The CONTAFLEX GM3 58 (acofilcon A) 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 off75 diopters or less where the astigmatism does not interfere with visual acuity. 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.

Device Description

The CONTAFLEX GM3 58% Spherical Soft Contact Lenses are fabricated from acofilcon A, 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, (acofficon A) 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 42% acofilcon A and 58% 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 A 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 A) 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 58% water by weight.

AI/ML Overview

This 510(k) premarket notification for the CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lens focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting de novo acceptance criteria. Therefore, the information provided relates primarily to the comparison with the predicate device and the safety and efficacy of the new device.

Here's an analysis of the provided text, addressing your points where applicable based on the available information:

Acceptance Criteria and Device Performance

There are no explicit "acceptance criteria" in the format of specific thresholds for performance metrics (e.g., minimum visual acuity improvement, maximum adverse event rate) that the device must meet independently. Instead, the study aims to show substantial equivalence to the predicate device, the "BENZ 55G" contact lens. This means the new device is considered acceptable if its safety and efficacy are no different than the legally marketed predicate device.

The "device performance" is reported through preclinical and clinical studies demonstrating this equivalence.

Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Metric/Characteristic	Acceptance Criteria (Demonstrate Equivalence to Predicate)	Reported Device Performance (CONTAFLEX GM3 58%)
Preclinical	Toxicology	Equivalent to predicate device (Benz 55G) in terms of in-vitro cytotoxicity, systemic toxicity, and acute ocular irritation.	In-Vitro Cytotoxicity: Meets ISO 10993-5 requirements (Agarose Overlay Method). Systemic Toxicity: Meets requirements of systemic injection test and is considered non-toxic. Acute Ocular Irritation: No ocular irritation produced. Conclusion: Demonstrated safety equivalent to Benz 55G.
	Shelf Life	Equivalent to predicate device (Benz 55G).	Referenced data granted to Contamac Ltd. for 510(k) 973597. Supports substantial equivalence to Benz 55G.
	Solution Compatibility	No significant changes to lens parameters after 30 cycles of cleaning and conditioning with recommended care regimen.	Lenses subjected to 30 cycles of cleaning and conditioning. No significant changes to base curve, back vertex power, total diameter, and overall physical appearance observed.
	Material Properties	Substantially equivalent material properties to predicate device.	Intended Use: Identical to predicate.Functionality: Identical to predicate.Indications: Identical to predicate.Production Method: Identical to predicate (Lathe-cut).FDA Group #: Identical to predicate (Group # 2 >50% Water, Nonionic Polymers).USAN name: Acofilcon A (differs from predicate: Hioxifilcon A).Water Content: 58.0% (identical to predicate).Oxygen Permeability: 25.5 x 10^-11 (cm^2/sec)(ml O2/ml x mm Hg @ 35°C) (predicate: 23.0 x 10^-11).Specific Gravity: 1.103 (predicate: 1.045).
Clinical	Safety	Equivalent to predicate device (Benz 55G) in adverse events, slit lamp findings, symptoms/complaints, and keratometry changes.	Not explicitly reported with numerical performance metrics for CONTAFLEX vs. Benz 55G. The summary states: "The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G." Specific data like adverse event rates are not provided in this summary.
	Efficacy	Equivalent to predicate device (Benz 55G) in refractive changes, lens visual acuity, lens VA line changes, comfort, vision, and average wearing time.	Not explicitly reported with numerical performance metrics for CONTAFLEX vs. Benz 55G. The summary states: "The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G." Specific data like visual acuity measures are not provided in this summary.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 122 eyes (61 patients) were enrolled in the clinical study. 100 eyes (50 patients) completed the study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions "CONTAMAC Ltd." with an address in "Saffron Walden, Essex England CB11 4JX," which suggests the study or at least the sponsor is based in the UK. The study is described as a "clinical study carried out." It is a prospective study as patients were "entered into the study" and followed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 5 investigators were involved in the clinical study.
- Qualifications of Experts: Their specific qualifications (e.g., "ophthalmologist with X years of experience") are not provided in the document. They are referred to as "investigators," implying medical professionals involved in clinical eye care.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the clinical study data (e.g., for adverse events or efficacy assessments). It simply lists the safety and efficacy measures that were tracked.
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, an MRMC comparative effectiveness study was not done. This device is a contact lens and does not involve AI assistance or human readers interpreting medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm. The "standalone" performance here would refer to the lens's physical and optical properties, and its performance in daily wear, which was assessed in the preclinical and clinical studies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the preclinical studies, laboratory testing and standardized methods (e.g., ISO 10993-5, revised Fatt method) were used to determine material properties and toxicity.
- For the clinical study, the "safety and efficacy measures" (Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints, Keratometry Changes, Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time) are essentially clinical outcomes data and clinical assessments by the investigators. These assessments, presumably based on established ophthalmological practices, serve as the "ground truth" for the lens's performance in vivo.
The sample size for the training set:
- Not applicable in the context of this device. This is a medical device (contact lens), not an AI algorithm requiring a "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design, based on established material science and ophthalmological principles.
How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.

Summary

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CONTAMA

510(k) Premarket Notification

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:

K023349

Applicant information:

Date Prepared:	October 2, 2002
Name:	CONTAMAC Ltd.
Address	Bearwalden Business ParkSaffron 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 58% (acofilcon A) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut)

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CONTAMAC 510(k) Premarket Notification

Equivalent Devices:

The CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device

Predicate device: "BENZ 55G" manufactured/distributed by Benz Research and Development. 510(k) number; K952620

Device Description:

Image /page/1/Picture/5 description: The image shows a series of numbers and a letter that appear to be created with a splattered or textured effect. The characters are K, 0, 2, 3, 4, and 9. The characters are all black and stand out against a white background. The splattered effect gives the characters a rough and uneven appearance.

The non-ionic lens material, (acofficon A) 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 42% acofilcon A and 58% 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 A 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 A) 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 58% water by weight. The physical properties of the lens are:

Refractive Index Light Transmission Water Content Specific Gravity Oxygen Permeability

1.52 (dry) 1.40 (hydrated) greater than 93% 58 % 1.103 (hydrated) 25.50 X 1011 (cm2/sec) (ml O2/ml x mm Hg @ 35 ℃), (revised Fatt method).

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Intended Use:

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 58 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX GM3 58 Soft Contact Lens is equivalent to the currently marketed Benz 55G contact lens material. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cytotoxicity: 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 58 Soft Contact Lens material to the already marketed Benz 55G.

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 cycles.

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510(k) Premarket Notification

Clinical Testing

Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the CONTAFLEX GM3 58 Soft Contact Lens material when used as a daily wear contact lens for the correction of visual acuity.

CONTAMA

A total of 122 eyes (61 patients) were entered into the study by 5 investigators. Prior to entry into this study each patient was required to read and sign a statement of informed consent. All patients who signed a Statement of Informed Consent are accounted for in this report. Of the 122 eves (61 patients enrolled), 100 eyes (50 patients) completed the study.

The safety and efficacy measures for the study were:

Safety: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes.

Efficacy: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time.

The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G.

Substantial Equivalence:

The CONTAFLEX GM3 58 Soft Contact Lens is substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified previously. The difference between the two devices is the USAN name.

The following table depicts the pre-clinical characteristics of the CONTAFLEX GM3 58 material, as well as the predicate device.

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Substantial Equivalence table

Pre-Clinicalequivalency / Device	Contaflex GM3 58%(acofilcon A)	BENZ 55G(hioxifilcon A)
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	Acofilcon A	Hioxifilcon A
7.)	Water Content	58.0%	58.0%
8.)	Oxygen Permeability	25.5 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method).	23.0 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method).
9.)	Specific Gravity	1.103	1.045

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

ood and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

Medvice Consulting, Inc. c/o Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K023349

Trade/Device Name: Contaflex GM3 58% (acofilcon A) Spherical 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: October 2, 2002 Received: October 7, 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

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Page 2 - Martin Dalsing

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. 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) 594-4692. 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" (21CFR Part 807.97). 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

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510(k) Premarket Notification

INDICATIONS FOR USE STATEME

Device Name

CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lens for Da Wear (clear and tinted, lathe-cut)

INDICATIONS FOR USE:

The CONTAFLEX GM3 58 (acofficon A) 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.

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

Concurrence (Division Sign-Off of Device Evaluation (ODE)
Division of Ophthalmic Ear, Nose and Throat Devices	Daniel W. C. Brown, Ph.D.

510(k) Number	K023349
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Prescription Use (Per 21 CFR 801.109)	X
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Over-The-Counter Use
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(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.