(86 days)
510(k) 973597
No
The description focuses on the material composition and physical properties of a standard soft contact lens, with no mention of AI or ML capabilities.
No.
The device is indicated for the correction of visual acuity, which is a functional improvement rather than the treatment or prevention of a disease.
No
Explanation: The device is a contact lens indicated for the correction of visual acuity in persons with myopia or hyperopia. It does not identify, assess, or monitor a medical condition.
No
The device description clearly states it is a physical contact lens made from polymacon material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens, designed for placement on the eye to correct vision.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Anatomical Site: The device is applied to the eye, not used to analyze biological samples.
IVD devices are used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This contact lens does not perform such tests.
N/A
Intended Use / Indications for Use
The CONTAFLEX 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:
Refractive Index: 1.438 (hydrated)
Light Transmission (clear): greater than 94%
Light Transmission (tinted): greater than 94%
Water Content: 38% ± 2%
Specific Gravity: 1.170
Oxygen Permeability: 7.93 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye / cornea
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 preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX 38 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 38 Soft Contact Lens is equivalent to the currently marketed Benz polymacon contact lens material.
Toxicology: In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
510(k) 973597
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).
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 OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K023987 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
Date Prepared:
November 25, 2002
| Name: | CONTAMAC Ltd. |
|---|---|
| Address | Bearwalden Business Park |
| Saffron Walden | |
| Essex England CB11 4JX | |
| Contact Person: | Robert McGregor |
| Phone number: | 44-1799 542 000 |
| US Agent: | Medvice Consulting, Inc. |
| Martin Dalsing | |
| Phone number | (970) 243-5490 |
| Fax number | (970) 243-5501 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | CONTAFLEX 38 (polymacon) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut) |
1
CONTAMA
Equivalent Devices:
The CONTAFLEX 38 (polymacon) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device
"BENZ 38" Predicate device: Manufactured/distributed by Benz Research and Development. 510(k) number: K961103
Device Description:
The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:
| Refractive Index | 1.438 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 94% |
| Light Transmission (tinted) | greater than 94% |
| Water Content | 38% ± 2% |
| Specific Gravity | 1.170 |
| Oxygen Permeability | 7.93 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). |
2
Intended Use:
The CONTAFILEX 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Description of Safety:
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX 38 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 38 Soft Contact Lens is equivalent to the currently marketed Benz polymacon contact lens material. A summary of these results from the preclinical studies is presented below.
Toxicology:
In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.
Shelf Life
Shelf life requirements are satisfied via referencing rights granted to Contamac Ltd. for 510(k) 973597. The data presented supports substantial equivalence of this CONTAFLEX 38 Soft Contact Lens material to the already marketed Benz polymacon.
Substantial Equivalence:
The CONTAFLEX 38 Soft Contact Lens is substantially equivalent to the predicate device as depicted in the following table, and does not raise different questions of safety and effectiveness than the predicate device identified previously.
The following table depicts the pre-clinical characteristics of the CONTAFLEX 38 material, as well as the predicate device.
3
Substantial Equivalence table
| | Pre-Clinical
equivalency / Device | CONTAFLEX 38
(polymacon) | BENZ 38
(polymacon) |
|-----|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Intended Use | Indicated for daily wear for the
correction of visual acuity in
aphakic and not aphakic persons
with non-diseased eyes with
myopia or hyperopia. | Indicated for daily wear for the
correction of visual acuity in
aphakic and not aphakic persons
with non-diseased eyes with
myopia or hyperopia. |
| 2.) | Functionality | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. |
| 3.) | Indications | Daily wear, Soft (hydrophilic)
contact lens | Daily wear, Soft (hydrophilic)
contact lens |
| 4.) | Production Method | Lathe-cut | Lathe-cut |
| 5.) | FDA Group # | Group # 1