(85 days)
No
The device is a contact lens solution, and the description focuses on its chemical composition and intended use for cleaning and disinfecting lenses. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is a multi-purpose solution for cleaning, rinsing, disinfecting, and storing contact lenses, not for treating a disease or condition in the body.
No
The device is a multi-purpose solution for cleaning, disinfecting, and storing contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile aqueous solution contained in a plastic bottle, indicating it is a liquid chemical product, not software.
Based on the provided text, 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. This is a device used on a medical device (contact lenses), not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description confirms it's a solution for contact lens care.
- 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.)
- Providing diagnostic information
- Measuring analytes or biomarkers
Therefore, SOLO-Care™ Brand Multi-Purpose Solution is a medical device for contact lens care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate)and PMMA contact lenses as recommended by your eye care practitioner.
Product codes
86 LPN
Device Description
SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution used in the care contact lenses and is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal. storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner. It may also be uses as a diluent for enzymatic cleaning tablets, which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablet. The solution is contains in a plastic bottle and consists of a sterile isotonic solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate and polyhexanide 0.0001%. Each bottle is supplied sterile and is labeled with a lot number and expiration date.
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
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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
A series of pre-clinical studies have been completed to demonstrate the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution; all studies have previously been submitted under P940042, K 982168, and under K983291. To support the claim of 10-minute disinfection, a series of microbiological testing has been completed at time perlods ranging from 10 minutes to 4 hours. A compatibility study was also successfully completed to demonstrate compatibility with PMMA lenses. All results were satisfactory.
Key Metrics
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
K99/403
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION
Submitter Information 1.
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley (Senior Regulatory Affairs Associate) Telephone No. 770-418-3897
- Device Name 2. Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION
3. Predicate Devices
Currently marketed SOLO-Care™ Brand MULTI-PURPOSE SOLUTION was selected as the predicate devices for this submission. This product was selected because the formulation and indications for use are identical to the device proposed in this submission.
4. Description of the Devices
SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution used in the care contact lenses and is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal. storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner. It may also be uses as a diluent for enzymatic cleaning tablets, which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablet. The solution is contains in a plastic bottle and consists of a sterile isotonic solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate and polyhexanide 0.0001%. Each bottle is supplied sterile and is labeled with a lot number and expiration date.
5. Indications for Use
SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner.
હ્ Description of Safety and Substantial Equivalence
A series of pre-clinical studies have been completed to demonstrate the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution; all studies have previously been submitted under P940042, K 982168, and under K983291. To support the claim of 10-minute disinfection, a series of microbiological testing has been completed at time perlods ranging from 10 minutes to 4 hours. A compatibility study was also successfully completed to demonstrate compatibility with PMMA lenses. All results were satisfactory.
7. Substantial Equivalence
SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to the predicate device. SOLO-Care Brand Multi-Purpose Solution in a 10-minute disinfection cycle time is substantially equivalent to a 4-hour disinfection cycle time.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird, and two wavy lines that form the tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 1999
Mr. Steven Dowdley Senior Associate, Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097-1556
Re: K991403 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: April 20, 1999 Received: April 22, 1999
Dear Mr. Dowdley:
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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Page 2 - Mr. Steven Dowdley
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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PART III. INDICATIONS FOR USE STATEMENT
This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number:
Device Name: SOLO-Care ™ Brand Multi-Purpose Solution
Indications for Use:
SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate)and PMMA contact lenses as recommended by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
or Over-the-Counter:
Nyji Smith
(Division Sign-Off) Division of Ophthalmic Devices K941403 510(k) Number_