(34 days)
N18-033/S31
No
The summary describes contact lenses and a labeling modification, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia), visual acuity, and distance and near vision, which are functions of vision correction, not therapeutic treatment of an ocular disease or condition.
No
Explanation: The device is a contact lens intended for correcting vision (refractive ametropia, presbyopia, astigmatism) and protecting against UV radiation, not for diagnosing medical conditions.
No
The device is a contact lens, which is a physical medical device, not software. The 510(k) describes a labeling modification for a previously cleared contact lens.
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 Lenses are for the correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia). This is a therapeutic or corrective function, not a diagnostic one.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. Contact lenses do not fit this definition.
- Device Description: The description refers to a previous clearance for contact lenses, which are medical devices for vision correction.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a medical device intended for vision correction.
N/A
Intended Use / Indications for Use
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE BIFOCAL 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 or less of astigmatism.
The ACUVUE 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 or less of astigmatism.
The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
ACUVUE 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 or for 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)
LPL
Device Description
The device description does not change from that cleared under K962804.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and into the 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)
Non-clinical studies (microbiology, toxicology, chemistry, shelf-life, and leachability) on the lens material were not conducted because the lens material, etafilcon A, does not change. Non-clinical studies were conducted to support the following modified Actions in the labeling. The average UV blocking for ACUVUE Contact Lenses with UV Blocker for UVA is 82% and for UVB is 97%.
This 510(k) describes a labeling modification: an additional Indications Statement. There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in N18-033/S31 and K962804 supports the clinical safety of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
UVA is 82% and for UVB is 97%.
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.
N18-033/S31
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
Summary of 510(k) Submission
| Name and
address of
submitter | Vistakon, Johnson & Johnson Vision Products, Inc.
4500 Salisbury Road, Suite 300
Jacksonville, Florida 32216
Contact: Martine D. Martino
Phone: (904) 443-1808
Date Prepared: April 1, 1999 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of
device | The trade name is ACUVUE (etafilcon A) soft (hydrophilic) contact
lenses, clear and visibility tint, with UV blocker, for daily wear The common or usual name is Soft (hydrophilic) Contact Lens (daily
wear). The FDA Classification is Class II. |
| Predicate
devices | The predicate device is ACUVUE (etafilcon A) soft (hydrophilic) contact
lenses, clear and visibility tint, with UV blocker, for daily wear covered under
K962804. |
| Description of
device | The device description does not change from that cleared under K962804. |
| | Continued on next page |
| Intended use | The reason for the 510(k) is to add the following Indications Statement (see bold text ) for ACUVUE (etafilcon A) soft (hydrophilic) contact lenses, clear and visibility tint, with UV blocker, for daily wear. The revised Indications Statement is included with this 510(k): |
| | The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. |
| | The ACUVUE BIFOCAL 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 or less of astigmatism. |
| | The ACUVUE 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 or less of astigmatism. |
| | The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. |
| | ACUVUE 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 or for 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. |
1
Summary of 510(k) Submission, Continued
Continued on next page
2
Summary of 510(k) Submission, Continued
| Characteristics | The characteristics do not change. They are the same as previously submitted
in N18-033/S31 and K962804. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical
studies | Non-clinical studies (microbiology, toxicology, chemistry, shelf-life, and
leachability) on the lens material were not conducted because the lens
material, etafilcon A, does not change. Non-clinical studies were conducted to support the following modified
Actions in the labeling. The average UV blocking for ACUVUE Contact Lenses with UV
Blocker for UVA is 82% and for UVB is 97%. |
| Clinical studies | This 510(k) describes a labeling modification: an additional Indications
Statement. There is no change in lens material, the manufacturing process,
nor the parameters and properties, therefore, the clinical data previously
submitted in N18-033/S31 and K962804 supports the clinical safety of the
subject device. |
| Conclusions
drawn from
studies | Additional studies were not conducted, therefore, the conclusions drawn from
studies previously submitted in N18-033/S31 and K962804 support the non-
clinical and clinical safety of the subject device. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized representation of a human figure, consisting of three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 6 1999
Vistakon™ Johnson & Johnson Vision Care Products, Inc. C/O Ms. Martine D. Martino P.O. Box 10157 Jacksonville, FL 32247
Re: K991134
Trade Name: ACUVUE (etafilcon A) soft (hydrophilic) contact lens, clear and with visibility tint, with UV blocker, for daily wear Regulatory Class: II Product Code: LPL Dated: April 1, 1999 Received: April 2, 1999
Dear Ms. Martino:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
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 affecting your device can be found in the Code 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Martine D. Martino
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph L. Rosenthal, M.D.
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications Statement
K991134 510(k) Number:
ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Device Name: Tint with UV Blocker
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE BIFOCAL 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 or less of astigmatism.
The ACUVUE 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 or less of astigmatism.
The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
ACUVUE 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 or for 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.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Karin Waibmtor
(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use ✓ 510(k) Number K991134 OR Over the Coumer
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