(103 days)
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No
The document describes a standard contact lens and its material properties, with no mention of AI or ML in its intended use, device description, or performance studies.
No.
The device is indicated for the correction of refractive ametropia (myopia and hyperopia), which is a condition requiring correction, not treatment.
No
The device is a contact lens used for vision correction (refractive ametropia), not for diagnosing a condition.
No
The device description clearly states it is a "hemispherical flexible shell" made of a "hydrophilic polymer," which is a physical object (a contact lens) and not software.
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 description clearly states that this device is a contact lens intended for the correction of refractive ametropia (vision problems) by being placed directly on the eye. It is a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
- Intended Use: The intended use is to correct vision, not to diagnose a condition based on laboratory analysis.
Therefore, based on the provided information, this contact lens is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves 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 a chemical or hydrogen peroxide disinfection system. 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 disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device, and to establish the safety and effectiveness of the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear. All testing was conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994. Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
2 2000 FEB
Image /page/0/Picture/1 description: The image shows the words "SPECIALTY" and "ULTRAVISION INC." stacked on top of each other. The word "SPECIALTY" is in a sans-serif font and is slightly blurred. The words "ULTRAVISION INC." are in a serif font and are much clearer. The word "ULTRAVISION" is much larger than the word "INC."
K 993580
510(k) Summary
Submitter Information:
Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, CA 95008 Garold Edwards, O.D., F.A.A.O. Contact Person: Vice President, Technical Affairs (408) 341-0700 Telephone: Fax: (408) 341-0717
Date Prepared: October 19, 1999
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | Specialty 55 (methafilcon A) Soft (Hydrophilic) Single |
| Vision Contact Lens for Daily Wear | |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |
Predicate Devices:
The Specialty 55 (methafilcon A) Soft Single Vision Contact Lens for Daily Wear was selected as the predicate device. This device, which was cleared under 510(k) K984090, is manufactured from the same polymer and the same lens design.
Description of Devices:
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.
1
Comparison to Predicate Device
| PARAMETER | Specialty 55 (methafilcon A)
Soft (Hydrophilic) Single
Vision Contact Lens for Daily
Wear | Specialty 55 (methafilcon A)
Soft (Hydrophilic) Single
Vision Contact Lens for Daily
Wear |
|-------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| material | methafilcon A | methafilcon A |
| material classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| indication for use | myopia, hyperopia | myopia, hyperopia |
| water content | 55% | 55% |
| light transmittance | Approximately 98% | Approximately 98% |
| Dk (35° C) | 18.8 x 10 -11 | 18.8 x 10 -11 |
| powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue visibility |
| refractive index | 1.42 | 1.42 |
| specific gravity | 1.06 | 1.06 |
| Method of manufacture | Molded | Molded |
| Tint | D&C Green #6 | Vat Blue #6 |
| Tint process | Entrapment process during
polymerization | Entrapment process during
polymerization |
Indications for Use:
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves 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 a chemical or hydrogen peroxide disinfection system. 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 disinfection systems.
Description of Safety and Substantial Equivalence:
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device, and to establish the safety and effectiveness of the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear. All testing was conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994. Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts.
Conclusion:
Information submitted in the 510(k) establishes that the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear has comparable physicochemical properties to the predicate device and does not raise questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.
2
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" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes above a wavy line, symbolizing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 FEB
Garold L. Edwards, O.D. Vice President, Technical Affairs Specialty Ultravision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008
Re: K993580
Trade Name: Specialty 55 (methafilcon A) Soft (hydrophilic) Single Vision Lens For Daily Wear (cast-molded, visitint with D & C Green #6)
Regulatory Class: II Product Code: 86 LPL Dated: January 14, 2000 Received: January 18, 2000
Dear Dr. Edwards:
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 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 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 - Garold L. Edwards, O.D.
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 (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
4
INDICATIONS STATEMENT
Device Name:
Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear
Indications for Use:
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) 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 a chemical or hydrogen peroxide disinfection system. 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 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__ Over-the-Counter Use OR
E.S. Co. Ph.D.
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K 993580
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