Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard soft contact lens and its material composition. There is no mention of any computational or analytical features that would suggest the use of AI or ML.

Therapeutic

No.
The contact lens is indicated for the correction of visual acuity in non-diseased eyes, not for treating any condition or disease.

Diagnostic

No

Explanation: This device is a soft contact lens intended for the correction of visual acuity, which is a therapeutic function, not a diagnostic one. It helps people see better, but it does not diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical contact lens made from specific materials and manufactured using a cast molding process. It is a tangible hardware device.

IVD (In Vitro Diagnostic)

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 visual acuity in the eye. This is a direct interaction with the body for a therapeutic purpose (correcting vision).
Device Description: The device is a contact lens, which is a physical object placed on the surface of the eye.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.

IVD devices are specifically designed to be used in vitro (outside the living body) to diagnose, monitor, or screen for diseases or conditions. This contact lens does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LPL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Eye care practitioners

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K992692

Reference Device(s)

K952620, K992692, K964528

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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 Corporation
7575 Commerce Court
Sarasota, FL 34243
Contact Person:	Donna Hovanec
Manager, Quality Systems
Hydrogel 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 Contact
Lens for Daily Wear (cast-molded, with a
visibility 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.

1

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.

Intended Use (Indications):

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.

2

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 Lens
Group II | Hydrophilic Lens
Group II |
| Method of Manufacture | Cast Molded | Cast Molded |
| Indications for Use | 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. | The 59% Extreme H₂O®
(hioxifilcon A) 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.

Substantial Equivalence: Comparison to Predicate Device

3

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.

4

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.

5

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

6

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.

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.

(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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