(62 days)
P830012-S003,P830006-S005,P840006-S007,P780013-S004,P850002-S005
No
The device description focuses on the physical design and material of a contact lens, and there are no mentions of AI, ML, image processing, or data analysis related to the device's function.
No.
The document describes a contact lens designed for vision correction and ocular comfort, not for treating a specific disease or condition. Its function is to provide an aspheric optical correction and facilitate tear exchange, which is related to general eye health and comfort, not direct therapy.
No
The device description indicates that the SeeSoft contact lens is an aspheric lens designed for vision correction and to facilitate tear exchange and oxygen flow, which are therapeutic functions, not diagnostic ones. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly describes a physical contact lens made of polymacon, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses entirely on the physical characteristics and function of a contact lens, which is a device used in vivo (on the body). There is no mention of testing samples outside of the body (in vitro).
- Device type: Contact lenses are classified as medical devices, but not typically as IVDs. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD-specific information: The text does not include any information related to typical IVD characteristics such as analytes, sample types, test methods, or performance metrics like sensitivity and specificity in the context of diagnostic testing.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The SeeSoft (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design, a front surface asphere with a spherical base. The most plus power is in the center of the lens, with the power becoming more minus towards the periphery. The lenses have been designed so as to allow about 1 mm movement on the blink, which provides tear exchange to increase oxygen under the lens and assist in the removal of corneal metabolic wastes. The material is FDA approved polymacon (2-HEMA) which, when fully hydrated, is 38% water.
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
P830012-S003, P830006-S005, P840006-S007, P780013-S004, P850002-S005
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/1 description: The image shows the text 'MAY 28 1996'. The text appears to be stamped or printed on a document. The date is written in a format where the month is abbreviated to 'MAY', followed by the day '28', and the year '1996'.
Unitens Corp. U S A 10431 72nd Street North, Largo, FL 34647-1511 S (800) 446-2020 AX (813) 545-1883
Summary of Safety and Effectiveness for the SeeSoft (polymacon) Soft (hydrophilic) Aspheric Contact Lens
Image /page/0/Picture/4 description: The image shows the word "UNILENS" in bold, black letters. The word is underlined with a thick, black line. The letter "O" in the word is stylized with a line through it.
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 SeeSoft (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 SeeSoft (polymacon) Aspheric Contact Lens is a front surface asphere with a spherical base. The most plus power is in the center of the lens, with the power becoming more minus towards the periphery. This is a similar design as the other 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.