(53 days)
P920008, K941607
None
No
The summary describes standard contact lenses and their material properties, with no mention of AI or ML technology.
No.
Explanation: The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are refractive conditions, not diseases or injuries requiring therapeutic intervention.
No
The device is a contact lens used for correction, not diagnosis, of refractive errors.
No
The device description clearly states it is a physical contact lens made of a hydrophilic polymer, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these are contact lenses intended for daily wear to correct refractive errors (myopia, hyperopia, astigmatism, and presbyopia) by being placed on the surface of the eye (cornea and sclera). This is a physical device used for vision correction, not a test performed on a biological sample.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes in the context of disease or condition identification.
Therefore, the 55 SV, 55 Multifocal, and 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are medical devices, but they fall under the category of vision correction devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic 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 55 Multifocal (ocufilcon C) 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 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens is inclicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non- diseased eyes.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care 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 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.
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
Eye care 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)
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the 55 SV, the 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.
Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The 55 SV lenses were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the extracts. Physicochemical testing of the 55 lenses demonstrated equivalency to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P920008, K941607
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
JUL 1 - 2005
Image /page/0/Picture/2 description: The image shows the words "United Contact Lens" in a stylized font. Below the words "United Contact Lens" is a black box with the words "SOFT CONTACT LENSES" in white font. The words "United Contact Lens" are stacked on top of each other, with "United" on top, "Contact" in the middle, and "Lens" on the bottom.
19111 - 615 Avenue NE, Suite 5. Arlington, Washington 98223 Office: 425-743-7343 Fax: 425-743-8795 Toll Free: 800-446-1666
510(k) Summary
Submitter Information:
United Contact Lens Inc. 19111 61st Ave. NE #5 Arlington, WA 98223 Registration No. 2918644
| Contact Person: | Garold L. Edwards, O.D., F.A.A.O. |
|---|---|
| Regulatory Consultant | |
| Telephone: | (408) 221 - 3860 |
| Fax: | (425) 743 - 8795 |
May 4, 2005 Date Prepared:
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | 55 SV (ocufilcon C) Soft |
| (Hydrophilic) Contact Lens for Daily Wear |
55 Multifocal (ocufilcon C) Soft (Hydrophilic)
Contact Lens for Daily Wear
55 Toric (ocufilcon C) Soft (Hydrophilic)
Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |
Predicate Devices:
The 55 F (ocufilcon C) Soft (Hydrophilic) Single Vision Contact Lens, the 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens and the 55 Toric Contact Lens were selected as the predicate devices manufactured in the same facility, using the same formulation, under the same quality system packaging and sterilization processes as the subject devices.
1
Description of Devices:
The 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.
| PARAMETER | 55 SV, 55 Toric and 55
Multifocal Soft
(hydrophilic) Contact
Lenses for Daily Wear | 55 F, Toric 55 and Multifocal
(ocufilcon C) Soft
(hydrophilic) Contact Lenses
for Daily Wear |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Submission number | N/A | P920008/K941607 |
| Material | ocufilcon C | ocufilcon C |
| Material classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| Indication for use | myopia, hyperopia,
astigmatism and
presbyopia | myopia, hyperopia,
astigmatism and presbyopia |
| Water content | 54.9% | 54.4% |
| Visible light
transmittance | 98.9% | 98.3% |
| Dk (35° C) | $18.77 x 10^{-11}$ | $18.78 x 10^{-11}$ |
| Powers | +12.00 D to -20.00 D;
Continuous add power to
+3.00 (55 Multifocal only);
Cylinder powers -0.50 D to
-2.50 D (55 Toric only) | +20.00D to -20.00 D
Continuous add power to
+3.00 (55 Multifocal only);
Cylinder powers -0.50 D to
6.00D (Toric 55 only) |
| Color | Blue visibility,
Reactive Blue #19 | clear |
| Refractive index | 1.415 | 1.414 |
| Method of
manufacture | Molded | Lathed |
Comparison to Predicate Device
2
Indications for Use:
The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic 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 55 Multifocal (ocufilcon C) 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 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens is inclicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non- diseased eyes.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care 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.
Description of Safety and Substantial Equivalence:
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the 55 SV, the 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.
Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The 55 SV lenses were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the extracts. Physicochemical testing of the 55 lenses demonstrated equivalency to the predicate devices.
Conclusion:
Information submitted in the 510(k) establishes that the 55 SV, the 55 Multifocal and the 55 Toric Contact Lenses (ocufilcon C) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that the physical lens properties are stable. Therefore, the devices are substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font and is horizontally aligned. The background is plain and white, which makes the text stand out.
Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
JUL 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United Contact Lens, Inc. c/o Garold L. Edwards, O.D., F.A.A.O Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018
Re: K051184
Trade/Device Name:
55 SV (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Multifocal (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Toric (ocufilcon C) 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: May 4, 2005 Received: May 9, 2005
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 your 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.
4
Page 2 - Garold L. Edwards, O.D., F.A.A.O
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS STATEMENT
Device Names:
55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear
55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear
55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear
Indications for Use:
The 55 SV (ocufilcon C) Soft (Hydrophilic) 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 55 Multifocal (ocufilcon C) 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 55 Toric (ocutilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care 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.
Prescription Use X
Over-the-Counter Use_
06 001
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. O
OR
n of Ophthalmic Ear, and Throat Devises
K051184 510(k) Number