(87 days)
Not Found
No
The document describes a contact lens and its material composition and intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia, which are therapeutic interventions to address vision problems.
No
The device is a contact lens used for the optical correction of refractive ametropia and/or presbyopia, and not for diagnosing any condition. Its intended use is to correct vision and, in some cases, alter eye appearance, not to diagnose diseases.
No
The device description clearly states it is a physical contact lens made of a specific material (etafilcon A) and is supplied in a sterile state. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a contact lens designed for the optical correction of refractive errors (myopia, hyperopia, astigmatism) and presbyopia. It is worn on the surface of the eye to improve vision.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the body. Its function is purely optical correction.
Therefore, this device falls under the category of a medical device, specifically an ophthalmic device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 0.75D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Tinted, is also indicated for daily wear to enhance or alter the appearance of the eye.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.
When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
Product codes
LPL, MVN
Device Description
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal-toric design. 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 composition of the lens is 42% etafilcon A and 58% water by weight when hydrated and stored in buffered saline solution with or without povidone. The lens is supplied in a sterile state.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Visibility Tinted with UV Blocker for Daily Wear, 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 UV Blocking for ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lenses for Presbyopia, Visibility Tinted with UV Blocker averages 97% in the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will enhance or alter the appearance of the eye. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green, vat orange 1, and Reactive Blue Dye #4.
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 / 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)
Nonclinical performance data: The device is made from the same material and uses the same manufacturing process as the predicate device, VISTAKON® (etafilcon A) (K062614). All nonclinical testing supporting the predicate device is representative of the subject device. Finished product testing for verification of the modified design was conducted to demonstrate that lenses meet specification tolerances.
Clinical Performance Data: Clinical performance data to demonstrate substantial equivalence are not required because the proposed alternative multifocal design has the same indications, is the same etafilcon A material, and uses the same manufacturing and sterilization processes as the predicate device (K062614). Additionally, the multifocal design type is the same as the predicate device cleared under K073459.
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 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three intertwined snakes forming a triple helix. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
Johnson & Johnson Vision Care, Inc. Mr. Scott Durland Senior Manager, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, Florida 32256
Re: K141670
Trade/Device Name: ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 (b) (1) Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 20, 2014 Received: June 23, 2014
Dear Mr. Durland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141670
Device Name
ACUVUE® (etaffilcon A) Soft (hydrophilic) Contact Lear & Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear
Indications for Use (Describe)
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 0.75D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Timed, is also indicated for daily wear to enhance or alter the appearance of the eye.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the ACUVUE® (etafficon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.
When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(K) SUMMARY
Submitter Information
| Company: | Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, FL 32256 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Scott Durland |
| Email: | sdurland@its.jnj.com |
| Telephone: | 904-443-3548 |
| FAX: | 904-443-1424 |
| Date: | June 20, 2014 |
Identification of the Device
| Common Name: | Soft Contact Lens |
|---|---|
| Device Name: | ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for |
| Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) | |
| with UV (ultraviolet) Blocker for Daily Wear | |
| Classification Name: | Soft (Hydrophilic) Contact Lens, Daily Wear |
| Device Classification: | Class II, 21 CFR 886.5925 (b) (1) |
| Product Code: | LPL, MVN |
Predicate Device(s)
- Material: VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and ● Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear most recently cleared via K062614, hereafter also referred to VISTAKON® (etafilcon A);
- Optical Design: CIBA VISION+ (lotrafilcon B) soft contact lenses cleared via ● K073459, hereafter also referred to CIBA VISION (lotrafilcon B)
1 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation.
5
Description of Device
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal-toric design. 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 composition of the lens is 42% etafilcon A and 58% water by weight when hydrated and stored in buffered saline solution with or without povidone. The lens is supplied in a sterile state.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Visibility Tinted with UV Blocker for Daily Wear, 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 UV Blocking for ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lenses for Presbyopia, Visibility Tinted with UV Blocker averages 97% in the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will enhance or alter the appearance of the eye. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green, vat orange 1, and Reactive Blue Dye #4.
S5 Table 1, S5 Table 2, and S5 Table 3 contain property and parameter ranges for the subject device.
| Water Content | 58% |
|---|---|
| Refractive Index (@ 20°C) | 1.40 |
| Oxygen Permeability (Fatt method, edge corrected) | $21.4 x 10^{-11}$ (cm²/sec)(mL O₂/mL * mm Hg) |
| Light Transmission - Visible | Minimum 85% |
| Light Transmission - UVA (316 nm to 380 nm) | " 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation. |
™ 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation.
9
| Predicate Device | Predicate Device | Subject Device | |
|---|---|---|---|
| CIBA VISION® (lotrafilcon B) | |||
| (K073459) | VISTAKON® (etafilcon A) | ||
| (K062614) | ACUVUE® (etafilcon A) Soft | ||
| (hydrophilic) Contact Lenses for | |||
| Presbvopia | |||
| Multifocal | for the optical correction of refractive | ||
| ametropia (myopia & hyperopia) and/or | |||
| presbyopia in phakic or aphakic persons | |||
| with non-diseased eyes who may | |||
| require reading addition of +3.00D or | |||
| less and who may have up to | |||
| approximately 1.50D of astigmatism | for the optical correction of distance | ||
| and near vision in presbyopic phakic | |||
| or aphakic persons with non-diseased | |||
| eyes who may have 0.75D of | |||
| astigmatism or less | for the optical correction of refractive | ||
| ametropia (myopia and hyperopia) | |||
| and/or presbyopia in phakic or aphakic | |||
| persons with non-diseased eyes who | |||
| may need up to 4.00D of ADD power | |||
| and have 0.75D of astigmatism or less | |||
| Multifocal-Toric | for the optical correction of refractive | ||
| ametropia (myopia, hyperopia, | |||
| astigmatism and presbyopia) in phakic | |||
| or aphakic persons with non-diseased | |||
| eyes. The lenses may be worn by | |||
| persons who have +6.00D or less of | |||
| refractive and/or corneal astigmatism | for the optical correction of distance | ||
| and near vision in presbyopic phakic | |||
| or aphakic persons with non-diseased | |||
| eyes who may have 10.00D of | |||
| astigmatism or less | for the optical correction of refractive | ||
| ametropia (myopia, hyperopia, and/or | |||
| astigmatism) and presbyopia in phakic | |||
| or aphakic persons with non-diseased | |||
| eyes who may need up to 4.00D of | |||
| ADD power and have 10.00D of | |||
| astigmatism or less | |||
| Cosmetically | |||
| tinted | N/A | to enhance or alter the apparent color | |
| of the eye | to enhance or alter the appearance of | ||
| the eye | |||
| UV statement | N/A | helps protect against transmission of | |
| harmful UV radiation to the cornea | |||
| and into the eye | contains a UV Blocker to help protect | ||
| against transmission of harmful UV | |||
| radiation to the cornea and into the eye | |||
| Predicate Device | Predicate Device | Subject Device | |
| CIBA VISION® (lotrafilcon B) | |||
| (K073459) | VISTAKON® (etafilcon A) | ||
| (K062614) | ACUVUE® (etafilcon A) Soft | ||
| (hydrophilic) Contact Lenses for | |||
| Presbyopia | |||
| Wear Schedule | The lenses may be prescribed for daily | ||
| wear with removal for cleaning and | |||
| disinfection (chemical, not heat) prior to | |||
| reinsertion, as recommended by the eye | |||
| care professional. | May be prescribed for daily wear. Eye | ||
| Care Practitioners my prescribe the | |||
| lenses either for single-use disposable | |||
| wear or frequent/planned replacement | |||
| wear with cleaning, disinfection, and | |||
| scheduled replacement (see "Wearing | |||
| Schedule"). | |||
| When prescribed for frequent/planned | |||
| replacement wear, the VISTAKON® | |||
| (etafilcon A) contact lens is to be | |||
| cleaned, rinsed, and disinfected each | |||
| time the lens is removed. | |||
| The etafilcon A contact lens is to be | |||
| discarded after the recommended | |||
| wearing period as prescribed by the | |||
| Eye Care Professional. When | |||
| prescribed for frequent/planned | |||
| replacement wear, the lenses may be | |||
| disinfected using a chemical | |||
| disinfection system only. | |||
| When prescribed for single-use | |||
| disposable wear, (See "Wearing | |||
| Schedule") the VISTAKON® | |||
| (etafilcon A) contact lens is to be | |||
| discarded after each removal. | Eye Care Practitioners may prescribe | ||
| the lenses either for single-use | |||
| disposable wear or frequent/planned | |||
| replacement wear with cleaning, | |||
| disinfection, and scheduled | |||
| replacement. | |||
| When prescribed for single-use | |||
| disposable wear, the ACUVUE® | |||
| (etafilcon A) Soft Contact Lens for | |||
| Presbyopia is to be discarded after | |||
| each removal. | |||
| When prescribed for frequent/planned | |||
| replacement wear, the ACUVUE® | |||
| (etafilcon A) Soft Contact Lens for | |||
| Presbyopia is to be cleaned, rinsed, | |||
| and disinfected each time the lens is | |||
| removed. The contact lens is to be | |||
| discarded after the recommended | |||
| wearing period as prescribed by the | |||
| Eye Care Professional. When | |||
| prescribed for frequent/planned | |||
| replacement wear, the lenses may be | |||
| disinfected using a chemical | |||
| disinfection system only. |
Indication Comparison S5 Table 6:
10
Indication Comparison (Continued) S5 Table 6:
11
510(k) Premarket Notification ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear Johnson & Johnson Vision Care, Inc. (JJVCI)
4 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation. Note: UV = ultraviolet
12
Nonclinical Performance Data
The device is made from the same material, and uses the same manufacturing process as the predicate device, VISTAKON® (etafilcon A). Therefore, all nonclinical testing supporting the predicate device in K062614 is also representative of the subject device.
Additionally, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, finished product testing for verification of the modified design was conducted to demonstrate that lenses meet specification tolerances.
Clinical Performance Data
The proposed alternative multifocal design has the same indications, is the same etafilcon A material, and uses the same manufacturing and sterilization processes as the predicate device in K062614. Additionally, the multifocal design type is the same as the predicate device cleared under K073459. Demonstration of the physical and chemical equivalency of the subject device to the predicate devices support the safety and effectiveness of the subject device for an alternate multifocal lens design configuration. Therefore, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, clinical performance data to demonstrate substantial equivalence are not required.
Conclusions Drawn from the Nonclinical and Clinical Tests
Information presented in this Premarket Notification establishes that the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is as safe and effective as the predicate devices when used in accordance with the labeled directions for use.
Other Information
Not applicable.