(118 days)
Not Found
No
The summary describes standard contact lenses and their material properties and clinical performance, with no mention of AI or ML.
No.
The device is indicated for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) and/or presbyopia, which fixes a condition, rather than treating or curing a disease or injury.
No
Explanation: The device, CIBA Vision® (nelfilcon A) soft contact lenses, is indicated for the optical correction of refractive ametropia and/or presbyopia. This describes a corrective function, not a diagnostic one. It is used to correct a condition, not to identify or measure it.
No
The device description clearly details a physical contact lens made of a specific polymer material with defined physical properties and supplied in sterile packaging. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the optical correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a direct interaction with the body for a therapeutic/corrective purpose, not for diagnosing a condition by examining samples outside the body.
- Device Description: The description focuses on the physical properties and material of a contact lens, which is a medical device for vision correction.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such examination.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. Contact lenses are medical devices used in vivo (in the body) for vision correction.
N/A
Intended Use / Indications for Use
CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft 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.
CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes
LPL
Device Description
The nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD).
Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges:
• Power Range: -20.00D to +20.00D
• Center Thickness: 0.010 mm for -3.00D spherical (varies with power)
Lenses have the following properties:
• Refractive index: 1.38
• Light transmittance: approximately 96 %T
• Water content : 69% by weight
• Oxygen permeability . 26 barrer
measured at 35°C (single point Dk-Polarographic method)
Lenses are supplied sterile in sealed blister-packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other CIBA Vision marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers 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). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
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 non-clinical tests and a clinical study were performed to demonstrate the substantial equivalence of the device to the predicate device. 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 verify that the modified nelfilcon A lenses have material characteristics comparable to the predicate nelfilcon A soft contact lenses and are nontoxic and biocompatible. Clinically, the lens performed satisfactorily in a daily disposable wear investigation. Results from all tests demonstrate the substantial equivalence to previously FDA cleared predicate (control) lenses.
Non-clinical Testing:
A series of non-clinical testing was performed to verify equivalence of the device to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).
The results of all non-clinical testing on (nelfilcon A) contact lens demonstrate:
- Lens physical and material properties of the device are substantially equivalent to . the predicate lens.
- . The lens material and extracts of the device are substantially equivalent to the predicate device and are non toxic and non-irritatina.
Clinical Testing:
The CIBA Vision® (nelfilcon A) contact lens was investigated in a clinical study for daily disposable wear. The clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812). The study assessed the clinical performance of the lenses as compared to an FDA cleared and commercially available contact lens.
Clinical evaluation of the CIBA Vision® (nelfilcon A) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to the control lens when used under daily disposable wear conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
21 September 2007 Page 1 of 3 v01
Nelfilcon A Soft Contact Lenses for Daily Wear 510(k) Summary of Safety and Substantial Equivalence
510(k) Summary
JAN
2 4 2006
1. Submitter Information:
| Company: | CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 |
|--------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martina Heim, PhD, RAC
Senior Regulatory Specialist, Global Regulatory Affairs
martina.heim@cibavision.com |
| Telephone:
FAX: | 678-415-3565
678-415-3454 |
| Date Prepared: | 21 September 2007 |
2. Device Name:
- . Common Name: Soft Contact Lens
- CIBA Vision® (nelfilcon A) Trade/Proprietary Name: .
- Classification Name: . Daily Wear Soft Contact Lens
- Device Classification: Class II [21 CFR 886.5925 (b) (1)] .
3. Predicate Device:
CIBA Vision's Focus® DAILIES® (nelfilcon A) soft contact lenses have been selected as predicate devices for the modified CIBA Vision® (nelfilcon A) lenses. CIBA Vision obtained FDA 510(k) clearance for (nelfilcon A) lenses for daily wear on November 27, 1996 (K963487).
4. Description of Device:
The nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD).
Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges:
| • | Power Range: | -20.00D to +20.00D | |
|---|---|---|---|
| --- | -------------- | -------------------- | -- |
- . Center Thickness: 0.010 mm for -3.00D spherical (varies with power)
1
Image /page/1/Picture/0 description: The image is a logo for CIBA Vision, a Novartis Company. The logo is black and white and features the words "CIBA Vision." in a bold, sans-serif font. The "i" in "Vision" is replaced with an eye symbol. Below the company name is the text "A Novartis Company" in a smaller font.
.
CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
21 September 2007 Page 2 of 3 v01
Nelfilcon A Soft Contact Lenses for Daily Wear 510(k) Summary of Safety and Substantial Equivalence
Lenses have the following properties:
- . Refractive index: 1.38
- . Light transmittance: approximately 96 %T
- Water content : 69% by weight
- Oxygen permeability . 26 barrer
measured at 35°C (single point Dk-Polarographic method)
Lenses are supplied sterile in sealed blister-packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other CIBA Vision marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers 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). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
5. Indications for Use:
CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft 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.
CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
6. Description of Safety and Substantial Equivalence:
A series of non-clinical tests and a clinical study were performed to demonstrate the substantial equivalence of the device to the predicate device. 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 verify that the modified nelfilcon A lenses have material characteristics comparable to the predicate nelfilcon A soft contact lenses and are nontoxic and biocompatible. Clinically, the lens performed satisfactorily in a daily disposable wear investigation. Results from all tests demonstrate the substantial equivalence to previously FDA cleared predicate (control) lenses.
2
Image /page/2/Picture/0 description: The image shows the logo for CIBA Vision, a Novartis company. The logo features the word "CIBA" in large, bold, black letters on the top line. Below "CIBA" is the word "Vision" in a stylized font, with the "i" replaced by an eye symbol. Underneath the word "Vision" is the text "A Novartis Company" in a smaller font.
CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
Nelfilcon A Soft Contact Lenses for Daily Wear 510(k) Summary of Safety and Substantial Equivalence
Non-clinical Testing:
A series of non-clinical testing was performed to verify equivalence of the device to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).
The results of all non-clinical testing on (nelfilcon A) contact lens demonstrate:
- Lens physical and material properties of the device are substantially equivalent to . the predicate lens.
- . The lens material and extracts of the device are substantially equivalent to the predicate device and are non toxic and non-irritatina.
Clinical Testing:
The CIBA Vision® (nelfilcon A) contact lens was investigated in a clinical study for daily disposable wear. The clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812). The study assessed the clinical performance of the lenses as compared to an FDA cleared and commercially available contact lens.
Clinical evaluation of the CIBA Vision® (nelfilcon A) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to the control lens when used under daily disposable wear conditions.
Substantial Equivalence:
The CIBA Vision® (nelfilcon A) contact lens is substantially equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of water content (69% water) and ionic characteristics (FDA Group II: high water, nonionic), clinical performance, and indications for use.
Any differences which may exist between the CIBA Vision® (nelfilcon A) soft contact lens and other Group II soft hydrophilic contact lenses do not adversely affect the safety and effectiveness of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
JAN 2 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CIBA Vision Corporation c/o Martina Heim, Ph.D., RAC Senior Regulatory Specialist 11460 Johns Creek Parkway Duluth, GA 30097
Re: K072777
Trade/Device Name: CIBA Vision® (nelfilcon A) One-Day Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: December 21, 2007 Received: December 26, 2007
Dear Dr. Heim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. B. Egelston, m.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Part III. Indications for Use Statement, v01, 21 September 2007, Page 1 of 1 Premarket Notification 510(k): (nelfilcon A) Soft Contact Lenses for Daily Wear
PART III. INDICATIONS FOR USE STATEMENT
510(k) Number:
KO72777
Device Name:
CIBA Vision® (nelfilcon A) Soft Contact Lenses
Indications For Use:
CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft 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.
CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single-use daily disposable wear. The 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)
Chandnamallika Ghosh
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
| 510(k) Number | K072777 |
|---|---|
| --------------- | --------- |
| Prescription Use: | or Over the Counter Use |
|---|---|
| ------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |