The CONTAFLEX GM3 49 (acofilcon B) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may be disinfected using a chemical disinfecting system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The CONTAFLEX GM3 49% Spherical Soft Contact Lenses are fabricated from acofilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Glycerol Methacrylate 2.3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint. Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The acofilcon B name has been adopted by the United States Adopted Names Council (USAN).

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 (acofilcon B) 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 filly hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index: 1.52 (dry) 1.42 (hydrated)
Light Transmission: greater than 96%
Water Content: 49 %
Specific Gravity: 1.142 (hydrated)
Oxygen Permeability: 15.89 X 10-11 (cm2/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method).

AI/ML Overview

The provided text describes a 510(k) summary for a soft contact lens and focuses on demonstrating substantial equivalence to predicate devices through pre-clinical testing, rather than reporting on a clinical study with a specific AI-powered device. Therefore, many of the requested categories for AI-specific studies (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable to this document.

Here's the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense for performance, but rather demonstrates substantial equivalence to predicate devices based on various pre-clinical characteristics. The table below summarizes these characteristics and the reported values for the CONTAFLEX GM3 49% lens and its predicate.

Pre-Clinical Equivalency / Device	CONTAFLEX GM3 49% (acofilcon B) Reported Performance	BENZ-G3X (hioxifilcon B) Predicate Value
Intended Use	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.	Same
Functionality	After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	Same
Indications	Daily wear, Soft (hydrophilic) contact lens	Same
Production Method	Lathe-cut	Same
FDA Group #	Group # 2 >50% Water, Nonionic Polymers	Same
USAN name	Acoficon B	Hioxifilcon B
Water Content	48.0%	48.0%
Oxygen Permeability	15.89 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).	16.40 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).
Specific Gravity	1.142	1.137

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

Sample Size for Test Set: Not applicable. This document details pre-clinical material testing and solution compatibility, not a clinical study with a "test set" in the context of an AI device.
Data Provenance: Not applicable for a clinical test set. The data originates from pre-clinical toxicology tests (in-vitro, systemic, acute ocular irritation) and solution compatibility studies performed by Contamac Ltd. or referenced through rights granted to Contamac Ltd. (for shelf life).

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

Not applicable. There is no "ground truth" for a test set established by experts in the context of an AI study described here. Pre-clinical material properties are measured objectively.

4. Adjudication method for the test set

Not applicable. No expert-based adjudication for a test set 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

No. This document does not mention an MRMC study or any AI component.

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

No. This document does not describe an algorithm or AI device.

7. The type of ground truth used

Not applicable in the context of an AI algorithm. For the pre-clinical tests, the "ground truth" is based on objective measurements of material properties (e.g., water content, oxygen permeability, specific gravity, refractive index, light transmission) and biological responses in standardized toxicology assays (e.g., cytotoxicity, systemic toxicity, ocular irritation). Solution compatibility was assessed by comparing initial and final lens parameters after 30 cleaning/conditioning cycles.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it's not an AI/machine learning device.

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

Not applicable, as there is no training set mentioned.

Summary

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FEB 1 4 2003

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:

K024045

Applicant information:

Date Prepared:	November 27, 2002
Name:	CONTAMAC Ltd.
Address	Bearwalden Business Park
	Saffron WaldenEssex England CB11 4JX
Contact Person:	Robert McGregor
Phone number:	44-1799 542 000
US Agent:	Medvice Consulting, Inc.
	Martin Dalsing
Phone number	(970) 243-5490
Fax number	(970) 243-5501

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	CONTAFLEX GM3 49% (acofilcon B) Spherical SoftContact Lens for Daily Wear (clear and tinted, lathe-cut)

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Equivalent Devices:

The CONTAFILEX GM3 49% (acofilcon B) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device

Predicate devices:	"BENZ-G3X" manufactured/distributed by Benz Research and Development.(hioxifilcon B)510(k) number; K964528
	"CONTAFLEX GM3 58%" manufactured by Contamac Ltd.(acofilcon A)510(k) number: K023349

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its filly hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index	1.52 (dry) 1.42 (hydrated)
Light Transmission	greater than 96%
Water Content	49 %
Specific Gravity	1.142 (hydrated)
Oxygen Permeability	15.89 X 10-11 (cm2/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method).

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Intended Use:

The lens may be disinfected using a chemical disinfecting system.

Evecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Description of Safety:

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX GM3 49 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX GM3 49 Soft Contact Lens is equivalent to the currently marketed Benz-G3X contact lens material, as well as the CONTAFLEX GM3 58. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cvtotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.

Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.

Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.

Shelf Life

Shelf life requirements are satisfied via referencing rights granted to Contamac Ltd. for 510/k) 973597. The data presented supports substantial equivalence of this CONTAFLEX GM3 49 Soft Contact Lens material to the already marketed Benz-G3X.

Solution Compatibility

Studies were conducted on blue tinted lens material. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of the base curve, back vertex power, total diameter and overall lens physical appearance were recorded prior to and upon completion of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cvcles.

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Substantial Equivalence:

The CONTAFLEX GM3 49 Soft Contact Lens is substantial equivalent and does not raise different questions of safety and effectiveness than the predicate devices identified previously. The difference between the two devices is the USAN name.

The following table depicts the pre-clinical characteristics of the CONTAFLEX GM3 49 material, as compared to the predicate device.

	Pre-Clinicalequivalency / Device	CONTAFLEX GM3 49%(acofilcon B)	BENZ-G3X(hioxifilcon B)
1.)	Intended Use	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia.	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia.
2.)	Functionality	After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina.	After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina.
3.)	Indications	Daily wear, Soft (hydrophilic)contact lens	Daily wear, Soft (hydrophilic)contact lens
4.)	Production Method	Lathe-cut	Lathe-cut
5.)	FDA Group #	Group # 2 >50% Water, NonionicPolymers	Group # 2 >50% Water, NonionicPolymers
6.)	USAN name	Acoficon B	Hioxifilcon B
7.)	Water Content	48.0%	48.0%
8.)	Oxygen Permeability	15.89 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method).	16.40 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method).
9.)	Specific Gravity	1.142	1.137

Substantial Equivalence table

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird-like figure. The emblem is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

FEB 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contamac, Ltd C/O Martin Dalsing Medvice Consulting, Inc. 623 Glacier Dr. Grand Junction, CO 81503

Re: K024045 Trade/Device Name: CONTAFLEX GM3 49% (acofilcon B) Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 27, 2002 Received: December 6, 2002

Dear Mr. Dalsing:

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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Page 2 -- Mr. Martin Dalsing

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) 594-4613. 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 may be obtained 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/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

Enclosure

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INDICATIONS FOR USE STATEMENT

CONTAFLEX GM3 49% (acofilcon B) Spherical Soft Contact Lens for Daily Device Name: Wear (clear and tinted, lathe-cut)

INDICATIONS FOR USE:

The CONTAFLEX GM3 58 (acofilcon B) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

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)
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Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Savota

(Division Sign Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K024045

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.