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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens for Daily Wear. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a new device meets predefined acceptance criteria through a traditional clinical study with statistical significance targets. Instead, the "study" is a comparison to the predicate device to show it performs similarly and is thus safe and effective.

Here's an analysis of the provided information in the context of acceptance criteria and the "study" that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally that the new device's properties are either identical or "substantially equivalent" to the predicate device, and any differences do not raise new questions of safety or effectiveness. The document effectively presents a comparison of the new device's properties against the predicate device.

Parameter	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (FREQUENCY UV™)	Comparison / Result
Material	Etafilcon A	Etafilcon A	Equivalent
Indication for use	Myopia, hyperopia, and astigmatism	Myopia, hyperopia, and astigmatism	Equivalent
Water content	58%	58%	Equivalent
% transmittance @ 593nm	96.42%	93.91%	Similar (within acceptable range for visibility)
% transmittance @ 280-315 nm	2.4% (with UV Blocker)	9.5% (with benzotriazole UV absorbing monomer)	Similar (both block UV-B) - stated "less than 10%" in description as a target
% transmittance @ 316-380 nm	15.55% (with UV Blocker)	7.86% (with benzotriazole UV absorbing monomer)	Similar (both block UV-A) - stated "less than 10%" in description as a target
Dk (35 °C) (Edge Corrected)	15.09 X 10"	15.62 X 10"	Similar (Oxygen Permeability)
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D	Equivalent
Color	Clear and blue visibility	Clear and aqua visibility	Different tint color (visibility aid, not functional difference)
Specific gravity	0.98-1.12	0.98-1.12	Equivalent
Refractive index	1.4	1.39	Similar
Tensile strength	0.64	1.12	Different, but likely within acceptable limits for a contact lens
Modulus	0.22	0.35	Different, but likely within acceptable limits for a contact lens
Elongation at Break	228	249	Different, but likely within acceptable limits for a contact lens
Toughness	0.74	1.12	Different, but likely within acceptable limits for a contact lens
Manufacturing method	Cast Molding	Cast Molding	Equivalent
Toxicology Testing	Non-toxic (for Acuvue, implicit by marketing clearance)	Non-toxic (cytotoxicity, systemic toxicity, ocular irritation)	Equivalent
Residual Monomer & Color Leach	Acceptable levels (for Acuvue, implicit)	Not contain leachable color nor significant levels of residual monomers	Equivalent

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify a distinct "test set" sample size in the way a clinical trial would. For material property comparisons, it implies laboratory testing of samples from the device production.
Data Provenance: The data for the FREQUENCY UV™ comes from direct testing of the device itself ("Preclinical Testing" and "COMPARISON OF PHYSICAL/OPTICAL PROPERTIES" sections). The predicate device data (Acuvue) is presented as established characteristics for a previously cleared product. The data is likely from the United Kingdom (Aspect Vision Care, Ltd.'s location) for the new device, and presumably from the US for the predicate's marketing clearance. This is retrospective for the predicate and prospective for the tests performed on the FREQUENCY UV™ to demonstrate substantial equivalence.

3. Number of Experts for Ground Truth and Qualifications

This type of submission (510(k) for contact lenses) does not typically involve expert consensus for "ground truth" in the diagnostic sense, as it focuses on material properties and performance equivalence.
The "experts" involved would be the engineers, chemists, and statisticians who designed and conducted the physical, chemical, and biological compatibility tests, along with the regulatory review team at the FDA (Division of Ophthalmic Devices). Their qualifications are implicit in their professional roles and adherence to regulatory standards for device testing.

4. Adjudication Method

Not applicable in the conventional sense of a clinical trial where image interpretations or clinical outcomes are adjudicated. The "adjudication" here is the FDA's review process, where their experts assess whether the presented data for the new device demonstrates substantial equivalence to the predicate, and whether any differences raise new safety or effectiveness concerns.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an imaging algorithm or diagnostic tool that requires human interpretation of outputs.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (contact lens), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for this submission are the established physical, chemical, and biological properties of the contact lens material and design, as measured by standard laboratory tests (e.g., water content, Dk, transmittance, tensile strength, cytotoxicity). For the predicate device, its 'truth' is its FDA clearance (K962804) based on similar prior testing. The overall "ground truth" is that the device is safe and effective when its properties are substantially equivalent to a legally marketed predicate.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a contact lens.

Summary

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K980634

APR 22 1998

510 (k) Summary

SUBMITTER:

Submitted on behalf of:

Company Name:	Aspect Vision Care, Ltd.
Address:	South Point, HambleSouthampton S031 4RFUnited 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.

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COMPARISON OF PHYSICAL/OPTICAL PROPERTIES:

PARAMETER	FREQUENCY UV™Hydrophilic ContactLens for Daily Wear(clear and tinted)	Acuvue (etafilcon A)Hydrophilic Contact Lensfor Daily Wear (clear andtinted with UV Blocker)

material	etafilcon A	Etafilcon A
indication for use	myopia, hyperopia andastigmatism	myopia, hyperopia andastigmatism
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:

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 <10% ●
% Transmittance @ 316-380nm <10% t
0.98-1.12 Specific Gravity (calculated): t
Surface Character: clear .

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58% Water Content: .
Oxygen Permeabllity (Dk)" : .

*[Fatt Method for determination of oxygen permeability, edge corrected]

INDICATIONS FOR USE:

Device Nams: FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

The FREQUENCY™ UV (etafilcon 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.

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.

PARAMETERS AVAILABLE:

The FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens (clear and tinted)

Powers:	+10.00 to -10.00D
Center Thickness:	0.07 mm
Diameter:	14.2 mm
Base Curve:	8.6, 8.9 mm (minus lenses) and 8.8 mm (plus lenses)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S." is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1998

Aspect Vision Care, Ltd. c/o Mr. Martin S. Knopf Associates, Inc. 90 West Main Street Freehold, NJ 07728

Re: K980634

Trade Name: Frequency UV (Etafilcon A) Soft (hydrophilic) Daily Wear Contact Lens, Clear and Aqua Visibility tinted with UV Blocker (Sperical and Cast-Molded) Regulatory Class: Class II Product Code: 86 LPL Dated: February 16, 1998 Received: February 19,1998

Dear Mr. Knopf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System "" Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Martin S. Knopf

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number--- ---(800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

Device Name: FREQUENCY™ UV (etafilcon A) (Hydrophilic Contact Lens for Daily Wear (clear and aqua visibility tinted)

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR	Over-the-Counter Use
------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----	----------------------	--

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K980634

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.