(85 days)
The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lens for single-use disposable wear (See "Wearing Schedule").
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses provide improved comfort for patients who experience mild discomfort and itching associated with allergies during contact lens wear compared to lenses replaced at intervals of greater than 2 weeks when worn on a daily disposable basis. | Clinical research has shown that when worn on a daily disposable basis, ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses provided improved comfort for 2 out of 3 (approximately 67%) patients who reported suffering from itching and mild discomfort associated with allergies during contact lens wear. The study concludes that this supports the proposed labeling statement. |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the additional clinical study supporting the labeling modification. However, it mentions that this study demonstrated improved comfort for "2 out of 3 patients." This implies a small, likely prospective clinical study. The country of origin for the data is not specified, but given the submitter's location (Jacksonville, Florida) and the FDA submission, it likely originates from the United States or a region following similar clinical guidelines.
3. Number of Experts and Qualifications:
Not applicable. This device is a contact lens, and the study focuses on patient-reported comfort, not diagnostic image interpretation. The "experts" would be the patients themselves reporting on their comfort levels.
4. Adjudication Method:
Not applicable. The study's focus is on patient-reported comfort, not on expert adjudication of diagnostic findings. Patient comfort is a subjective measure, and adjudication in the traditional sense (e.g., by multiple clinical experts) is not typically used for such outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for a contact lens and focuses on patient comfort.
6. Standalone Performance Study:
A standalone performance study was done in the sense that the clinical research directly assessed the comfort provided by the ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses when worn on a daily disposable basis. This was an "algorithm only" equivalent as the device itself is the intervention being tested, without human-in-the-loop interpretation.
7. Type of Ground Truth Used:
The ground truth for this study was patient-reported outcomes (PROs), specifically patient comfort and the experience of itching and mild discomfort associated with allergies during contact lens wear.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The clinical study directly evaluated the performance of the physical contact lens.
9. How Ground Truth for the Training Set was Established:
Not applicable. As noted above, this is not an AI/ML device, so there is no training set in the context of machine learning. The "ground truth" (patient comfort) for the clinical study was established through patient self-reporting.
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FEB 2 6 2002
| Name andAddress ofSubmitter | VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, Florida 32256Contact: James W. ParzialePhone: (904) 443-1808Date Prepared: November 28, 2001 |
|---|---|
| Identification ofDevice | Trade Name: ACUVUE® Brand (etafilcon A) soft (hydrophilic) contactlenses; clear and tinted (visibility and/or cosmetic) with UV blocker; fordaily wear Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear) Classification: Class II under 21 CFR 886.5925 |
| PredicateDevices | The predicate devices are the:ACUVUE® Brand (etafilcon A) soft (hydrophilic) Contact Lenses clearand visibility tinted with UV blocker cleared most recently via K994324on February 23, 2000, and ACUVUE® 2 COLOURS Brand (etafilcon A) soft (hydrophilic) ContactLens with UV blocker cleared most recently via K010114 on April 11,2001. The additional indication is substantially equivalent to the labeling of:CIBA Vision Corporation, Focus® DAILIES® (nefilcon A) ONE-DAYCONTACT LENSES most recently cleared via K003586 on February 8,2001. |
| Description ofDevice | The device descriptions do not change from those cleared under K994324 andK010114. |
| Intended Use | The ACUVUE® Brand Contact Lenses (spherical) are indicated for daily wearto enhance or alter the apparent color of the eye for lenses with cosmetic tintand/or for the correction of refractive ametropia (myopia and hyperopia) inaphakic or not-aphakic persons with non-diseased eyes who may have 1.00 Dor less of astigmatism.The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL ContactLenses are indicated for daily wear to enhance or alter the apparent color of |
| Intended Use,continued | the eye for lenses with cosmetic tint and for the correction of distance andnear vision in presbyopic, aphakic or not-aphakic persons with non-diseasedeyes who may have 0.75 D or less of astigmatism. |
| The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC ContactLenses are indicated for daily wear to enhance or alter the apparent color ofthe eye for lenses with cosmetic tint and for the correction of visual acuity inaphakic or not-aphakic persons with non-diseased eyes that are hyperopic ormyopic and may have 10.00 D or less of astigmatism. | |
| The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCALContact Lenses are indicated for daily wear to enhance or alter the apparentcolor of the eye for lenses with cosmetic tint and for the correction of distanceand near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less. | |
| ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking ContactLenses help protect against transmission of harmful UV radiation to thecornea and into the eye. | |
| Eye Care Practitioners may prescribe the lens for either single-use disposablewear (See "Wearing Schedule"). | |
| Reason For510(k) | The reason for the 510(k) is to revise the "Wearing Schedule" section ofthe Package Insert and the "Introduction" section of the PatientInstruction Guide Disposable Daily Wear to include the followingstatements: |
| When worn on a daily disposable basis, ACUVUE® Brand (etafilcon A) Soft(hydrophilic) Contact Lenses provide improved comfort for patients whoexperience mild discomfort and itching associated with allergies duringcontact lens wear compared to lenses replaced at intervals of greater than 2weeks. | |
| Clinical research has shown that when worn on a daily disposable basis,ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses providedimproved comfort for 2 out of 3 patients who reported suffering fromitching and mild discomfort associated with allergies during contact lenswear. | |
| TechnologicalCharacteristics | The technological characteristics do not change. They are the same aspreviously submitted in K994324 and K010114. |
| Non-ClinicalStudies | Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, andleachability) on the lens material were not conducted since the lens material,etafilcon A, does not change. |
| Clinical Studies | This 510(k) describes a labeling modification to the "Wearing Schedule"section of the Package Insert and to the "Introduction" section of thePatient Instruction Guide Disposable Daily Wear. There is no change inlens material, the manufacturing process, nor the parameters and properties,therefore, the clinical data previously submitted in K994324 and K010114supports the clinical safety of the subject device. An additional studysupports the proposed labeling modification. |
| Conclusions | Additional safety studies were not conducted, therefore, the conclusionsdrawn from studies previously submitted in K994324 and K010114 supportthe non-clinical and clinical safety of the subject device. The additionalstudy supports the proposed labeling statement to be added to thePackage Insert and the Patient Instruction Guide Disposable Daily Wear. |
510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with the emblem of the U.S. Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text around the seal reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Vistakon, Division of Johnson & Johnson Vision Care, Inc. c/o James W. Parziale 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K013973
Trade/Device Name: ACUVUE® Band (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 30, 2001 Received: December 3, 2001
Dear Mr. Parziale:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the cherosare) to device Amendments, or to devices that have been reclassified in chaonnent unit of 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 therefore, mander the Act include requirements for annual registration, listing of devices, confors provisions or use ice, 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 (1 charkst Approval), it they of Sale, 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 mspections, the Food and Drag reasult in regulatory action. In addition, FDA may publish comply with the GMT regarating your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promations 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 - James W. Parziale
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w you'll ought finding of substantial equivalence of your device to a legally prematics notification: "The slassification 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 If you desire specific at 1100.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 F F ac 6613. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1010. First of Compliance at (301) 594-4639. Also, please note the your dones, prease connecting by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications Statement
510(k) Number (if known):
ACUVUE® Brand (etafilcon A) soft (hydrophilic) contact lenses; clear Device Name: and with tint (visibility and/or cosmetic) with UV blocker; for daily wear
Indications for Use:
The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter The ACO v OE - Brain over for lenses with cosmetic tint and/or for the correction of refractive ule apparent oolor of the vyeropia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated The ACO VOL - Brand (variater the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for THE TCO VOL "Brand (varent color of the eye for lenses with cosmetic tint and for durry wour of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.
The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic thatouted for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lens for single-use disposable wear (See "Wearing Schedule").
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
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K013973
§ 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.