(62 days)
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No
The device description focuses on the material, manufacturing process, and optical design of a contact lens, with no mention of AI or ML.
No.
The device description clearly indicates it is a contact lens, which is a vision correction device and not generally classified as a therapeutic device.
No
Explanation: The device is described as a "Soft (Hydrophilic) Aspheric Contact Lens" intended for vision correction, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made from polymacon, not software.
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 Description: The description clearly states that the device is a "Soft (Hydrophilic) Aspheric Contact Lens." Contact lenses are medical devices that are placed directly on the eye to correct vision.
- Lack of IVD Indicators: The text does not mention any analysis of biological samples, diagnostic testing, or any other activity related to in vitro diagnostics.
The description focuses entirely on the material, manufacturing process, design, and function of a contact lens.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The material from which the lens will be manufactured is FDA approved polymacon (2-HEMA) which, when fully hydrated, is 38% water. The FreeSoft (polymacon) Aspheric Contact Lens is a front surface asphere with a base curve consisting of multiple radii. The front asphere creates the most plus power in the center of the lens, with the power becoming more minus towards the periphery. The multiple radii in the base curve produce increased plus power in the lens. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.
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
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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.
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
MAR 2 8 1996
Summary of Safety and Effectiveness for the FreeSoft (polymacon) Soft (hydrophilic) Aspheric Contact Lens
Unitens Corp. U S A 10431 72nd Street North, Largo, FL 34647-1511 (813) 544-2531 WATS (800) 446-2020 FAX (813) 545-1883
ENS
The material from which the lens will be manufactured is FDA approved polymacon (2-HEMA) which, when fully hydrated, is 38% water. This polymer is the original soft (hydrophilic) contact lens material and has been tested for performance, comfort and oxygen transmissibility since 1972. It is the most widely employed polymer in the contact lens industry. There are over four FDA approved manufacturers of polymacon polymer.
The equipment and processes which Unilens Corp., USA uses to manufacture polymacon lenses are identical to those which are used to manufacture their other hydrophilic lenses.
The FreeSoft (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design the same as many other lenses on the market, such as the Unilens 38 (polymacon) Aspheric Contact Lens (510(k) K941836), Ideal Optics PS (polymacon) Aspheric Contact Lens (PMA No. P830012-S003), the Fulfocus (polymacon) Aspheric Contact Lens manufactured by Contact Lens Corporation of America (PMA No. P830006-S005), the Allvue (polymacon) Aspheric Contact Lens manufactured by Salvatori Ophthalmics (PMA No. P840006-S007) and the VX Soft Lens (polymacon) Aspheric Contact Lens manufactured by GBF Contact Lens (PMA No. P780013-S004 approved August 13, 1991).
The FreeSoft (polymacon) Aspheric Contact Lens is a front surface asphere with a base curve consisting of multiple radii. The front asphere creates the most plus power in the center of the lens, with the power becoming more minus towards the periphery. The multiple radii in the base curve produce increased plus power in the lens. This is a similar design as the other aspheric lenses listed above and the Unilens (hefilcon A) Soft (Hydrophilic) Aspheric Contact Lens which has been manufactured at this facility since our approval June 6, 1990 under PMA No. P850002-S005. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.
It is felt that a lens made of a polymer, such as polymacon, which has been safely used for over 20 years and utilizing an accepted aspheric design which has good movement on the eye and a record of healthy wear, should produce the safest of conditions.
Unilens Corp., USA has been approved to manufacture lenses made of lower water content polymers since October 1985. The major part of our manufacture has been Soft (Hydrophilic) Contact Lenses for Daily Wear. The present application is for a slightly lower water content (38%) polymacon for Daily Wear. Unilens Corp., USA has almost 10 years experience in the manufacture of this type of lens. Our facility was last inspected by the FDA on February 22, 1993 .
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.