(61 days)
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No
The description focuses on the material properties and physical characteristics of a contact lens, with no mention of AI or ML.
No
The device is a contact lens intended for the correction of visual acuity, which is a compensatory function rather than a therapeutic one for a disease or condition.
No
The device is a contact lens intended for correcting visual acuity, not for diagnosing medical conditions.
No
The device description clearly states it is a soft contact lens fabricated from isofilcon, which is a physical material. It describes the lens's physical properties and how it conforms to the eye. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a contact lens. It is a medical device that is placed directly on the eye to correct vision. It does not analyze any biological specimens.
The description clearly states its purpose is for "correction of visual acuity" and describes its physical properties and how it interacts with the eye. This aligns with the definition of a medical device, specifically a contact lens, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.
Product codes
LPL
Device Description
The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, 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.
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 (isofilcon) 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; 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 36% water by weight. The physical properties of the lens are:
Refractive Index Light Transmission: Water Content Specific Gravity Oxygen Permeability
1.435 (hydrated) greater than 93% T 35.5 % by weight 1.19 (hydrated) 3.7 X 1011 (cm /sec) (ml Oxml x mm Hg @ 21 C), (as measured by Schema Versatae)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
K973847 The assigned 510(k) number is:
Applicant information:
| Date Prepared: | October 10, 1997 | |
|---|---|---|
| Name: | Alden Optical Laboratories | |
| Address | 13295 Broadway | |
| Alden, New York 14004 | ||
| Contact Person: | Charles H. Creighton | |
| Phone Number: | 800.253.3669 | |
| Consultant: | Martin Dalsing | |
| Phone Number: | 970.243.5490 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | AL-47 Toric |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
1
Equivalent Devices:
The AL-47 Toric is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include Optima Toric manufactured by Bausch & Lamb Co, the Soft 38 Toric manufactured by California optics and the AL-47 (spherical) manufactured by Alden Optical.
Device Description:
The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, 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.
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 (isofilcon) 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; 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 36% water by weight. The physical properties of the lens are:
Refractive Index Light Transmission: Water Content Specific Gravity Oxygen Permeability
1.435 (hydrated) greater than 93% T 35.5 % by weight 1.19 (hydrated) 3.7 X 1011 (cm /sec) (ml Oxml x mm Hg @ 21 C), (as measured by Schema Versatae)
Intended Use:
The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.
2
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to AL-47 (spherical), PMA # P820078. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.
The following matrix illustrates that the production method, lens function and material of the AL-47 Toric contact lens is substantially equivalent to the predicate devices. In addition, the water content, polymer, DK value, refractive index, specific gravity, and light transmission are as well substantially equivalent.
| | Characteristic | AL-47 Toric | PREDICATE
DEVICE(S) |
|-----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 1.) | PRODUCTION
METHOD | Lathe-Cut | SAME |
| 2.) | LENS FUNCTION | Refractive medium that focuses light rays
from near and distant objects on the retina,
while compensating for refractive error,
including (astigmatism) | SAME |
| 3.) | MATERIAL | Hydrophilic Polymer | SAME |
| a. | Water Content | 36% | 38%/45% |
| b. | Polymer Content | 65% | 62%/55% |
| c. | Polymer | isofilcon | polymacon/hefilcon B |
| d. | DK Value | 3.7 | 18.8/13.0 |
| e. | Refractive Index | 1.43 (hydrated) | 1.43 (hydrated) |
| f. | Specific Gravity | 1.19 (hydrated) | 1.180 (hydrated) |
| g. | FDA polymer group
number | Group # 1
Low water