(84 days)
No
The summary describes colored contact lenses for vision correction and cosmetic purposes, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device is indicated for "occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic uses.
No
Explanation: The device is a contact lens indicated for daily wear to enhance or alter eye color, for managing certain eye conditions, and for correcting refractive ametropia. Its functions are therapeutic and cosmetic, not diagnostic.
No
The device description clearly states that the device is a physical contact lens made of methafilcon A, 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 Function: The description clearly states that these are contact lenses intended for placement on the eye for purposes like vision correction, color enhancement, ocular masking, and occlusive therapy. They do not analyze samples taken from the body.
- Intended Use: The intended use focuses on managing conditions related to the eye itself or altering its appearance, not on diagnosing conditions through analysis of bodily fluids or tissues.
Therefore, the Leo Colors, Leo Aspheric Colors, and Leo Toric Colors contact lenses are medical devices, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses l. are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eves that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia. amblyopia or extreme photophobia.
Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to 2. enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal. iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eves. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL; MVN
Device Description
The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic lenses. The lens material, methafilcon A, is a random co-polymer of hydroxyethylmethacrylate and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. The lenses are made by modifying the uncolored methafilcon A base lens by affixing colorants on that portion of the front surface that corresponds to the iris. The colorants Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 are listed in 21 CFR Part 73.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic. A leachability study was conducted to assess the color fastness of the listed dyes used to tint the Leo Colors. Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. The study demonstrates that after two weeks of extraction at 37°C in saline, undetectable levels (
§ 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
Goper Vision P
Leo Colors Methafilcon A
510(k) Summary
Premarket Notification
Ko41138
-
- SUBMITTER:
Submitted on Behalf of:
- Company Name:
- I Address:
- I Phone:
- Fax:
2. CONTACT PERSON:
- Company Name:
- E Address:
- 트 Phone:
- 트 Fax:
Bonnie Tsymbal
April 28, 2004
Unit 2. South Point
011 44 2380 605200 011 44 2380 605299
Hamble SO3 4RF Southampton UK
CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688
CooperVision Manufacturing, Ltd.
-
- DATE SUMMARY PREPARED:
4. DEVICE IDENTIFICATION:
-
프 Trade Name:
Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lens -
I Common Name: Hydrophilic Soft Contact Lens
-
I Classification
-
트 Device Classification:
Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)
5. DEVICE DESCRIPTION:
The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic lenses. The lens material, methafilcon A, is a random co-polymer of hydroxyethylmethacrylate and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. The lenses are made by modifying the uncolored methafilcon A base lens by affixing colorants on that portion of the front surface that corresponds to the iris. The colorants Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 are listed in 21 CFR Part 73.
1
| Chemical Name | CI Number | CFR# |
|---|---|---|
| Titanium dioxide | 77891 | 73.3126 |
| Poly (hydroxyethyl methacrylate)-dye | ||
| copolymer | C.I. Reactive Blue 21 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye | ||
| copolymer | C.I. Reactive Red 180 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye | ||
| copolymer | C.I. Reactive Yellow 15 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye | ||
| copolymer | C.I. Reactive Black 5 | 73.3121 |
6. INTENDED USE
-
- Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eve, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
-
- Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia an extreme photophobia.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eve care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.
2
7. PREDICATE DEVICE:
The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear manufactured by Cooper\ision Manufacturing Ltd. Is equivalent to the Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164) and Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear (K001090)
As the methafilcon A base lens is produced at the same manufacturing facility as the Frequency 55, Frequency Colors and Expressions, the physical, optical and chemical properties are the same. They are all in Lens Group 4, high water ionic polymer as established by FDA and located in the May 1994 Guidance Document for Daily Wear Contact Lenses.
| | Leo Colors
Subject Device | Frequency 55
Predicate Device
K971164 | Frequency Colors
Predicate Device
K001090 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Methafilcon A | Equivalent | Equivalent |
| Material
Classification | Hydrophilic lens, Group 4 | Equivalent | Equivalent |
| Indication for use | Daily Wear
Myopia, hyperopia and
astigmatism | Daily Wear
Myopia and hyperopia | Daily Wear
Myopia, hyperopia and
astigmatism |
| Water Content | 55% | Equivalent | Equivalent |
| Light transmittance | >90.0% | Equivalent | Equivalent |
| Dk (35°) | 15.04 | Equivalent | Equivalent |
| Index of Refraction | 1.41 | Equivalent | Equivalent |
| Powers | -20.00 to +20.00D | Equivalent | Equivalent |
| Colorants | Titanium Dioxide
CI Reactive Blue 21
CI Reactive Red 180
CI Reactive Yellow 15
CI Reactive Black 5. | CI Reactive Blue 4 | Carbozale violet
chromim oxide green
dihydrodinaphto brown
dihydrodioxo yellow
phthalocyanine green
iron oxide red
iron oxide brown
iron oxide black
phthalocyanine blue
and titanium dioxide |
| Tint Process | Ink jetting
post lens forming. | In-monomer tint | Pad printing
post lens forming |
| Manufacturing
Method | Molded or FIPS II | Molded | Molded or FIPS II |
3
PRECLINICAL INFORMATION 8.
The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.
A leachability study was conducted to assess the color fastness of the listed dyes used to tint the Leo Colors. Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. The study demonstrates that after two weeks of extraction at 37°C in saline, undetectable levels (