(85 days)
No
The summary describes contact lenses and a labeling modification, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the correction of refractive ametropia (myopia and hyperopia), visual acuity, and distance and near vision, which are therapeutic purposes.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that these contact lenses are for "correction of refractive ametropia (myopia and hyperopia)," "correction of distance and near vision," and "correction of visual acuity." They are also indicated for cosmetic purposes and UV protection. There is no mention of the device being used to identify, detect, or monitor conditions or diseases. Its primary purpose is to correct vision, not to diagnose.
No
The device described is a contact lens, which is a physical medical device, not software. The 510(k) is for a labeling modification to existing contact lenses.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that these are contact lenses worn on the eye for vision correction and/or cosmetic purposes. They are applied directly to the body and do not involve testing samples taken from the body.
- Lack of IVD Keywords: The text does not contain any keywords typically associated with IVDs, such as "assay," "reagent," "sample," "laboratory," "diagnosis," or "testing."
The device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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").
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The device descriptions do not change from those cleared under K994324 and K010114.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
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)
This 510(k) describes a labeling modification to the "Wearing Schedule" section of the Package Insert and to the "Introduction" section of the Patient Instruction Guide Disposable Daily Wear. There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K994324 and K010114 supports the clinical safety of the subject device. An additional study supports the proposed labeling modification.
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.
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.
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
:
FEB 2 6 2002
| Name and
Address of
Submitter | VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, Florida 32256
Contact: James W. Parziale
Phone: (904) 443-1808
Date Prepared: November 28, 2001 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of
Device | Trade Name: ACUVUE® Brand (etafilcon A) soft (hydrophilic) contact
lenses; clear and tinted (visibility and/or cosmetic) with UV blocker; for
daily wear Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear) Classification: Class II under 21 CFR 886.5925 |
| Predicate
Devices | The predicate devices are the:
ACUVUE® Brand (etafilcon A) soft (hydrophilic) Contact Lenses clear
and visibility tinted with UV blocker cleared most recently via K994324
on February 23, 2000, and ACUVUE® 2 COLOURS Brand (etafilcon A) soft (hydrophilic) Contact
Lens 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-DAY
CONTACT LENSES most recently cleared via K003586 on February 8,
2001. |
| Description of
Device | The device descriptions do not change from those cleared under K994324 and
K010114. |
| Intended Use | The ACUVUE® Brand Contact Lenses (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 |
| Intended Use,
continued | 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 either single-use disposable
wear (See "Wearing Schedule"). |
| Reason For
510(k) | The reason for the 510(k) is to revise the "Wearing Schedule" section of
the Package Insert and the "Introduction" section of the Patient
Instruction Guide Disposable Daily Wear to include the following
statements: |
| | When worn on a daily disposable basis, 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. |
| | 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 patients who reported suffering from
itching and mild discomfort associated with allergies during contact lens
wear. |
| Technological
Characteristics | The technological characteristics do not change. They are the same as
previously submitted in K994324 and K010114. |
| Non-Clinical
Studies | Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, and
leachability) 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 the
Patient Instruction Guide Disposable Daily Wear. There is no change in
lens material, the manufacturing process, nor the parameters and properties,
therefore, the clinical data previously submitted in K994324 and K010114
supports the clinical safety of the subject device. An additional study
supports the proposed labeling modification. |
| Conclusions | Additional safety studies were not conducted, therefore, the conclusions
drawn from studies previously submitted in K994324 and K010114 support
the non-clinical and clinical safety of the subject device. The additional
study supports the proposed labeling statement to be added to the
Package Insert and the Patient Instruction Guide Disposable Daily Wear. |
510(k) Summary
.
Continued on next page
1
510(k) Summary, continued
Continued on next page
2
510(k) Summary, Continued
3
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.
4
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
5
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