(213 days)
Not Found
PMA (P820063)
No
The summary describes a rigid gas permeable contact lens with specific material properties and dimensions. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
Yes
The device is indicated for the correction of visual acuity and attenuation of bright light and glare, which are therapeutic functions.
No
The device is a contact lens designed for the correction of visual acuity and attenuation of bright light/glare. Its function is to modify vision, not to diagnose a condition.
No
The device description clearly describes a physical contact lens made of specific materials with defined physical dimensions and properties. There is no mention of software as the primary or sole component of the device.
Based on the provided information, 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 Function: The SportSight GP contact lenses are described as rigid gas permeable contact lenses intended for correcting visual acuity, attenuating bright light, reducing glare, and protecting against UV radiation. They are worn directly on the eye.
- Lack of In Vitro Testing: The description focuses on the physical properties of the lens and its performance in correcting vision and filtering light. There is no mention of testing biological samples or diagnosing any condition based on such tests.
- Intended Use: The intended use is for vision correction and protection, not for diagnosing a disease or condition.
Therefore, the SportSight GP contact lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SportSight The GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight ™ GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight ™ GP (paflufocon C) toric contact lenses are Good not morelors with reating of up to 6.00 diopters. SportSight ™ GP (paflufocon C) bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight ™ GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight ™ GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to, the cornea and into the eye
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
The SportSight GP (paflufocon C) intensely tinted, rigid gas permeable contact lenses are available in SportSight Gray. The Gray tinted lens contains D&C Red # 17, D & C Green No. 6, and Perox Yellow No. 9.
The lenses have the following dimensions:
SPORTSIGHT GP (paflufocon C) Refractive Index .. 1.466(Nd at 25°C) Luminous Transmittance (driving allowed) 8% - 26% ** Luminous Transmittance (driving prohibited) 1% - 8% ** Wetting Angle (Receding Angle) 12.81 1.14 Specific Gravity Hardness (Shore D) 84
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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
K 993586
510(k) Summary
Company Name: Paragon Vision Sciences Submitter. Address: 947 East Impala Ave. Mesa AZ 85204 Phone: 480-892-7602 Fax: 480-892-3226 Registration: Owner Operator # 9024618
Manufacturer:
Company Name: Paragon Vision Sciences Address: 947 East Impala Ave. Mesa AZ 85204 Phone: 480-892-7602 Fax: 480-892-3226: Registration. Site Registration #2020433
Official Correspondent: William E. Meyers, Ph.D. % Paragon Vision Sciences Address: 947 East Impala Ave. Mesa AZ 85204 Phone: 480-507-7606 Fax: 480-892-3226 Reason for 510(k) Submission: Material change
12/10/98 Date of submission
Device Identification:
Trade Name: SportSight GP_TM Common Name: contact lens Classification Name: rigid gas permeable contact lens for daily wear Reference: 21 CFR 886.5916;rigid gas permeable contact lens, Class
II- daily wear
Indications For Use:
The SportSight The GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight ™ GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight ™ GP (paflufocon C) toric contact lenses are Good not morelors with reating of up to 6.00 diopters. SportSight ™ GP (paflufocon C) bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight ™ GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight ™ GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to, the cornea and into the eye
1
The lenses have the following dimensions:
SPORTSIGHT GP (paflufocon C) Refractive Index .. 1.466(Nd at 25°C) Luminous Transmittance (driving allowed) 8% - 26% ** Luminous Transmittance (driving prohibited) 1% - 8% ** Wetting Angle (Receding Angle) 12.81 1.14 Specific Gravity Hardness (Shore D) 84