(196 days)
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.
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] 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]
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format as performance metrics against predefined thresholds. Instead, it demonstrates substantial equivalence to a predicate device, implying that meeting or exceeding the predicate's characteristics constitutes acceptance. The "Comparison to Predicate Device" table serves as the primary source for this.
| Parameter | UltraCon and UltraCon S (Reported Performance) | LifeStyle GP (Predicate Device Performance) | Note |
|---|---|---|---|
| Material | carbosilfocon A | telefocon B | Different material, but same classification. Non-clinical tests confirmed safety. |
| Material Classification | Hydrophobic Lens Group 2 | Hydrophobic Lens Group 2 | Same classification. |
| Indication for Use | myopia, hyperopia, astigmatism | myopia, hyperopia, astigmatism | Identical indications. |
| Water Content | 0.5% | less than 0.5% | Comparable. |
| Light Transmittance | 96.5% | 96% | Comparable, slightly better. |
| Dk (35° C) | 44 x 10⁻¹¹ | 43.5 x 10⁻¹¹ | Comparable, slightly better. |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters | Identical. |
| Color | blue visibility | blue, green, brown, and gray | Different color options, but for visibility tint, not clinical performance. |
| Specific Gravity | 1.105 | 1.126 | Comparable. |
| Refractive Index | 1.57 at 20° C | 1.480 at 20° C | Different, but considered acceptable within the context of substantial equivalence. |
| Wetting Angle | < 19° | < 30° | Better (lower wetting angle generally indicates better wettability). |
| Method of Manufacture | Gel Flow Molding | Lathe cut | Different manufacturing method, but non-clinical tests confirmed safety and performance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of subjects. The text mentions a "three month clinical evaluation" and that "Performance of the UltraCon S lens was substantially equivalent to performance of the predicate lens with respect to safety and efficacy." The typical sample size for such a study in the 1990s could range from dozens to a few hundred, but the exact number is not provided.
- Data Provenance: Prospective (clinical evaluation performed at six investigational sites). The country of origin is implicitly the USA, as Specialty UltraVision, Inc. is based in Campbell, CA, and the FDA is the regulatory body.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated. The "six investigational sites" suggest multiple clinicians/ophthalmologists were involved in the evaluation, but it doesn't specify if a panel of experts established a ground truth for the test set. Instead, their observations and assessments during the clinical evaluation constituted the "performance" data.
- Qualifications of Experts: Implied to be ophthalmic professionals (e.g., ophthalmologists, optometrists) at the investigational sites, who are qualified to assess contact lens safety and efficacy. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The phrase "clinical evaluation... assessed the safety and effectiveness of the lens" suggests that data was collected, analyzed, and evaluated by the study investigators and then reviewed by the sponsor, but no specific adjudication method (like 2+1 voting) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study compared the UltraCon S lens's clinical performance to that of a predicate lens, which is a comparative study, but it wasn't presented as an MRMC analysis focused on human reader improvement with AI assistance. This device is a contact lens, not an AI diagnostic tool.
- Effect Size of Human Readers with vs. without AI: Not applicable, as this is a medical device (contact lens) and not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
- Standalone Performance: Not applicable, as this device is a physical contact lens, not an algorithm.
7. Type of Ground Truth Used:
- For the clinical evaluation, the "ground truth" was established by clinical observation and assessment of safety and effectiveness by qualified ophthalmic professionals at the investigational sites. This includes direct patient examination, reporting of adverse events, and evaluation of visual acuity and lens fit. It's essentially "expert clinical assessment/outcomes data."
- For the non-clinical testing, ground truth was based on standardized in vitro and in vivo toxicology, biocompatibility, and physicochemical tests.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is a medical device (contact lens), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.
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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 100Campbell, CA 95008 | ||
|---|---|---|---|
| Contact Person: | Ivalee CohenDirector, 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 GasPermeable Contact Lens for Daily WearandUltraCon S (carbosilfocon A) Rigid GasPermeable 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
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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]
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Comparison to Predicate Device
| PARAMETER | UltraCon and UltraCon SRigid Gas PermeableContact Lens for DailyWear | LifeStyle Gp Rigid GasPermeable Contact Lensfor Daily Wear (K963010) |
|---|---|---|
| material | carbosilfocon A | telefocon B |
| materialclassification | Hydrophobic Lens Group 2 | Hydrophobic Lens Group 2 |
| indication for use | myopia, hyperopia andastigmatism | myopia, hyperopia andastigmatism |
| 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 | < 19° | < 30° |
| Method ofmanufacture | Gel Flow Molding | Lathe cut |
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.
Description of Safety and Substantial Equivalence:
A series of non-clinical tests and a clinical study were performed to demoristrate 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 quideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is non-toxic and biocompatible, and has material characteristics comparable to or better than other currently marketed RGP lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the substantial equivalence to the predicate lens.
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.
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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.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Ms. Ivalee I. Cohen Director, Regulatory and Clinical Affairs Specialty ULTRAVISION, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008
Re: K980197
Trade Name: UltraCon and UltraCon S (Carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Sperical and Aspheric) Visibility tinted with D & C Green No. 6 Regulatory Class: II Product Code: 86 HQD Dated: June 5, 1998 Received: June 8, 1998
Dear Ms. Cohen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Ivalee I. Cohen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS STATEMENT
Device Name:
UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear
UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear
Indications for Use:
The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are 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 lenses may be disinfected using a chemical disinfection system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ---------------------- | -- |
| E.Y.C. (Division Sign-Off) Division of Ophthalmic Devices | ||
|---|---|---|
| 510(k) Number | K980197 |
| gs | |
|---|---|
| -- | ---- |
§ 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.