(73 days)
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No
The document describes a standard contact lens and its material properties, with no mention of AI or ML in its design, function, or intended use.
No
The device is indicated for correcting refractive errors (myopia, hyperopia, presbyopia, astigmatism) and improving visual acuity, which are considered vision correction and not therapeutic treatments for disease. While it does mention "non-diseased eyes," its primary purpose is refractive correction.
No.
This device, a contact lens, is intended for the correction of refractive errors and not for diagnosing a condition or disease.
No
The device description clearly states it is a physical contact lens made of a copolymer material, which is a hardware component.
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 for the "correction of refractive ametropia" and "correction of distance and near vision." This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and material of a contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This contact lens does not perform any such tests.
N/A
Intended Use / Indications for Use
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. The lens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. The VISTAKON Contact Lens is a hemispherical shell.
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
eyes
Indicated Patient Age Range
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Intended User / Care Setting
Eye care practitioners
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies: The safety of the lens material in the spherical design has been confirmed through a clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). The study evaluated at least 50 patients with a 2:1 ratio of subject device to predicate device for three (3) months. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time. fit assessment and discontinuations. The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Optima FW (polymacon) Visibility Tinted Contact Lens
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.
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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).
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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 510(k) Submission K 964b12
| Summary | The 510(k) submission summary consists of these sections Name and address of submitter Identification of device Predicate device Description of device Intended use Characteristics Non clinical studies Clinical studies Conclusions drawn from studies Flow Chart for 510(k) Daily Wear Contact Lens Materials |
|---|---|
| Name and | |
| address of | |
| submitter | Vistakon, Johnson & Johnson Vision Products, Inc. |
| 4500 Salisbury Road, Suite 300 | |
| Jacksonville, Florida 32216 | |
| Contact: Susan L. Walton | |
| Phone: 904/443-1439 | |
| Date Prepared: November 14, 1996 | |
| Identification of | |
| Device | Trade name: VISTAKON (genfilcon A) Contact Lens, clear and with visibility tint. Common or usual name: Soft (hydrophilic) Contact Lens (daily wear) FDA Classification: Class II |
| Predicate | |
| Device | Optima FW (polymacon) Visibility Tinted Contact Lens |
| Continued on next page | |
| Description of | |
| Device | The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available as |
| a spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. The | |
| lens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate and | |
| methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and | |
| ethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibility | |
| tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for | |
| handling. The VISTAKON Contact Lens is a hemispherical shell. | |
| Intended Use | The VISTAKON Contact Lens (spherical) is indicated for daily wear for the |
| correction of refractive ametropia (myopia, hyperopia and presbyopia) | |
| in aphakic or non-aphakic persons with non-diseased eyes who may | |
| have 1.00 D of astigmatism or less. | |
| The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for | |
| the correction of distance and near vision in presbyopic aphakic or | |
| non-aphakic persons with non-diseased eyes who may have 0.75 D of | |
| astigmatism or less. | |
| The VISTAKON TORIC Contact Lens is indicated for daily wear for the | |
| correction of visual acuity in aphakic or non-aphakic persons with non- | |
| diseased eyes that are hyperopic or myopic and may have 10.00 D of | |
| astigmatism or less. | |
| Eye care practitioners may prescribe the lens for single-use disposable wear or | |
| for frequent/planned replacement wear, with cleaning disinfection and | |
| scheduled replacement (see WEARING SCHEDULE). When prescribed for | |
| frequent/planned replacement, the lens may be disinfected using a chemical | |
| disinfection system only. | |
| Characteristics | The VISTAKON (genfilcon A) Contact Lens is classified into FDA Group I |
| for contact lens materials. The predicate device was chosen from FDA Group | |
| I. The VISTAKON (genfilcon A) Contact Lens is compared to the predicate | |
| device in the following table. | |
| Continued on next page |
:
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| | VISTAKON (genfilcon A)
Contact Lens with visibility
tint | | Optima FW Visibility Tinted
Contact Lens | |
|-------------------------|----------------------------------------------------------------|------------|---------------------------------------------|------------|
| | Measured | Label | Measured | Label |
| Water Content, % | 47.5 | 48 | 41.2 | 38.6 |
| Refractive Index @ 20°C | 1.43 | 1.43 | 1.44 | 1.43 |
| Dk, non-edge corrected | 14.1 | 13.0 | 7.5 | 8.5* |
| Color (if tinted) | light blue | light blue | light blue | light blue |
| Base Curve, mm | 8.6 | 8.6 | 8.4 | 8.7 |
| Diameter, mm | 14.0 | 14.0 | 14.0 | 14.0 |
| Power, D | -0.99 | -1.00 | -0.98 | -1.00 |
Dk units = x 10''' (cm²/sec) (ml O½ml x mm Hg) *edge correction method not identified in Bausch & Lomb labeling
| Non clinical
| Studies | Included as non clinical studies are chemistry, toxicology, lenses and package, microbiology |
|---|---|
| Chemistry | Material property data were generated on the subject device and the predicate device. The data for both devices reflect properties of Group I lenses. The lens care product manufacturers have previously shown compatibility of Group I lenses with their products. |
| The shelf-life stability for VISTAKON (genfilcon A) Contact Lenses is based upon approved stability protocols from N18-033. The initial shelf-life of the lens will be declared based on the data generated under one of these protocols. Shelf-life will not be claimed until a minimum of six months of real time data have been collected and found to be acceptable. | |
| Studies were conducted to determine the leachable materials from the subject and predicate devices. The results indicate that, at the levels of detection reported, there are no significant differences between the subject device and the predicate device. | |
| Continued on next page |
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In accordance with the May 1994 Guidance Document for Daily Wear contact Toxicology, lenses, toxicology studies have been conducted on the VISTAKON (genfilcon genfilcon A lens A) soft (hydrophilic) contact lenses, clear and with visibility tint. material 1. The Ocular Irritation study indicates the extracts would not be considered ocular irritants under the conditions of the study. The USP Systemic Toxicity study indicates the extracts would not be 2. considered systemically toxic under the conditions of the study. 3. The Cytotoxicity study indicates that the lens is not cytotoxic under the conditions of the study. No additional toxicology studies have been conducted on the plastic primary Toxicology, package packaging materials, as the materials are the same as those previously tested materials and reported under N18-033. The lens sterilization process, moist heat sterilization, has been validated to Microbiology deliver a minimum SAL of 10d. The lens care product manufacturers have established a reasonable assurance of disinfection efficacy of their care products with the lens groups for which they are approved. The lens will be presented in the same primary package currently used for other products approved under N18-033. There are shelf-life stability data which support lens sterility throughout the shelf-life claimed for the product. The safety of the lens material in the spherical design has been confirmed Clinical studies through a clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). The study evaluated at least 50 patients with a 2:1 ratio of subject device to predicate device for three (3) months. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time. fit assessment and discontinuations. The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device.
Continued on next page
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Conclusions drawn from studies
1. Validity of Scientific Data
Toxicology studies were conducted by a contract laboratory under Good Laboratory Practice Regulations. Microbiology, chemistry, shelf-life stability, and leachables studies were conducted by in-house laboratories and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
2. Safety and Effectiveness
The data presented in this Premarket Notification support the safety and effectiveness of the subject device when used in accordance with the labeled directions for use and for the requested indication. The subject device has been shown to be substantially equivalent to the predicate device.
3. Risk and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.