(75 days)
N18-033
Not Found
No
The summary describes a standard contact lens and its material properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, presbyopia, astigmatism) rather than for treating an underlying disease or condition.
No
The device is a contact lens intended for daily wear to correct refractive ametropia (vision correction), not to diagnose a condition.
No
The device description clearly states it is a physical contact lens made of a copolymer material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ACUVUE Contact Lens is for the correction of refractive ametropia and visual acuity. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description focuses on the material and physical properties of the contact lens, designed for placement on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are typically used to perform tests on samples like blood, urine, or tissue to detect diseases, infections, or other medical conditions. Contact lenses, as described here, are used to improve vision by correcting refractive errors.
N/A
Intended Use / Indications for Use
The ACUVUE 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 ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens for either single-use disposable wear or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The ACUVUE Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm.
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
Eye care practitioners
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 following information summarizes the nonclinical data. The references to 6.b. Nonclinical studies with lens care apply only to the frequent replacement wear schedule of studies the device.
In accordance with the May 1994 Guidance Document for Daily Wear contact 6. b. 1. Toxicology lenses, toxicology studies have been conducted on the molded etafilcon A soft (hydrophilic) contact lenses with visibility and UV absorber. The Ocular Irritation and USP Systemic Toxicity studies indicate the extracts would not be considered ocular irritants, nor systemically toxic under the conditions of the study. 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 packaging materials, as the materials are the same as those previously tested and reported under N18-033.
Two additional toxicology studies have been conducted on the neat UV absorbing additive. These studies were: (1) 4 week Oral Gavage Toxicity Study in Rats with a 2 week Recovery and (2) The Ames Salmonella/Microsome Reverse Mutation Assay - Preincubation Method. The results of the studies were: Based on the data presented in the 4 Week Oral Gavage Toxicity Study, the no observable adverse effect level for the test article in rats appears to be 50 mg/kg; the results of Ames Salmonella/Microsome Reverse Mutation Assays - Preincubation Method indicate that under the conditions of the study, the test article did not induce positive increases in the numbers of histidine revertants per plate of any of the tester strains either in the presence or absence of Aroclor-induced rat liver microsomes.
6.b.2. Microbiology
The lens sterilization process, moist heat sterilization, has been validated to deliver a minimum SAL of 10°. The lens falls into FDA Group IV. 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 is shelf-life stability data supporting that the lens remains sterile through the shelf-life claimed for the product.
Material property data were generated on the current and modified materials. There are no significant differences in the properties of the current or modified materials except where expected, % T in the UV range. The lens care product manufacturers have previously shown compatibility of group IV lenses with their products.
Shelf-life stability protocols have been approved under N18-033. The initial shelf-life of the lens will be declared based on the data generated under an approved protocol. 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 finished lens. The results indicate that, at the levels of detection reported, there are no leachable monomers or additives.
Clinical studies were not required for this Premarket notification as the USAN name and process are the same as the predicate device.
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.
ACUVUE (etafilcon A) Contact Lens clear and with visibility tint
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
§ 886.5925 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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· OCT
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Summary of 510(k) Submission
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| 1. Name and
address of
submitter | Vistakon, Johnson and Johnson Vision Products, Inc.
4500 Salisbury Road, Suite 300
Jacksonville, Florida 32216
Contact: Denise E. McEachern
Phone: 904-443-1762
Date Prepared: July 17, 1996 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Identification
of Device | a. Trade name: ACUVUE (etafilcon A) Contact Lens clear and visibility tint
with UV blocker
b. Common or Usual Name: Soft (hydrophilic Contact Lens (daily wear)
c: Classification II |
| 3. Predicate
Device | ACUVUE (etafilcon A) Contact Lens clear and with visibility tint |
| 4. Description
of Device | The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as a
spherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lens
material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and
methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate
and ethylene glycol dimethacrylate. The ACUVUE Contact Lens with visibility
tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for
handling. A benzotriazole UV absorbing monomer is used to block UV
radiation. The average transmittance characteristics are less than 5 % in the
UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to
380 nm. |
1
S. Intended Use The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in (indications) aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens for either single-use disposable wear or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
A characteristics comparison to the predicate device is presented below. 6. 2 Characteristics
| Characteristic | Predicate Device
Measured (avg) | Subject Device
Measured (avg) | Subject and
Predicate Device
Label Claim |
|-----------------------------------------|----------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|
| % Water Content | 59% | 60% | 58% |
| Refractive Index @ 20° C | 1.40 | 1.40 | $1.40 \pm 0.01$ |
| Dk (Fatt method, non-edge
corrected) | $30 \times 10^{-11}$ (cm²/sec)*
(ml O₂/mlmmHg) | $26 \times 10^{-11}$ (cm²/sec)
(ml O₂/mlmmHg) | $28 + 5.6 \times 10^{-11}$ cm²/sec)
(ml O₂/ml*mmHg) |
| Color | light blue | light blue | light blue |
| % T @ 593 nm | Conforms | Conforms | 85 % minimum |
| % T @ 280 - 315 nm | N/A | 2.0 | avg Two additional toxicology studies have been conducted on the neat UV absorbing additive. These studies were: (1) 4 week Oral Gavage Toxicity Study in Rats with a 2 week Recovery and (2) The Ames Salmonella/Microsome Reverse Mutation Assay - Preincubation Method. The results of the studies were: Based on the data presented in the 4 Week Oral Gavage Toxicity Study, the no observable adverse effect level for the test article in rats appears to be 50 mg/kg; the results of Ames Salmonella/Microsome Reverse Mutation Assays - Preincubation Method indicate that under the conditions of the study, the test article did not induce positive increases in the numbers of histidine revertants per plate of any of the tester strains either in the presence or absence of Aroclor-induced rat liver microsomes.
6.b.2. Microbiology
The lens sterilization process, moist heat sterilization, has been validated to deliver a minimum SAL of 10°. The lens falls into FDA Group IV. 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 is shelf-life stability data supporting that the lens remains sterile through the shelf-life claimed for the product.
3
| 6.b.3.
Chemistry | Material property data were generated on the current and modified materials.
There are no significant differences in the properties of the current or modified
materials except where expected, % T in the UV range. The lens care product
manufacturers have previously shown compatibility of group IV lenses with
their products. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.b.4. Shelf-life | Shelf-life stability protocols have been approved under N18-033. The initial
shelf-life of the lens will be declared based on the data generated under an
approved protocol. Shelf-life will not be claimed until a minimum of six
months of real time data have been collected and found to be acceptable. |
| 6.b.5.
Leachables | Studies were conducted to determine the leachable materials from the finished
lens. The results indicate that, at the levels of detection reported, there are no
leachable monomers or additives. |
| 6.c. Summary of
Clinical Studies | Clinical studies were not required for this Premarket notification as the USAN
name and process are the same as the predicate device. |
| 6.d. Conclusions
Drawn from
Studies | 1. Validity of Scientific Data
Toxicology studies were conducted by a contract laboratory under
Good Laboratory Practice Regulations. The laboratory has been
audited by Vistakon and found to be in compliance. 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 an
daily wear basis. The benefits to the patient are the same as those for
other soft (hydrophilic) contact lenses. |
| | |