(35 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, comparing it to existing predicate devices. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device description clearly identifies it as a contact lens, which is generally not considered a therapeutic device. It's used for vision correction and lens comfort, not for treating a disease or disorder.
No
Explanation: The device is described as a contact lens, which is a corrective device, not a diagnostic one. Its function is to provide vision correction and oxygen exchange, not to diagnose a condition.
No
The device description clearly describes a physical contact lens made of polymacon, which is a hardware component.
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 designed for placement on the eye. There is no mention of analyzing samples from the human body outside of the body.
- Clear description of a contact lens: The device is explicitly described as a "Soft (Hydrophilic) Aspheric Contact Lens" and its design and intended interaction with the eye are detailed.
- Predicate devices are contact lenses: The listed predicate devices are all other types of contact lenses.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Power Plus (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design. The Power Plus (polymacon) Aspheric Contact Lens is a front surface asphere consisting of multiple aspheric zones 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 material from which the lens will be manufactured is FDA approved polymacon (2-HEMA) which, when fully hydrated, is 38% water. The lenses have been designed so as to allow about 1 mm movement on the blink.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
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
APR 1 0 1996
Summary of Safety and Effectiveness for the Power Plus (polymacon) Soft (hydrophilic) Aspheric Contact Lens
Unilens Corp. U S A 10431 72nd Street North, Largo, FL 34647-1511 (813) 544-2531 WATS (800) 446-2020 FAX (813) 545-1883
1 K960926 |
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 Power Plus (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 Power Plus (polymacon) Aspheric Contact Lens is a front surface asphere consisting of multiple aspheric zones 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 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.