(61 days)
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. 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.
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.
This document is a 510(k) premarket notification for a contact lens, establishing substantial equivalence to a previously marketed device. It does not contain an acceptance criteria table or a study proving that the device meets specific acceptance criteria in the manner typically found in a clinical study report for an AI/medical device. The approval is based on equivalence to another contact lens already on the market.
Therefore, many of the requested elements for an AI device submission are not applicable to this document.
However, I can extract information related to the device and its intended use, and explain why other sections are not present:
1. A table of acceptance criteria and the reported device performance
This document does not contain explicit acceptance criteria and corresponding reported device performance in the format of a clinical study or AI performance evaluation. The "acceptance" is based on demonstrating substantial equivalence to a predicate device.
The closest equivalent to "performance" stated is that the physical, optical, and chemical properties of the FREQUENCY 38™ (polymacon) Hydrophilic 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).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a contact lens, not a study evaluating an AI algorithm on a test set. Substantial equivalence is primarily based on manufacturing information and previous approvals of predicate devices, not on a new clinical trial with a defined test set in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment with experts for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a clinical study with adjudication for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance would be present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for an AI algorithm is not relevant here. The ground truth for the safety and effectiveness of the contact lens is implicitly tied to its equivalence to previously approved, legally marketed predicate devices which have established safety and effectiveness through their own approval processes and market experience.
8. The sample size for the training set
Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, ground truth establishment is not relevant.
Summary of Relevant Information from the Document:
While the document doesn't fit the typical structure of an AI device submission, here's what can be extracted regarding the device itself:
- Device Name: FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
- Common Name: contact lens
- Predicate Device: The LifeStyle 4 Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
- Basis for Substantial Equivalence: Aspect Vision Care, Ltd. received all manufacturing information (formulation, processes, QC/QA, shelf life) from the predicate device manufacturer and has the right to reference its premarket notifications (K950283 and K963001). They will also manufacture the devices at the same location as the predicate devices.
- Device Description: Soft contact lenses made of HEMA crosslinked with EGDMA, designed to fit over the corneal surface for corrective refraction.
- Indications for Use: For daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Can be prescribed for daily wear in a Frequent Replacement Program and disinfected using heat, chemical, or hydrogen peroxide disinfection systems.
- Parameters Available:
- Powers: +20.00 to -20.00D
- Center Thickness: 0.07 mm
- Diameter: 14.0 mm
- Base Curve: 8.6 mm
- Regulatory Class: II
- Product Code: 86 LPL
This document is a regulatory submission demonstrating substantial equivalence for a medical device (contact lens), not a clinical study report for an AI-powered diagnostic or therapeutic device. Therefore, the requested information pertaining to acceptance criteria and study design for AI evaluation is not present.
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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, HambleSouthampton S031 4RFUnited 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
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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 |
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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.
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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
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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)
§ 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.