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.

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%.

AI/ML Overview

The provided document describes the 510(k) summary for "Karats Multipurpose Solution." It details preclinical and clinical studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, acceptance criteria for medical devices like contact lens solutions are predefined benchmarks or thresholds the device must meet to be considered safe and effective. While the document mentions meeting standards and demonstrating substantial equivalence, it does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes results and comparisons to a predicate device.

Based on the text, here's an attempt to infer and present the information in a table format, focusing on what was evaluated and the general outcomes:

Metric Category	Acceptance Criteria (Inferred from study goals & FDA context)	Reported Device Performance (Karats Multipurpose Solution)
Lens Compatibility	No significant difference in optical and physical changes of lenses compared to control solution.	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	Must be non-cytotoxic and non-irritant.	Results of the testing demonstrated that Karats Multi-Purpose Solution is non-cytotoxic and is a non-irritant.
Microbiological	Meets stand-alone criteria with organic load for disinfection; meets regimen test criteria (under 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 regimen test criteria.
Clinical Safety	Equivalent safety profile (e.g., in visual acuity, symptoms, slit lamp findings) compared to predicate device. Low incidence of adverse events.	Contact lens visual acuity approximately similar (69% Karats 257 eyes, 75% SOLO-care Plus eyes having final VA same or better than baseline). Symptoms were equivalent. Slit lamp findings generally low grade (<2). Trend for less corneal staining with Karats 257. Few more reports of mild burning on insertion with Karats 257.
Clinical Efficacy/Preference	Substantial equivalence to predicate device in performance parameters (comfort, lens awareness, deposits, wear time) or superiority without compromising safety.	Karats 257 had fewer lens deposits at 1-month. Slightly longer period of hours of comfortable wear. Trend for less corneal staining. Subjectively Karats was rated higher for overall comfort and preferred for lens awareness at 1-month (overall comfort ~0.5 grade higher, lens awareness more favorably scored – statistically significant). Approximately twice as many SOLO-care® lenses had deposits at 1-month. Additional ~0.25 hour of comfortable wear for Karats 257 eye at 1-month (statistically significant). No difference in image analysis.
Overall Conclusion	Substantially equivalent to the predicate device for stated indications.	The results of the study showed that Karats Multipurpose Solution is substantial equivalence to SOLO-care® Plus.

2. Sample Size for the Test Set and Data Provenance

Clinical Study (Test Set): The document describes a "one-month prospective, randomized, double masked trial consisting of baseline, two-week, and final one-month visits." It also states, "Subjects compared the test and control products on a contra-lateral basis and were randomized into two treatment groups."
- Sample Size: The exact number of subjects or eyes included in the clinical study (Karats 257 versus SOLOCare Plus) is not explicitly stated in the provided text. It mentions percentages for visual acuity and relative comparisons of symptoms, deposits, and comfort, but no N value.
- Data Provenance: The document does not specify the country of origin for the data. It was a prospective clinical trial.

3. Number of Experts Used and Qualifications for Ground Truth

The document does not provide information regarding the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). For contact lens solution studies, ground truth for clinical observations (like slit lamp findings, corneal staining, deposits) is typically established by the clinical investigators (optometrists/ophthalmologists) participating in the trial, but their specific qualifications or the method of reaching "ground truth" (e.g., independent evaluations) are not detailed here.

4. Adjudication Method for the Test Set

The document mentions the clinical trial was a "double masked trial," meaning neither the subjects nor the investigators were aware of the treatment assignment. This helps reduce bias in data collection. However, it does not describe a specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in clinical observations or interpretations among multiple readers/clinicians, which might not be a standard requirement for this type of device study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This study focused on comparing two contact lens solutions in human subjects. The concept of "human readers" and "AI assistance" is not applicable to this submission.

6. Standalone (Algorithm Only) Performance

Not applicable in the context of AI algorithms. However, in the microbiological section, the language "meets the stand-alone criteria with organic load for disinfection" refers to a laboratory test where the solution's efficacy against microbes is tested independently, without a human "rub" step. This is a "standalone" performance for the chemical solution's disinfectant properties, not for an AI algorithm.

7. Type of Ground Truth Used

For the clinical study (Karats 257 versus SOLOCare Plus), the ground truth was primarily based on:
- Subjective Assessments: Patient-reported symptoms, comfort, lens awareness, and preference.
- Clinical Observations: Visual acuity measurements, slit lamp findings (e.g., corneal staining, presence of deposits) performed by eye care practitioners.
For preclinical studies (Lens Compatibility, Cytotoxicity, Microbiological), the ground truth was established through:
- Laboratory Measurements: Quantifiable optical and physical changes in lenses.
- Standardized Cytotoxicity Assays: Biological response of cells to the solution.
- Standardized Microbiological Assays: Measuring the reduction of specific microorganisms by the solution.

8. Sample Size for the Training Set

This device is a contact lens solution, not an AI algorithm. Therefore, the concept of a "training set" for machine learning is not applicable to this submission. The "training" in a broader sense would refer to the development and formulation process of the solution, which is not detailed in terms of sample sizes here.

9. How Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" and associated ground truth for an AI algorithm is not applicable to this medical device submission.

Summary

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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

న్న Indications for Use

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 (<2). There was a trend for less corneal staining with Karats 257.

Karats 257 had fewer lens deposits at 1-month, a slightly longer period of hours of comfortable wear and a trend for less corneal staining. Subjectively Karats was rated higher for overall comfort and preferred for lens awareness at the 1-month visit. There was no difference in image analysis. There were a few more reports of mild burning on insertion with Karats 257. Overall comfort was approximately 0.5 of a grade higher, and lens awareness was also more favorably scored with the Karats 257 treated lens and these were statistically significant. Approximately twice as many SOLO-care ® treated lenses were reported with slight, moderate, or severe deposits at the one-month visit as compared to Karats 257 treated lenses, although there was no difference at the two-week visit. Approximately an additional quarter hour of comfortable wear was reported for the Karats 257 eye at the one-month visit that was a statistically significant difference.

The results of the study showed that Karats Multipurpose Solution is substantial equivalence to SOLO-care ® Plus.

7. Substantial Equivalence

The date provided in this 510(k) submission concludes that Karats Multipurpose Solution is substantially equivalent to SOLO-Care Plus Multipurpose Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses (replaced in 30 days or less) as recommended by your eye care practitioner.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract design of an eagle, with three stylized lines representing the bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2002

CIBA Vision Corporation C/O Steven Dowdley. RAC 11460 Johns Creek Parkway Duluth, GA 30097

Re: K021635

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

Regulation Number and Section

§ 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.”