(81 days)
Not Found
No
The description focuses on the material, design, and intended use of contact lenses, with no mention of AI or ML technology.
No.
Therapeutic devices are used to treat or cure a disease or condition. This device is indicated for the correction of ametropia (myopia, hyperopia, and astigmatism), which is a refractive error of the eye, not a disease. while it improves vision, it does not treat or cure any underlying disease.
No
The device is a contact lens indicated for the correction of ametropia and presbyopia, which are refractive errors, not for diagnosing conditions.
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 medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these are contact lenses intended for daily wear to correct vision problems (ametropia, presbyopia, astigmatism) by covering the cornea and sclera. They are physical devices that interact with the eye, not devices that analyze biological samples.
- Lack of Mention of Biological Samples or Testing: The text does not mention any analysis of biological samples, diagnostic testing, or providing information about a disease state based on such analysis.
Therefore, the Igel 55 UV contact lenses are medical devices, but they fall under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eves in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.
The Igel 55 UV 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 7.00 Diopters.
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 Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. 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%). A UV absorbing compound has been incorporated into the lens polymer. All 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
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 the Igel 55 UV, the Igel UV Multifocal and the Igel 55 UV Toric (methafilcon A) Contact Lenses for Daily Wear. Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. Extraction and analysis of the lenses showed no detectables. The Igel 55 UV lenses passed the requirements of sterility and stability testing.
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
ARE PTELTD
JUN 0 4 2002
Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '20', then '8', and ends with '55'. The characters are written in a handwritten style, with varying stroke thicknesses.
510(k) Summary
Submitter Information:
IGEL Visioncare Pte. Ltd. 139 Joo Seng Road, #05-01 ATD Centre Singapore 368362 Registration Number: 9614154
Contact Person: Mr Stephen D Newman, Chief Executive Officer
+65 67491090 Telephone: 465 62848534 Fax:
Date Prepared: March 5, 2002
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | Igel 55 UV (methafilcon A) Soft |
| (Hydrophilic) Contact Lens for Daily Wear |
Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic)
Contact Lens for Daily Wear
Igel 55 UV Toric (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 Specialty 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens, the Specialty 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens and the Specialty 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens were selected as the predicate devices.
The Igel 55 UV lenses are manufactured in the same facility, under the same quality system, using the same moulding, tinting, packaging and sterilization processes. The Igel 55 UV lenses contain the same UV blocking agent as the Specialty 55 UV lenses, and the manufacturing process for adding the UV blocking agent is the same.
Description of Devices:
The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic
1
polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.
Comparison to Predicate Device
| PARAMETER | Igel 55 UV, Igel 55 UV
Multifocal, and Igel 55 UV Toric
Soft (Hydrophilic) Contact
Lenses for Daily Wear | Specialty 55 UV, Specialty 55
UV Multifocal and Specialty 55
UV Toric Soft (Hydrophilic)
Contact Lenses for Daily Wear |
|--------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submission number | | K003526 |
| Material | methafilcon A | methafilcon A |
| Material | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| classification | | |
| Indication for use | myopia, hyperopia, presbyopia | myopia, hyperopia, presbyopia |
| | and astigmatism | and astigmatism |
| Water content | 55% | 55% |
| Visible light | 90.3% | 90.3% |
| transmittance | | |
| UV transmittance |