(104 days)
Not Found
No
The summary describes standard contact lenses and their material properties, with no mention of AI or ML technology.
No
The device is indicated for vision correction of refractive ametropia (myopia or hyperopia), not for treating a disease or condition therapeutically.
No
Explanation: The device, contact lenses, is indicated for vision correction of refractive ametropia. It is used to correct a pre-diagnosed condition, not to diagnose a condition.
No
The device description clearly states it is a physical contact lens made of 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 vision correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes. This is a direct treatment or correction of a physical condition (refractive error), not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The device is a contact lens, a physical object placed on the eye to alter light refraction. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device does not provide information about a patient's health status based on in vitro testing.
The device is clearly a medical device intended for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- PEGAVISION Aquamax (Etafilcon A) Daily 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 0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.
-
- PEGAVISION Aquamax (Etafilcon A) Bi-weekly 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 0.00D to -12.00D. The lens is intended 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.
Product codes
LPL, MVN
Device Description
Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. 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 30% in the UVA range of 315-380mm. 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners
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 Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily 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.
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
APR 1 7 2012-
510(k) SUMMARY
Submitter Information
| (
| Company: |
|---|
Date Prepared:
PEGAVISION CORPORATION
2F-1 No.5, Shing Yeh St. Shan Ding Vil. Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan Mr. Tony Hsu. President Contact Person: Phone: 886-3-329-8808 Fax: E-Mail:
886-3-329-8897 tonyhsu@pegavision.com.tw
Dec. 27, 2011
Identification of Device
| Trade Name: | Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic)
Contact Lenses |
|----------------------|---------------------------------------------------------------------------------|
| | Aquamax (Etafilcon A) Daily 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
-
- PEGAVISION Aquamax (Etafilcon A) Daily 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
1
0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.
-
- PEGAVISION Aquamax (Etafilcon A) Bi-weekly 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 0.00D to -12.00D. The lens is intended 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.
Description of Device
Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. 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 30% in the UVA range of 315-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Summary of Clinical Study
Etafilcon A 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
ACUVUE (Etafilcona A) Contact lens, clear and visibility tint with UV blocker, K .
2
962808 Submitted by Vistakon USA
- Discon Plus (Etafilcon A) Contact Lens, visibility tint with UV blocker, K083288, . submitted by Innova Vision, Taiwan.
Clinical studies for Aquamx Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily 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 (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses ACUVUE Contact Lens clear and visibility tint with UV blocker (K962804); and Discon Plus Contact Lens visibility tint with UV Blocker. The evidence of substantial equivalence to the predicate lenses is described below.
a) Technological characteristics studies
The technological characteristics of Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.
| Characteristic | Aquamax
(Etafilcon A)
Bi-Weekly
Disposable Soft
(Hydrophilic)
Contact Lenses | Aquamax
(Etafilcon A) Daily
Disposable Soft
(Hydrophilic)
Contact Lenses | ACUVUE
(K962804) | Discon Plus
(K083288) |
|-------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| FDA Group | Group IV
50 % water, ionic
polymer | Group IV
50 % water,
ionic polymer | Group IV
50 % water
ionic polymer | Group IV
50 % water
ionic polymer |
| USAN Name | Etafilcon A | Etafilcon A | Etafilcon A | Etafilcon A |
| Production Method | Cast molding | Cast molding | Cast molding | Cast molding |
3
| Characteristic | Aquamax
(Etafilcon A)
Bi-Weekly
Disposable Soft
(Hydrophilic)
Contact Lenses | Aquamax
(Etafilcon A) Daily
Disposable Soft
(Hydrophilic)
Contact Lenses | ACUVUE
(K962804) | Discon Plus
(K083288) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| Water content | 58 % | 58 % | 58 % | 58 % |
| Refractive Index | 1.402 | 1.402 | 1.40 | 1.407 |
| Oxygen
permeability (edge
corrected)) @35
°C | 19.3 x 10-11
(cm²/sec)(mL
O₂/mL-mmHg) | 19.3 x 10-11
(cm²/sec)(mL
O₂/mL-mmHg) | 26 x 10-11
(cm²/sec)(mL
O₂/mL-mmHg) | 24 x 10-11
(cm²/sec)(mL
O₂/mL-mmHg) |
| Power(Diopter) | 0.00 to -12.00 D | 00.00 to -12.00 D | + 20.00 to -20.00D | + 20.00 to -20.00D |
| % transmittance: | | | | |
| % T at 593 nm | >95 % | >95 % | >85 % | >93 % |
| % T at 380-315 nm |