(151 days)
The provided text does not contain any K/DEN numbers for the predicate devices. It only lists the names of the predicate devices.
Not Found
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a contact lens solution, with no mention of AI or ML technologies.
No
The device is a multi-purpose solution for cleaning and disinfecting contact lenses, which are considered medical devices, but the solution itself is not directly therapeutic; rather it maintains the lenses that aid in vision.
No
The device is a multi-purpose solution for cleaning, disinfecting, and storing contact lenses, not for diagnosing a medical condition. Its function is to maintain medical devices (contact lenses), not to provide a diagnosis.
No
The device description clearly states it is a sterile aqueous solution containing various chemical ingredients and is contained in a plastic bottle. This indicates a physical 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, protein removal, and storing soft contact lenses. This is a direct interaction with a medical device (contact lenses) and not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a sterile aqueous solution for contact lens care. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids, or providing diagnostic information.
Therefore, based on the provided information, SOLO-Care™ Brand Multi-Purpose Solution is a contact lens care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SOLO-Care Brand Multi-Purpose Solution is indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by an eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
86 LPN
Device Description
SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, daily protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
Preclinical Testing: A series of preclinical tests were performed to asses the safety and effectiveness of the solution. All preclinical toxicology and microbiology tests were conducted in accordance with GLP requlation (21 CFR Part 58). Results of the testing demonstrated that SOLO-Care Brand Multi-Purpose Solution is safe and effective as a multi-purpose soft (hydrophilic) contact lenses solution.
Clinical Testing: A one month clinical evaluation was conducted in accordance with current Good Clinical Practices and published requlations (21 CFR Parts 50, 56, 312, 812). The clinical results provide valid scientific evidence that SOLO-care™ Multi-Purpose Solution is substantially equivalent to ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner for the removal of visible protein. There were also no safety or efficacy issues raised with SOLO-care™ Multi-Purpose Solution used without a rinse prior to insertion.
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.
Bausch & Lomb ReNu® Multi-Purpose Solution, Bausch & Lomb ReNu® 1 Step Enzymatic Cleaner
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
K 982168
SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley (Senior Regulatory Affairs Associate) Telephone No. 770-418-3897
2. Device Name
Classification Name: Proprietary Name:
Soft (hydrophilic ) Contact Lens Solution SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION
3. Predicate Devices
Bausch & Lomb ReNu® Multi-Purpose Solution and Bausch & Lomb ReNu® 1 Step Enzymatic Cleaner have been selected as the predicate devices for SOLO-Care™ Brand MULTI-PURPOSE SOLUTION. This combination of products was selected becuase when used as a system it is indicated for removing protein from soft contact lenses.
4. Description of the Devices
SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, daily protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
5. Indications for Use
SOLO-Care Brand Multi-Purpose Solution is indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by an eye care practitioner.
1
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies were completed to demonstrated the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution, and to establish substantial equivalence to currently marketed, predicate 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. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate devices.
Preclinical Testing:
A series of preclinical tests were performed to asses the safety and effectiveness of the solution. All preclinical toxicology and microbiology tests were conducted in accordance with GLP requlation (21 CFR Part 58). Results of the testing demonstrated that SOLO-Care Brand Multi-Purpose Solution is safe and effective as a multi-purpose soft (hydrophilic) contact lenses solution.
Clinical Testing:
A one month clinical evaluation was conducted in accordance with current Good Clinical Practices and published requlations (21 CFR Parts 50, 56, 312, 812). The clinical results provide valid scientific evidence that SOLO-care™ Multi-Purpose Solution is substantially equivalent to ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner for the removal of visible protein. There were also no safety or efficacy issues raised with SOLO-care™ Multi-Purpose Solution used without a rinse prior to insertion.
7. Substantial Equivalence
SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution used with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner in that both SOLO-Care Brand Multi-Purpose Solution and ReNu Multi-Purpose Solution with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner are indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wing-like shapes extending from the head, resembling a bird in flight.
NOV 17 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Dowdley Senior Associate, Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097-1556
Re: K982168 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution (Daily Protein Removal Claim for use with Soft Lenses) Regulatory Class: II Product Code: 86 LPN Dated: September 22, 1998 Received: September 24, 1998
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. Roerl lorentbal
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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INDICATIONS FOR USE STATEMENT
Device Name:
SOLO-Care ™ Brand Multi-Purpose Solution
Indications for Use:
SOLO-Care ™ Brand Multi-Purpose Solution is indicated for use In dally cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ದ or Over-the-Counter: B
Erio
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982168