(132 days)
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No
The 510(k) summary describes a physical contact lens with specific material properties and design features. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a contact lens used for vision correction, specifically for individuals who have undergone corneal refractive surgery. While it improves quality of life by correcting vision, it does not treat or cure a disease or medical condition in the way a therapeutic device would.
No
Explanation: The device is a contact lens designed to correct refractive ametropia and improve visual acuity, not to diagnose a medical condition. Its function is therapeutic/corrective, not diagnostic.
No
The device description clearly indicates it is a physical contact lens made from specific materials with defined physical properties, not a software program.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states this device is a contact lens intended to be worn on the eye (cornea) for the correction of vision. It does not involve the analysis of biological samples.
- The intended use is for vision correction and specialized use after corneal surgery. This is a therapeutic and corrective function, not a diagnostic one.
- The device description focuses on the physical properties and design of the contact lens. This is consistent with a medical device intended for direct application to the body, not for analyzing samples.
Therefore, the FLEXI.ENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Lens is a medical device, specifically a contact lens, and not an IVD.
N/A
Intended Use / Indications for Use
The FLEXI.ENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
Product codes
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Device Description
The FIFXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric hase curve and a spherical front surface. The lens is lathe cut from methafilcon A. a random copolymer of 2-hydroxyethy) methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. It consists of 45% methafilcon A and 55% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The physical properties of the lens are as follows: ·
Refractive Index: 1.4153
Light Transmittance: greater than 95%T
Water Content: 55%
Oxygen Permeability: Dk=18 X 10-11 at 35 °C (measured by the standard Fatt method)
Specific Gravity: 1.090 g/cc
The FT.FXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear was developed to improve the visual acuity of those patients who require improved vision after photorefractive keratectomy, radial keratotomy, and other corneal refractive procedures. Other factors taken into consideration were the following:
- The topographical profile is such that it is difficult to achieve a satisfactory posterior lems surface to cornea alignment with rigid gas permeable contact l enses .
- Conventional soft (hydrophilic) contact lens designs do not readily align with the visual axis of the PRS or RK eye or supply sufficient masking of the corneal astigmatism.
- Conventional toric soft (hydrophilic) contact lenses are limited in their ability to provide a stable level of visual acuity on cases of extreme central flattening in conjunction with irregular astigmatism.
The Harrison Post Refractive Surgery Lens differs from the standard spherical FLEXIENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00n will be approximately 0.30mm thick at the center). The size of the optical zone is generally 8.0mm. The peripheral carrier is thinner than most standard soft (hydrophilic) contact lenses, approximately 0.08mm to 0.10mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral aspheric design. In some cases the periphery is manufactured with a steeper curvature than the base curve.
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
The Sponsor is referencing a small clinical study that was run in Canada. These patients had previously been fitted with the FLEXLENS (hefilcon A) HARRISON POST REPRACTIVE SURGERY THENS. These same patients were refit with the FTEXTENS 55 (methafilcon A) HARRISON POST REFRACTIVE SURGERY TANS. These patients were fit and a follow-up visit was made at an average of 2.4 months.
Their distribution was 10 patients with 12 eyes. The The principal investigator was Keith W. Harrison, FCSSA The lens was fitted to 6 patients following Photorefractive Keratectomy (PRK), 3 patients following a Radial Keratotomy (RK) and one patient following a a corneal keratoplasty (also aphakic).
The study indicates there was no substantial change from one polymer to the other. Both types of lens were made from identical parameters, the only difference was the water content.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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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
SUMMARY of SAFETY AND EFFECTIVENESS
T . General Information:
ﺔ ﺍﻟﺘﻲ
- A. Generic (USAN) Name:
methafilcon A
1 1996
-
B. Device Trade Name:
A ) FLEXTENS 55 (methafilcon HARRISON Post Refractive Surgery Tens for Daily Wear -
C. Sponsor's Name and Address
FLEXIENS LIC 3241 South Zuni Street Englewood, CO 80110 (800) 223-3539 -
K962000 D. 510(k) Number:
TT. Indications
The FLEXI.ENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
- TTT. Device Description
The FIFXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric hase curve and a spherical front surface. The lens is lathe cut from methafilcon A. a random copolymer of 2-hydroxyethy) methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. It consists of 45% methafilcon A and 55% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The physical properties of the lens are as follows: ·
| * Refractive Index: | 1.4153 |
|---|---|
| * Light Transmittance: | greater than 95%T |
| * Water Content: | 55% |
| * Oxygen Permeability: | Dk=18 X 10-11 at 35 °C |
| (measured by the standard Fatt method) | |
| * Specific Gravity: | 1.090 g/cc |
The FT.FXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear was developed to improve the visual acuity of those patients who require improved vision after photorefractive keratectomy, radial keratotomy, and other corneal refractive procedures. Other factors taken into consideration were the following:
-
- The topographical profile is such that it is difficult to achieve a satisfactory posterior lems surface to cornea alignment with rigid gas permeable contact l enses .
1
-
- Conventional soft (hydrophilic) contact lens designs do not readily align with the visual axis of the PRS or RK eye or supply sufficient masking of the corneal astigmatism.
-
- Conventional toric soft (hydrophilic) contact lenses are limited in their ability to provide a stable level of visual acuity on cases of extreme central flattening in conjunction with irregular astigmatism.
The Harrison Post Refractive Surgery Lens differs from the standard spherical FLEXIENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00n will be approximately 0.30mm thick at the center). The size of the optical zone is generally 8.0mm. The peripheral carrier is thinner than most standard soft (hydrophilic) contact lenses, approximately 0.08mm to 0.10mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral aspheric design. In some cases the periphery is manufactured with a steeper curvature than the base curve.
-
TV. Alternative Practices or Procedures
Alternative practices or procedures are in the use of available prescription products; soft (hydrophilic) contact lenses. RGP contact lenses or spectacles) -
V. Technical Summaries
A. Pre Clinical
- Toxicology
This was run on methafilcon A the FLEXLENS original 510 (k) K950294 approved by FDA 04/11/1996
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- Microhiology
This was run on methafilcon A for the FLEXT.ENS original 510(k) K950294 approved by the FDA 04/11/1996
- Microhiology
-
- Compatibilitv
This was run on methafileon A for the FIRXLENS original 510(k) K950294 approved by the FDA 04/11/1996
- Compatibilitv
-
4 Stabilitv
This was run on methafileon A for the FLEXI.ENS original 510(k) K950294 approved by the FDA 04/11/1996.
Presently we are have the shelf life at 2 years.
2
-
- Preservative Uptake Tests
This was run on methafileon A for the FLEXIENS original 510(k) K950294 approved by the FDA 04/011/1996
- Preservative Uptake Tests
-
B. Clinical
1
The Sponsor is referencing a small clinical study that was run in Canada. These patients had previously been fitted with the FLEXLENS (hefilcon A) HARRISON POST REPRACTIVE SURGERY THENS. These same patients were refit with the FTEXTENS 55 (methafilcon A) HARRISON POST REFRACTIVE SURGERY TANS. These patients were fit and a follow-up visit was made at an average of 2.4 months.
Their distribution was 10 patients with 12 eyes. The The principal investigator was Keith W. Harrison, FCSSA The lens was fitted to 6 patients following Photorefractive Keratectomy (PRK), 3 patients following a Radial Keratotomy (RK) and one patient following a a corneal keratoplasty (also aphakic).
The study indicates there was no substantial change from one polymer to the other. Both types of lens were made from identical parameters, the only difference was the water content.
FIRXLENS, I.C.C's last FDA inspection was completed on March 7, 1996.
- C. Potential Safety and Effectiveness as well as Adverse Affects of the Device on Health would be about the same as that of any other methafilcon A daily wear lens.
- D. Conclusion drawn from Study
This lens should be the equivalent of any other Flexlens daily wear lens made of methafilcon A.
- 在 A favorable recommendation from the FDA is anticipated for the manufacture and distribution of FLAXI.FINS 55 ۔ (methafilcon A) HARRISON POST REFRACTIVE SURGERY LENS for Daily Wear. Should any additional information be required, it will be supplied by the individual whose name and address is on the cover letter of this 510(k) Notification .