(77 days)
K 021635
Not Found
No
The device is a multi-purpose contact lens solution, which is a chemical product, not a software or hardware device that would typically incorporate AI/ML. The description focuses on chemical composition and performance studies related to cleaning and disinfection efficacy.
No.
The document indicates that the device is a multi-purpose solution for cleaning, rinsing, disinfecting, and storing soft contact lenses, and for daily protein removal, not for treating a disease or condition.
No
The device is a multi-purpose solution for cleaning, disinfecting, and storing contact lenses. Its intended use is for maintenance and care of lenses, not for diagnosing any medical condition.
No
The device is a multi-purpose solution for contact lenses, which is a chemical product, 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 direct interaction with a medical device (contact lens) and not a diagnostic test performed on a biological sample from the human body.
- Device Description: The description lists the chemical components of a contact lens solution. This is consistent with a device used for the care of a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the efficacy of the solution in cleaning and disinfecting contact lenses, enzyme compatibility, cytotoxicity, and microbiological efficacy against microbes on the lenses. These are all related to the function of the solution in maintaining the contact lens, not diagnosing a disease.
- Predicate Device: The predicate device is also a multi-purpose contact lens solution, further supporting that this is not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
AQuify Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, storing for soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multi-Purpose Solution is also indicated for taily protein removal of lenses replaced in 30 days or less.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
AQuify Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001.
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
Not Found
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 series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K021635. The non-clinical and clinical studies were completed to demonstrate the substantial equivalence of AQUIFY MPS to other currently marketed solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions.
In Vitro Cleaning Efficacy: Results of the study showed that AQuify MPS is substantially equivalent to currently marketed products in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K021635.
Enzyme Compatibility: The study was conducted to evaluate the proteolytic activity of Unizyme tablets in AQuify MPS (KARATS - 257), SOLOcare Plus and ReNu Multiplus lens care solutions. The results demonstrated that Unizyme tablets dissolved in either AQuify MPS was substantially equivalent to other multi-purpose solution when used as a diluents.
Cytotoxicity: A series of cytotoxicity studies were previously conducted to demonstrate the safety of AQu MPS. Results of the testing demonstrated that AQuify MPS is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K021635.
Microbiological: Two series of microbiological studies were conducted to demonstrate the microbial efficacy AQuify Multi-Purpose Solution. For the regimen evaluated, the product met both the secondary stand alone criteria and the regimen test criteria for disinfection efficacy.
Clinical Testing: A series of clinical studies have been conducted, submitted and reviewed in 510(k) submission K021635. Data from the clinical studies supported the substantial equivalence of AQuily Multi-Purpose Solution.
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.
K 021635
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
§ 886.5928 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
PART IX. 510(k) SUMMARY
FEB = 2 2004
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 Multi-Purpose Solution
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Telephone No.
Steven Dowdley 678-415-3897
2. Device Name
Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution AQUIFY Multi-purpose Solution
3. Predicate Device(s)
AQuify Multi-purpose Solution (KARATS Multi-purpose Solution) - K 021635
4. Description of the Device
AQuify Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001.
5. Indications for Use
AQuify Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, storing for soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multi-Purpose Solution is also indicated for taily protein removal of lenses replaced in 30 days or less.
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K021635. The non-clinical and clinical studies were completed to demonstrate the substantial equivalence of AQUIFY MPS to other currently marketed solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions.
In Vitro Cleaning Efficacy
Results of the study showed that AQuify MPS is substantially equivalent to currently marketed products in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K021635.
Enzyme Compatibility
The study was conducted to evaluate the proteolytic activity of Unizyme tablets in AQuify MPS (KARATS - 257), SOLOcare Plus and ReNu Multiplus lens care solutions. The results demonstrated that Unizyme tablets dissolved in either AQuify MPS was substantially equivalent to other multi-purpose solution when used as a diluents.
1
Cytotoxicity
A series of cytotoxicity studies were previously conducted to demonstrate the safety of AQuify MPS. Results of the testing demonstrated that AQuify MPS is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K021635.
Microbiological
Two series of microbiological studies were conducted to demonstrate the microbial efficacy AQuify Multi-Purpose Solution. For the regimen evaluated, the product met both the secondary stand alone criteria and the regimen test criteria for disinfection efficacy.
Clinical Testing
A series of clinical studies have been conducted, submitted and reviewed in 510(k) submission K021635. Data from the clinical studies supported the substantial equivalence of AQuily Multi-Purpose Solution.
7. Substantial Equivalence
The data provided in this 510(k) submission concludes that AQuify Multi-Purpose Solution is substantially equivalent to currently cleared KARATS Multi-Purpose Solution for cleaning, rinsing, chemical (not heat) disinfecting, storing and daily protein removal (when used for lenses replace in and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eve care practitioner.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CIBA Vision Corporation c/o Steven Dowdley 11460 Johns Creck Pkwy. Duluth. GA 30097
FEB - 2 2004
Re: K033608
Trade/Device Name: AQuify Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care Regulatory Class: Class II Product Code: LPN Dated: January 6, 2004 Received: January 7, 2004
Dear Mr. Dowdley:
We have reviewed your Scction 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 sct 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 - 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 Ralph Rosenthal
A. Ralph Rosenthal, M.D. Dircctor Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PART 111. INDICATIONS FOR USE STATEMENT
| 510(k) Number: (Number to be assigned) | or over-the-counter: |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K033608 |