(60 days)
Not Found
No
The document describes the material properties, design parameters, and intended use of soft contact lenses. There is no mention of any computational analysis, algorithms, or data processing that would suggest the use of AI or ML.
No.
The Lotrafilcon B contact lenses are indicated for the optical correction of refractive ametropia and presbyopia, which means they correct vision rather than treat a disease or condition. They are devices designed for optical correction, not for therapeutic purposes.
No
The device is a contact lens intended for optical correction of refractive errors, not for diagnosing eye conditions.
No
The device description clearly indicates it is a physical contact lens made of a hydrogel material, not software.
Based on the provided information, 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). This is a physical correction of vision, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is a contact lens, a physical object placed on the eye. It does not contain reagents or components designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely optical.
- Performance Studies: The performance studies focus on biocompatibility, material properties, and equivalence to predicate contact lenses, not on the accuracy of a diagnostic test.
In summary, this device is a medical device used for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism.
Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic persons with non-diseased eves and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.
Product codes
LPL, MVN
Device Description
The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Contact lenses contain the color additive phthalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.
Lotrafilcon B lens designs include spherical. toric, multifocal toric lenses in the following parameter ranges:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with design and power (Example: 0.08 mm for -3.00D spherical)
Lenses have the following properties:
- Refractive index: 1.42 (hydrated)
- Light transmittance: > 94 %
- Water content : 33% by weight in normal saline
- Oxygen permeability 110 x 10-11
[(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Lotrafilcon B contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with or without additives [1% Copolymer 845, or 1% Copolymer 845 and 0.04% (400 ppm) polyoxyethylene-polyoxybutylene copolymer (EO45BO10)]. The compatibility and package integrity of the blister pack packaging system have been demonstrated and successfully used for other 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care professionals
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 were performed to demonstrate the substantial equivalence of lotrafilcon B contact lenses packaged with saline additive (modified saline) 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 ISO standards, as applicable. Results verify that lenses packaged in modified saline remain nontoxic and biocompatible and have material characteristics comparable to, or better than, other currently marketed soft contact lenses. Results from all tests demonstrate substantial equivalence to the predicate lenses.
A series of nonclinical testing was performed to verify the equivalence of lenses packaged in modified saline to the predicate device. Nonclinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58). The results of all nonclinical testing demonstrate:
- The lens material, lens extracts and package saline of the device in modified saline are equivalent to the predicate and remain non toxic and non-irritating.
- Lens physical and material properties of the device in modified saline are consistent with industry-marketed lenses and equivalent to or better than the predicate lens.
- Like the predicate device, the device in modified saline is compatible with commonly available lens care products.
In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2016
Alcon Laboratories, Inc. Ms. Alicia Plesnarski Director, Global Regulatory Affairs 6201 South Freeway Fort Worth, Texas 76134-2099
Re: K160609
Trade/Device Name: Air Optix Plus Hydraglyde, Air Optix Plus Hydraglyde For Astigmatism, Air Optix Plus Hydraglyde Multifocal, Air Optix Plus Hydraglyde Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 29, 2016 Received: March 3, 2016
Dear Ms. Plesnarski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice
1
requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for 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
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Indications for Use
510(k) Number (if known) K160609
Device Name
AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses
Indications for Use (Describe)
Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism.
Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic persons with non-diseased eves and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.
Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) SUMMARY
This summary document is being prepared in accordance with section 21 CFR 807.92.
The submitter of the 510(k) is:
Alicia M. Plesnarski, RAC Director, Regulatory Affairs, Alcon Vision Care Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Phone: (678) 415-3924 Fax: (678) 415-3454 email: alicia.plesnarski@alcon.com
Date Summary Prepared: 12 April 2016
Device Subject to this 510(k):
| Trade Name: | AIR OPTIX® plus HydraGlyde® |
|---|---|
| Common Name: | (lotrafilcon B) Soft Contact Lens |
| Classification Name: | Soft (hydrophilic) Contact Lens |
| [21 CFR 886.5925 (b) (1)] | |
| Product code: | LPL: MVN |
Predicate Device(s)
The predicate device is the Alcon® AIR OPTIX® AQUA (lotrafilcon B) contact lens packaged in phosphate buffered saline (PBS) +1% Copolymer 845. Lotrafilcon B contact lenses are a Group V silicone hydrogel according to ISO 18369-1:2006/Amd. 1:2009. The predicate device (in PBS saline or PBS +1% Copolymer saline) has FDA Premarket Notification 510(k) clearance for daily wear (K033919, March 12, 2004; K073459, 28-Feb-2008).
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Device Description
The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Contact lenses contain the color additive phthalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.
Lotrafilcon B lens designs include spherical. toric, multifocal toric lenses in the following parameter ranges:
| • Diameter Range: | 13.0 to 15.0 mm |
|---|---|
| • Base Curve Range: | 8.0 to 9.2 mm |
| • Power Range: | -20.00D to +20.00D |
| • Center Thickness: | varies with design and power |
| (Example: 0.08 mm for -3.00D spherical) |
Lenses have the following properties:
- . Refractive index: 1.42 (hydrated)
- Light transmittance: > 94 % ●
- Water content : 33% by weight in normal saline
- Oxygen permeability 110 x 10-11 ●
[(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Lotrafilcon B contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with or without additives [1% Copolymer 845, or 1% Copolymer 845 and 0.04% (400 ppm) polyoxyethylene-polyoxybutylene copolymer (EO45BO10)]. The compatibility and package integrity of the blister pack packaging system have been demonstrated and successfully used for other 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).
Indications for Use
Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
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Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and have up to approximately 1.50 diopters of astigmatism.
Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia) and presbyopia in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of refractive and/or corneal astigmatism.
Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, as recommended by the eye care professional.
Brief Summary of Nonclinical Tests and Results
A series of nonclinical tests were performed to demonstrate the substantial equivalence of lotrafilcon B contact lenses packaged with saline additive (modified saline) 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 ISO standards, as applicable. Results verify that lenses packaged in modified saline remain nontoxic and biocompatible and have material characteristics comparable to, or better than, other currently marketed soft contact lenses. Results from all tests demonstrate substantial equivalence to the predicate lenses.
A series of nonclinical testing was performed to verify the equivalence of lenses packaged in modified saline to the predicate device. Nonclinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58). The results of all nonclinical testing demonstrate:
- . The lens material, lens extracts and package saline of the device in modified saline are equivalent to the predicate and remain non toxic and non-irritating.
- Lens physical and material properties of the device in modified saline are consistent with . industry-marketed lenses and equivalent to or better than the predicate lens.
6
- Like the predicate device, the device in modified saline is compatible with commonly . available lens care products.
Substantial Equivalence Comparison and Conclusion
Table 1 provides a side-by-side comparison of the device in modified saline as compared to the predicate device in terms of intended use and technological information.
| Table 1 Substantial Equivalence Comparison | |||
|---|---|---|---|
| Predicate Devices | Device in Modified Saline | ||
| Trade Name | O2OPTIX® | AIR OPTIX® AQUA | AIR OPTIX® plus HydraGlyde® |
| Submission Number | K033919/ | ||
| P010019/S003 | K073459 / | ||
| P010019/S008 | 510(k) # to be assigned | ||
| Device Classification Name | Daily Wear Soft Contact Lens 21 CFR 886.5925 (b) (1) | Same | Daily Wear Soft Contact Lens |
| 21 CFR 886.5925 (b) (1) | |||
| Extended Wear Soft Contact Lens | |||
| 21 CFR 886.5925 (b) (2) | Same | -- | |
| Intended Use | Vision correction | Same | Same |
| Wearing Schedule | Daily wear and extended wear up to six nights | Same | Daily wear |
| Replacement Schedule | Up to one month | Same | Same |
| Material Classification | Group V (silicone hydrogel) soft contact lens material according to ISO 18369-1:2006/Amd.1:2009 | Same | Same |
| Lens Material | Lotrafilcon B | Same | Same |
| Surface Treatment | Plasma treated | Same | Same |
| Manufacturing Method | Double-side molding | Same | Same |
| Visibility Tint | Copper phthalocyanine blue | Same | Same |
| Predicate Devices | Device in Modified Saline | ||
| Lens Designs | Spherical, toric, | ||
| multifocal, multifocal | |||
| toric | Same | Same | |
| Power Range | +20.00 to -20.00D | Same | Same |
| Base Curve Range | 8.0 to 9.2 mm | Same | Same |
| Diameter Range | 13.0 to 15.0 mm | Same | Same |
| Water Content | 33% | Same | Same |
| Refractive Index | 1.422 | Same | Same |
| Oxygen | |||
| Permeability | ~110* | Same | Same |
| Sterilization | Steam sterilization, | ||
| validated autoclave | Same | Same | |
| Packaging | Global blister pack | Same | Same |
| Package Storage | |||
| Saline Solution | Phosphate buffered | ||
| saline | Phosphate | ||
| buffered saline | |||
| with (or | |||
| without) | |||
| 1% Copolymer | |||
| 845 | Phosphate buffered saline | ||
| with 1% Copolymer 845 | |||
| and | |||
| 0.04% (400 ppm) ethylene | |||
| oxide-butylene oxide | |||
| (EO45BQ10) copolymer |
Table 1 Substantial Equivalence Comparison
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Table 1 Substantial Equivalence Comparison
*Dkc, boundary layer corrected Dk single point coulometric method (barrer units)
Lotrafilcon B soft contact lenses packaged in modified saline are equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.
Any differences which may exist between lotrafilcon B soft contact lenses packaged in modified saline and the predicate device or other Group V silicone hydrogel soft contact lenses do not adversely affect the safety and effectiveness of the device.