(146 days)
No
The description focuses on the material properties and physical characteristics of a contact lens, with no mention of AI or ML technology.
No.
The primary purpose of this device is to correct refractive errors (myopia and hyperopia) and astigmatism, which are visual acuities, not to provide therapy for a disease or condition. The "Indications for Use" specifies "non-diseased eyes".
No
Explanation: This device is a contact lens indicated for the correction of refractive ametropia and astigmatism. Its purpose is to correct vision, not to diagnose a condition.
No
The device description clearly states it is a physical contact lens made of a hydrophilic polymer, 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 ametropia (myopia and hyperopia) and astigmatism. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and composition of a contact lens designed to be worn on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied to the cornea and sclera, which is consistent with a contact lens for vision correction.
- Performance Studies: The performance studies focus on toxicology and equivalence to a predicate contact lens, not on diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
In summary, the FREQUENCY™ 55 UV contact lens is a medical device intended for vision correction, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera with the following dimensions:
- 14.0mm to 15.0mm Chord Diameter: ●
- Center Thickness: 0.03mm to 0.40mm ●
- 8.40mm to 9.30mm Base Curve:
- Spherical Powers: -20.00 Diopters to +20.00 Diopters .
The physical/optical properties of the lens are:
- 1.40 Refractive Index: .
- % Transmittance @590nm: >90% 0
- % Transmittance @ 280-315nm
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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
JAN 2 0 1999
510 (k) Summar
SUBMITTER:
Submitted on behalf of:
| Company Name:
Address: | Aspect Vision Care Ltd.
South Point, Hamble
Southampton SO31 4RF
United Kingdom |
|---------------------------|-----------------------------------------------------------------------------------------------|
| Phone: | 00 1 44 1703 605 200 |
| Fax: | 00 1 44 1703 605 299 |
| CONTACT PERSON: | Ivor Atkinson |
| DATE SUMMARY PREPARED: | August 24, 1998 |
| TRADE NAME: | FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact
Lens for Daily Wear (clear and tinted) |
| COMMON NAME: | Contact Lens |
SUBSTANTIALLY EQUIVALENT TO:
FREQUENCY 55 UV (methafiloon A) Hydrophilic Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lenses for Daily Wear (clear and tinted) that received marketing clearance pursuant to K973063, currently marketed in the US. A comparison of properties is found in the chart below.
Preclinical Testing
The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens in non toxic. Furthermore, the results of residual monomer and colour leachability testing demonstrate that the respective extracts did not contain leachable colour or significant levels of residual monomers.
The physical optical, and chemical properties of the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted). This lens is in Group 4, lonic, high water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994.
The lens will be sterilised and packaged in the same manner as previously cleared in K973063 and K971164. This lens will also be sterility released by parametric release, as cleared in K971164.
1
COMPARISON OF PHYSICAL/OPTICAL PROPERTIES:
| PARAMETER | FREQUENCY 55 UVTM
Hydrophilic Contact
Lens for Daily Wear
(clear and tinted with UV
Blocker) | FREQUENCY 55 Hydrophilic
Contact Lens for Daily Wear
(clear and tinted) |
|------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| material | methafilcon A | methafilcon A |
| indication for use | myopia, hyperopia and
astigmatism | myopia, hyperopia and
astigmatism |
| water content | 55% | 55% |
| % transmittance @ 590nm | 93.58% | 95.47% |
| % transmittance @ 280-315 nm | 6.00 | 82.47 |
| % transmittance @ 316-380 nm | 4.09 | 95.30 |
| Dk (35°C) (Edge Corrected) | $14.00 X 10^{-11}$ | $15.50 X 10^{-11}$ |
| powers | -20.00 to+20.00 D | -20.00 to+20.00 D |
| color | clear and aqua visibility | clear and blue visibility |
| refractive index | 1.4027 | 1.4052 |
| tensile strength | 1.26 | 0.66 |
| Modulus | 0.32 | 0.48 |
| Elongation at Break | 287 | 179 |
| Toughness | 1.27 | 0.38 |
| manufacturing method | cast molding | cast molding |
DESCRIPTION of the DEVICE:
The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera with the following dimensions:
- 14.0mm to 15.0mm Chord Diameter: ●
- Center Thickness: 0.03mm to 0.40mm ●
- 8.40mm to 9.30mm Base Curve: �
- Spherical Powers: -20.00 Diopters to +20.00 Diopters .
The physical/optical properties of the lens are:
- 1.40 Refractive Index: .
- % Transmittance @590nm: >90% 0
- % Transmittance @ 280-315nm