(44 days)
BOSTON Advanced Conditioning Solution, BOSTON Classic, Boston Simplicity Solution
Not Found
No
The device description and performance studies focus on the chemical composition and cleaning/disinfecting efficacy of a contact lens solution, with no mention of AI or ML technologies.
No.
The device is a contact lens cleaning and disinfecting solution, not a device used to treat or prevent a disease.
No.
The device is a contact lens solution for cleaning, rinsing, disinfecting, and conditioning contact lenses, not for diagnosing medical conditions.
No
The device is a sterile aqueous solution contained in a plastic bottle, clearly indicating it is a physical product (liquid and container) 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 cleaning, rinsing, disinfecting, and conditioning contact lenses. This is a direct interaction with a medical device (contact lens) and not a test performed on a biological sample from the human body to provide diagnostic information.
- Device Description: The description details the chemical composition of a contact lens solution, not a reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, SOLO-Care ™ Hard Solution falls under the category of a medical device used for the care and maintenance of other medical devices (contact lenses), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SOLO-Care ™ Hard Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning fluore acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.
Product codes
86 MRC
Device Description
SOLO-Care ™ HARD Solution is a sterile aqueous solution containing hydroxyethylicellulose, tris amino, sodium chloride, disodium edetate, poloxamer 407, polyoxyethylene polyoxpropylene block copolymer, and is preserved polyhexanide 0.0002%. SOLO-Care ™ HARD Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, ninsing, disinfecting and conditioning rigid gas permeable and hard contact lenses as recommended by an 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
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)
Preclinical Testing:
- Cleaning Effectiveness - Critical Micelle: Results demonstrated that the surfactant concentration is formulated in SOLO-Care Hard Solution at sufficiently high levels to maintain its activity for cleaning and detergency.
- Contact Wetting Angle: Dynamic contact angle analysis indicated that the SOLO-care Hard Solution is statistically equivalent to predicate solution Boston Simplicity in terms of surface wettability of the lens.
- Solution Compatibility: Compatibility testing of SOLO-care HARD with CAB, silicon acrylate and fluorsilicone acrylate lens materials was conducted to demonstrate compatible with various material types. The study showed that after 30 cycles all parameters were still within the ANSI/ISO reference range for rigid gas permeable lenses for both solutions. In addition, there was no change in the cosmetic appearance of the lenses.
- Stability (chemical and microbiological): Shelf life for SOLO-Care HARD Solution has been demonstrated on 3 lots of product. Chemical stability testing was conducted at 4℃, 25℃, 30℃ and 40℃ on pH, osmolarity, viscosity, appearance and active ingredients. Based on the data collected, the trends observed and the estimated calculations of the accelerated test samples the shelf life for SOLO-care HARD Solution is 24 months.
- Preservative Effectiveness: Studies were performed to evaluate the preservative effectiveness of SOLO-Care HARD Solution. The results demonstrate that SOLO-Care Hard meets the requirements of the ISO/DIS 14730 Preservative Effectiveness Test against the panel organisms tested.
- Disinfection Efficacy: The ISO Regimen Test was performed in accordance with ISO/CD 14729 to determine the antimicrobial effectiveness of the SOLO-Care Hard regimen. The results demonstrated that the solution meets the requirements of the standard.
- Toxicology Results: L929 Direct Contact Material Assay, L929 Agar Overlay Diffusion Assay, Growth Inhibition Test, and Ocular Irritation Test were conducted. Results demonstrated that the solution and lenses treated with the solution did not cause a toxic response or increase ocular irritation.
Clinical Testing:
- Three clinical studies were used to evaluate SOLO-care Hard Solution. Overall 166 contact lens wearers were enrolled and were exposed to the test and control solution from a wearing period of 1 month to 6 months.
- The data from the studies were examined using descriptive statistics, tests for normality, analysis of variance and/or t-tests where appropriate. Analysis of all data from the studies showed that the test and control solutions were substantially equivalent. No additional safety concerns were raised regarding the test solution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BOSTON Advanced Conditioning Solution, BOSTON Classic, Boston Simplicity Solution
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
Brand HARD'Solution CIBANIslon Corporation
VII. I = 510(k) SUMMARY
,在此外交通的重要的意见,在此次的主要的主要。在此次的一个人的一个人的一个人的一个人的一个人
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.
SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ HARD SOLUTION
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth. Georgia 30097 Contact Person: Steven Dowdley (Senior Requlatory Affairs Associate) Telephone No. 678-415-3897
Device Name 2.
Classification Name: Proprietary Name:
Rigid Gas Permeable Contact Lens Solution SOLO-CARE™ HARD SOLUTION
3. Predicate Devices
The predicate devices selected for this submission was BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution. These products were selected because of similarities in the indication and formulation of this product and the proposed device.
4. Description of the Devices
SOLO-Care ™ HARD Solution is a sterile aqueous solution containing hydroxyethylicellulose, tris amino, sodium chloride, disodium edetate, poloxamer 407, polyoxyethylene polyoxpropylene block copolymer, and is preserved polyhexanide 0.0002%. SOLO-Care ™ HARD Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, ninsing, disinfecting and conditioning rigid gas permeable and hard contact lenses as recommended by an eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
ട. Indications for Use
SOLO-Care ™ Hard Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning fluore acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner,
6. Description of Safety and Substantial Equivalence
A series of preclinical and clinical studies were completed the safety and effectiveness of SOLO-Care Hard 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 that the solution is non-toxic and biocompatible, and is comparable to other currently marketed contact lens solutions.
Preclinical Testing
Cleaning Effectiveness - Critical Micelle
Results demonstrated that the surfactant concentration is formulated in SOLOCare Hard Solution at sufficiently high levels to maintain its activity for cleaning and detergency.
1
Contact Wetting Angle
Dynamic contact angle analysis indicated that the SOLO-care Hard Solution is statistically equivalent to predicate solution Boston Simplicity in terms of surface wettability of the lens.
Solution Compatibility
Compatibility testing of SOLO-care HARD with CAB, silicon acrylate and fluorsilicone acrylate lens materials was conducted to demonstrate compatible with various material types. The study showed that after 30 cycles all parameters were still within the ANSI/ISO reference range for rigid gas permeable lenses for both solutions. In addition, there was no change in the cosmetic appearance of the lenses.
Stability (chemical and microbiological)
Shelf life for SOLO-Care HARD Solution has been demonstrated on 3 lots of product filled in white polypropylene bottles. Chemical stability testing was conducted at 4℃, 25℃, 30℃ and 40℃ on pH, osmolarity, viscosity, appearance and active ingredients. Based on the data collected, the trends observed and the estimated calculations of the accelerated test samples the shelf life for SOLO-care HARD Solution is 24 months.
Preservative Effectiveness
Studies were performed to evaluate the preservative effectiveness of SOLOCare HARD Solution. The results demonstrate that SOLO-Care Hard meets the requirements of the ISO/DIS 14730 Preservative Effectiveness Test against the panel organisms tested.
Disinfection Efficacy
The ISO Regimen Test was performed in accordance with ISO/CD 14729 to determine the antimicrobial effectiveness of the SOLO-Care Hard regimen. The results demonstrated that the solution meets the requirements of the standard.
Toxicology Results
L929 Direct Contact Material Assay, L929 Agar Overlay Diffusion Assay, Growth Inhibition Test, and Ocular Irritation Test were conducted in accordance with and in conformance to applicable regulations. Results demonstrated that the solution and lenses treated with the solution did not cause a toxic response or increase ocular irritation.
Clinical Testing
Three clinical studies were used to evaluated SOLO-care Hard Solution. Overall 166 contact lens wearers were enrolled and were exposed to the test and control solution from a wearing period of 1 month to 6 months.
The data from the studies were examined using descriptive statistics, tests for normality, analysis of variance and/or t-tests where appropriate. Analysis of all data from the studies showed no that the test and control solutions were substantially equivalent. In additional safety concerns were raised regarding the test solution.
7. Substantial Equivalence
SOLO-Care Hard Solution is substantially equivalent.to BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution in terms of usage, formulation similarities, and indications for use in daily cleaning (Boston Simplicity only), rinsing, chemical (not heat) disinfecting, storing and wetting of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2000
Mr. Steven Dowdley, RAC Senior Associate. Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097
Re: K993949 Trade Name: SOLO-Care ™ Hard Solution (RGP multipurpose solution) Regulatory Class: II Product Code: 86 MRC Dated: October 12, 1999 Received: November 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, RAC
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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ARD Solution 3 0 3 on Concernation 1 3
PART III. INDICATIONS FOR USE STATEMENT
K993949 This is a new 510 (k) Notification. (number to be assigned) 510(k) Number:
Device Name: SOLO-Care ™ Hard Solution
Indications for Use:
motionerie to: Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Or over-the-counter: 0
Lamuel W.C. Brinson, M.D.
പ്ര
Division of Ophthalmic Devices K993949 510(k) Number _
Confidential