(43 days)
Not Found
No
The document describes a contact lens with a specific material and design for vision correction. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is indicated for the correction of refractive ametropia and presbyopia, which are vision impairments, not for treating a disease or restoring a function. While it corrects a physical condition, it does not involve therapeutic action on a disease.
No
Explanation: The device is a contact lens intended for the correction of refractive ametropia and presbyopia, which are treatments for existing conditions rather than diagnostic activities.
No
The device description clearly states it is a physical contact lens made of a hydrophilic polymer, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Saview 55 Multifocal contact lens is a medical device that is placed directly on the eye to correct vision. It does not analyze or test any biological specimens from the body.
- Intended Use: The intended use is for the correction of refractive errors and presbyopia, which is a direct treatment/management of a physical condition, not a diagnostic test.
The information provided clearly describes a contact lens, which is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
Product codes
LPL
Device Description
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and a portion of the adjacent sclera
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
Not Found
Key Metrics
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
APR 0 4 2003
510(k) Summary
Submitter Information:
St. Shine Optical Co., Ltd. 4.5F No. 276-2, Sec.1, Ta Tong Rd. Hsi Chih City, 221 Taipei Hsein Taiwan R.O.C.
Contact Person:
Garold L. Edwards, O.D., F.A.A.O. Regulatory Consultant 2091 Upper Scenic Drive Felton, California 95018
(408) 221-3860 Telephone: (408) 265-8639 Fax:
Date Prepared: February 7, 2003
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | Saview Multifocal (methafilcon A) Soft |
| (Hydrophilic) Contact Lens for Daily Wear | |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |
Predicate Devices:
The Saview 55 F (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, the Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear and the PolyVue Unisoft (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear were selected as the predicate devices.
The Saview 55 Multifocal lenses will be manufactured and sterilized at the same manufacturing site, using identical moulding, sterilization and packaging processes as the Saview 55 F and the Saview Toric 55.
Description of Devices:
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.
1
Comparison to Predicate Device
| Device | Saview 55 Multifocal
(methafilcon A) Soft
(hydrophilic) Contact
Lens | Saview 55F and
Saview Toric 55
(methafilcon A) Soft
(hydrophilic) Contact
Lenses | PolyVue Silver Chord,
Unisoft (methafilcon
A) Spherical,
Aspherical and Toric
Soft (hydrophilic)
Contact Lens |
|--------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K020917
K021295 | K980818 |
| Material | methafilcon A | methafilcon A | methafilcon A |
| Material classification | Hydrophilic Lens
Group 4 | Hydrophilic Lens
Group 4 | Hydrophilic Lens
Group 4 |
| Indication for use | myopia, hyperopia and
presbyopia | myopia, hyperopia and
astigmatism | myopia, hyperopia,
astigmatism and
presbyopia |
| Water content | 55% | 55% | 55% |
| Visible light
transmittance | 97.6% | 97.6% | > 95% |
| Dk (35° C) | $19.5 \times 10^{-11}$ | $19.5 \times 10^{-11}$ | $18.83 \times 10^{-11}$ |
| Powers | +12.00 to -20.00
Diopters; continuous
add power to +3.25 | +12.00 to -20.00
Diopters | +20.00 to -20.00
Diopters; continuous
add power to +3.25 |
| Color | blue visibility | blue visibility | clear or green visibility |
| Refractive index | 1.3974 (wet) | 1.3974 | 1.415 |
| Method of
manufacture | Moulded | Moulded | Lathe cut |
Indications for Use:
The Saview Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
Discussion of Safety and Substantial Equivalence:
Information submitted in the 510(k) establishes that the Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens has physicochemical properties comparable to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date.
Conclusion:
The devices are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the logo. The word "DEPARTMENT" is at the bottom of the logo.
APR o 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Shine Optical Co., Ltd. c/o Garold L. Edwards Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018
Re: K030548
Trade/Device Name: Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 7, 2003 Received: February 20, 2003
Dear Mr. Edwards:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
A. halyi korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS STATEMENT
Device Names:
Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use:
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting 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. Brown, PH.D.
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises510(k) Number_K030548