The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with disposal as recommended by the eyecare practitioner. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Device Description

The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.

Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

1.445 (hydrated) Refractive Index greater than 90% Light Transmission (clear) Light Transmission (tinted) greater than 90%

Water Content 38 % ± 2% Oxygen Permeability 8.4 X 10-1 (cm /sec) (ml O /ml x mm Hg @ 35 C), (revised Fatt method).

AI/ML Overview

The provided document does not contain information about acceptance criteria and a study proving a device meets them in the context of device performance, as it is a 510(k) Summary for a soft contact lens aiming for clearance based on substantial equivalence to predicate devices rather than a performance study with acceptance criteria.

The 510(k) summary focuses on demonstrating that the HD/HDT (polymacon) Soft Contact Lens for Daily Wear is substantially equivalent to previously cleared devices. It does not present a new clinical study with specific performance metrics and acceptance criteria for the device itself. Instead, it leverages existing data and the substantial equivalence pathway.

Therefore, many of the requested categories cannot be populated.

Here's a breakdown of the available information and why other fields cannot be filled:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the context of a new performance study for the HD/HDT lens. The submission relies on the established safety and performance profiles of the predicate devices.
Reported Device Performance: Not presented as a distinct set of performance metrics from a new study in this document. The document primarily details the physical properties of the lens material (water content, oxygen permeability, refractive index, light transmission) and states that its toxicity is "Non-Toxic," which are material characteristics rather than performance metrics against acceptance criteria in a clinical study.

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A)	N/A

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. There is no specific "test set" for a new performance study described. The document refers to pre-clinical data (cytotoxicity, systemic injection, ocular eye irritation) from a previously cleared device (K013220).
Data Provenance: The pre-clinical data is referenced from K013220. No country of origin or retrospective/prospective nature is specified for this referenced data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set or ground truth establishment by experts is described for this submission.

4. Adjudication method for the test set:

Not applicable. No new test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a soft contact lens, and an MRMC study with AI assistance is irrelevant to its intended use and the nature of this 510(k) submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

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

7. The type of ground truth used:

Not applicable in the context of a new performance study. The safety profile is established through pre-clinical toxicology and manufacturing/chemistry data referenced from previous 510(k) submissions (K013220, K002099).

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set.

Summary of what the document does provide regarding device evaluation:

Pre-Clinical Performance Data: The document explicitly states that "Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test can be referenced in the 510(k) # K013220." This indicates that these standard safety tests were performed and documented in a prior submission, and the current device leverages those results due to material similarity.
Substantial Equivalence: The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (K013220, K982110, K980818) based on:
- Similar indications for use (with the addition of "early presbyopia up to 1.25 diopters").
- Target population.
- Hydrophilic materials (polymacon).
- Physical construction.
- Established safety and effectiveness profiles of the predicate devices.
- A table (Substantial Equivalence Matrix) compares the subject device with predicates on manufacturing, indications, intended use, manufacturing method, USAN name/material, water content, and toxicity.

In conclusion, this 510(k) summary is for a contact lens seeking clearance based on substantial equivalence, not a new performance study that would entail detailed acceptance criteria, test sets, or ground truth establishment as typically found in submissions for novel or complex devices requiring extensive new performance data.

Summary

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MAY 1 6 2002

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: K020608
Applicant information:

Date Prepared:	February 19, 2002
Name:	PolyVue Technologies, Inc.
Address	Seven Hazel AvenueLarkspur, CA 94939
Contact Person:	Mr. Harold E. JohnsonPresident/CEO
Phone number:	(415) 945-9043
USA Consultant:	Med-Vice Consulting, Inc.Ms. Deanna Werber
Phone number:	(970) 243-5490
Fax number:	(970) 243-5501
Email address:	dwerber@FDApproval.com

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	HD/HDT, (polymacon) Soft Contact Lens for Daily Wear(clear and tinted, fully cast-molded lens)

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Purpose of 510(k) Submission:

NEW INDICATION ~

A new indication of "early presbyopia" up to 1.25 diopters is being added to the previously cleared HD/HDT, (polymacon) Soft Contact Lens for Daily Wear reference K013220.

Equivalent Devices:

The HD/HDT, (polymacon) Soft Contact Lenses are substantially equivalent to the following predicate devices:

Predicate devices:

"HD/HDT" (polymacon) K013220, approval by Poly Vue Technologies, Inc. .
"PolyVue" (polymacon) K982110, approval by Optech, Inc. .
"PolyVue" Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. .

Device Description:

The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

1.445 (hydrated) Refractive Index greater than 90% Light Transmission (clear) Light Transmission (tinted) greater than 90%

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Water Content Oxygen Permeability 38 % ± 2% 8.4 X 10-1 (cm /sec) (ml O /ml x mm Hg @ 35 C), (revised Fatt method).

Intended Use:

The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of ITIC \porymated.h} I spiritorio is with non-diseased eyes with myopia or hyperopia and early visual actiry in not apinatio persons who new by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the The IID I (polymaton) Issphoric roskic persons with non-diseased eyes with myopia or hyperopia, contection of visual would in not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available clear or timed and may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with Dyour prociment may prescribed replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Pre-Clinical Performance Data:

Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test can be referenced in the 510(k) # K013220. In addition, data for all relevant manufacturing information, including verification data can be referenced in the 510(k) # K013220.

Concerning compatibility testing, the recommended lens care products (cleaning, rinsing and disinfection) have been approved for use with lens of the same lens group. Therefore, no additional compatibility testing is included.

With regard to preservative uptake and release studies, since the subject contact lens material (polymacon) is not a new and/or modified lens material, no additional studies need be conducted.

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Substantial Equivalence:

The HD/HDT, Soft Contact Lens will be manufactured according to specified process controls and a The more box , box of arogram currently in place and referenced in 510(k) K002099.

Reference K013220 for he final lens packaging and sterilization of the lenses.

The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the THE ESTADISICU Salery promo (pro onlined to the previously. Being similar with respect to indications for use, target population, hydrophilic materials, physical construction and safety & to mucations for use, target population, areas the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the equivalencies between the HD/HDT, Soft Contact Lens and the substantial equivalent predicate devices.

SubstantialEquivalency	HD/HDT'Subject Device'	HD/HDT,'Predicate Device'	Poly Vue'Predicate Device'	Poly Vue Silver Chord'Predicate Device'
Manufacture	Poly Vue Technologies	Poly Vue Technologies	Optech, Inc.	Steven A. Dunn, Inc.
INDICATION	Soft Contact Lenses for dailywear are indicated for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopiaand/or possesses refractiveastigmatism not exceeding 5.00diopters, and early presbyopiaup to 1.25 diopters.	Soft Contact Lenses for dailywear are indicated for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopiaand/or possesses refractiveastigmatism not exceeding 5.00diopters, and/or are presbyopic.	Soft Contact lenses for dailywear are indicated for thecorrection of refractiveametropia (myopia andhyperopia), presbyopia andastisgmatism in aphakic and notaphakic persons with non-diseased eyes.	Soft Contact lenses for dailywear are indicated for thecorrection of refractiveametropia (myopia andhyperopia), and astisgmatism inaphakic and not aphakicpersons with non-diseased eyes.
INTENDEDUSE	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic) ContactLens
ManufacturingMethod	Fully-molded	Fully-molded	Lathe-cut(Semi-Mold)	Lathe-cut(Semi-Mold)
USAN nameMaterial name	polymacon	polymacon	polymacon	methafilcon A
Water Content(%)	38.0%	38.0%	38.0%	55.0%
Toxicity(safety)	Non-Toxic	Non-Toxic	Non-Toxic	Non-Toxic

Substantial Equivalence Matrix

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2002

Poly Vue Technologies, Inc. c/o Deanna Werber Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K020608

Trade/Device Name: HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully cast-molded lens) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: February 19, 2002 Received: February 25, 2002

Dear Ms. Werber:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to oegill inding of substantial equivalence of your device to a legally promatication. "The PDF interior 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F F ar 3613. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 - 1010 - 12 - 101 - 12 - 101 - 10 - 4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

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INDICATIONS FOR USE STATEMENT

HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, Device Name: fully cast-molded lens)

INDICATIONS FOR USE:

The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of The IID (porymacon) I sopherrous with non-diseased eyes with myopia or hyperopia and early visual active in not apliance persons who note by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the The MD I (porymacom) in not aphakic persons with non-diseased eyes with myopia or hyperopia, Concellon of visual actity in hot uphane peing 5.00 diopters and early presbyopia up to 1.25 diopters. possesses it cractive astiginatism not oneoouhs very to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with Eyecan oplaintoners may problish raily of any of except bed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown, PHD
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K020608

Prescription Use ✗
(Per 21 CFR 801.109)
or
(Optional Format 1-2-96)

Over-The-Counter Use __

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.