(223 days)
Not Found
Not Found
No
The device description and performance studies focus on the chemical composition and cleaning/disinfection properties of a contact lens solution, with no mention of AI or ML.
No.
The device is a multi-purpose solution for cleaning and disinfecting contact lenses, not a therapeutic device intended to treat a disease or condition.
No
The device is a multi-purpose solution for cleaning, conditioning, rinsing, disinfecting, and storing contact lenses, as clearly stated in the "Intended Use / Indications for Use" section. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile, buffered, isotonic, aqueous solution containing various chemical components, indicating it is a physical product (a 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 the cleaning, conditioning, rinsing, disinfection, and storage of contact lenses. This is a direct interaction with a medical device (contact lenses) and the user, not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description lists chemical components of a solution. While it has a biological effect (disinfection), it's not designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or kits for testing
- Measuring analytes or markers
The device is clearly a contact lens care product, which falls under a different regulatory category than IVDs. The performance studies focus on cleaning efficacy, lens compatibility, microbiology (disinfection), biocompatibility, and clinical safety and efficacy related to contact lens wear. These are all relevant to a contact lens solution, not an IVD.
N/A
Intended Use / Indications for Use
For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.
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 Studies: ALCON® Multi-Purpose Solution is an isotonic aqueous solution which contains a surface active agent, TETRONIC® 1304. The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration (CMC). The TETRONIC® 1304 concentration is well above the CMC, which ensures the effective cleaning function of the product. These findings are supported by results of clinical evaluations.
Compatibility Studies: Lens compatibility studies performed show that ALCON® Multi-Purpose Solution is compatible with silicone hydrogel lenses.
Microbiology Studies: A series of studies based on 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, the ANSI Contact Lens Care Products Standard and EN ISO 14730:2000 Ophthalmic optics- Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date were completed to demonstrate the microbiological efficacy of ALCON® Multi-Purpose Solution. These results indicate ALCON® Multi-Purpose Solution meets satisfactory levels of disinfection and preservative efficacy.
Biocompatibility: Based on the results of the preclinical evaluations, ALCON® Multi-Purpose Solution is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.
Clinical Studies: Two clinical studies were conducted using ALCON® Multi-Purpose Solution. The control product was Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution. The safety and efficacy of the ALCON® Multi-Purpose Solution were clinically acceptable. Subjects assigned to the ALCON® Multi-Purpose Solution regimen had statistically less corneal staining compared to the control regimen with silicone hydrogel lenses.
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.
Not Found
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
071236
510(k) SUMMARY
Submitted by:
Kim B. Kracke Assistant Director, Regulatory Affairs Alcon, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-8338 (Phone) (817) 551-4630 (Fax)
DEC 1 2 2007
Device Name:
Proprietary Name: ALCON® Multi-Purpose Solution
Common Name: Soft (hydrophilic) Contact Lens Care Solution
Classification Name: Under 21 CFR §886.5928 titled Soft (hydrophilic) contact lens care products, this solution is classified as a Class II -- Special Controls Product.
Indications for Use:
For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.
Description:
ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.
TETRONIC® is a trademark of BASF.
Substantial Equivalence:
1
ALCON® Multi-Purpose Solution is substantially equivalent in terms of its actions and indications for use to ALCON® Opti-Free® RepleniSH® Multi-Purpose Disinfecting Solution and ALCON® Unique-pH® Multi-Purpose Solution.
Safety and Effectiveness:
Cleaning Studies:
ALCON® Multi-Purpose Solution is an isotonic aqueous solution which contains a surface active agent, TETRONIC® 1304. The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration (CMC). The TETRONIC® 1304 concentration is well above the CMC, which ensures the effective cleaning function of the product. These findings are supported by results of clinical evaluations.
Compatibility Studies:
Lens compatibility studies performed show that ALCON® Multi-Purpose Solution is compatible with silicone hydrogel lenses.
Microbiology Studies:
A series of studies based on 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, the ANSI Contact Lens Care Products Standard and EN ISO 14730:2000 Ophthalmic optics- Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date were completed to demonstrate the microbiological efficacy of ALCON® Multi-Purpose Solution. These results indicate ALCON® Multi-Purpose Solution meets satisfactory levels of disinfection and preservative efficacy.
2
Biocompatibility:
Based on the results of the preclinical evaluations, ALCON® Multi-Purpose Solution is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.
Clinical Studies:
Two clinical studies were conducted using ALCON® Multi-Purpose Solution. The control product was Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution. The safety and efficacy of the ALCON® Multi-Purpose Solution were clinically acceptable. Subjects assigned to the ALCON® Multi-Purpose Solution regimen had statistically less corneal staining compared to the control regimen with silicone hydrogel lenses.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a protective shape.
MAY 29 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcon Research, Ltd. c/o Kim Kracke Assistant Director, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099
Re: K071236
Trade/Device Name: Alcon Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: October 25, 2007 Received: October 26, 2007
Dear Ms. Kracke:
This letter corrects our substantially equivalent letter of December 12, 2007.
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 (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 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.
4
This letter will allow you to continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Eweneth Boun PhD
Image /page/4/Picture/5 description: The image contains a handwritten word, "for", in a simple, cursive style. The letters are connected, and the word is written in black ink on a white background. The "f" has a loop extending above and below the main body of the letter, and the "or" is written in a continuous stroke.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name:
Alcon Multi-Purpose Solution
Indications For Use:
For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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)
Nya Smith
(Division Sign-Off) Division of Ochthalmic Ear, Nosse aren Inroat Devises
Page 1 of /
5": Number K07/236