(91 days)
Not Found
No
The description focuses on the material composition, manufacturing process, and physical properties of the contact lens, with no mention of AI or ML for design, fitting, or analysis.
No.
The device is indicated for the correction of refractive errors and management of irregular corneal conditions, as well as temporary reduction of myopia, not for therapeutic purposes.
No
Explanation: The device is a contact lens intended for correcting refractive errors and managing corneal conditions. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical contact lens made from a specific material (siloxanyl fluoromethacrylate copolymer) and available in various physical configurations. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Hyper GP contact lens is for the correction of refractive error and management of irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, a physical object placed on the eye to alter vision. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: The description focuses on the physical properties of the lens material, its design configurations, and how it corrects vision. There is no mention of it being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
- Clinical Performance Data: The summary of performance studies describes biocompatibility and physical properties, not diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
In summary, the Hyper GP contact lens is a medical device used for vision correction and management of corneal conditions, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Hyper GP (tisilfocon A) 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 nondiseased eyes with myopia or hyperopia.
The Hyper GP (tisilfocon A) 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 nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Hyper GP (tisilfocon A) 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 Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eves 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 Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
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 (comma separated list FDA assigned to the subject device)
HQD, MUW
Device Description
The Hyper GP (tisilfocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm).
The Hyper GP (tisilfocon A) 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, D&C Violet No. 2 and D&C Red No. 17.
The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.
The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.
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 Studies:
A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Hyper GP (tisilfocon A) Daily Wear Contact Lens. 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 nonclinical testing on the Hyper GP (tisilfocon A) Daily Wear Contact Lens demonstrate that:
- The finished lenses (uncoated and coated with Tangible™ Hydra-PEG) are not toxic and ● not irritating,
- The physicochemical, mechanical, and optical properties of the Tangible™ Hydra-PEG ● coated and uncoated lenses are substantially equivalent to the predicate device.
- 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.
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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 23, 2018
Contamac Ltd. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K182304
Trade/Device Name: Hyper GP (tisilfocon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD, MUW Dated: October 24, 2018 Received: October 26, 2018
Dear Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
2
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 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
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
3
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: K182304
I. SUBMITTER
- October 24th, 2018 Date Prepared:
| Name: | Contamac Ltd. |
|---|---|
| Address: | Carlton House |
| Shire Hill | |
| Saffron Walden | |
| Essex CB11 3AU | |
| Contact Person: | Robert McGregor |
| Managing Director | |
| Phone number: | 01799 514800 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Hyper GP (tisilfocon A) Daily Wear Contact Lens |
|---|---|
| Common | |
| Name: | Daily wear rigid gas permeable contact lens |
| Classification | |
| Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory | |
| Class: | Class II |
| Product Code: | HQD; MUW |
4
III. PREDICATE DEVICE
The Hyper GP (tisilfocon A) Daily Wear Contact Lens is substantially equivalent to the following predicate devices:
- . "Rigid Gas Permeable Contact Lenses (tisilfocon A)" By Menicon Co., Ltd. 510(k) number; K103561
- . "OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)" by Contamac Ltd. 510(k) number; K160859
- . "Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lenses" by Contamac Ltd. 510(k) number; K161100
IV. DEVICE DESCRIPTION
The Hyper GP (tisilfocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm).
The Hyper GP (tisilfocon A) 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, D&C Violet No. 2 and D&C Red No. 17.
The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.
The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness. The following table depicts the contact angle of the coated vs. uncoated lenses:
5
| Hyper GP tisilfocon A | ||
|---|---|---|
| Uncoated | Tangible™ Hydra-PEG | |
| Coated | ||
| Average Sessile Drop Contact Angle | ||
| (degrees) n=30 | 106.2 | 37.34 |
| Standard Deviation | 5.31 | 5.30 |
The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Hyper GP (tisilfocon A) Daily Wear Contact Lens is the Poly Vial Contact Lens Case. When shipped "wet", the Hyper GP (tisilfocon A) Daily Wear Contact Lens may be 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 physical properties of the Hyper GP (tisilfocon A) Daily Wear Contact Lens is as follows:
| | Hyper GP (tisilfocon A) | Hyper GP (tisilfocon A) with
TangibleTM Hydra-PEG |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Refractive Index (dry) | 1.4378 | 1.4398 |
| Light Transmission (@380-780nm) | 91.694 | 93.427 |
| UVA Transmission (@316-380nm) | 14.241 | 16.105 |
| UVB Transmission (@280-315nm) | 0.011 | 0.020 |
| Oxygen Permeability
(Dk)
ISO/FATT Method | $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @
35°C) | $180 \times 10^{-11}$ (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, C.I. Solvent
Yellow No. 18, D&C Violet No. 2 and
D&C Red No. 17 | D&C Green No. 6, C.I. Solvent
Yellow No. 18, D&C Violet No. 2
and D&C Red No. 17 |
The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 12.00mm | ± 0.05 mm |
| Center Thickness | Varies | ± 0.02 mm |
| Chord Diameter | 7.00mm to 22.00mm | ± 0.10mm |
| Spherical Power | -30.00 D to +30.00 D | |
| (in 0.25D steps) | ± 0.12 (0 to = 5D) |