(222 days)
No
The device description and performance studies focus on the chemical composition and microbiological efficacy of a contact lens cleaning solution. There is no mention of AI or ML in the document.
No
The device is a multi-purpose disinfecting solution for contact lenses, not a therapeutic device. Its purpose is cleaning and disinfecting lenses, not treating a disease or condition.
No
The device is a multi-purpose disinfecting solution for contact lenses, primarily used for cleaning, disinfection, and storage. Its intended use does not involve diagnosing any medical condition or disease.
No
The device description clearly states it is a sterile, buffered, aqueous solution containing various chemical components, indicating it is a physical product (liquid) 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 the cleaning, disinfection, and storage of contact lenses. This is a product used on a medical device (contact lenses) to maintain their hygiene and functionality, not a product used to diagnose a condition or collect and analyze a sample from the human body.
- Device Description: The description details the chemical composition of a contact lens solution.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or providing information about a patient's health status. The performance studies focus on the efficacy of the solution in cleaning and disinfecting contact lenses and its compatibility with the lenses and the eye.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Product codes
LPN
Device Description
Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.
Mentions image processing
Not Found
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
Not Found
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)
Cleaning: The cleaning efficacy of Alcon MPDS was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants. Cleaning efficacy studies conducted with Alcon MPDS indicate that it is effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses. Studies also demonstrated cleaning activity when lenses were soaked in Alcon MPDS.
Compatibility: The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses.
Microbiology: Alcon conducted a series of studies based on FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products., ANSI Z80, EN ISO 14729:2001 Ophthalmic optics- Contact lens care products- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 14730:2000 Opthalmic optics- Contact lens care products- Antimicrobial preservative efficacy testing and guidance on determining discard date to demonstrate the microbiological efficacy of Alcon MPDS. Alcon MPDS exceeds the criteria for disinfection and preservative efficacy.
Biocompatibility: Alcon MPDS was tested in compliance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. Based on the results of the comprehensive preclinical evaluations, Alcon MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.
Clinical: A clinical study was conducted to evaluate the safety and efficacy of the Alcon® MPDS in silicone hydrogel and soft (hydrophilic) contact lens wearers. The control product was Bausch & Lomb™ renu@ fresh™ Multi-Purpose Solution. The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control. Alcon MPDS is substantially equivalent to the control. The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974723, K083757, K050729, K071236
Reference Device(s)
Not Found
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
MAY 1 0 2011
510(k) SUMMARY
Submitted by:
Beth L. Schultz Manager II, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 568-6143 (Phone) (817) 551-4630 (Fax)
Device Name:
Proprietary Name: Alcon Multi-Purpose Disinfecting Solution Common Name: Soft (Hydrophilic) Contact Lens Care Solution Classification Name: Under 21 CFR §886.5928 titled Soft (hydrophilic) contct lens care products, this solution is classified as a Class II - Special Controls Product.
Indications for Use:
For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Description:
Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.
+Tetronic® is a trademark of BASF.
1
Substantial Equivalence:
Alcon MPDS meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Alcon MPDS is substantially equivalent in terms of its actions and intended use to Bausch & Lomb™ renu® fresh™ multi-purpose solution (K974723), Bausch & Lomb™ BioTrue™ multi-purpose solution (K083757), Alcon OPTI-FREE® Replenish® Multi-Purpose Disinfecting Solution (K050729) and Alcon Multi-Purpose Solution (K071236). A summary of the test results is provided below:
Safety and Effectiveness:
Cleaning:
The cleaning efficacy of Alcon MPDS was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants. Cleaning efficacy studies conducted with Alcon MPDS indicate that it is effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses. Studies also demonstrated cleaning activity when lenses were soaked in Alcon MPDS.
Compatibility:
The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses.
Microbiology:
Alcon conducted a series of studies based on FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products., ANSI Z80, EN ISO 14729:2001 Ophthalmic optics- Contact lens care products- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 14730:2000 Opthalmic optics- Contact lens care products- Antimicrobial preservative efficacy testing and guidance on determining discard date to demonstrate the
2
microbiological efficacy of Alcon MPDS. Alcon MPDS exceeds the criteria for disinfection and preservative efficacy.
Biocompatibility:
Alcon MPDS was tested in compliance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. Based on the results of the comprehensive preclinical evaluations, Alcon MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.
Clinical:
A clinical study was conducted to evaluate the safety and efficacy of the Alcon® MPDS in silicone hydrogel and soft (hydrophilic) contact lens wearers. The control product was Bausch & Lomb™ renu@ fresh™ Multi-Purpose Solution. The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control. Alcon MPDS is substantially equivalent to the control. The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal.
3
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 stylized eagle with three stripes representing health, human services, and the U.S. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alcon Research, Ltd. C/O Beth L. Schultz O.D. Manager II, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099
MAY 1 0 2011
) Re: K102860 g
.
Trade/Device Name: Alcon Multi-Purpose Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: April 28, 2011 Received: April 29, 2011
Dear Dr. Schultz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 – Dr. Beth L. Schultz
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
- . http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Marina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure .
5
Indications for Use
K102860 510(k) Number (if known):
Alcon Multi-Purpose Disinfecting Solution Device Name:
Indications for Use:
For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Prescription Use Over-The-Counter Use AND/OR X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102860