(113 days)
No
The summary describes a rigid gas permeable contact lens with specific material properties and surface treatment. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material biocompatibility and physical properties.
No.
The device is indicated for the correction of refractive error and management of irregular corneal conditions, which addresses a physiological condition but does not inherently treat or cure a disease.
No
The device is a contact lens intended for correcting refractive error in aphakic persons, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of specific materials and treated with a surface technology. It is a tangible medical 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 error in aphakic persons with non-diseased eyes. This is a therapeutic or corrective purpose, not a diagnostic one.
- Device Description: The device is a contact lens, which is a physical device worn on the eye to alter vision. It does not perform any in vitro testing on biological samples.
- Lack of Diagnostic Function: The description focuses on the physical properties of the lens, its material composition, and its ability to correct vision. There is no mention of it being used to diagnose a disease or condition by testing samples outside the body.
- Anatomical Site: The device is applied to the eye, which is an in vivo application, not an in vitro one.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in 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.
The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only
The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens 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 siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (roflufocon C, D, and E) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens 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 with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer 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 280nm - 315nm and 95% in the UVA range of 316 - 380mm.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
- Chord Diameter: 7.0mm to 22.0mm
- Center Thickness: Varies
- Base Curve: 5.0mm to 8.0mm
- Spherical Powers: -20.00 Diopters to +20.00 Diopters
- Toric Powers: up to -10.00 Diopters
- Add Powers: up to +4.00 Diopters
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)
Non-clinical Testing: A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.
Test results:
- The finished lenses are not toxic and not irritating,
- Bioburden levels are below the acceptance criteria (
§ 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Contamac Ltd. % Mr. Bret Andre Principal Consultant Evereg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068
Re: K161100
Trade/Device Name: Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: June 23, 2016 Received: June 27, 2016
Dear Mr. Andre:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
1
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161100
Device Name
Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses
Indications for Use (Describe)
The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in 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.
The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only
The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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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: | K161100 |
|---|---|
| Applicant information: | |
| Date Prepared: | June 23rd, 2016 |
| Name: | Contamac Ltd. |
| Address | Carlton House |
| Shire Hill | |
| Saffron Walden | |
| Essex CB11 3AU | |
| Contact Person: | Robert McGregor |
| Managing Director | |
| Phone number: | 44-1799 542 000 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number | (503) 372-5226 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Product Code: | HQD |
| Classification Name: | Daily Wear Rigid Gas Permeable Contact Lens |
| (21 CFR 886.5916) | |
| Trade Name: | Optimum GP with HPT (roflufocon C, D, and E) Daily |
| Wear Contact Lenses |
5
Purpose of 510(k) Submission:
~ New Technology ~
The Optimum GP Daily Wear Contact Lenses—cleared under 510(k) K033594 and K070628-are modified to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, HPT treated contact lenses demonstrate a measureable improvement in the contact angle in comparison with the untreated lenses. The application of HPT to the surface of Optimum GP with HPT Daily Wear Contact Lenses does not change the design or indications for use in comparison with the untreated lenses, the predicate device (K033594 and K070628).
Predicate Devices:
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:
"Optimum GP (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses" By Contamac Ltd. 510(k) number; K033594 and K070628 -primary predicate
"IntelliWave4 with HPT (safrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K152046 -reference predicate
Device Description:
The Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens 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 siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (roflufocon C, D, and E) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The following table depicts the enhanced contact angle of the Optimum GP with HPT Daily Wear Contact Lens versus the predicate device:
6
| roflufocon C | roflufocon D | roflufocon E | ||||
|---|---|---|---|---|---|---|
| Uncoated | HPT Coated | Uncoated | HPT Coated | Uncoated | HPT Coated | |
| Average Captive | ||||||
| Bubble Dynamic | ||||||
| Contact Angle | ||||||
| (degrees) n=3 | 95.30 | 40.28 | 93.28 | 40.40 | 93.64 | 36.90 |
| Standard Deviation | 0.55 | 6.44 | 2.13 | 5.05 | 3.47 | 8.04 |
| % Standard Deviation | 0.58 | 15.98 | 2.28 | 12.51 | 3.71 | 21.78 |
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens 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 with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer 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 280nm - 315nm and 95% in the UVA range of 316 - 380mm.
| (roflufocon c) | (roflufocon d) | (roflufocon e) | |
|---|---|---|---|
| Refractive Index | 1.4406 | 1.4333 | 1.4332 |
| Light Transmission | |||
| (clear) | >97% | >97% | >97% |
| Light Transmission | |||
| (tinted) | >90% | >90% | >90% |
| Specific Gravity | 1.178 | 1.166 | 1.155 |
| Oxygen Permeability | |||
| (Dk) | |||
| ISO/FATT Method | $65 \times 10^{-11}$ | ||
| (cm2/sec) (ml O₂/ml x | |||
| mm Hg @ 35 °C) | $100 \times 10^{-11}$ | ||
| (cm2/sec) (ml O₂/ml x mm Hg | |||
| @ 35°C) | $125 \times 10^{-11}$ | ||
| (cm2/sec) (ml O₂/ml x mm Hg | |||
| @ 35°C) | |||
| Visitint lenses contain | |||
| one or more of the | |||
| following color | |||
| additives conforming | |||
| 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 |
The physical properties of the Optimum GP with HPT Contact Lens are as follows:
7
The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
- 7.0mm to 22.0mm Chord Diameter: ●
- Center Thickness: Varies
- Base Curve:
- Spherical Powers:
- Toric Powers:
- Add Powers: ●
5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters
- up to +4.00 Diopters
Intended Use:
The Optimum GP with HPT (roflufocon C. D. and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error 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.
The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error 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.
The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only
The Optimum GP with HPT (roflufocon C. D. and E) Irregular Cornea 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.
Testing:
- Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the Optimum GP with HPT Daily Wear Contact Lens demonstrate that:
8
- The finished lenses are not toxic and not irritating,
- . Bioburden levels are below the acceptance criteria (