The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Device Description

The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IGEL Visioncare contact lenses, formulated to answer your specific questions.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed performance metrics and statistical analyses typically associated with novel device approvals. Therefore, some of your requested information (e.g., specific effect sizes, adjudication methods for clinical studies with human readers, specific training set details, or sample sizes for clinical trials if not explicitly mentioned) may not be present or directly inferable from this type of regulatory document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices. The performance criteria are the physicochemical properties that are compared directly to the predicate devices.

Parameter	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (IGEL 55 UV Lenses)
Material	methafilcon A	methafilcon A
Material Classification	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
Indications for Use	myopia, hyperopia, presbyopia, and astigmatism	myopia, hyperopia, presbyopia, and astigmatism
Water content	55%	55%
Visible light transmittance	90.3%	90.3%
UV transmittance	< 10%	< 10%
Dk (35°C)	18.9 x 10⁻¹¹	18.9 x 10⁻¹¹
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
Color	blue visibility, Reactive Blue #19	blue visibility, Reactive Blue #19
Refractive index	1.42	1.42
Specific gravity	1.06	1.06
Method of manufacture	Moulded	Moulded
Systemic Injection Tests	Non-toxic	Non-toxic
Primary Ocular Irritation Test	Non-irritating	Non-irritating
Cytotoxicity Tests	Non-toxic	Non-toxic
Extractables	No detectables	No detectables
Sterility	Passed requirements	Passed requirements
Stability	Passed requirements	Passed requirements

Study Details

Sample size used for the test set and the data provenance:
- The document primarily references pre-clinical tests for safety and effectiveness. It states, "A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Igel 55 UV, the Igel UV Multifocal and the Igel 55 UV Toric (methafilcon A) Contact Lenses for Daily Wear."
- The specific sample sizes for these pre-clinical tests (e.g., number of animals for Systemic Injection, Primary Ocular Irritation, Cytotoxicity; number of lenses for extractables, sterility, stability) are not specified in this summary document.
- Data provenance: Not explicitly stated, but these types of tests are typically conducted in laboratories and are considered retrospective in the context of a 510(k) submission, meaning the data was collected prior to the submission date. There is no indication of country of origin for the test data itself, beyond the submitter being in Singapore.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. "Ground truth" for the pre-clinical tests would be established by standard laboratory protocols and analyses, not typically by expert consensus in the way a clinical image review might be. The tests performed (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, Extractables, Sterility, Stability) yield objective results (e.g., toxic/non-toxic, irritating/non-irritating, pass/fail for sterility) rather than requiring subjective expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., images, patient symptoms) by multiple human experts. The pre-clinical tests described are objective laboratory analyses with pre-defined pass/fail criteria.
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 type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a contact lens, and its evaluation relies on physicochemical properties and pre-clinical biocompatibility/safety tests, not AI-assisted human reading.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This question pertains to the performance of an AI algorithm as a standalone diagnostic tool. The device here is a contact lens, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physicochemical properties (water content, Dk, transmittance, etc.), the ground truth is established through standardized laboratory measurement methods and analytical chemistry.
- For biocompatibility and safety tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, Extractables, Sterility, Stability), the ground truth is based on the results of validated laboratory assays and compliance with established biological reactivity standards (e.g., ISO standards for medical devices). These results are objective (e.g., "non-toxic," "no detectables," "passed requirements").
The sample size for the training set:
- Not applicable. This question is relevant for machine learning or AI models. The IGEL contact lenses are a manufactured medical device, not an AI system that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this device.

Summary

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ARE PTELTD

JUN 0 4 2002

Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '20', then '8', and ends with '55'. The characters are written in a handwritten style, with varying stroke thicknesses.

510(k) Summary

Submitter Information:

IGEL Visioncare Pte. Ltd. 139 Joo Seng Road, #05-01 ATD Centre Singapore 368362 Registration Number: 9614154

Contact Person: Mr Stephen D Newman, Chief Executive Officer

+65 67491090 Telephone: 465 62848534 Fax:

Date Prepared: March 5, 2002

Device Name:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Names:	Igel 55 UV (methafilcon A) Soft(Hydrophilic) Contact Lens for Daily WearIgel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic)Contact Lens for Daily WearIgel 55 UV Toric (methafilcon A) Soft (Hydrophilic)Contact Lens for Daily Wear
Classification Name:	Soft (Hydrophilic) Contact Lens
Device Classification:	Class II (21 CFR 886.5925)

Predicate Devices:

The Specialty 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens, the Specialty 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens and the Specialty 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens were selected as the predicate devices.

The Igel 55 UV lenses are manufactured in the same facility, under the same quality system, using the same moulding, tinting, packaging and sterilization processes. The Igel 55 UV lenses contain the same UV blocking agent as the Specialty 55 UV lenses, and the manufacturing process for adding the UV blocking agent is the same.

Description of Devices:

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polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

Comparison to Predicate Device

PARAMETER	Igel 55 UV, Igel 55 UVMultifocal, and Igel 55 UV ToricSoft (Hydrophilic) ContactLenses for Daily Wear	Specialty 55 UV, Specialty 55UV Multifocal and Specialty 55UV Toric Soft (Hydrophilic)Contact Lenses for Daily Wear
Submission number		K003526
Material	methafilcon A	methafilcon A
Material	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
classification
Indication for use	myopia, hyperopia, presbyopia	myopia, hyperopia, presbyopia
	and astigmatism	and astigmatism
Water content	55%	55%
Visible light	90.3%	90.3%
transmittance
UV transmittance	< 10%	< 10%
Dk (35°C)	$18.9 x 10^{-11}$	$18.9 x 10^{-11}$
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
Color	blue visibilityReactive Blue #19	blue visibility,Reactive Blue #19
Refractive index	1.42	1.42
Specific gravity	1.06	1.06
Method of	Moulded	Moulded
manufacture

Indications for Use:

The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eves in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

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The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Igel 55 UV, the Igel UV Multifocal and the Igel 55 UV Toric (methafilcon A) Contact Lenses for Daily Wear. Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. Extraction and analysis of the lenses showed no detectables. The Igel 55 UV lenses passed the requirements of sterility and stability testing.

Conclusion:

Information submitted in the 510(k) establishes that the Iqel 55 UV, the Igel 55 UV Multifocal and the Igel 55 UV Toric Contact Lenses (methafilcon A) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf iff testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen D. Newman Chief Executive Officer IGEL Visioncare PTE LTD 139 Joo Seng Road #05-01 ATD Centre Singapore 368362

JUN 0 4 2002

Re: K020855

Trade/Device Name: IGEL 55UV (methafilcon A), IGEL 55UV Multifocal (methafilcon A) and IGEL 55UV Toric (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 5, 2002 Received: March 15, 2002

Dear Mr. Newman:

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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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INDICATIONS STATEMENT

Device Names:

Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-the-Counter Use
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(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K020855
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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.