(118 days)
Not Found
No
The summary describes standard contact lenses and their manufacturing process, with no mention of AI or ML technology.
No.
The device is indicated for vision correction of refractive ametropia (myopia or hyperopia) and to protect against harmful UV radiation, not for treating a disease or therapeutic condition.
No
Explanation: The provided text describes contact lenses used for vision correction and protection against UV radiation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of polymacon, a hydrogel material, and is manufactured using a cast molding method. It is supplied sterile in a blister package. This indicates a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Aquamax contact lenses are for "vision correction of refractive ametropia" and are worn directly on the eye. They are a medical device used for vision correction, not for analyzing biological samples.
- Intended Use: The intended use is to correct vision in people with myopia or hyperopia, not to diagnose or monitor a disease through laboratory testing.
The provided information describes a contact lens, which is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Eye Care Practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes (cornea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners / 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)
Clinical studies for Aquamx (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
Non-clinical Study: All tests were conducted in accordance with the May 1994 FDA guideline title Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens (K020927); and Frequency 38 (Polymacon) Soft (Hydrophilic) Contact Lens (K042824).
Biocompatibility: The standard cytotoxicity, maximization sensitization and ocular irritation tests were carried out for both Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and negative responses were recorded for all tests. The validity of blister package for lenses was demonstrated by passing the standard extraction tests.
Microbiology: Steam sterilization process had been validated to deliver a minimum SAL of 10^6, thereby complying with the requirement of FDA group IV. There is shelf-life stability supporting that these lenses remain sterile through the expiration date claimed for the product.
Bacteriostatic Validation: The steam sterilizer was tested for effectiveness by measuring and demonstrating the uniformity of temperature at different location inside the sterilizer over test period. Tested microorganisms were killed under tested conditions as compared to control. Lenses remained sterilized and there was no microbial growth for a period of 5 years tested under accelerated condition. Seal of lens packages remained tight for a period of 5 years as demonstrated by the constant peeling strength tested under accelerated condition.
Leachability: Studies were conducted to determine the leachable materials from the finished lenses. The results show that, at the levels of the detection reported, there are no leachable monomers and additive residues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI23973
1.4 510(k) SUMMARY
APR 2 3 2013
The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).
Submitter Information
| Company: | PEGAVISION CORPORATION |
|---|---|
| 2F-1 No.5, Shing Yeh St. Shan Ding Vil. Kwei Shan Hsiang, | |
| Taoyuan Hsien 333, Taiwan | |
| Contact Person: | Mr. Tony Hsu, President |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | tonyhsu@pegavision.com.tw |
| Date Prepared: | Dec. 17, 2012 |
Identification of Device
| Trade Name: | Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic)
Contact Lenses
Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic)
Contact Lenses |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925,
Product Code LPL
Lenses, Soft Contact (Disposable), 21CFR. 886.5925,
Product Code MVN |
| FDA Classification: | Class II |
Indication for use
Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be
1
K123973
prescribed in spherical powers ranging from +20.00D to -20.00D.
- Eye Care Practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Description of Device
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Summary of Clinical Study
Polymacon lenses have been used widely. Its safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA
- Soflens Multifocal (Polymacon) Visibility Tinted Contact lens, K 020927 . Submitted by Bausch & Lomb Inc.
- Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens, K 042824, . submitted by Cooper Vision Inc.
Clinical studies for Aquamx (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
l - 1 1
2
Non-clinical Study
All tests were conducted in accordance with the May 1994 FDA guideline title Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses.
The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens (K020927); and Frequency 38 (Polymacon) Soft (Hydrophilic) Contact Lens (K042824). The evidence of substantial equivalence to the predicate lenses is described below.
a) Technological characteristics studies
The technological characteristics of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.
| Characteristics | Aquamax
(Polymacon)
Quarterly
Disposable Soft
(Hydrophilic)
Contact Lens | Aquamax
(Polymacon)
Monthly
Disposable Soft
(Hydrophilic)
Contact Lens | Soflens Multifocal
(Polymacon)
Visibility Tinted
Contact Lens | Frequency 38
(Polymacon) Soft
(hydrophilic)
Contact Lens |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|
| FDA Group | Group I
95 % | > 95 % | > 96 % | > 97 % |
| % T at 380-316 nm |