(22 days)
Not Found
No
The device description and intended use clearly indicate it is a chemical solution for cleaning contact lenses, with no mention of AI or ML capabilities.
No
The device is a solution for cleaning and disinfecting contact lenses, which falls under maintenance rather than direct therapeutic treatment for a medical condition.
No
The device is a multi-purpose disinfecting solution for contact lenses, used for cleaning, disinfecting, and storage. It is not described as detecting or monitoring physiological states or diseases.
No
The device description clearly states it is a sterile, buffered, isotonic, aqueous solution containing various chemical components, indicating it is a liquid 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, disinfecting, and storing contact lenses, and as a diluent for protein removers. These are all actions performed on the contact lens itself, which is a medical device, not on a biological specimen from the human body.
- Device Description: The description lists chemical components of a solution used for contact lens care. It does not describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely related to the maintenance of a medical device (contact lenses).
N/A
Intended Use / Indications for Use
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.
Product codes
86 LPN
Device Description
Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.
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)
The risk analysis method used to assess the impact of the minor specification modification was prEN 1441, Risk Assessment of Medical Devices. Also an eight day ocular irritation evaluation of the formulation with the minor specification modification was conducted with soft contact lenses in rabbits. Based on the results of this study, Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) should not present an ocular hazard to the consumer under normal use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K9845775
Submitted by:
Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4702 (Phone) (817) 551-4630 (Fax)
Device Name:
| Common Name: | Contact Lens Care Multi-Purpose Solution |
|---|---|
| Proprietary Name: | Multi-Purpose Disinfecting Solution ID 90746 |
| (Minor specification modification) |
Indications for Use:
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Multi-Purpose Disinfecting Solution ID 90746 can also be used to dissolve OPTI-ZYME® Enzymatic Cleaner
Description:
Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.
Substantial Equivalence:
Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) is substantially equivalent, in terms of its actions and indications for use, to Multi-Purpose Disinfecting Solution ID 90746 (K973332). Multi-Purpose Disinfecting Solution
1
ID 90746 (minor specification modification) 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.
Safety and Effectiveness:
The risk analysis method used to assess the impact of the minor specification modification was prEN 1441, Risk Assessment of Medical Devices. Also an eight day ocular irritation evaluation of the formulation with the minor specification modification was conducted with soft contact lenses in rabbits. Based on the results of this study, Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) should not present an ocular hazard to the consumer under normal use conditions. Multi-Purpose Disinfecting Solution ID 90746 (minor specification) 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.
・・・・・・・・・・・・・・・・・・・・・
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Image /page/2/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 lines representing its wings, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099
Re: K984575
Trade Name: Multi-Purpose Disinfecting Solution ID 90746 Product Code: 86 LPN Dated: December 22, 1998 Received: December 23, 1998
Dear Mr. Larsen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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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Mr. Ralph H. Larsen - Page 2
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Multi-Purpose Disinfecting Solution ID 90746
Indications for Use:
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Myra Smuth | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K984575 |