The Specialty 55 Multifocal (methafilcon A) 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 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 Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision 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 lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. 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 disinfection systems.

Device Description

The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethy) methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are tinted using Vat Blue #6 in an entrapment tinting process during polymerization of the lens.

AI/ML Overview

Here is an analysis of the acceptance criteria and study information for the Specialty 55 Multifocal and Specialty 55 Single Vision Contact Lenses, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. Therefore, the "acceptance criteria" are implied to be meeting the performance characteristics of the predicate devices. The table below presents the physicochemical properties of the new device and its predicate devices, where "reported device performance" refers to the values stated for the Specialty 55 lenses.

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (Specialty 55)
Material	methafilcon A or hefilcon C	methafilcon A
Material Classification	Hydrophilic Lens Group 4 (methafilcon A predicates) or Group 2 (hefilcon C predicate)	Hydrophilic Lens Group 4
Indication for Use	Correction of myopia, hyperopia, and presbyopia (multifocal predicate) or myopia, hyperopia, and astigmatism (IGEL 56)	Myopia, hyperopia, and presbyopia (multifocal); myopia, and hyperopia (single vision)
Water Content	55% (methafilcon A predicates) or 56% (hefilcon C predicate)	55%
Light Transmittance	90 to 97% (methafilcon A predicates) or 90 to 94% (hefilcon C predicate)	98%
Dk (35° C)	$19.7 \times 10^{-11}$ (hefilcon C predicate) or $18.8 \times 10^{-11}$ (methafilcon A predicate)	$18.8 \times 10^{-11}$
Powers	+20.00 to -20.00 Diopters (methafilcon A predicates) or +6.00 to -12.00 Diopters (hefilcon C predicate)	+20.00 to -20.00 Diopters
Color	Blue visibility	Blue visibility
Refractive Index	1.41 (predicates)	1.42
Specific Gravity	1.09 (methafilcon A predicate) or 1.16 (hefilcon C predicate)	1.06
Method of Manufacture	Molded	Molded
Tint	Vat Blue #6 (Specialty 55) or Reactive Blue #4 (Specialty Progressive/Choice AB)	Vat Blue #6
Tint Process	Entrapment process during polymerization (Specialty 55, IGEL 56) or Wet lens tinting process (Progressive/Choice AB)	Entrapment process during polymerization
Systemic Toxicity	Non-toxic	Non-toxic (from Systemic Injection test)
Ocular Irritation	Non-irritating	Non-irritating (from Primary Ocular Irritation test)
Cytotoxicity	Non-cytotoxic	Non-cytotoxic (from Cytotoxicity test)
Solution Compatibility	Compatible with chemical and hydrogen peroxide regimens	Compatible with chemical and hydrogen peroxide regimens (from Solution Compatibility test)
Dye Leachability	No detectable leachability of dye	No detectable leachability of dye (from Extraction test for Vat Blue #6)

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

The document does not specify a "test set" in the context of a clinical trial with human subjects for the current device. The studies described are preclinical (laboratory-based) tests. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a human subject test set is not provided.

The document mentions that "A series of preclinical tests were performed to demonstrate the safety and effectiveness of the Specialty 55 Multifocal and Specialty 55 (methafilcon A) Single Vision Contact Lenses for Daily Wear". These tests include:

Systemic Injection
Primary Ocular Irritation
Cytotoxicity
Solution Compatibility
Dye Extraction for leachability of Vat Blue #6
Physicochemical testing (e.g., water content, Dk, light transmittance, refractive index, specific gravity)

The provenance of this preclinical data is not explicitly stated but is implied to be from laboratory testing supporting the manufacturer's submission.

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

Not applicable, as a human clinical trial "test set" with expert adjudicated ground truth is not described. The ground truth for the preclinical tests would be based on validated laboratory methods and standards.

4. Adjudication Method for the Test Set

Not applicable, as a human clinical trial "test set" with expert adjudication is not 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

Not applicable. The device is a soft contact lens, not an AI-assisted diagnostic tool.

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

Not applicable, as the device is a soft contact lens, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety and effectiveness claims is established through:

Physicochemical Measurement Standards: For parameters like water content, Dk, light transmittance, refractive index, specific gravity, and powers, the ground truth is based on established scientific and industry standards for contact lens properties.
Biocompatibility Standards: For systemic injection, primary ocular irritation, and cytotoxicity tests, the ground truth is based on recognized biocompatibility testing standards to determine non-toxicity and non-irritation.
Chemical Analysis: For dye leachability, the ground truth is established through chemical analysis methods to detect the presence or absence of the dye.
Compatibility Protocols: For solution compatibility, the ground truth is established via protocols demonstrating material integrity and performance after disinfection with specified solutions.

The overall "ground truth" for the submission is the substantial equivalence to predicate devices that have already been cleared for marketing. This means the new device is deemed safe and effective because its characteristics are sufficiently similar to devices already on the market.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/algorithm-based device and therefore does not have a "training set" in that context. The preclinical tests described would involve specific numbers of lenses or biological samples according to the testing protocols, but these are not considered a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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JUL - 7 1999

K984090

Image /page/0/Picture/2 description: The image shows the logo for Ultravision Inc. The word "SPECIALTY" is written in white letters on a black rectangle at the top of the logo. Below the rectangle, the word "ULTRAVISION" is written in large, bold, black letters. The letters "INC." are written in smaller, black letters in the bottom right corner of the logo.

510(k) Summarv

Submitter Information:

Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, CA 95008

Contact Person:	Ivalee Cohen
	Director, Regulatory and Clinical Affairs

Telephone:	(408) 341-0700
Fax:	(408) 341-0717

May 24, 1999 Date Prepared:

Device Name:

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

Description of Devices:

307 ORCHARD CITY DRIV CAMPBELL, CA 95008 TEL: 888-29-ULTRA 408-341-0700 FAX: 408-341-0717

323 44™ AVENUE N.E. LGARY, ALBERTA ANADA T2E 6LS TEL: 800-668-9251 403-291-1919 403-291-6477

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Predicate Devices:

The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens and the Specialty Choice AB (methafilcon A) Soft Single Vision Contact Lens, and the IGEL 56 (hefilcon C) Soft (hydrophilic) Contact Lens were selected as the predicate devices.

The Specialty Choice AB and Specialty Progressive lenses were cleared under 510(k) K963488, and are manufactured by a molding process that uses the methafilcon A polymer and the same lens designs as the Specialty 55 lenses. The dye tinting process is different, the lenses are tinted with Reactive Blue #4 after lens hydration using a wet lens tinting process, where the Specialty 55 lenses are in-monomer tinted.

The IGEL 56 lenses were cleared under 510(k) K974837, and were selected as predicate devices because, although they are molded from a different polymer, and tinted with a different dye, they are produced in the same facility, under the same quality system, using the same molding, in-monomer tinting, packaging and sterilization processes as the Specialty 55 lenses.

PARAMETER	Specialty 55Multifocal andSpecialty 55 Soft(Hydrophilic)Contact Lenses forDaily Wear	ProgressiveMultifocal andChoice AB Soft(Hydrophilic)Contact Lenses forDaily Wear	IGEL 56 Soft(hydrophilic) ContactLenses for DailyWear
material	methafilcon A	methafilcon A	hefilcon C
materialclassification	Hydrophilic LensGroup 4	Hydrophilic LensGroup 4	Hydrophilic LensGroup 2
indication foruse	myopia, hyperopia,and presbyopia	myopia, hyperopia,and presbyopia	myopia, hyperopia andastigmatism
water content	55%	55%	56%
lighttransmittance	98%	90 to 97%,dependent upon tint	90 to 94%
	Dk (35° C)	$18.8 x 10^{-11}$	$19.7 x 10^{-11}$
powers	+20.00 to -20.00Diopters	+20.00 to -20.00Diopters	+6.00 to -12.00Diopters
	color	blue visibility	blue visibility
refractive index	1.42	1.41	1.41
specific gravity	1.06	1.09	1.16
Method ofmanufacture	Molded	Molded	Molded
	Tint	Vat Blue #6	Reactive Blue #4
Tint process	Entrapment processduring polymerization	Wet lens tintingprocess	Entrapment processduring polymerization

Comparison to Predicate Device

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Indications for Use:

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. 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 disinfection systems.

Description of Safety and Substantial Equivalence:

A series of preclinical tests were performed to demonstrate the safety and effectiveness of the Specialty 55 Multifocal and Specialty 55 (methafilcon A) Single Vision 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. A Solution Compatibility test, using chemical and hydrogen peroxide regimens showed Specialty 55 lenses to be compatible with both regimens. Specialty 55 lenses were extracted and evaluated for presence of the Vat Blue #6 dye. Results show no detectable leachability of the dye. Physicochemical testing of the Specialty 55 lenses determined equivalency to the predicate devices.

Conclusion:

Information submitted in the 510(k) establishes that the Specialty 55 Multifocal and Specialty 55 Single Vision Contact Lenses (methafilcon A) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three wavy lines extending from the head, resembling hair or a flowing garment.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 1999

Ms. Ivalee I. Cohen Director, Regulatory and Clinical Affairs Specialty UltraVision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008

Re: K984090

Trade Name: Specialty 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (blue visibility tinted); Specialty 55 (methalfilcon A) Soft (hydrophilic) Single Vision Contact Lens for Daily Wear (blue visibility tinted) Regulatory Class: II Product Code: 86 LPL Dated: May 25, 1999 Received: May 27, 1999

Dear Ms. Cohen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Ms. Ivalee I. Cohen

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

Device Names:

Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and

Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear

Indications for Use:

Myra Smith

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K984090

(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

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.