(62 days)
No
The device description and performance studies focus on the material properties and equivalence to a predicate device, with no mention of AI/ML algorithms or data processing for diagnosis or treatment.
No.
The device is indicated for the correction of refractive ametropia and astigmatism, which are conditions addressed by corrective devices, not by devices that treat disease or provide therapy.
No
Explanation: The device is a contact lens indicated for correcting refractive errors (myopia, hyperopia, astigmatism), not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of specific materials, not a software program.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Function: The FREQUENCY UV contact lens is a device that is placed on the eye to correct vision. It does not analyze any biological samples from the body.
- Intended Use: The intended use is for the correction of refractive errors and astigmatism, which is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the lens itself, not on any components or processes for analyzing biological samples.
Therefore, the FREQUENCY UV contact lens falls under the category of a medical device, but specifically a corrective or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility 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)
86 LPL
Device Description
The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% 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 UV (etafilcon 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:
- Chord Diameter: . 14.0mm to 15.0mm
- 0.03mm to 0.40mm Center Thickness: ●
- Base Curve: 8.40mm to 9.30mm
- Spherical Powers: -20.00 Diopters to +20.00 Diopters .
The physical/optical properties of the lens are:
- 1.39 Refractive Index: .
- % Transmittance @593nm: >90% .
- % 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
APR 22 1998
510 (k) Summary
SUBMITTER:
Submitted on behalf of:
| Company Name: | Aspect Vision Care, Ltd. |
|---|---|
| Address: | South Point, Hamble |
| Southampton S031 4RF | |
| United Kingdom |
Phone: Fax:
011 44 1703 455 567 011 44 1703 455 523
CONTACT PERSON:
Martin S. Knopf
DATE SUMMARY PREPARED: February 16, 1998
TRADE NAME: FREQUENCY UV™ (etaflicon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
FREQUENCY UV (etafilcon A ) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are substantially equivalent to Acuvue (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker) that received marketing clearance pursuant to K962804, currently marketed in the U.S. 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 is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color nor significant levels of residual monomers.
The physical optical, and chemical properties of the FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the Acuvus (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker) from Vistakon, Inc.
This lens is in Group 4. Ionic, 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 physical, optical, and chemical properties of the FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the Acuvue (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker).
The lens will be sterilized and packaged in the same manner as previously cleared in K971164. This lens will also be sterility released by parametric release, as cleared in 1971164.
1
COMPARISON OF PHYSICAL/OPTICAL PROPERTIES:
| PARAMETER | FREQUENCY UV™
Hydrophilic Contact
Lens for Daily Wear
(clear and tinted) | Acuvue (etafilcon A)
Hydrophilic Contact Lens
for Daily Wear (clear and
tinted with UV Blocker) |
|-------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | | |
| material | etafilcon A | Etafilcon A |
| indication for use | myopia, hyperopia and
astigmatism | myopia, hyperopia and
astigmatism |
| water content | 58% | 58% |
| % transmittance @ 593nm | 93.91% | 96.42% |
| % transmittance @ 280-315 nin | 9.5 | 2.4 |
| % transmittance @ 316-380 nm | 7.86 | 15.55 |
| Dk (35 °C) (Edge Corrected) | 15.62 X 10" | 15.09 X 10" |
| powers | -20.00 to+20.00 D | -20.00 to+20.00 D |
| color | clear and aqua visibility | clear and blue visibility |
| specific gravity | 0.98-1.12 | 0.98-1.12 |
| refractive index | 1.39 | 1.4 |
| tensile strength | 1.12 | 0.64 |
| Modulus | 0.35 | 0.22 |
| Elongation at Break | 249 | 228 |
| Toughness | 1.12 | 0.74 |
| manufacturing method | Cast Molding | Cast Molding |
DESCRIPTION of the DEVICE:
D
The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% 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 UV (etafilcon 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:
- Chord Diameter: . 14.0mm to 15.0mm
- 0.03mm to 0.40mm Center Thickness: ●
- Base Curve: 8.40mm to 9.30mm
- Spherical Powers: -20.00 Diopters to +20.00 Diopters .
The physical/optical properties of the lens are:
- 1.39 Refractive Index: .
- % Transmittance @593nm: >90% .
- % Transmittance @ 280-315nm | OR | Over-the-Counter Use | |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|--|
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|--|
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K980634 |
(Optional Format 1-2-96)