(511 days)
No
The document describes a chemical solution for contact lens care and does not mention any computational or algorithmic components.
No.
The device is a solution for cleaning, disinfecting, and storing contact lenses, not for treating or curing a medical condition.
No
The document describes a contact lens solution for cleaning, rinsing, disinfecting, and storing lenses, and for daily protein removal. It does not mention any function for diagnosing a medical condition or disease.
No
The device description clearly states it is a sterile aqueous solution containing various chemical components, indicating it is a physical product (liquid solution) and 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 for cleaning, rinsing, disinfecting, and storing contact lenses, as well as daily protein removal from contact lenses. This is a product used on a medical device (contact lenses) to maintain their function and hygiene, not a product used to diagnose a condition or analyze a biological sample from the human body.
- Device Description: The description lists chemical components of a solution. This aligns with a cleaning and disinfecting product, not a diagnostic test.
- 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 analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The performance studies focus on the efficacy of the solution in cleaning, disinfecting, and maintaining the properties of contact lenses, as well as clinical evaluation of comfort and preference when using the solution with contact lenses. These are all relevant to a contact lens care product, not an IVD.
N/A
Intended Use / Indications for Use
AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.
Product codes
LPN
Device Description
AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.
Mentions image processing
Dark Field Image Analysis
With reqards to dark field image analysis, there were no statistically significant differences in the investigator appraisal of lens deposits, front surface wetting and objective dark-field image analysis of lenses worn for 90 days. Both the test and control product provided clinically acceptable lens cleanliness when used according to their directions for use as measured by dark filed image analysis of the returned lenses.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies
Cleaning Studies: Previous studies have demonstrated the cleaning capacity of AQuify Multipurpose Solution with soft contact lenses. The study previously submitted and reviewed under K021635 demonstrated that AQuify MPS is substantially equivalent in terms of daily protein removal.
Dehydration Effect: Using a dynamic vapor sorption system, lenses treated with AQuify Multipurpose Solution showed an effect on the steady state water content at a relative humidity of 50%. AQuify MPS was statistically better than control lens multipurpose solution tested at increasing the steady-state water content within a lens group. All groups of lenses indicate that AQuify had a higher water content after 60 minutes at a relative humidity of 50%. This demonstrates that AQuify increased the water holding capabilities of the hydrogel lenses tested.
Microbiology: A series studies were also completed to demonstrate the microbiological efficacy of AQuify Multipurpose Solution. These studies were submitted and reviewed under K021635. These studies demonstrate that AQuify Multipurpose Solution meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. The product also meets the USP Modified criteria for Preservative Effective Testing and USP Sterility Test requirements.
Toxicology: A series toxicology studies were completed, submitted and reviewed under K021635.
Clinical Evaluation: The trial was a three-month prospective, randomized, single masked trial consisting of baseline, two-week, one-month and final three-month visits. Subjects compared the Aquify Multipurpose Solution and ReNu Multipurpose Solution on a contra-lateral basis. Study participants were all randomized for which eye used the test and which eye used the control product. The primary objective of this clinical trial was to evaluate safety, efficacy, and preference between AQUIFY Multipurpose Solution and ReNu Multipurpose Solution. Both solutions used a pre-rinse and a minimum 4 hour to overnight soak.
Symptoms: There were no significant differences in the AQUIFY Multipurpose Solution and control solution with regards to symptoms.
Efficacy at Two Weeks: Statistically significant differences in favor of AQuify MPS were found for overall comfort and particularly overall dryness and overall lens awareness 1-10 scores and for lens awareness preference at the two-week visit. There were also strong trends that were almost statistically significant for overall comfort and lens awareness in favor of AQuify MPS.
Efficacy at One Month: Statistically significant differences in favor of AQuify MPS were found for overall comfort and dryness 1-10 scores and for overall comfort, dryness, and lens awareness preferences.
Efficacy at 3 Months: Statistically significant differences in favor of AQuify MPS were found for insertion and overall comfort 1-10 scores and for insertion comfort, overall comfort, dryness, and lens awareness preferences.
Efficacy Conclusions: Overall comfort 1-10 scores and preferences were consistently statistically significantly better with AQuify MPS over ReNu Multiplus throughout the trial. AQuify MPS was also statistically significantly preferred for less dryness throughout the trial having higher mean 1-10 scores for all subjective categories for all visits over ReNu Multiplus. AQuify MPS was increasingly preferred as the trial progressed to almost a 4:1 ratio (42% versus 11%) by the final visit with over 50% of the subjects expressing a preference.
Dark Field Image Analysis: With reqards to dark field image analysis, there were no statistically significant differences in the investigator appraisal of lens deposits, front surface wetting and objective dark-field image analysis of lenses worn for 90 days. Both the test and control product provided clinically acceptable lens cleanliness when used according to their directions for use as measured by dark filed image analysis of the returned lenses.
Key Metrics
comfort, dryness, lens awareness
Predicate Device(s)
KARATS Multipurpose Solution, ReNu Multipurpose Solution, Complete Comfort Plus Multipurpose Solution, Opti-Free Express Multipurpose Solution
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
OCT 2 8 2004
Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is in black and white and features the word "CIBA" in large, bold letters above the word "Vision". The "i" in "Vision" is replaced with an eye symbol. Below the word "Vision" is the text "A Novartis Company" in a smaller font.
510(k) SUMMARY
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.
510(k) SUMMARY for AQuify Multipurpose Solution
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- Submitter Information CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley Telephone No. 678-415-3897
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- Proprietary Name: AQuify Multipurpose Solution Classification Name: Soft (hydrophilic) Contact Lens Solution
ന് Predicate Device(s)
KARATS Multipurpose Solution (for lenses replaced in less than 30 days) ReNu Multipurpose Solution Complete Comfort Plus Multipurpose Solution Opti-Free Express Multipurpose Solution
4. Description of the Device
AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.
5. Indications for Use
AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.
6. Description of Safety and Substantial Equivalence
Cleaning Studies
Previous studies have demonstrated the cleaning capacity of AQuify Multipurpose Solution with soft contact lenses. The study previously submitted and reviewed under K021635 demonstrated that AQuify MPS is substantially equivalent in terms of daily protein removal.
Dehydration Effect
Using a dynamic vapor sorption system, lenses treated with AQuify Multipurpose Solution showed an effect on the steady state water content at a relative humidity of 50%. AQuify
1
MPS was statistically better than control lens multipurpose solution tested at increasing the steady-state water content within a lens group. All groups of lenses indicate that AQuify had a higher water content after 60 minutes at a relative humidity of 50%. This demonstrates that AQuify increased the water holding capabilities of the hydrogel lenses tested.
Microbiology
A series studies were also completed to demonstrate the microbiological efficacy of AQuify Multipurpose Solution. These studies were submitted and reviewed under K021635. These studies demonstrate that AQuify Multipurpose Solution meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. The product also meets the USP Modified criteria for Preservative Effective Testing and USP Sterility Test requirements.
Toxicology
A series toxicology studies were completed, submitted and reviewed under K021635.
Clinical Evaluation
The trial was a three-month prospective, randomized, single masked trial consisting of baseline, two-week, one-month and final three-month visits. Subjects compared the Aquify Multipurpose Solution and ReNu Multipurpose Solution on a contra-lateral basis. Study participants were all randomized for which eye used the test and which eye used the control product.
The primary objective of this clinical trial was to evaluate safety, efficacy, and preference between AQUIFY Multipurpose Solution and ReNu Multipurpose Solution. Both solutions used a pre-rinse and a minimum 4 hour to overnight soak.
Symptoms
There were no significant differences in the AQUIFY Multipurpose Solution and control solution with regards to symptoms.
Efficacv at Two Weeks
Statistically significant differences in favor of AQuify MPS were found for overall comfort and particularly overall dryness and overall lens awareness 1-10 scores and for lens awareness preference at the two-week visit. There were also strong trends that were almost statistically significant for overall comfort and lens awareness in favor of AQuify MPS.
Efficacy at One Month
Statistically significant differences in favor of AQuify MPS were found for overall comfort and dryness 1-10 scores and for overall comfort, dryness, and lens awareness preferences.
Efficacy at 3 Months
Statistically significant differences in favor of AQuify MPS were found for insertion and overall comfort 1-10 scores and for insertion comfort, overall comfort, dryness, and lens awareness preferences
Efficacy Conclusions
Overall comfort 1-10 scores and preferences were consistently statistically significantly better with AQuify MPS over ReNu Multiplus throughout the trial. AQuify MPS was also statistically significantly preferred for less dryness throughout the trial having higher mean 1-10 scores for all subjective categories for all visits over ReNu Multiplus. AQuify
2
MPS was increasingly preferred as the trial progressed to almost a 4:1 ratio (42% versus 11%) by the final visit with over 50% of the subjects expressing a preference.
Dark Field Image Analysis
With reqards to dark field image analysis, there were no statistically significant differences in the investigator appraisal of lens deposits, front surface wetting and objective dark-field image analysis of lenses worn for 90 days. Both the test and control product provided clinically acceptable lens cleanliness when used according to their directions for use as measured by dark filed image analysis of the returned lenses.
7. Conclusion Drawn from Data Supporting Equivalence Determination:
We conclude that AQUIFY Multipurpose Solution is substantially equivalent to ReNu Multiplus Multipurpose Solution when used to clean, rinse, chemical (not heat) disinfect and store soft (hydrophilic) contact lenses on a conventional replacement schedule of three months or longer
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2004
CIBA Vision Corporation c/o Mr. Steven Dowdley 11460 Johns Creek Parkway Duluth, Georgia 30097
Re: K031753
Trade/Device Name: AQuify Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Solution Regulatory Class: Class II Product Code: LPN Dated: September 7, 2004 Received: September 8, 2004
Dear Mr. Dowdley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 (21 CFR Part 807): labeling (21 CFR Part 801); 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.
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Page 2- Mr. Steven Dowdley
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 kalgi korenthal
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
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number: K031753
Device Name: AQuify Multi-Purpose Solution
Indications for Use:
AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuity Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: or over-the-counter: 内 Avision Sign-Off Division of Ophthalmi Nose and Throat De 510(k) Number