(196 days)
Not Found
No
The device description and performance studies focus on the material properties, physical dimensions, and clinical performance of a rigid gas permeable contact lens. There is no mention of any computational algorithms, data processing, or learning capabilities.
Yes
The device is indicated for correction of refractive ametropia and its safety and effectiveness are established through non-clinical and clinical tests, which are characteristics of a therapeutic device.
No.
The device description clearly states it is a "Rigid Gas Permeable Contact Lens for Daily Wear" indicated for "correction of refractive ametropia," which is a treatment rather than a diagnostic function.
No
The device description clearly outlines a physical contact lens made of specific materials with defined dimensions and physical/optical properties. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes". This describes a device used in vivo (on the body) to correct vision, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical characteristics and material properties of a contact lens, which is consistent with a medical device for vision correction.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not fit this definition.
N/A
Intended Use / Indications for Use
The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
- UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear
The UltraCon (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 UltraCon Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
- Chord Diameter: 8.5 to 10,5 mm .
- 0.10 mm to 0.28 mm Center Thickness: .
- 7.0 to 8.5 mm Base Curve: .
- +12.00 D to-20.00 D Powers: .
The physical/optical properties of the lens are:
- Specific Gravity 1.105 .
- 1.57 at 20°C Refractive Index: .
- 98.5% Light Transmittance: .
- Hydrophobic Surface Character: .
- 0.5% Water Content: .
- 19° (CLMA method) Wetting Angle: .
- Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) . at 35°C
*[Fatt method used for determination of oxygen permeability]
- UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear
The UltraCon S (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 diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. 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 UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
- Chord Diameter: 12.0 mm to 14.0 mm
- Center Thickness: 0.10 mm to 0.28 mm
- Base Curve: 7.0 to 8.5 mm
- Powers: +12.00 D to-20.00 D
- Peripheral Curves: C, D, and E
The physical/optical properties of the lens are:
- Specific Gravity 1.105
- Refractive Index: 1.57 at 20°C
- Light Transmittance: 96.5%
- Surface Character: Hydrophobic
- Water Content: 0.5%
- Wetting Angle: 19° (CLMA method)
- Oxygen Permeability (Dk)*: 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) at 35°C
*[Fatt method used for determination of oxygen permeability]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
A series of non-clinical tests and a clinical study were performed to demonstrate the safety and effectiveness of the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear, and to establish substantial equivalence to the predicate lens. All testing was conducted in accordance with the May, 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations.
Non-Clinical Testing:
In vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety of the device. All tests were conducted in accordance with 21 CFR Part 58. GLP requlations. Physicochemical and leachability testing was performed to establish device characteristics. Results of the testing demonstrate that the lens material and extracts are not toxic and non irritating, and that the lens physical and material properties are consistent with marketed contact lenses.
Clinical Testing:
A three month clinical evaluation of the UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at six investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the safety and effectiveness of the lens, and compared its clinical performance to the predicate lens. Performance of the UltraCon S lens was substantially equivalent to performance of the predicate lens with respect to safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 4 1998
Image /page/0/Picture/1 description: The image shows the logo for Ultravision Inc. The word "SPECIALTY" is written in white letters on a black rectangle at the top of the image. Below that, the word "ULTRAVISION" is written in large, bold, black letters, with the letters "INC." in smaller letters below and to the right.
D
510(k) Summary
Submitter Information:
| Company: | Specialty UltraVision, Inc.
307 Orchard City Drive, Suite 100
Campbell, CA 95008 | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Ivalee Cohen
Director, Regulatory and Clinical Affairs | | |
| Telephone: | (408) 341-0700 | | |
| Fax: | (408) 341-0717 | | |
| Date Prepared: | January 16, 1998 | | |
| Device Name: | | | |
| Common Name: | Rigid Gas Permeable Contact Lens | | |
| Trade/Proprietary Names: | UltraCon (carbosilfocon A) Rigid Gas
Permeable Contact Lens for Daily Wear
and
UltraCon S (carbosilfocon A) Rigid Gas
Permeable Contact Lens for Daily Wear | | |
| Classification Name: | Rigid Gas Permeable Contact Lens | | |
Device Classification:
Predicate Device:
The predicate device is the LifeStyle GP (telefocon B) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K963010. This device was selected as the predicate device because of its similarities in intended use (daily wear), Dk value, and material type (FDA Group II: containing silicone but not fluorine).
Class II (21 CFR 886.5916)
Description of Devices:
1. UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear
The UltraCon (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
FEL: 888-29-ULTR. 408-341-0717
800-668-925 403-291-1919 403-291-547
1
The UltraCon Rigid Gas Permeable Contact Lens for Daily handling tint. Wear is a hemispherical shell of the following dimensions:
- Chord Diameter: 8.5 to 10,5 mm .
- 0.10 mm to 0.28 mm Center Thickness: .
- 7.0 to 8.5 mm Base Curve: .
- +12.00 D to-20.00 D Powers: .
The physical/optical properties of the lens are:
- Specific Gravity 1.105 .
- 1.57 at 20°C Refractive Index: .
- 98.5% Light Transmittance: .
- Hydrophobic Surface Character: .
- 0.5% Water Content: .
- 19° (CLMA method) Wetting Angle: .
- Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) .
at 35°C
*[Fatt method used for determination of oxygen permeability]
2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear
The UltraCon S (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 diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. 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 UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
| • | Chord Diameter: | 12.0 mm to 14.0 mm |
|---|---|---|
| • | Center Thickness: | 0.10 mm to 0.28 mm |
| • | Base Curve: | 7.0 to 8.5 mm |
| • | Powers: | +12.00 D to-20.00 D |
| • | Peripheral Curves: | C, D, and E |
The physical/optical properties of the lens are:
| • Specific Gravity | 1.105 |
|---|---|
| • Refractive Index: | 1.57 at 20°C |
| • Light Transmittance: | 96.5% |
| • Surface Character: | Hydrophobic |
| • Water Content: | 0.5% |
| • Wetting Angle: | 19° (CLMA method) |
| • Oxygen Permeability (Dk)*: | 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) |
| at 35°C |
*[Fatt method used for determination of oxygen permeability]
2
Comparison to Predicate Device
| PARAMETER | UltraCon and UltraCon S
Rigid Gas Permeable
Contact Lens for Daily
Wear | LifeStyle Gp Rigid Gas
Permeable Contact Lens
for Daily Wear (K963010) |
|----------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| material | carbosilfocon A | telefocon B |
| 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% | less than 0.5% |
| light transmittance | 96.5% | 96% |
| Dk (35° C) | 44 x 10-11 | 43.5 x 10-11 |
| powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue, green, brown and gray |
| specific gravity | 1.105 | 1.126 |
| refractive index | 1.57 at 20° | 1.480 at 20° C |
| wetting angle | E.Y.C. (Division Sign-Off) Division of Ophthalmic Devices | |
|---|---|---|
| 510(k) Number | K980197 |
| gs | |
|---|---|
| -- | ---- |