contact Lens is equivalent Lens is equivalent to the the surely marketed predicate devices previously identified. A summary of these results from the preclinical studies is presented below.
Toxicology:
In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.
Packaging
The primary container for shipping the OPTIMUM GP Rigid Gas Permeable Contact Lenses is the Alcon Contact Lens Case, with clearance under 510(k) K974281. The lens is shipped (wet) non-sterile in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) 014162. The solution contains lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.
Shelf Life
The OPTIMUM GP Rigid Gas Permeable lens is a hydrophobic contact lens material with