(55 days)
K0033594
No
The summary describes a rigid gas permeable contact lens made of specific chemical compounds and mentions its manufacturing process (lathe cut). There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is a contact lens used for vision correction and management of irregular corneal conditions, not for treating a disease or disorder in a therapeutic manner.
No
Explanation: The device is a contact lens used for the management of irregular corneal conditions, not for diagnosing them. It is a treatment or corrective device.
No
The device description clearly describes a physical contact lens made of specific materials and available in different forms (lathe cut, clear, tinted). It is a tangible medical device, not software.
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 for diagnosis, monitoring, or screening.
- Device Function: The OPTIMUM GP contact lens is a medical device that is placed on the eye to correct vision and manage irregular corneal conditions. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use clearly states it's for managing irregular corneal conditions in otherwise non-diseased eyes, which is a therapeutic and corrective function, not a diagnostic one based on analyzing samples.
The device description, intended use, and lack of any mention of analyzing biological samples all confirm that this is a therapeutic/corrective medical device, not an IVD.
N/A
Intended Use / Indications for Use
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
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 (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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
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
The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was demonstrated in 510(k) K0033594.
Key Metrics
Not Found
Predicate Device(s)
510(k) #K053124, 510(k) #K020006
Reference Device(s)
K0033594
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
K070628
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:
Applicant information:
| Date Prepared: | February 15, 2007 |
|---|---|
| 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 (roflufocon A, B, C, D & E) Daily Wear |
| Contact Lens. | |
| Purpose of 510(k): | Additional Indications for Use. |
1
Equivalent Devices:
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent to the following predicate devices.
PREDICATE DEVICES
Predicate device manufacturer:
Device name:
- 1.) Polymer Technology
1400 North Goodman Street Rochester. NY 14603
and the Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses 510(k) #K053124
Boston ES® (enflufocon A), Boston EO (enflufocon B),
- 2.) Lens Dynamics 14998 W. 6th Avenue, Suite 830 Golden, CO 80401
Dyna Intra-Limbal Lens 510(k) #K020006
Device Description:
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was demonstrated in 510(k) K0033594.
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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 - 315mm and 95% in the UVA range of 316 - 380nm.
2
| (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 | |||||
| Medical Devices | 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 |
The physical properties of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are:
Indication for Use:
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Substantial Equivalence:
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent and does not raise different questions of safety and effectiveness than the predicate device identified previously.
The following comparison table depicts characteristics of the OPTIMUM GP material, as well as the predicate devices.
3
| | Characteristics
Comparison | OPTIMUM GP | BOSTON ES, EO&
XO | Dyna Intra-Limbal
Lens | |
|-----|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | New Device | Predicate Device | Predicate Device | |
| 1.) | Indication for Use | The OPTIMUM GP
(roflufocon A, B, C, D & E)
Daily Wear Contact Lens
may be prescribed
in otherwise non-diseased
eyes that require
a rigid gas permeable lens for
the management
of irregular corneal conditions
such as:
keratoconus, pellucid
marginal degeneration
or following penetrating
keratoplasty or following
refractive (e.g. LASIK)
surgery. | The Boston ES®
(enflufocon A) , Boston
EO® (enflufocon B) and
Boston XO® (hexafocon
A) RGP contact lenses may
be prescribed in otherwise
non-diseased eyes that
require a rigd contact lens
for management of
irregular corneal conditions
such as keratoconus,
pellucid marginal
degeneration, or following
penetrating keratoplasty or
refractive (e.g. LASIK)
surgery. | TheDyna Intra-Limbal
(enflufocon or hexafocon
A) Lens lens may be
prescribed in otherwise non
diseased eyes that require a
rigid contact lens for the
management of irregular
corneal conditions such as
keratoconus, pellucid
marginal degeneration or
following penetrating
keratoplasty. | |
| 2.) | Device and
Classification | Class II
Daily wear, Rigid Gas
Permeable RGP
Contact Lens
HQD | Class II
Daily wear, Rigid Gas
Permeable RGP Contact
Lens
HQD | Class II
Daily wear, Rigid Gas
Permeable RGP Contact
Lens
HQD | |
| 3.) | Production
Method | Lathe-cut | Lathe-cut | Lathe-cut | |
| 4.) | FDA Group # | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate | |
| 5.) | Water Content |