(27 days)
No
The document describes a standard soft contact lens and does not mention any AI or ML components or functionalities.
No.
The device is indicated for the correction of refractive ametropia (myopia and hyperopia), presbyopia, and astigmatism, which are refractive errors, not diseases or therapeutic conditions.
No
This device is a contact lens intended for daily wear to correct refractive errors (myopia, hyperopia, presbyopia, astigmatism) and is not described as being used for diagnosing conditions or diseases.
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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PolyVue Silver Chord, Unisoft contact lens is a device that is placed on the eye's surface to correct vision problems (refractive ametropia, presbyopia, astigmatism). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for the correction of refractive errors and presbyopia, not for diagnostic testing.
Therefore, this device falls under the category of a medical device, but specifically a contact lens for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-aphakic persons with non-diseased eyes.
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.
Product codes
86 LPL
Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal 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 of functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness), presbyopia 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 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
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)
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
510 (k) Summary
SUBMITTER:
MAR 30 1998
Submitted on behalf of:
| Company Name: | Stephen A. Dunn, Inc. |
|---|---|
| Address: | 1329 Lusitana Street |
| Honolulu, HI 96813 |
Telephone: Fax:
(808) 599-2742 (808) 521-2823
CONTACT PERSON: Martin S. Knopf
DATE SUMMARY PREPARED: February 27, 1998
TRADE NAME: The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) is equivalent to PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, and Toric Hydrophilic Contact Lenses for Daily Wear which received marketing clearance pursuant to K953807 as currently marketed in the U.S.
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to Stephen A. Dunn, Inc.'s currently marketed PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, and Toric Hydrophilic Contact Lenses for Daily Wear. PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is the same lens material that Stephen A. Dunn, Inc. received marketing clearance pursuant to K953807. This lens conforms to and is substantially equivalent to spherical, aspherical, presbyopic and astigmatic lens designs that are currently marketed in the United States. The intended use and target population are substantially equivalent.
This lens is in Group 4 ionic, 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 PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) and the PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, and Toric Hydrophilic Contact Lenses for Daily Wear which received marketing clearance pursuant to K953807 are substantially equivalent.
025 s
C
1
SIMILARITIES and DIFFERENCES:
| PARAMETER | PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) | PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical and Toric Hydrophilic Contact Lenses for Daily Wear |
|---|---|---|
| material | methafilcon A | methafilcon A |
| indication for use | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism |
| water content | 55% | 55% |
| light transmittance | >95% | >95% |
| Dk (35°C) | $18.83 X 10^{-11}$ | $18.83 X 10^{-11}$ |
| powers | -20.00 to+20.00 D | -20.00 to+20.00 D |
| color | clear and green tinted | clear |
| Color additive used | Phthalocyanine Green | N/A |
| specific gravity | 1.09 | 1.09 |
| refractive index | 1.415 | 1.415 |
DISCUSSION OF SIMILARITIES AND DIFFERENCES
The PolyVue Silver Chord, Unisoft (methafficon A) Spherical, Toric and Multificcal Hydrophlic Contact Lenses for Daily Wear (clear and linted) has the same intended use and target population as the company's referenced predicate device.
PolyVue Silver Chord, Unisoft (methallicon A) Sohencal, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tirted) differs from some of the predicate devices characteristics with respect to the addition of an approved color additive and the additional, alternative manufacturing process. These issues will now be discussed in turn.
1. Materials
methafilcon A. This is identical for both the subject and predicate device
2. Blocompatibility
Identical, since the material is the same
ri Labeling Compared to Predicate Labeling
Labeling for daily wear soft contact lenses has been provided by reference in the predicate application for Stephen A. Durn, Inc., pursuant to K950807. The only modification to this labeling is the inclusion of the color additive, phthalocyanine green to the device description. This labeling follows the recommended labeling which is supplied in the Guidance Document for Daily Wear Soft Contact Lenses issued by FDA May 1994. Each of the labeling elements, the Vial Label, Package Insert, Professional Fitting and Information Guide and Patient Instruction Booklet.
026 ో ప్ర
2
4. Manufacturing Method
In a standard lathing process for a soft lens, the lenses are fully lathe cut from cast molded buttons. This is the currently cleared manufacturing method for the predicate lens. The subject lens will be either fully lathed from these buttons or may alternatively be manufactured from a molded button, which incorporates a molded base curve. The front surface will then be lathe cut. The process shall be validated to demonstrate that the finished product is equivalent to a standard lathe cut lens. Samples will be periodically taken to continually assure that the finished lens specifications are complied with.
DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal 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 of functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness), presbyopia 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 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
INDICATIONS FOR USE:
Device Name: PolyVue Silver Chord. Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-aphakic persons with non-diseased eyes.
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:
PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted
| powers: | 20.00 to -20.00D |
|---|---|
| Center Thickness: | 0.17 mm |
| Diameter: | 14.5 mm |
| Base Curve: | 8.3 mm and 8.6 mm |
For the Multifocal Design: Add Powers:
Continuous adds to +3.25
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, torso, and legs. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1998
Stephen A. Dunn, Inc. c/o Mr. Martin S. Knopf President and CEO Knopf Associates, Inc. 90 West Main Street Freehold, NJ 07728
Re: K980818
Trade Name: Poly Vue, Silver Chord and Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tint)
Regulatory Class: II Product Code: 86 LPL Dated: February 27, 1998 Received: March 3, 1998
Dear Mr. Knopf:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are 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 devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the .. current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 devices 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.
4
Page 2 - Mr. Martin S. Knopf
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS STATEMENT
Device Name: PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in aphakic and not-aphakic persons with non-diseased eyes.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
| X | OR Over-The-Counter Use |
|---|---|
| --- | ------------------------- |
Daniel W. C. Breton Ph.D (Optional Format 1-2-96)
(Division Sign-Off)
Division Imin Devices
| 510(k) Number | K980818 |
|---|---|
| --------------- | --------- |
Signature