(265 days)
Not Found
No
The document describes a standard soft contact lens made of a specific material for vision correction. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No
The device is indicated for correction of visual acuity, which means it aids or improves vision, but it does not treat or cure a disease or condition.
No
The device is a soft contact lens intended for correcting visual acuity, not for diagnosing medical conditions or diseases. Its purpose is to correct refractive errors (myopia or hyperopia), not to identify them.
No
The device description clearly describes a physical contact lens made of specific materials and with physical properties, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AQUASOFT ALL-DAY and ALL-DAY T contact lenses are designed to correct visual acuity by being placed directly on the eye. They are a medical device used for vision correction, not for analyzing biological samples.
- Intended Use: The intended use clearly states correction of visual acuity in individuals with myopia or hyperopia, and potentially astigmatism. This is a functional correction, not a diagnostic test.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself, not on any components or processes related to analyzing biological samples.
Therefore, the AQUASOFT ALL-DAY and ALL-DAY T contact lenses fall under the category of medical devices for vision correction, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AOUASOFT ALL-DAY (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT ALL-DAY T (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
LPL
Device Description
The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3 -dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in sodium carbonate buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 57% water by weight. The physical properties of the lens are:
Refractive Index: 1.4058 (wet)
Light Transmission: greater than 95%
Water Content: 57 %
Specific Gravity: 1.1287 (hydrated)
Oxygen Permeability: 20.0 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (Fatt method, ISO 9913-1).
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
Eyecare 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)
Not Found
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
MAY 1 5 2006
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K052290 Applicant information: Initial Date Prepared: August 15, 2005 : Name: ClearLab PTE, Ltd. Address 139, Joo Seng Raod #06-01 Singapore 368362 Contact Person: Mike Read Phone number: Country code 65+ 67491090 Fax number: Country code 65+ 62848534 Parent Company: 1800 CONTACTS, Inc. 66 E. Wadsworth Park Drive 3rd. Floor Draper, UT 84020 FDA US Agent/ Medvice Consulting, Inc. Official Correspondent: Martin Dalsing Phone number (970) 243-5490 Fax number (970) 243-5501 Device Information: Device Classification: Class II Classification Number: LPL Classification Name: Lenses, Soft Contact, Daily Wear Trade Name:
AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens.
1
Equivalent Predicate Devices:
The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft Contact Lenses are substantially equivalent to the following predicate devices:
-
- Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp.
-
- Benz-G 5X (hioxifilcon A), K983773, Manufactured by Benz Research & Development
-
- MIERU (etafilcon A), K030167, manufactured by ClearLab International PTE LTD.
Device Description:
The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3 -dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in sodium carbonate buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 57% water by weight. The physical properties of the lens are:
| Refractive Index | 1.4058 (wet) |
|---|---|
| Light Transmission | greater than 95% |
| Water Content | 57 % |
| Specific Gravity | 1.1287 (hydrated) |
| Oxygen Permeability | 20.0 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (Fatt method, ISO 9913-1). |
2
Intended Use:
The AOUASOFT ALL-DAY (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT ALL-DAY T (hioxifileon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Technological Characteristics:
The technological characteristics of the AQUASOFT ALL-DAY & ALL-DAY T contact lens as compared to the technological characteristics of the predicate devices are illustrated on the following page.
3
| Pre-Clinical
equivalency /
Device | AQUASOFT
ALL-DAY
& ALL-DAY T
(hioxifilcon A)
New Device | Extrreme H2O
(hioxifilcon A)
predicater device | Benz-G 5X
(hioxifilcon A)
predicater device | MIERU
(etafilcon A)
predicate device |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily
wear for the correction
of visual acuity in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | Indicated for daily
wear for the correction
of visual acuity in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | Indicated for daily
wear for the correction
of visual acuity in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | Indicated for daily
wear for the correction
of visual acuity in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. |
| Functionality | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina. | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina. | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina. | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina. |
| Indications | Daily wear, Soft
(hydrophilic) contact
lens | Daily wear, Soft
(hydrophilic) contact
lens | Daily wear, Soft
(hydrophilic) contact
lens | Daily wear, Soft
(hydrophilic) contact
lens |
| Production
Method | Cast-molded | Cast-molded | Lathe-Cut | Cast-molded |
| FDA Group # | Group # 2 >50%
Water, non-ionic
Polymer | Group # 2 >50%
Water, non-ionic
Polymer | Group # 2 >50%
Water, non-ionic
Polymer | Group # 4 >50%
Water, ionic Polymer |
| USAN name | hioxifilcon A | hioxifilcon A | hioxifilcon A | etafilcon A |
| Water
Uptake(%) | 57.0% | 61.2% | 58.0% | 58.0% |
| Oxygen
Permeability
(Dk) | 20.0 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg @
35 degrees C), (Fatt
method, ISO 9913-1). | 20.5 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg @
35 degrees C), (revised
Fatt method). | 20.2 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg @
35 degrees C), (revised
Fatt method). | 19.9 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg @
35 degrees C), (revised
Fatt method). |
| Specific
Gravity | 1.129 | 1.118 | not measured | 1.017 |
Table #1, Aquasoft All-Day as compared to predicate devices
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2006
ClearLab PTE., LTD c/o Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Drive, Suite # B7 Grand Junction, CO 81505
Re: K052290
Trade/Device Name: Aquasoft All-Day & All-Day To (hioxifilcon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: May 2, 2006 Received: May 5, 2006
Dear Mr. Dalsing:
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.
5
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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/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
6
INDICATIONS FOR USE
510(k) Number:
K052290
Device Name:
AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens.
INDICATIONS FOR USE:
The AQUASOFT ALL-DAY (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT ALL-DAY T (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Prescription Use
X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mysa Smith
n of Onlithalmic Ear Nose and Throat Devis
510(k) Number
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