(51 days)
The FREQUENCY 55™ (methafilcon A ) 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 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 chemical or hydrogen peroxide disinfection systems.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which vield 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 center 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.
The provided 510(k) summary (K971164) describes a contact lens and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance data. Therefore, many of the requested fields cannot be directly extracted from this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a format suitable for such a table. It primarily asserts that the physical, optical, and chemical properties of the FREQUENCY 55™ lens are equivalent to its predicate device, The LifeStyle FREQUENCY™ Progressive (methafilcon A) Soft Contact Lens for Daily Wear.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence of physical, optical, and chemical properties to predicate device | "The physical, optical, and chemical properties of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle FREQUENCY Progressive (methafilcon A) Soft Contact Lens for Daily Wear (clear and tinted)." |
| Manufacturing information alignment with predicate device | "Aspect Vision Care, Ltd. has received from the manufacturer of the LifeStyle FREQUENCY Progressive... all manufacturing information including; but not limited to, formulation, manufacturing processes... lens parameter tolerances, sterilization and packaging, quality control/quality assurance, established shelf life data, shelf life protocol) necessary to manufacture the devices..." |
| Manufacturing location | "Aspect Vision Care, Ltd, will manufacture these devices at the same manufacturing location as the predicate devices." |
| Indications for Use (same as predicate) | "The FREQUENCY 55™ (methafilcon A ) 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 Diopters that does not interfere with visual acuity." (This matches the predicate's intent for a similar lens type). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific "test set" in the context of a clinical performance study. The submission relies on demonstrating equivalence through manufacturing information and the inherent properties of the material and design, presumed to be identical to the predicate device. Therefore, no sample size or data provenance for a test set is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. No test set involving human review or adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This is a 510(k) submission for a contact lens, which typically focuses on material safety, manufacturing equivalence, and performance characteristics rather than reader studies of diagnostic accuracy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The device is a physical contact lens, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profile of the predicate device (The LifeStyle FREQUENCY™ Progressive (methafilcon A) Hydrophilic Multifocal Contact Lens for Daily Wear). The submission aims to establish that the new device is sufficiently similar to the predicate that its safety and effectiveness can be inferred. This "ground truth" is based on the previously cleared device's regulatory approval and presumed successful market history.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no establishment of ground truth for it.
In summary:
This 510(k) submission is for a contact lens and follows a "substantial equivalence" pathway. Its primary focus is on demonstrating that the new device is functionally and materially the same as a legally marketed predicate device, leveraging the predicate's established safety and effectiveness. It does not contain information about clinical studies with specific acceptance criteria, test sets, or expert review panels typically found in submissions for AI-powered diagnostic devices.
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MAY 2 | 1997
510 (k) Summary K 971164
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
DATE SUMMARY PREPARED: April 17, 1997
FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact TRADE NAME: Lens for Daily Wear (clear and tinted)
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact Lens for Daily Wear (clear and tinted) is equivalent to The LifeStyle FREQUENCY™ Progressive (methafficon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) currently marketed in the U.S.
The FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) is substantially equivalent to the LifeStyle FREQUENCY Progressive (methafilcon A) Hydrophilic Multifocal Contact Lens for Daily Wear manufactured by The LifeStyle Company, Inc. Aspect Vision Care, Ltd. has received from the manufacturer of the LifeStyle FREQUENCY Progressive (methafilcon A) Hydrophilic Multifocal Contact Lens for Daily Wear all manufacturing information including; but not limited to, formulation, manufacturing processes (including polymentation 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 K951893 and K963011. In addition. Aspect Vision Care, Ltd, will manufacture these devices at the same manufacturing location as the predicate devices.
This lens is in Group 4, lonic, high 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 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle FREQUENCY Progressive (methafilcon A) Soft Contact Lens for Daily Wear (clear and tinted).
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DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which vield 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 center 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 55 (mothafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
The FREQUENCY 55™ (methafilcon A ) 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 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 chemical or hydrogen peroxide disinfection systems.
PARAMETERS AVAILABLE:
The FREQUENCY 55™ (methafficon A ) 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 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
K971164 Re:
Trade Name: Frequency™ 55 (Methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (Clear and Visibility tint, Spherical and Cast-molded) Regulatory Class: II Product Code: 86 LPL Dated: March 25, 1997 Received: March 31, 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 (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,
A. Ralph Rosenthal, M.D.
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™ 55 (methafilcon A) (Hydrophilic Contact Lens for Daily Wear (clear and tinted)
The FREQUENCY 55 (methafilcon A) 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 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 chemical or hydrogen peroxide disinfection systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaiuation (ODE)
Prescription Use
OR
Over-the-Counter Use
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Division Sign-Off
5/14/97
(Optional Format 1-2-96)
Division Sign-Off
Division of
m: Devices
510(k) Number: K97 11 64
103
§ 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.