(190 days)
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No
The summary describes a sterile solution for contact lens comfort and provides performance data related to lens compatibility, cytotoxicity, microbiology, and clinical testing. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The intended use states it is for temporary relief from dryness and irritation associated with contact lens wearing, which is a palliative and not a therapeutic effect.
No
Explanation: The device is described as "Lens Comfort Drops" used to "moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing." This indicates a palliative or symptomatic relief purpose, not a diagnostic one. There is no mention of identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is a "sterile solution containing sodium hyalvronate, sodium chloride, sodium phosphate and sodium perborate stabilized with phosphoric acid as a preservative," indicating it is a liquid solution, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing." This is a direct application to the eye for comfort and relief, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description lists the chemical components of a sterile solution for use with contact lenses. It does not describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
The device is clearly intended for direct application to the eye to improve comfort while wearing contact lenses.
N/A
Intended Use / Indications for Use
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from w dryness and irritation associated with contact lens wearing.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
AQuily Comfort Drops is a sterile solution containing sodium hyalvronate, sodium chloride, a AQuify Lens Comfort Drops is a stenle solution containing bouldn't phosphoric acid as a preservative.
sodium phosphate and sodium perborate stabilized with phosphoric acid as
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A one month clinical study was conducted to evaluate the substantial equivalence of AQuify Lens A one mont offinitured. Stay the Jurpose Lubricating and Rewetting Drops. The results of the study demonstrated no differences in biomicroscopy findings, symptoms, or vision safety Study demonotration no afficients Comfort Drops (HAM) and the control treatment groups. In addition, there were no adverse differences for shown in the test cell for lens surface addition, there were no advertive ratings. The findings of this study demonstrate the substantial equivalence of AQuify Lens Comfort Drops.
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.
Bausch and Lomb - ReNu Multiplus Lubricating and Rewetting Drops, Pfizer - Visine for Contacts, Biomatrix - Hylashield CL Lubricating Eye Drops
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
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
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0132 04
APR 0 3 2002
510(k) SUMMARY 2010 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary in response to the requirements address information upon which the substantial equivalence determination is based.
SUMMARY OF SAFETY AND EFFECTIVENESS FOR AQuify Lens Comfort Drops
- Submitter Information 1. CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person:Steven Dowdley Telephone No. 678-415-3897
- Device Name 2. Soft (hydrophilic) Contact Lens Solution Classification Name: AQuify Lens Comfort Drops Proprietary Name:
-
- Predicate Devices Bausch and Lomb - ReNu Multiplus Lubricating and Rewetting Drops Pfizer - Visine for Contacts Biomatrix - Hylashield CL Lubricating Eye Drops
Description of the Devices 4.
AQuily Lens Comfort Drops is a sterile solution containing sodium hyalvronate, sodium chloride, a AQuify Lens Comfort Drops is a stenle solution containing bouldn't phosphoric acid as a preservative.
sodium phosphate and sodium perborate stabilized with phosphoric acid as
Indications for Use 5.
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from w dryness and irritation associated with contact lens wearing.
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies were completed to demonstrate the substantial A selles of precimied and olinion station of the predicate device(s). All testing described equivalence of AQuily Lens Obmort Drops to the productions. Results demonstrate the in accordance with and biocompatible, and is comparable to other currently marketed soft -Sontact lens solutions. Results from all tests demonstrate the substantial equivalence to previously FDA approved predicate device.
Lens Compatibility Data:
There was no significant difference between AQuify Lens Comfort Drops and the control rnloro with respect to optical (power, base curve and diameter) and physical (visual Solution with respool to option (porchanges in the measured properties of lenses. The results further showed that the changes observed in lens power and diameter were within ANSI specifications. The proposed solution was found to be substantially equivalent to the control solution
1
Cytotoxicity
A series of comprehensive cytotoxicity studies were conducted to evaluate the safety of AQuify A denos of comprehensive of the testing demonstrated that AQuify Lens Comfort Drops is noncvtotoxic and is a non-irritant.
Microbiological
Microbiogical
AQuify Lens Comfort Drops tested for microbiological safety and effectiveness using the FDA AQuily Lens Contact lens solution. The solution met the acceptance criteria for the ISO/FDA Preservative Effectiveness Test.
Clinical Testing
A one month clinical study was conducted to evaluate the substantial equivalence of AQuify Lens A one mont offinitured. Stay the Jurpose Lubricating and Rewetting Drops. The results of the study demonstrated no differences in biomicroscopy findings, symptoms, or vision safety Study demonotration no afficients Comfort Drops (HAM) and the control treatment groups. In addition, there were no adverse differences for shown in the test cell for lens surface addition, there were no advertive ratings. The findings of this study demonstrate the substantial equivalence of AQuify Lens Comfort Drops.
7. Substantial Equivalence
Stantial Equivalence
The data provided in this 510(k) submission concludes that AQuify Lens Comfort Drops is The data provided in this of to(t) bubiniscion is submission (ReNu Multiplus Substantially equivalent to the predicate devices and Hylashield CL Lubricating Eye Drops).
Lubricating and Rewetting Drops, Visine for Contacts, and Hylashield CL Lubricatin
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Dowdley CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097
APR 0 3 2002
Re: K013204
Trade/Device Name: AQuify Lens Comfort Drops Regulation Number: 886.5928 Regulatory Class: Soft (hydrophilic) contact lens care products Product Code: LPN Regulation Number: 886.5918 Regulatory Class: Rigid gas permeable contact lens care products Product Code: MRC Dated: January 24, 2002 Received: January 30, 2002
Dear Mr. Dowdley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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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K0/3204
[PART ]]]. INDICATIONS FOR USE STATEMENT . CONSULTION CONSULTION CONSULTION CANAL CONSULTION
This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number:
Device Name: AQuify Lens Comfort Drops
Indications for Use:
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | ☐ or over-the-counter: ☑ |
|---|---|
| ------------------- | -------------------------- |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
| 510(k) Number | K013204 |
|---|---|
| --------------- | --------- |