(167 days)
No
The summary describes a physical contact lens and its clinical evaluation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for keratoconus management, which involves treating an irregular corneal surface. This goes beyond simple refractive correction and suggests a therapeutic aim.
No
The device, a contact lens, is used to correct refractive ametropia and manage keratoconus, not to diagnose medical conditions. Its function is therapeutic/corrective. The "diagnostic fitting visit" mentioned in the performance studies refers to the process of fitting the lens, not the lens itself performing a diagnosis.
No
The device description clearly describes a physical contact lens made of a specific material with defined dimensions and curves, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is a contact lens designed to be worn on the corneal surface of the eye. It is a medical device, but it does not involve the analysis of biological samples.
- The description focuses on the physical properties and clinical performance of the contact lens. There is no mention of any diagnostic testing, analysis of bodily fluids or tissues, or any other activity typically associated with IVDs.
N/A
Intended Use / Indications for Use
The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.
Product codes
86HQD
Device Description
The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
- Chord Diameter: 10.5 mm to 14.0 mm
- Center Thickness: 0.10 mm to 0.35 mm
- Base Curve: 6.0 to 8.5 mm
- Powers: Plano to-20.00 D
- Peripheral Curves: A. B. C. D. E. F and G
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal surface
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
A four week clinical evaluation of the EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at five investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the clinical performance of the EpiCon K lens in subjects with bilateral keratoconus. Subjects were seen at an Initial Visit. which was a diagnostic fitting visit. Subjects were seen at a Dispensing Visit, and after 1, 2 and 4 weeks of lens wear. The EpiCon K lens was dispensed to 38 keratoconic subjects, and 18 subjects (47.4%) completed the 4 weeks of the study period while 20 subjects (52.6%) discontinued.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: A four week clinical evaluation of the EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at five investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the clinical performance of the EpiCon K lens in subjects with bilateral keratoconus. Subjects were seen at an Initial Visit. which was a diagnostic fitting visit. Subjects were seen at a Dispensing Visit, and after 1, 2 and 4 weeks of lens wear. The EpiCon K lens was dispensed to 38 keratoconic subjects, and 18 subjects (47.4%) completed the 4 weeks of the study period while 20 subjects (52.6%) discontinued. Two adverse reactions were reported during the study period, both of which resolved without sequelae upon discontinuation of lens wear.
Based on the clinical data analysis, it was determined that the incidence of positive slit lamp findings, subject symptoms, problems and complaints, keratometry and refractive changes, visual acuity with the lens, lens wearing time and lens comfort were within the expected range for keratoconic eyes wearing RGP lenses.
Clinical performance of the EpiCon K lens was substantially equivalent to the clinical performance of the predicate lens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/2 description: The image shows the word "ULTRAVISION" in large, bold, black letters. Below the word "ULTRAVISION" is the abbreviation "INC." in smaller, black letters. The font appears to be a serif font. The background is white.
510(k) Summary
| Company: | Specialty UltraVision, Inc.
307 Orchard City Drive, Suite 100
Campbell, CA 95008 |
|----------|----------------------------------------------------------------------------------------|
| Contact: | Garold L. Edwards, O.D., F.A.A.O.
Vice President. Technical Affairs |
Telephone: (408) 341-0700 Fax: (408) 341-0717
Date Prepared: December 6, 1999
Device Name:
| Common Name: | Rigid Gas Permeable Contact Lens |
|---|---|
| Trade/Proprietary Names: | EpiCon K (carbosilfocon A) Rigid Gas |
| Permeable Contact Lens for Daily Wear |
Classification Name: Rigid Gas Permeable Contact Lens
Device Classification: Class II (21 CFR 886.5916)
Predicate Device:
The predicate device is the UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K980197. This device was selected as the predicate device because it is manufactured from the same polymer, using similar lens designs, at the same manufacturing facility, under the same Quality System and using the same manufacturing equipment.
Description of Device:
.
The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
- . Chord Diameter: 10.5 mm to 14.0 mm
- Center Thickness: 0.10 mm to 0.35 mm
- Base Curve:
6.0 to 8.5 mm
- Plano to-20.00 D
- Powers: . . Peripheral Curves: A. B. C. D. E. F and G
1323 44™ AVENUE N.E. CALGARY, ALBERTA CANADA T2E 6L5 TEL: 800-668-9251 403-291-1919 FAX: 403-291-6477
1
Comparison to Predicate Device
| PARAMETER | EpiCon K Rigid Gas
Permeable Contact Lens for
Daily Wear | UltraCon S Rigid Gas
Permeable Contact Lens for
Daily Wear |
|----------------------------|----------------------------------------------------------------|------------------------------------------------------------------|
| material | carbosilfocon A | carbosilfocon A |
| material
classification | Hydrophobic Lens Group 2 | Hydrophobic Lens Group 2 |
| indication for use | myopia, hyperopia and
astigmatism | myopia, hyperopia and
astigmatism |
| water content | 0.5% | 0.5% |
| light transmittance | 96.5% | 96.5% |
| Dk (35° C) | 52 x 10-11 | 52 x 10-11 |
| powers | Plano to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue visibility |
| specific gravity | 1.105 | 1.105 |
| refractive index | 1.49 at 20° | 1.49 at 20° |
| wetting angle |