The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive 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 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and 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 55 Toric (ocutilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear 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.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care 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 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.

AI/ML Overview

Acceptance Criteria and Study for United Contact Lens Products

The provided document describes a 510(k) premarket notification for three soft contact lens products: 55 SV, 55 Multifocal, and 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear.

The acceptance criteria for these devices were established by demonstrating substantial equivalence to predicate devices. This means that the new devices have comparable physicochemical properties and do not raise new questions of safety and effectiveness compared to existing, legally marketed devices.

The study proving the device meets acceptance criteria involved pre-clinical tests and physicochemical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Substantial equivalence to predicate devices (55 F, Toric 55, and Multifocal (ocufilcon C) Soft (hydrophilic) Contact Lenses for Daily Wear) in terms of safety, effectiveness, and physicochemical properties. This is implicitly demonstrated by comparing key material and performance parameters.

Parameter	Predicate Device Performance (Acceptance Criteria)	Subject Device Performance
Material	ocufilcon C	ocufilcon C
Material Classification	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
Indication for Use	myopia, hyperopia, astigmatism and presbyopia	myopia, hyperopia, astigmatism and presbyopia
Water Content	54.4%	54.9%
Visible Light Transmittance	98.3%	98.9%
Dk (35° C)	$18.78 \times 10^{-11}$	$18.77 \times 10^{-11}$
Powers	+20.00D to -20.00 D; Continuous add power to +3.00 (55 Multifocal); Cylinder powers -0.50 D to -6.00D (Toric 55)	+12.00 D to -20.00 D; Continuous add power to +3.00 (55 Multifocal); Cylinder powers -0.50 D to -2.50 D (55 Toric)
Color	clear	Blue visibility, Reactive Blue #19
Refractive Index	1.414	1.415
Method of Manufacture	Lathed	Molded
Toxicity/Irritation	Non-toxic, non-irritating (implied by predicate history)	Non-toxic, non-irritating (demonstrated)
Residue	Safe amounts (implied by predicate history)	No evidence of unsafe amounts (demonstrated)
Sterility & Physical Stability	Sterile and stable for shelf life (implied by predicate history)	Remaining sterile and physically stable for shelf life (demonstrated)

Note: The "Acceptance Criteria" for individual parameters are interpreted as matching or being acceptably close to the predicate device's performance, as the overarching goal is substantial equivalence.

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

The document does not explicitly state the numerical sample size for "test sets" in the context of clinical trials with human subjects. Instead, it refers to pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, and residue evaluation) and physicochemical testing. These tests are typically conducted on a representative sample of manufactured lenses and materials, not a "test set" from a typical clinical study.

Sample Size: Not explicitly stated for each test (e.g., number of lenses, number of animals for in vivo tests). However, the "resulsts showed no evidence of unsafe amounts of residue" suggests a sufficient sample was tested to draw conclusions.
Data Provenance: The tests described (Systemic Injection, Primary Ocular Irritation, Cytotoxicity Tests, residue evaluation, physicochemical testing, shelf life testing) are laboratory-based and pre-clinical. There is no mention of human clinical data or retrospective/prospective studies on human subjects in this 510(k) summary for establishing substantial equivalence. The data would have been generated internally by United Contact Lens Inc. or a contracted lab.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" for showing substantial equivalence relies on objective laboratory measurements and established regulatory standards for material safety and performance, rather than expert consensus on a clinical test set. The submission focuses on comparing the new device's technical specifications and safety profile to those of a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable. No adjudication method (like 2+1 or 3+1 often used for image-based ground truth establishment) is mentioned or relevant to the types of pre-clinical and physicochemical tests 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

This information is not applicable. The device is a contact lens, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This information is not applicable. As stated above, the device is a contact lens, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for these contact lenses was based on:

Objective physicochemical measurements: Comparative data for water content, visible light transmittance, Dk, refractive index, and power ranges against the predicate device.
Established safety standards: Results from Systemic Injection, Primary Ocular Irritation, and Cytotoxicity Tests indicating non-toxicity and non-irritation, which align with accepted biological safety assessments for medical devices.
Residue analysis: Demonstrating that extracted lenses have no unsafe amounts of residue.
Shelf life testing: Confirming sterility and physical stability over time.

These measurements and tests serve as the objective evidence (ground truth) against which the new devices' performance was compared to the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of developing this medical device. The process involves design, manufacturing, and testing to meet specifications and demonstrate equivalence, not machine learning model training.

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

This information is not applicable as there was no training set.

Summary

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JUL 1 - 2005

K051184

Image /page/0/Picture/2 description: The image shows the words "United Contact Lens" in a stylized font. Below the words "United Contact Lens" is a black box with the words "SOFT CONTACT LENSES" in white font. The words "United Contact Lens" are stacked on top of each other, with "United" on top, "Contact" in the middle, and "Lens" on the bottom.

19111 - 615 Avenue NE, Suite 5. Arlington, Washington 98223 Office: 425-743-7343 Fax: 425-743-8795 Toll Free: 800-446-1666

510(k) Summary

Submitter Information:

United Contact Lens Inc. 19111 61st Ave. NE #5 Arlington, WA 98223 Registration No. 2918644

Contact Person:	Garold L. Edwards, O.D., F.A.A.O.
	Regulatory Consultant
Telephone:	(408) 221 - 3860
Fax:	(425) 743 - 8795

May 4, 2005 Date Prepared:

Device Name:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Names:	55 SV (ocufilcon C) Soft(Hydrophilic) Contact Lens for Daily Wear55 Multifocal (ocufilcon C) Soft (Hydrophilic)Contact Lens for Daily Wear55 Toric (ocufilcon C) Soft (Hydrophilic)Contact Lens for Daily Wear
Classification Name:	Soft (Hydrophilic) Contact Lens
Device Classification:	Class II (21 CFR 886.5925)

Predicate Devices:

The 55 F (ocufilcon C) Soft (Hydrophilic) Single Vision Contact Lens, the 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens and the 55 Toric Contact Lens were selected as the predicate devices manufactured in the same facility, using the same formulation, under the same quality system packaging and sterilization processes as the subject devices.

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Description of Devices:

PARAMETER	55 SV, 55 Toric and 55Multifocal Soft(hydrophilic) ContactLenses for Daily Wear	55 F, Toric 55 and Multifocal(ocufilcon C) Soft(hydrophilic) Contact Lensesfor Daily Wear
Submission number	N/A	P920008/K941607
Material	ocufilcon C	ocufilcon C
Material classification	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
Indication for use	myopia, hyperopia,astigmatism andpresbyopia	myopia, hyperopia,astigmatism and presbyopia
Water content	54.9%	54.4%
Visible lighttransmittance	98.9%	98.3%
Dk (35° C)	$18.77 x 10^{-11}$	$18.78 x 10^{-11}$
Powers	+12.00 D to -20.00 D;Continuous add power to+3.00 (55 Multifocal only);Cylinder powers -0.50 D to-2.50 D (55 Toric only)	+20.00D to -20.00 DContinuous add power to+3.00 (55 Multifocal only);Cylinder powers -0.50 D to6.00D (Toric 55 only)
Color	Blue visibility,Reactive Blue #19	clear
Refractive index	1.415	1.414
Method ofmanufacture	Molded	Lathed

Comparison to Predicate Device

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Indications for Use:

The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic 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 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia 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 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens is inclicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non- diseased eyes.

Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the 55 SV, the 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.

Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The 55 SV lenses were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the extracts. Physicochemical testing of the 55 lenses demonstrated equivalency to the predicate devices.

Conclusion:

Information submitted in the 510(k) establishes that the 55 SV, the 55 Multifocal and the 55 Toric Contact Lenses (ocufilcon C) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that the physical lens properties are stable. Therefore, the devices are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font and is horizontally aligned. The background is plain and white, which makes the text stand out.

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

JUL 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United Contact Lens, Inc. c/o Garold L. Edwards, O.D., F.A.A.O Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018

Re: K051184

Trade/Device Name:

55 SV (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Multifocal (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Toric (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: May 4, 2005 Received: May 9, 2005

Dear Mr. Edwards:

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 - Garold L. Edwards, O.D., F.A.A.O

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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INDICATIONS STATEMENT

Device Names:

55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

Indications for Use:

Prescription Use X

Over-the-Counter Use_

06 001

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. O

n of Ophthalmic Ear, and Throat Devises

K051184 510(k) Number

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.