(164 days)
Not Found
SOLOCare Plus Multipurpose Solution
No
The device is a contact lens solution, and the description focuses on its chemical composition and performance in cleaning and disinfecting lenses. There is no mention of AI or ML in the intended use, device description, or performance studies. The mention of "image analysis" appears to be in the context of evaluating lens properties, not as a core function of the solution itself.
No.
The primary purpose of this solution is for the care and maintenance of contact lenses (cleaning, rinsing, disinfecting, storing), not for treating or preventing a disease or condition in the human body itself.
No.
The device is a multi-purpose solution for cleaning and storing contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile aqueous solution with chemical components, indicating it is a physical 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, rinsing, disinfecting, protein removal, and storing soft contact lenses. This is a direct interaction with a medical device (contact lenses) and not a diagnostic test performed on a biological sample from the human body.
- Device Description: The description lists the chemical components of a contact lens solution. This is consistent with a device used for maintaining contact lenses, not for diagnosing a condition.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
The device is clearly intended for the care and maintenance of contact lenses, which are medical devices themselves.
N/A
Intended Use / Indications for Use
Karats MPS is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses as recommended by your eye care practitioner.
Product codes
LPN
Device Description
Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.
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)
A series of preclinical and clinical studies were completed to demonstrate the substantial equivalence of Karats Multi-Purpose Solution to the predicate device(s). All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatable, and is comparable to other currently marketed soft contact lens solutions.
Lens Compatibility Data: There was no significant difference between Karats Multi-Purpose Solution and the control solution, with respect to optical and physical changes in the measured properties of the lenses.
Cytotoxicity: A series of cytotoxicity studies were conducted to demonstrate the safety of Karats Multi-Purpose Solution. Results of the testing demonstrated that Karats Multi-Purpose Solution is non-cytotoxic and is a non-irritant.
Microbiological: Microbiological studies were conducted to demonstrate the microbial efficacy Karats Multi-Purpose Solution. The studies evaluated the performance of the product under a pre-rinse/ no rub regimen. The studies demonstrated that Karats Multi-Purpose Solution meets the stand-alone criteria with organic load for disinfection and meets the reqimen test criteria.
Clinical Testing: A clinical study was conducted to support the substantial equivalency of Karats Multipurpose to currently marketed SOLO-Care Plus Multipurpose Solution. The trial was planned as a one-month prospective, randomized, double masked trial consisting of baseline, two-week, and final one-month visits. Subjects compared the test and control products on a contra-lateral basis and were randomized into two treatment groups according to which eye is to use the test and which eye is to use the control solutions. Contact lens visual acuity was approximately similar between the eves with 69% of the Karats 257 eyes and 75% of the SOLO-care ® Plus eyes having a final VA same or better than the baseline. Symptoms were equivalent and slit lamp findings were generally of a low grade (
§ 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.”
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K0216355
OCT 2 8 2002
510(k) SUMMARY KO LANK TASHIN KA KA KARA KA KA KA KA KA KA KA KA KA K
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.
510 (k) SUMMARY FOR Karats Multipurpose Solution
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley Telephone No. 678-415-3897
2. Device Name Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution Karats Multipurpose Solution
Predicate Devices 3.
SOLOCare Plus Multipurpose Solution
4. Description of the Devices
Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.
న్న Indications for Use
Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies were completed to demonstrate the substantial equivalence of Karats Multi-Purpose Solution to the predicate device(s). 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 predicate device.
Lens Compatibility Data:
There was no significant difference between Karats Multi-Purpose Solution and the control solution, with respect to optical and physical changes in the measured properties of the lenses.
Cytotoxicity
A series of cytotoxicity studies were conducted to demonstrate the safety of Karats Multi-Purpose Solution. Results of the testing demonstrated that Karats Multi-Purpose Solution is non-cytotoxic and is a non-irritant.
Microbiological
Microbiological studies were conducted to demonstrate the microbial efficacy Karats Multi-Purpose Solution. The studies evaluated the performance of the product under a
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pre-rinse/ no rub regimen. The studies demonstrated that Karats Multi-Purpose Solution meets the stand-alone criteria with organic load for disinfection and meets the reqimen test criteria.
Clinical Testing
A clinical study was conducted to support the substantial equivalency of Karats Multipurpose to currently marketed SOLO-Care Plus Multipurpose Solution.
Karat 257 versus SOLOCare Plus
Karats 257 is a new multipurpose contact lens care solution designed to help increase contact lens comfort and provide a better lens wear experience. The primary objective was to evaluate safety, efficacy and preference between Karats Multipurpose Solution using a no rub/no rinse regimen compared to SOLO-care ® Plus multipurpose solution. The trial was planned as a one-month prospective, randomized, double masked trial consisting of baseline, two-week, and final one-month visits. Subjects compared the test and control products on a contra-lateral basis and were randomized into two treatment groups according to which eye is to use the test and which eye is to use the control solutions.
Contact lens visual acuity was approximately similar between the eves with 69% of the Karats 257 eyes and 75% of the SOLO-care ® Plus eyes having a final VA same or better than the baseline. Symptoms were equivalent and slit lamp findings were generally of a low grade ( Trade/Device Name: Karats Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: August 9, 2002 Received: August 12, 2002
Dear Mr. Dowdlev:
Wc 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 application (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 such 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.
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This letter will allow you to begin 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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PART III. INDICATIONS FOR USE STATEMENT
510(k) Number: K021635
Device Name: Karats Multi-Purpose Solution
Indications for Use:
Karats MPS is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses as recommended by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
or over-the-counter:
Karen Washington
(Division Sig Division of Ophthalmic Nose and Throat Dev
510(k) Number K021635