(61 days)
Not Found
No
The device description and intended use focus on the physical properties and refractive correction capabilities of a standard soft contact lens. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No
The device is indicated for correcting refractive errors (myopia, hyperopia, astigmatism) to improve visual acuity, which restores normal physiological function rather than treating a disease or therapeutic condition.
No
The device, a hydrophilic contact lens, is intended for the correction of refractive ametropia (myopia and hyperopia) and astigmatism. It provides corrective refraction and is not described as being used to diagnose a medical condition.
No
The device description clearly states it is a physical soft contact lens made of polymerized material, designed to fit over the corneal surface of the eye. This is a hardware 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 Function: The FREQUENCY 38™ contact lens is a medical device designed to be worn on the surface of the eye to correct refractive errors (myopia, hyperopia, astigmatism). It directly interacts with the eye to improve vision.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device itself is the therapeutic/corrective element.
Therefore, this device falls under the category of a medical device, specifically a contact lens, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2,00 Dlopters that does not interfere with visual acuity.
Evecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
Product codes
86 LPL
Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and conter over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 8mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneal surface of the eye
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
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MAY 2 | 1997
510 (k) Summary K97/049
SUBMITTER:
Submitted on behalf of:
| Company Name:
Address: | Aspect Vision Care, Ltd.
South Point, Hamble
Southampton S031 4RF
United Kingdom |
|---------------------------|-------------------------------------------------------------------------------------------|
| Phone: | 011 44 1703 455 567 |
| Fax: | 011 44 1703 455 523 |
CONTACT PERSON: Martin S. Knopf i
DATE SUMMARY PREPARED: April 16, 1997
TRADE NAME: FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to The LifeStyle4 Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) currently marketed in the U.S.
The FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) is substantially equivalent to the LifeStyle 4-Vue (polymacon) Hydrophilic Contact Leas for Daily Wear (clear and tinted) manufactured by The Life Style Company. Inc. Aspect Vision Care, Ltd. has received from the manufacturer of the LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear all manufacturing information including: but not limited to formulation, manufacturing processes (including polymerization conditions, tinting process, lens parameter tolerances, sterilization and packaging, quality control/quality assurance, established shelf life data, shelf life protocol) necessary to manufacture the devices, which are the subject of K963001 and K950283. Aspect Vision Care, Ltd. has also received from The LifeStyle Company, Inc. the right to reference its promarket notifications, K950283 and K983001. In addition. Aspect Vision Care, Ltd., will manufacture these devices at the same manufacturing location as the predicate devices.
This lens is in Group 1, non-ionic, low water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994, The physical, optical, and chemical properties of the FREQUENCY 38 (polymacon) Hydrophilic
1
Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle 4 Vue (polymacon) Soft Contact Lens for Daily Wear (clear and tinted).
DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and conter over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 8mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
INDICATIONS FOR USE:
Device Name: FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2,00 Dlopters that does not interfere with visual acuity.
Evecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
PARAMETERS AVAILABLE:
The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted)
| Powers: | +20.00 to -20.00D |
|---|---|
| Center Thickness: | 0.07 mm |
| Diameter: | 14.0 mm |
| Base Curve: | 8.6 mm |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 | 1997
Aspect Vision Care, Ltd. c/o Mr. Martin S. Knopf President and CEO of Knopf Associates, Inc. 84 West Main Street Freehold, NJ 07728
Re: K971049
Trade Name: Frequency™ 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear and Visibility tint, Spherical and Castmolded) Regulatory Class: II Product Code: 86 LPL
Dated: March 20, 1997 Received: March 21, 1997
Dear Mr. Knopf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Martin S. Knopf
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Aleryl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS STATEMENT
Device Name: FREQUENCY 38™ (polymacon) (Hydrophilic Contact Lens for Daily Wear (clear and tinted)
The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated frie i NEQUE.No i Co for daily wear for the conceased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
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NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
E is O 5/14/97
Division of Ophthalmic Devices
S10(k) Number K971049
(Optional Format 1-2-96)