DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes.

DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES® lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens, based on the provided document:

This document is a 510(k) Summary of Safety and Effectiveness for a "parametric release" of the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens. It's crucial to understand that a parametric release means the device itself is not new, but rather a change in the sterilization release criteria is being submitted. Therefore, the "study" described focuses on validating the sterilization process, not the clinical performance of the contact lens.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Sterilization)	Reported Device Performance (Sterilization)
Sterilization cycle: chamber temperature of 121 to 124°C for 45 consecutive minutes, with chamber pressure of 2.6 ± 0.2 bar.	A successful sterilization cycle includes these parameters. (Note: This is the description of the validated process, which by definition "meets" the criteria if the process is followed).
Deliver sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival.	The sterilization cycle is "based on an overkill approach, delivering sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival regardless of the number and heat resistance of the naturally occurring microorganisms."
Typical Sterility Assurance Level (SAL) obtained during validation study.	Consistently greater than 10⁻³².
Production bioburden levels (pre-sterilization).	Consistently below both 1000 vegetative CFU and 20 spore forming CFU over a 4-month period.

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

This document does not describe a clinical test set for device performance. Instead, it focuses on the sterilization process.

Test Set Description: The "test set" in this context refers to the samples used to validate the sterilization process and monitor bioburden.
Sample Size (Sterilization Validation): Not explicitly stated in terms of a number of devices. The validation is described as an "overkill approach" implying robust testing. The SAL of 10⁻³² is a result of extensive validation.
Sample Size (Bioburden Monitoring): "Results obtained from measurement of product bioburden over a 4-month period" suggests continuous monitoring, but a specific number of samples taken during this period is not provided.
Data Provenance: The document is from CIBA Vision Corporation, located in Duluth, GA, USA. The data would therefore be assumed to be from their manufacturing facilities. The nature of the data is prospective for both initial sterilization validation and ongoing bioburden monitoring.

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

Not applicable for this type of submission. There is no human expert "ground truth" involved in evaluating the performance of the sterilization process; it's based on objective physical measurements and microbiological assays. The "ground truth" is established by adherence to microbiological sterility standards.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication in the context of sterilization validation.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a material/process change related to sterilization, not an assessment of the clinical effectiveness or diagnostic performance of the device.

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

Not applicable. This is a physical medical device (contact lens) and a manufacturing process (sterilization), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is:

Sterilization Validation: Microbiological testing (e.g., spore strips, lethality calculations) demonstrating the destruction of a specified number of microorganisms, and physical monitoring of autoclave parameters (temperature, pressure, time). The target microbial reduction (12-log) and probability of survival (10⁻⁶) are established industry standards for sterility.
Bioburden Monitoring: Direct measurement of CFU (colony-forming units) of vegetative and spore-forming bacteria from product samples. This is a direct, objective microbiological measurement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the validation of a manufacturing process against established standards.

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

Not applicable, as it's not an AI/ML device. For the sterilization validation, the ground truth is established by:

Engineering principles and scientific validation protocols for steam sterilization processes.
Microbiological testing, often involving inoculation of representative product with a known challenge organism and subsequent culturing to demonstrate inactivation.
Adherence to regulatory standards and guidance (e.g., from FDA, ISO) for sterile medical devices.

Summary

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		CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, GA USA 30097			Page 1 of 3
AUG 18 1999	Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact LensParametric Release
	510(k) Summary of Safety and Effectiveness
			510(k) Summary		K992446
		1. Submitter Information:
		Company:	CIBA Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
		Contact Person:	Alicia M. Plesnarski, RACSenior Specialist, Global Regulatory Affairs
		Telephone:	678-415-3924
		FAX:	678-415-3033
		Date Prepared:	July 21, 1999
2. Device Name:
		Common Name:	Soft Contact Lens
		Trade/Proprietary Name:	Focus® DAILIES® ONE-DAY CONTACT LENS(nelfilcon A)
		Classification Name:	Daily Wear		Soft (hydrophilic) Contact Lens
		Device Classification:		Class II {21 CFR 886.5925 (b) (1)}
	3. Predicate Device(s):
		CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact LensClear lenses: K943487VISITINT® lenses: K984273

4. Description of Device:
		The DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lensintended for single use daily disposable wear. The lens material is 69% water and31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethylacrylamide).
		Lenses are supplied sterile in foil sealed blister packs containing isotonicphosphate-acetate buffered saline solution.

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Image /page/1/Picture/0 description: The image shows the logo for CIBA Vision, a Novartis company. The word "CIBA" is in large, bold, sans-serif font at the top. Below it, the word "Vision" is written in a similar font, with the "i" replaced by an eye symbol. Underneath, the text "A Novartis Company" is written in a smaller, sans-serif font.

CIBA Vision® Corporation 11460 Johns Creek Parkwav Duluth. GA USA 30097

Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens Parametric Release

510(k) Summary of Safety and Effectiveness

5. Indications for Use:

6. Description of Safety and Substantial Equivalence

6.1 Comparison to Predicate Device:

Design, material, chemical composition, manufacturing process, packaging and the sterilization method and cycle remain unchanged from description in cleared Premarket Notification 510(k) K963487 and K984273.

6.2 Clinical Testing:

Not conducted for quality assurance procedural change. Lenses remain unchanged from device described and approved in Premarket Notification 510(k) K963487 and K984273.

6.3 Non-clinical Testing:

Dailies lenses will continue to be manufactured as previously described in Premarket Notification 510(k) K963487 and K984273. The lens design. production process, packaging materials, finished product specifications and sterilization method and cycle remain unchanged. The only change involves the elimination of Biological Indicators as a sterilization release criteria. Having demonstrated controlled and validated sterilization conditions, verification through monitoring of physical operating parameters for the sterilizer to meet specifications becomes the mechanism for sterility release.

Validation of the Steam Sterilization Process: -
A successful sterilization cycle includes a chamber temperature of 121 to 124°C for 45 consecutive minutes, with chamber pressure of 2.6 ± 0.2 bar. The sterilization cycle is based on an overkill approach, delivering sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 100 probability of microbial survival regardless of the number and heat resistance of the naturally occurring microorganisms. The typical sterility assurance level (SAL) obtained during the execution of a validation study is consistently greater than 10-32

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CIBAVision.A Novartis Company	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, GA USA 30097	Page 3 of 3
Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact LensParametric Release
510(k) Summary of Safety and Effectiveness

Assessment of Bioburden Levels for Packaged Product: Results obtained from measurement of product bioburden over a 4-month period demonstrate production bioburden levels are well controlled. The average presterilization bioburden results were consistently below both 1000 vegetative CFU and 20 spore forming CFU.

6.4 Ongoing controls and monitoring

Each sterilization cycle will continue to be verified through monitoring and documented verification of autoclave equipment operating parameters. All relevant related equipment is appropriately calibrated and maintained. Revalidation of the sterilization autoclave is performed annually to verify and ensure consistent operation and sterilization effectiveness. Ongoing monitoring of product bioburden is conducted to ensure low and consistent bioburden levels in the production environment are maintained.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Ms. Alicia M. Plesnarski, Senior Specialist Global Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097-1556

Re: K992446

Trade Name: Focus® DAILIES® (nelfilcon A) One Day Soft Contact Lens (Parametric Release) Regulatory Class: II Product Code: 86 MVN Dated: July 21, 1999 Received: July 22, 1999

Dear Ms. Plesnarski:

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. Alicia M. Plesnarski

· 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 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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Device Name:

510(k) Number:

CIBA Vision® Focus® DAILIES® (nelfilcon A) One-Day Contact Lens

් පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා විද්‍යා පිහිටා පිහිටි පිහිටි ප

Indications For Use:

The Focus® DAILIES® (nelfilcon A) One-Day contact lens is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lens for single-use daily disposable wear. DAILIES (nelfilcon A) lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myra Smith

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K 992 446

Prescription Use:

Over the Counter Use

□

Premarket Notification 510(k): Parametric Release DAILIES (nelfilcon A) One-Day Contact Lens

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.