(85 days)
P820021, P890029
P820021, P890029
No
The 510(k) summary describes a standard soft contact lens with no mention of AI or ML technology in its intended use, device description, or performance studies.
No
Explanation: This device is for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is a corrective function rather than a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is described as a contact lens for the optical correction of refractive ametropia. It is a therapeutic device designed to correct vision, not to diagnose a condition.
No
The device is a physical contact lens made of a specific material (nelfilcon A) with defined physical dimensions and properties. The description focuses on the material composition, physical characteristics, and clinical performance of the lens itself, not on any software component.
Based on the provided text, the DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "optical correction of refractive ametropia (myopia, hyperopia, and astigmatism)". This is a physical correction of vision, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and material composition of the contact lens itself, designed to be worn on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze substances or characteristics in samples from the human body for diagnostic purposes.
- Clinical Testing: The clinical testing described focuses on the safety and effectiveness of the lens for vision correction and wearability, not on its ability to diagnose a condition.
IVD devices are typically used to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases or conditions. Contact lenses for vision correction do not fit this definition.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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 (polyviny) alcohol partially acetalized with Nformylmethyl 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 -8.00D (0.25D steps)
-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 {(cm² /sec)(mi O2 /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 DAILIÉS™ (nelfilicon A) ONE-DAY soft contact lens in foil packaging. Shelf-life studies are ongoing to determine extension of expiration dating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 requiations. 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.
evaluation of the DAILIES™ (nelfilcon A) ONE-DAY Clinical 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P820021, P890029
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| K963487 | |
|---|---|
| --------- | -- |
| CIBA
Vision | 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
11460 Johns Creek Parkway
Duluth, Georgia 30155 -1518 |
|-----------------|-------------------------------------------------------------------------------------|
| Contact Person: | Alicia M. Plesnarski, RAC
Senior Associate, Regulatory Affairs |
| Telephone: | 770-418-3924 |
| FAX: | 770-418-3033 |
| Date Prepared: | August 30, 1996 |
2. Device Name:
- Common Name: Soft Contact Lens ●
- Trade/Proprietary Name: DAILIES™ ONE-DAY CONTACT LENS . (nelfilcon A)
- . Daily Wear Classification Name: 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
1
| CIBA | CIBA Vision® Corporation |
|---|---|
| Vision | 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 (polyviny) alcohol partially acetalized with Nformylmethyl 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 -8.00D (0.25D steps) |
| -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 {(cm² /sec)(mi O2 /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 DAILIÉS™ (nelfilicon 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
Image /page/2/Picture/0 description: The image shows the logo and address of CIBA Vision Corporation. The address is 11460 Johns Creek Parkway, Duluth, GA USA 30155. The image also contains the text "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 requiations. 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.
evaluation of the DAILIES™ (nelfilcon A) ONE-DAY Clinical 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.
3
Image /page/3/Figure/0 description: The image shows the logo and contact information for CIBA Vision Corporation. The address listed is 11460 Johns Creek Parkway, Duluth, GA USA 30155. The image also contains the text "DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens" and "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.