(134 days)
N17-976
N17-976
No
The description focuses on the material and physical properties of a contact lens, with no mention of AI or ML.
No
The device is a contact lens used for the correction of refractive ametropia, which addresses visual defects rather than treating a disease or condition therapeutically.
No
The device is a contact lens used for correction of refractive ametropia, not for diagnosis.
No
The device description clearly states it is a soft (hydrophilic) contact lens made from hefilcon A, which is a physical material, not software.
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 FLEXIENS is a contact lens designed to be worn on the eye (corneal) for the correction of vision problems, particularly after refractive surgery. It is a physical device that interacts with the eye, not a test performed on a biological sample.
- Intended Use: The intended use clearly states "for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery." This describes a therapeutic or corrective function, not a diagnostic one.
Therefore, the FLEXIENS falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FLEXIENS (hefilcon 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
Not Found
Device Description
The FLEXI.ENS (hefilcon A) Harrison Post Refractive Surgery Contact Lens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric base curve and a spherical front surface. The lens is lathe cut from hefilcon A, a hydrophilic random copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone crosslinked with ethylene glycol dimethacrylate. It consists of 55% hefilcon A and 45% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The physical properties of the lens are as follows: Refractive Index: 1.43, Light Transmittance: greater than 95%T, Water Content: 45%, Oxygen Permeability: Dk=16 X 10-11 at 35 °C, Specific Gravity: 0.979 g/cc.
The FLEXIENS (hefilcon 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: 1. The topographical profile is such that it is difficult to achieve a satisfactory posterior lens surface to cornea alignment with rigid gas permeable contact lenses. 2. 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. 3. 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 FLEXLENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00D 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 0.08 mm to 0.10 mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral aspheric design, with a steeper curvature than the base curve. In some cases the periphery is manufactured aspheric design, with a steeper curvature than the base curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Sponsor is referencing a small clinical study that was run in Canada. There were 10 patients with 12 eyes. Average daily wear was 12.4 hours. The principal investigator was Keith W. Harrison, FCLSA. The lens was fitted to 6 patients following Photorefractive Keratectomy (PRK), 3 patients following a Radial Keratotomy (RK) and one patient following a corneal keratoplasty (also aphakic). The safety and effectiveness lens should be equivalent to any other FLEXIENS (hefilcon A) lens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
N17-976
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SUMMARY of SAFETY AND EFFECTIVENESS
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General Information: ت .
K961943 -
A. Generic (USAN) Name: hefilcon A
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B. Device Trade Name:
FLEXLENS (hefilcon A) HARRISON Post Refractive Surgery Lens for Daily Wear
OCT । 1996
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C. Sponsor's Name and Address
FLEXIENS LLC 3241 South Zuni Street Englewood, CO 80110 (800) 223-3539 -
D. 510(k) Number:
TT. Indications
The FLEXIENS (hefilcon 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.
- TIT. Device Description
The FLEXI.ENS (hefilcon A) Harrison Post Refractive Surgery Contact Lens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric base curve and a spherical front surface. The lens is lathe cut from hefilcon A, a hydrophilic random copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone crosslinked with ethylene glycol dimethacrylate. It consists of 55% hefilcon A and 45% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The physical properties of the lens are as follows:
| * Refractive Index: | 1.43 |
|---|---|
| * Light Transmittance: | greater than 95%T |
| * Water Content: | 45% |
| * Oxygen Permeability: | |
| (measured by the standard Fatt method) | Dk=16 X 10-11 at 35 °C |
| * Specific Gravity: | 0.979 g/cc |
The FLEXIENS (hefilcon 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 lens surface to cornea alignment with rigid gas permeable contact lenses.
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 FLEXLENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00D will be approximately 0.30mm The size of the optical zone is thick at the center). generally 8.0mm. The peripheral carrier is thinner than most standard soft (hydrophilic) contact lenses, approximately 0.08 mm to 0.10 mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral In some cases the periphery is manufactured aspheric design, with a steeper curvature than the base curve.
- 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.
-
TV. Alternative Practices or Procedures
Alternative practices or procedures are in the use of available prescription products: soft (hydrophilic) contact lenses or rigid gas permeable contact lenses or spectacles. -
V. Technical Summaries
ATTE 1888 CHI (1000 Comment Comment Comparent -
A. Pre Clinical
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- Toxicology
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This was run on hefilcon A for the original N17-976 approved by FDA 01/04/79
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- Microbiology
This was run on hefilcon A for the original N17-976 approved by the FDA 01/04/1979
- Microbiology
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- Compatibility
This was run on hefilcon A for the original N17-976 approved by the FDA 01/04/1979
- Compatibility
-
- Stability
This was run on hefilcon A for the original N17-976 approved by the FDA 01/04/1979. Presently we are have the shelf life at 4 years.
- Stability
-
- Preservative Untake Tests
2
This was run on hefilcon A for the original N17-976 approved by the FDA 01/04/1979
- B. Clinical
The Sponsor is referencing a small clinical study that was run in Canada. There were 10 patients with 12 Average daily wear was 12.4 hours. The eves. principal investigator was Keith W. Harrison, FCLSA 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).
FLEXIENS. I.C. last FDA inspection was completed on March 7, 1996.
- C. Potential Safety and Effectiveness as well as Adverse Effects of the Device on Health would be about the same as that of any other hefilcon A lens.
- D. Conclusion drawn from Study
The safety and effectiveness lens should be equivalent to any other FLEXIENS (hefilcon A) lens.
- F. Since the geometry of the FLEXIENS (hefilcon A) HARRISON POST REFRACTIVE SURGERY Lenses for Daily Wear is not much different from that of the standard Flexlens products a favorable recommendation from the FDA is anticipated. 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.
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