(23 days)
No
The 510(k) summary describes a standard contact lens with no mention of AI, ML, image processing, or any related performance metrics or training/test data.
No
The device is a contact lens intended for correcting refractive errors (myopia, hyperopia, astigmatism) rather than treating a disease or condition for therapeutic purposes.
No
The device is a contact lens intended for correcting refractive errors (myopia, hyperopia, astigmatism) in the eyes, not for diagnosing medical conditions.
No
The device description clearly states it is a contact lens, which is a physical medical device, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Aquaflex 2 Contact Lens is a device worn on the eye for the correction of refractive errors. It does not involve testing samples from the body.
The information provided describes a medical device used for vision correction, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
Product codes
LPL
Device Description
The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate.
The Aquaflex 2 Contact Lens is a hemispherical shell of the following dimensions:
Chord diameters: 12.5 to 17.0mm
Center thickness: varies with power; Standard design 0.10 mm to 0.56 mm and Superthin design 0.05 mm to 0.39 mm
Base curves: 7.0 to 10.5mm
Powers: -20.00 to +20.00D
Optical zone diameters: 5.0 to 10.0mm
The physical/optical properties of the lens are:
specific gravity: 1.18
refractive index (wet): 1.43
light transmittance: 98%
water content: 37.5%
oxygen permeability: 8.9 x 10-11 (cm/sec)(ml O2/ml x mm Hg), measured at 21°C (Fatt Method)
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BayVue (polymacon) Soft (hydrophilic) Contact Lens
Reference Device(s)
510(k) K971647
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.
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APR 1 3 2005
510(k) Summary
K 050743
Applicant Information
| Date prepared: | March 21, 2005 |
|---|---|
| Name: | Unilens Corp., USA |
| Address: | 10431 72nd Street, North |
| Largo, FL 33777 | |
| Contact person: | Josepha Bruno, Director Quality Assurance |
| Phone number: | (727) 544-2531 x306 |
| Fax number: | (727) 545-1883 |
Device Information
| Device classification: | Class II |
|---|---|
| Classification number: | LPL |
| Classification name: | Lenses, Soft Contact, Daily Wear |
| Trade name: | Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens |
Equivalent device
The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.
Predicate device: BayVue (polymacon) Soft (hydrophilic) Contact Lens
Device description
The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate.
The Aquaflex 2 Contact Lens is a hemispherical shell of the following dimensions:
| Chord diameters | 12.5 to 17.0mm |
|---|---|
| Center thickness | varies with power; Standard design 0.10 mm to 0.56 mm |
| and Superthin design 0.05 mm to 0.39 mm | |
| Base curves | 7.0 to 10.5mm |
| Powers | -20.00 to +20.00D |
| Optical zone diameters | 5.0 to 10.0mm |
1
The physical/optical properties of the lens are:
| specific gravity | 1.18 |
|---|---|
| refractive index (wet) | 1.43 |
| light transmittance | 98% |
| water content | 37.5% |
| oxygen permeability | 8.9 x 10-11 (cm/sec)(ml O2/ml x mm Hg), measured at 21°C (Fatt Method) |
Intended use
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
Substantial equivalence
The new device will be manufactured according to specified process controls and a quality management system currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the LL-Bifocal (tefilcon) Contact Lens, 510(k) K971647. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.
2
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
APR 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Unilens Corp., USA c/o Josepha Bruno Director, Quality Assurance 10431 72nd Street North Largo, FL 33777
Re: K050743
Trade/Device Name: Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 21, 2005 Received: March 21, 2005
Dear Ms. Bruno:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110c) that do noves, subject to the general controls provisions of the Act. The I ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is onashined (600 a00 rols. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivedants of your device complies with other requirements of the Act that I DA has made a acternmentations administered by other Federal agencies. You must of ally I colch statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements, as a manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Josepha Bruno
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/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): k050743___________________________________________________________________________________________________________________________________________
Device Name: Aquaflex 2 (tefilcon) Soft (Hydrophilic) Contact Lens
Indications for Use:
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive I he Aquariex 2 Conact Lons is no astigmatism up to 1.50 diopters or less in aphakic and/or anteropia (inyopia and ifyperopla) and antigation way be disinfected using either a heat or chemical disinfection system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X | ||
|---|---|---|---|
| AND/OR | Over-The-Counter-Use | ||
| (Part 21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K050743 |
|---|---|
| --------------- | --------- |
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