(272 days)
Not Found
No
The description focuses on the material properties, design, and intended use of contact lenses, with no mention of AI or ML technology.
No.
The contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are refractive errors and not diseases requiring therapeutic treatment.
No
The device description clearly states it is a contact lens used for the correction of ametropia and presbyopia, which are refractive errors, not conditions that require diagnosis.
No
The device description clearly states it is a physical contact lens made of a specific material (methafilcon A) and is a "hemispherical flexible shell". This indicates 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 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, presbyopia) by covering the cornea and sclera. This is a physical device used directly on the eye for vision correction, not a test performed on a biological sample.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The performance studies focus on safety and effectiveness as a contact lens, not diagnostic accuracy.
N/A
Intended Use / Indications for Use
The I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens 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 I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens 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 that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The I-55 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 (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
Product codes
LPL
Device Description
I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The I-55 Single Vision Contact Lens is available in a single vision lens design, the I-55 Toric Contact Lens is available in a back surface design, and the I-55 Multifocal Contact Lens is available in a concentric lens design. The lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.
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, eyes
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)
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of I-55 Single Vision, I-55 Toric, and I-55 Multifocal (methafilcon A) 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. I-55 lenses were extracted and evaluated for conformance to standards. Results showed no evidence of unacceptable levels of residues in the extracts. Physicochemical testing of I-55 lenses demonstrated equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary
Submitter Information:
PolyVue Distribution, Inc. 759 Appian Way Pinole, California 94564
| Contact Person: | Garold L. Edwards |
|---|---|
| Telephone: | |
| Fax: | (408) 221-3860 |
| (831) 335-0166 | |
| Date Prepared: | March 3, 2008 |
| Device Name: | |
| Common Name: | Soft (Hydrophilic) Contact Lens |
| Trade/Proprietary Names: | I-55 Single Vision (methafilcon A) Soft |
| (Hydrophilic) Contact Lens for Daily Wear | |
| I-55 Toric (methafilcon A) Soft (Hydrophilic) | |
| Contact Lens for Daily Wear | |
| I-55 Multifocal (methafilcon A) Soft (Hydrophilic) | |
| Contact Lens for Daily Wear |
Soft (Hydrophilic) Contact Lens Classification Name:
Class II (21 CFR 886.5925) Device Classification:
Predicate Devices:
The molded Definition AC (methafilcon A) Soft (Hydrophilic) Contact Lens was selected as the predicate device.
Description of Devices:
I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The I-55 Single Vision Contact Lens is available in a single vision lens design, the I-55 Toric Contact Lens is available in a back surface design, and the I-55 Multifocal Contact Lens is available in a concentric lens design. The lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the
1
initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.
Comparison to Predicate Devices
| Lens type | I-55 Single Vision,
I-55 Toric and I-55
Multifocal
(methafilcon A) Soft
(Hydrophilic) Contact
Lenses for Daily Wear | Definition AC
(methafilcon A) Soft
(Hydrophilic) Contact
Lenses for Daily Wear |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Predicate
device 510(k) | | K051095 |
| Material | methafilcon A | methafilcon A |
| Material
classification | Hydrophilic Lens Group 1 | Hydrophilic Lens Group 1 |
| Indication for
use | myopia, hyperopia,
astigmatism and
presbyopia | myopia, hyperopia,
astigmatism and
presbyopia |
| Water content | 55% | 55% |
| Visible light
transmittance | 99% | 98% |
| Dk (35° C) | $19.01 \times 10^{-11}$ | $18.86 \times 10^{-11}$ |
| Powers | +20.00 to -20.00
Diopters | +20.00 to -20.00
Diopters |
| Color | blue visibility | blue visibility |
| Refractive
Index | 1.415 | 1.416 |
| Specific gravity | 1.039 | 1.030 |
| Method of
manufacture | Molded | Molded |
2
Image /page/2/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K080794". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
Indications for Use:
The I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens 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 I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens 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 that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The I-55 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 (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
Description of Safety and Substantial Equivalence:
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of I-55 Single Vision, I-55 Toric, and I-55 Multifocal (methafilcon A) 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. I-55 lenses were extracted and evaluated for conformance to standards. Results showed no evidence of unacceptable levels of residues in the extracts. Physicochemical testing of I-55 lenses demonstrated equivalence to the predicate devices.
Conclusion:
Information submitted in the 510(k) establishes that I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) contact lenses have comparable physjcochemical 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 lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Poly Vue Distribution, Inc. c/o Garold L. Edwards, OD. FAAO 7077 McAdams Lane Felton, CA 95018
DEC 1 7 2008
Re: K080794
Trade/Device Name: I-55 Single Vision (methafilcon A) Soft (hydrophilic) Contact Lens for
Daily Wear
I-55 Toric (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear I-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: November 18, 2008 Received: November 21, 2008
Dear Dr. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
M. B. Egorlums, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K080794
Device Names:
I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Indications for Use:
I-55 Single Vision (methafilcon A) 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.
I-55 Toric (methafilcon A) 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 not aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 5.00 Diopters.
Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily I-55 Wear 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 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 chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ing-chun Shih
(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number
014