(36 days)
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No
The summary describes a contact lens and explicitly states that it is substantially equivalent to a predicate device, with no mention of AI or ML technology.
No
The device is a contact lens used to correct vision acuity, which is a prosthetic device, not a therapeutic device.
No
The device is described as a daily wear contact lens intended to correct vision acuity, not to diagnose a condition.
No
The device description clearly states it is a contact lens, which is a physical medical device, 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 to "correct the vision acuity of the patient" by being "fit on the cornea." This is a direct therapeutic or corrective action on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical characteristics and design of a contact lens, which is a medical device used for vision correction.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This contact lens does not fit that description.
N/A
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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
For Soft-55 Vifilcon A Daily Wear Plastic Contact Lens:
Summary Of Safety And Effectiveness
The Soft-55 daily wear contact lens design is substantially equivalent to the designs of the predicate lens currently in commercial distribution (Softcon® Daily Wear lens). The Soft-55 lens also has light transmission, refractive index and physical characteristics comparable to the predicate Softcon® Daily Wear lens. Because the design is equivalent and the lens properties are equivalent and the manufacturing processes are equivalent, no new issues of safety or effectiveness are introduced by the Soft-55 lens. The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the comea to correct the vision acuity of the patient. The lenses have identical indications, warnings, contra indications and produce the same effect on the eye. The Soft-55 lens is as safe and effective as the predicate device Softcon® Daily Wear lens.
K 961428
MAY 21 1996