The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Description

Extreme H2O® 54% (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical (G54 13.6 and G54 14.2) or toric (G54 Toric) lens designs. The Extreme H2O® 54% (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium borate. The lens is available with a blue visibility handling tint. phthalocyanato (2) - (copper).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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.

AI/ML Overview

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a comparison to a predicate device (59% Extreme H2O® (hioxifilcon A) soft contact lens) and chemical/physical/toxicological testing to establish substantial equivalence. Direct "acceptance criteria" and "reported performance" for specific clinical outcomes are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" are implied by demonstrating that the new device's material properties fall within the range of, or are comparable to, already cleared materials and predicate devices.

Property	Acceptance Criteria (Implied by Predicate/Cleared Materials)	Reported Device Performance (Extreme H2O® 54%)	Meets Criteria?
Material Classification	Hydrophilic Lens Group II	Hydrophilic Lens Group II	Yes
Method of Manufacture	Cast Molded	Cast Molded	Yes
Water Content	59% ± 2% (Predicate) / Bracketed by cleared materials	54% ± 2%	Yes
Refractive Index	1.404 hydrated (Predicate) / Bracketed by cleared materials	1.414 hydrated	Yes
Light Transmission	> 95%	> 95%	Yes
Specific Gravity	1.308 (dry) (Predicate) / Bracketed by cleared materials	1.300 (dry)	Yes
Oxygen Permeability (Dk units)	28 (Predicate) / Bracketed by cleared materials	21	Yes
Systemic Injection Test (Toxicology)	No biological reaction (for cleared materials)	No biological reaction within mice	Yes
Agar Diffusion Test (Toxicology)	Non-cytotoxic (for cleared materials)	Non-cytotoxic	Yes
Primary Ocular Irritation (Toxicology)	Non-irritant (for cleared materials)	Non-irritant to rabbits	Yes
Clinical Performance (Safety & Effectiveness)	Substantially equivalent to predicate device	No clinical studies performed (justified)	Yes

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a clinical study. The "test set" here refers to the new device (Extreme H2O® 54%), which underwent material characterization and toxicology testing.
Data Provenance: The toxicology tests were performed on the Extreme H2O® 54% material (hioxifilcon D). The document implies these were standard ISO tests. The country of origin and whether the data was retrospective or prospective is not specified for these specific tests, but they are generally carried out prospectively as part of product development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, was not established for this submission. The "ground truth" for the material properties and toxicology was based on established scientific and regulatory standards for material characterization and pre-clinical safety testing (e.g., ISO standards for toxicology).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a contact lens, not an AI algorithm. Its performance is inherent to the physical and chemical properties of the lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on:

Material Characterization: Scientific measurements of properties like water content, refractive index, light transmission, specific gravity, and oxygen permeability.
Toxicology Data: Results from standardized ISO safety tests (Systemic Injection Test, Agar Diffusion Test, Primary Ocular Irritation).
Substantial Equivalence to Predicate Device: The established safety and effectiveness of the legally marketed predicate device(s) (59% Extreme H2O® (hioxifilcon A) and Benz-G 3X (hioxifilcon B)).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable.

Summary

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K051438

JUL 1 8 2005 510(k) SUMMARY OF SAFETY AND EFFECTIVENES

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:

Applicant information:Date Prepared:	May 31, 2005
Name:Address:	Hydrogel Vision Corporation7575 Commerce CourtSarasota, FL 34243
Contact Person:	Donna HovanecManager, Quality SystemsHydrogel Vision Corporation
Phone number:	941-739-1382
Fax number:	941-758-6887
Device information:Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lens, Soft Contact, Daily Wear
Trade Name:	Extreme H2O® 54%(hioxifilcon D) Soft ContactLens for Daily Wear (cast-molded, with avisibility tint)

Purpose of 510(k) Submission:

Hydrogel Vision Corporation is requesting clearance from the FDA to manufacture and market the Extreme H2O® 54% soft contact lens.

Equivalent Device:

The Extreme H2O® 54% (hioxifilcon D) soft contact lens is substantially equivalent to our 59% Extreme H2O® (hioxifilcon A) soft contact lens already cleared under 510(k) K992692.

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Device Description:

Intended Use (Indications):

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HYDROGEL VISION CORPORATION 510(K) Premarket Notification

PROPERTY	Extreme H₂O® 54%BENZ-G 4X	59% Extreme H₂O®BENZ-G 5X
Lens Material	hioxifilcon D	hioxifilcon A
Material Classification	Hydrophilic LensGroup II	Hydrophilic LensGroup II
Method of Manufacture	Cast Molded	Cast Molded
Indications for Use	The Extreme H₂O® 54%(hioxifilcon D) soft contact lensfor daily wear is indicated for thecorrection of visual acuity inaphakic or not-aphakic personswith non-diseased eyes that aremyopic or hyperopic. Thespherical lens may be worn bypersons who exhibit astigmatismof 0.75 Diopters or less that doesnot interfere with visual acuity.The toric lens may be worn bypersons who exhibit astigmatismof up to 10.00 Diopters.Eye care practitioners mayprescribe the lens forfrequent/planned replacementwear, with cleaning disinfectionand scheduled replacement. Whenprescribed for frequent/plannedreplacement wear, the lens may bedisinfected using a chemicaldisinfection system.	The 59% Extreme H₂O®(hioxifilcon A) soft contact lensfor daily wear is indicated for thecorrection of visual acuity inaphakic or not-aphakic personswith non-diseased eyes that aremyopic or hyperopic. Thespherical lens may be worn bypersons who exhibit astigmatismof 0.75 Diopters or less that doesnot interfere with visual acuity.The toric lens may be worn bypersons who exhibit astigmatismof up to 10.00 Diopters.Eye care practitioners mayprescribe the lens forfrequent/planned replacementwear, with cleaning disinfectionand scheduled replacement. Whenprescribed for frequent/plannedreplacement wear, the lens may bedisinfected using a chemicaldisinfection system.
Water Content	54% ± 2%	59% ± 2%
Refractive Index	1.414 hydrated	1.404 hydrated
Light Transmission	>95%	> 95%
Specific Gravity	1.300 (dry)	1.308 (dry)
Tint	BluePhthalocyanato (2) - (copper)	BluePhthalocyanato (2) - (copper)
Packaging	Blister pack	Blister Pack
Oxygen Permeability -(ANSI Z80:2004Upgradedpolarographicmethod)* in Fatt Dkunits	21	28

Substantial Equivalence: Comparison to Predicate Device

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HYDROGEL VISION CORPORATION 510(K) Premarket Notification

Toxicology:

The following toxicology (1SO) tests were performed on the Extreme H2O® 54%:

. Systemic Injection Test - No biological reaction within mice
Agar Diffusion Test Non-cytotoxic .
Primary Ocular Irritation Non-irritant to rabbits .

Clinical Data:

It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Extreme H2O® 54% soft contact lens. Extreme H2O® 54% lenses are made from Benz-G 4X material (hioxifilcon D). This material is formulated from the same components as the previously cleared materials Benz-G 3X (hioxifilcon B) and Benz-G 5X (hioxifilcon A), but with different ratios of components that bracket the new material between these two cleared materials. The physical/chemical/toxicological results for the Extreme H2O® 54% soft contact lens made from hioxifilcon D indicate that this material falls between the previously cleared 59% Extreme H2O° soft contact lens (hixofilcon A) and the previously cleared Benz-G 3X (hioxifilcon B) in all respects. The Extreme H2O® 54% lens is manufactured using the same cast molding process as our currently marketed 59% Extreme H2O® (See K952620, K992692, and K964528). Therefore, there are no new issues of safety and effectiveness which would require clinical data.

Conclusion:

The information provided in this 510(k) establishes that the Extreme H2O® 54% (hioxifilcon D) soft contact lens is substantially equivalent in terms of the physical/chemical/optical and toxicological performance characteristics, the method of manufacture, packaging, and intended use to the predicate device 59% Extreme H2O® (hioxifilcon A) soft contact lens.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2005

Hydrogel Vision Corporation c/o Donna Hovanec Manager, Quality Systems 7575 Commerce Court Sarasota, FL 34243

Re: K051430

Trade/Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 31, 2005 Received: June 1, 2005

Dear Ms. Hovanec:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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HYDROGEL VISION CORPORATION 510(K) Premarket Notification

INDICATIONS FOR USE STATEMENT

Device Name: Extreme H2O® 54% (hioxifilcon D) soft contact lens

ﺴﺘﻨﺪﻳﻨﻴﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨ . . . . . . .

INDICATIONS FOR USE:

Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use	✓
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
K# Number	K051430

Prescription Use	or	Over-The-Counter
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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.