The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the comea and into the eye.

Device Description

The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.

AI/ML Overview

The provided document describes the safety and effectiveness of the GentleTouch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, submitted as a 510(k) premarket notification (K991000). The core of the submission is to demonstrate substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and the study as presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for all listed properties. Instead, it presents physical and mechanical properties of the GentleTouch UV lens and often compares them to existing lenses or established standards (like USP requirements). The primary acceptance criterion for the submission appears to be demonstrating substantial equivalence to a predicate device (GentleTouch lenses approved under PMA P890012) and similarity to other UV-blocking and tinted lenses (Precision UV, K961299 etc.).

Given this, the table below reflects what can be inferred as performance benchmarks or direct measurements.

Acceptance Criteria (Inferred/Compared To)	Reported Device Performance (GentleTouch UV)
Physical Properties
Refractive Index (21 °C)	1.394
Light Transmittance	95% minimum
Water Content	65%
Oxygen Permeability (Dk x 10⁻¹¹ (ccO2mm)/(cm² sec mmHg))	31
Mechanical Properties
Tensile Properties (compared to lathed GentleTouch)	Equivalent to lathed lenses
Toxicology
Cytotoxicity	No evidence of cell lysis or toxicity; met USP requirements
Systemic Injection	No mortality or systemic toxicity; met USP requirements
Ocular Irritation	Not considered irritants to ocular tissue
Residual Analysis
Detectable extractables in saline	No extractables detected
Lens Compatibility with Recommended Care (after 30 cycles)
Changes in parameters	Within manufacturing tolerances
Adverse effects on measured lens parameters	No adverse effects relative to uncycled controls
Tint color after 30 cycles	Still evident and effective
Light Transmittance (before and after cycling)
Significant difference	No significant difference

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

Sample Size: The document does not specify exact sample sizes for each test (e.g., how many lenses were tested for refractive index, number of animals for toxicology, or how many lenses were cycled for compatibility). The phrasing "Samples of lenses were extracted" and "The ultraviolet spectra of cycled lenses was individually measured" indicates a sample was used, but the quantity is not provided.
Data Provenance: The data is presented as a summary of preclinical studies and tests conducted by the applicant, Wesley Jessen Corporation. The country of origin is implicitly the USA, where the company is located and the application was filed. The studies are retrospective in the sense that the data has already been collected and presented as part of the submission.

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

This section is not applicable (N/A). The document describes device testing for physical, chemical, and biological properties, not a study involving human interpretation where "ground truth" would be established by experts (e.g., image reading). The "ground truth" here is the established scientific and regulatory standards for biocompatibility, material properties, and performance.

4. Adjudication Method for the Test Set:

N/A. As this is not a study involving human assessment or interpretation for a diagnostic or screening device, there is no adjudication method in the traditional sense. The tests are laboratory-based measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret cases with and without AI assistance. The submitted information focuses on the physical, chemical, and biological characteristics of a contact lens.

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

N/A. This is not an algorithm or AI-based device. The "performance" described is the inherent properties of the contact lens material and design.

7. The Type of Ground Truth Used:

The "ground truth" for the various tests relies on established scientific methodologies and regulatory standards:

Physical Properties: Measured values against material specifications and industry standards.
Mechanical Properties: Comparison against an existing, approved device (lathed GentleTouch lenses), implying the accepted performance of the predicate device is the "ground truth."
Toxicology: Compliance with USP (United States Pharmacopeia) requirements for cytotoxicity, systemic injection, and ocular irritation.
Residual Analysis: Absence of detectable extractables, as determined by High Performance Liquid Chromatography (HPLC) and spectrophotometric methods.
Lens Compatibility: Maintenance of parameters within manufacturing tolerances and no adverse effects compared to uncycled control lenses, using recognized disinfection systems.
Light Transmittance: Comparison of pre- and post-cycled measurements, with "no significant difference" being the benchmark.

8. The Sample Size for the Training Set:

N/A. The concept of a "training set" applies to machine learning algorithms, which is not relevant to this contact lens submission. The material properties were developed and optimized, but this is a manufacturing and materials science process, not an AI training process.

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

N/A. As there is no training set in the AI sense, this question is not applicable. The development of the lens material and manufacturing process would have involved iterative testing and refinement against desired specifications and performance targets, but this is distinct from establishing "ground truth" for an AI training set.

Summary

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JUN 28 1999

K991000

Summary of Safety and Effectiveness

A. General Information

1. Name and Address of Applicant:	Wesley Jessen Corporation333 East Howard AvenueDes Plaines, IL 60018
Contact Person:	Joseph F. FoosVice PresidentScientific AffairsPhone: (847) 294-3306Fax: (847) 294-3853
2. Name of the Device:
Proprietary Name:	GentleTouch™ UV (netrafilcon A)
Device Classification:	As per 21 CFR Section 886.5925 Soft(hydrophilic) daily wear contact lenses areclassified as Class II device

Product Code:

86 LPL

B. Indication for use:

The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact (ens is indicated for daily wear for the correction of refractive ametropia (myopla and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafileon A) lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye.

C. Description of device:

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Physical Properties

Physical Test	GentleTouch UV
Refractive Index (21 °C)	1.394
Light Transmittance	95% min.
Water Content	65%
Oxygen Permeability*	31

*Note: Permeability Coefficient Dk x 10°4 (ccO2mm)/(cm² sec mmHg), measured by the OX-Tran(R) *H" technology embodied in the new ASTM method F-1927.

Mechanical Properties

The GentleTouch UV contact lenses were compared to the current lathed GentleTouch lenses for tensile properties. The measured tensile properties show that the molded lenses are equivalent to the lathed lenses.

Toxicology

The safety of GentleTouch (netrafilcon A) has been established (PMA P890012). The preclinical studies on GentleTouch UV with the In-monomer-tint, UV absorbing monomer and new molding process were conducted to assure that the safety of this material, netrafilcon A, has not been altered by these changes. The studies are summarized below:

a. Cytotoxicity:

The negative controls and positive controls performed as anticipated. Under the condition of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the USP.

b. Systemic Injection:

Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the USP requirements.

C. Ocular irritation:

Under the conditions of this study, the SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.

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Residual Analysis

Samples of lenses were extracted in saline and the extracts analyzed by high performance liquid chromatography and spectraphotometric method to determine if extractables from the material would be detected. There were no extractables detected.

Lens Compatibility with the Recommended Lens Care Regimen

Any changes in parameters through 30 cycles were within manufacturing tolerances. Cycling in the ReNu Multipurpose System, in heat disinfection or in the AOSept System did not adversely affect measured lens parameters relative to the uncycled control lenses. Tint color was still evident after 30 cycles and is still effective as a handling tint.

Light Transmittance:

The ultraviolet spectra of cycled lenses was individually measured before and after cvcling. All variances were within the experimental tolerance. It can be considered that there was no significant difference between the light transmittance before and after cycling.

D. Safety & Effectiveness:

GentleTouch UV Soft (Hydrophilic) Contact Lenses are comparable to the previously marketed GentleTouch lenses of the same material as approved under PMA (P890012).

The approval of 510(k) K961299, marketed as Precision UV™ (vasurfilcon A) substantiates the safe and efficacious use of the IMT (D&C Green No.6 dve) as a handling tint and the UV absorbing monomer. UVAM, is also the same UV absorber utilized in Precision UV (K944722 & K982988). The use of the IMT (D&C Green No. 6, C.I. No. 61565) for tinting GentleTouch UV (netrafilcon A) hydrophilic soft contact lenses will be in accordance with the color additive listing provisions of 21 Code of Federal Regulations § 74.3206.

E. Conclusion

A thorough series of pre-clinical, toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint (IMT), UV absorbing monomer (UVAM) and molding process are equivalent to the original lathe process and the final lens specifications are substantially equivalent to the prior approved lathed process.

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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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right.

Public Health Service

JUN 28 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph F. Foos Vice President Scientific Affairs Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018-5903

Re: K991000

Trade Name: Gentle Touch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (visitint with D & C Green #6, cast-molded)

Regulatory Class: II Product Code: 86 LPL Dated: May 27, 1999 Received: June 1, 1999

Dear Mr. Foos:

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 (OS) 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 - Mr. Joseph F. Foos

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 Roerl lorentbal

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

510(k) Number (if known):

Device Name:

GentleTouch™ UV (netrafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Indication for Use:

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

Prescription Use	✓	OR	Over-The Counter

	(Division Sign-Off) Division of Ophthalmic Devices
				js

K 991000

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.