DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS

K963487 · Ciba Vision Corporation · LPL · Nov 27, 1996 · Ophthalmic

Device Facts

• Record ID: K963487
• Device Name: DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
• Applicant: Ciba Vision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-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 Story

Soft contact lens for daily disposable wear; composed of 69% water and 31% nelfilcon A polymer. Corrects refractive ametropia (myopia, hyperopia, astigmatism). Prescribed by eye care professionals for single-use; patient discards lens after one day of wear. No cleaning or disinfection required. Provides optical correction; improves patient convenience by eliminating lens care regimens.

Clinical Evidence

Three-month clinical evaluations conducted under GCP. Compared DAILIES™ to predicate control lenses in both daily wear and daily disposable modalities. Results demonstrated similar performance in vision, health, comfort, and fit.

Technological Characteristics

Material: 69% water, 31% nelfilcon A (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Group II (non-ionic). Oxygen permeability: 26 x 10⁻¹¹ (cm²/sec)(ml O₂/ml*mmHg) at 35°C. Refractive index: 1.38. Light transmittance: ≥ 97%. Sterilization: Steam autoclave.

Indications for Use

Indicated for daily wear for optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic persons with non-diseased eyes. Prescribed for single-use daily disposable wear.

Regulatory Classification

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.

Predicate Devices

• NewVues® (vifilcon A) (P820021)
• Excelens® (atlafilcon A) (P890029)

Submission Summary (Full Text)

{0}

PART IA. 510(k) SUMMARY
K963487

| CIBA Vision® Corporation
11460 Johns Creek Parkway
Duluth, GA USA 30155 | NOV 27 1996 |
| --- | --- |
| DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens | |
| 510(k) Summary of Safety and Substantial Equivalence | |

510(k) Summary

## 1. Submitter Information:

Company: Ciba Vision Corporation<br/>11460 Johns Creek Parkway<br/>Duluth, Georgia 30155 -1518

Contact Person: Alicia M. Plesnarski, RAC<br/>Senior Associate, Regulatory Affairs

Telephone: [phone]<br/>FAX: [phone]

Date Prepared: August 30, 1996

## 2. Device Name:

- Common Name: Soft Contact Lens
- Trade/Proprietary Name: DAILIES™ ONE-DAY CONTACT LENS (nelfilcon A)
- Classification Name: Daily Wear<br/>Soft (hydrophilic) Contact Lens
- Device Classification: Class II {21 CFR 886.5925 (b) (1)}

## 3. Predicate Device(s):

Two predicate lenses were selected to address both intended use (disposable) and material type (Group II / PVA) and include:

- NewVues® (vifilcon A), FDA Group IV, disposable contact lenses for daily or extended wear, CIBA® Vision Corporation - P820021
- Excelens® (atlafilcon A), FDA Group II, soft contact lenses for daily or extended wear, CIBA® Vision Corporation - P890029

.779

{1}

11/25/96 16:37 FAX [phone] CIBAVISION-WCAPS 003

| CIBA Vision® Corporation
11460 Johns Creek Parkway
Duluth, GA USA 30155 |
| --- |
| DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens
510(k) Summary of Safety and Substantial Equivalence |

## 4. Description of Device:

The DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENS is a new 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).

The DAILIES™ (nelfilcon A) ONE-DAY contact lens is available in a spherical lens design of the following dimensions:

- Chord Diameter: 13.8
- Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00)
- Base Curve: 8.6 mm
- Powers: +4.00D to -6.00D (0.25D steps)<br/>-6.50D to -8.00D (0.50D steps)

A clear lens has the following properties:

- Specific gravity: 1.06
- Refractive index: 1.38 (hydrated)
- Light transmittance: ≥ 97%
- Water content: 69% by weight in normal saline
- Oxygen permeability: 26 x 10⁻¹¹
$$\{(cm^2 /sec)(ml O_2 /ml*mmHg)\}$$
at 35°C (Fatt corrected).

Lenses are supplied sterile in foil sealed blister packs containing isotonic buffered saline solution. The packaging components have tested non-toxic when evaluated in in-vitro and in-vivo laboratory studies, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister packs are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a thirty (30) month shelf-life for the DAILIES™ (nelfilcon A) ONE-DAY soft contact lens in foil packaging. Shelf-life studies are ongoing to determine extension of expiration dating.

## 5. Indications for Use:

DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-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.

{2}

CIBA Vision® Corporation
11460 Johns Creek Parkway
Duluth, GA USA 30155
DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens
510(k) Summary of Safety and Substantial Equivalence

## 6. Description of Safety and Substantial Equivalence:

A series of nonclinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the DAILIES™ (nelfilcon A) ONE-DAY contact lens, and establish substantial equivalence to currently marketed, predicate (control) lenses. All testing was conducted in accordance with the May 1994 FDA guideline titled *Premarket Notification 510(k) Guidance Document for Class II Contact Lenses* and in conformance to applicable device regulations. Results demonstrate the lens is non-toxic and biocompatible, and has material characteristics comparable to other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in separate studies investigating both daily wear and daily disposable wearing modalities. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.

## Nonclinical Testing:

A series of *in vitro* and *in vivo* preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens. All nonclinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 58).

The results of the nonclinical testing on the DAILIES™ (nelfilcon A) ONE-DAY contact lens demonstrate that:

- The lens material is not toxic and the extracts non irritating.
- Extracts of the lens do not show the presence of residual lens starting materials.
- Lens physical and material properties are consistent with industry marketed lenses.
- The lens material remains unaffected, with respect to lens properties, by exposure to peroxide disinfection systems. The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device.

## Clinical Testing:

The DAILIES™ (nelfilcon A) ONE-DAY contact lens was investigated in both daily wear and daily disposable clinical studies. The three month clinical evaluations were conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). Studies assessed the safety and effectiveness, and clinical performance as compared to two predicate control lenses.

Clinical evaluation of the DAILIES™ (nelfilcon A) ONE-DAY lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under both re-use (daily wear) and single-use (disposable wear) conditions.

781

{3}

782

| CIBA Vision® Corporation
11460 Johns Creek Parkway
Duluth, GA USA 30155 |
| --- |
| DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens |
| 510(k) Summary of Safety and Substantial Equivalence |

## Substantial Equivalence:

The DAILIES™ (nelfilcon A) ONE-DAY contact lens is similar to other daily wear soft contact lenses in terms of water content (≥ 50% water), Dk values, ionic characteristics (Group II, non-ionic), clinical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen should replacement lenses not be available and emergency lens care is needed.

Any differences which may exist between the (nelfilcon A) contact lens and other Group II or Group IV soft hydrophilic plastic contact lenses do not adversely effect the safety and effectiveness of the device.