(112 days)
No
The document describes a physical contact lens and its material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery, which are therapeutic indications. It is also indicated for orthokeratology, a therapeutic intervention for myopia.
No
This device is a contact lens designed for correcting refractive errors and managing irregular corneal conditions, not for diagnosing them.
No
The device is a physical contact lens made of a specific material (hexafocon A) and has various physical parameters and coatings. It is not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the HEXA100 contact lens is for the correction of refractive error and management of irregular corneal conditions in living persons. This is a direct interaction with the human body for therapeutic and corrective purposes.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The HEXA100 does not perform any such examination of bodily specimens.
- Device Description: The device description details the material composition, physical properties, and design configurations of the contact lens itself, not a system for analyzing biological samples.
- Performance Studies: The performance studies focus on the biocompatibility, physical properties, and clinical safety and effectiveness of the contact lens when worn on the eye. They do not involve the analysis of in vitro samples.
Therefore, the HEXA100 contact lens falls under the category of a medical device intended for direct use on the human body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HEXA100 (hexafocon 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 HEXA100 (hexafocon 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 non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The HEXA100 (hexafocon 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 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 HEXA100 (hexafocon A) 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.
The HEXA100 (hexafocon 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 HEXA100 (hexafocon 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.
In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm.
The HEXA100 (hexafocon 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 HEXA100 (hexafocon 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 HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 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 10 Hydra-PEG, the underlying material (hexafocon 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 30mm in thickness. The following table depicts the contact angle of the coated HEXA100 (hexafocon A) Daily Wear Contact Lenses:
The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses 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 HEXA100 (hexafocon A) 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
The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:
- Chord Diameter: 6.5 to 11.5 mm
- Center Thickness: 0.10 to 0.70 mm
- Base Curve (BC): 6.5 to 11.0 mm
- Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
- Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
- Spherical Powers: -10.00 to +3.00 D
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 HEXA100 (hexafocon 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 non-clinical testing on the HEXA100 (hexafocon 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.
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.
510(k) number:
Applicant information:
| Date Prepared: | June 27th, 2017 |
|---|---|
| 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; MUW |
Classification Name: Daily Wear Rigid Gas Permeable Contact Lens (21 CFR 886.5916)
Trade Name: HEXA100 (hexafocon A) Daily Wear Contact Lens
Purpose of 510(k) Submission: ~ New Device ~
Predicate Devices:
The HEXA100 (hexafocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:
"Boston XO (hexafocon A) Daily Wear Contact Lens" -primary predicate By Bausch & Lomb, Inc.
1
510(k) number: K071043
"OPTIMUM GP OK (Orthokeratology) 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
Device Description:
The HEXA100 (hexafocon 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.
In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm.
The HEXA100 (hexafocon 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 HEXA100 (hexafocon 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 HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 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 10 Hydra-PEG, the underlying material (hexafocon 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 30mm in thickness. The following table depicts the contact angle of the coated HEXA100 (hexafocon A) Daily Wear Contact Lenses:
| HEXA 100 - Hexafocon A | ||
|---|---|---|
| Uncoated* | Tangible™ Hydra-PEG | |
| Coated* | ||
| Average Sessile Drop Contact Angle | ||
| (degrees) n=30 | 96.4° | 49.1° |
| Standard Deviation | 2.79 | 5.81 |
| % Standard Deviation | 2.90 | 11.82 |
*lenses were manufactured and soaked in borate buffered saline for 24 hours prior to contact angle measurement
The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or
2
"wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses 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 HEXA100 (hexafocon A) Daily Wear Contact Lenses are as follows:
| | HEXA100 (hexafocon A) | HEXA100 (hexafocon A) with
Tangible™ Hydra-PEG |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Refractive Index (dry) | 1.4136 | 1.4134 |
| Light Transmission (@380-780nm) | >91% | >94% |
| UVA Transmission (@316-380nm) |