Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel 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, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001

AI/ML Overview

The provided text describes the 510(k) summary for KARATS Multi-purpose Solution, a contact lens care product. It details various studies conducted to demonstrate its safety and substantial equivalence to other marketed solutions. However, the document does not present specific acceptance criteria in a table format alongside device performance data for each claim. Instead, it generally states that the product meets guidelines or demonstrates substantial equivalence.

Here's an attempt to extract and infer the information based on the provided text, acknowledging that specific acceptance values are not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Guidelines/Substantial Equivalence)	Reported Device Performance
Silicone Hydrogel Lens Compatibility: No significant difference in optical and physical changes compared to saline control.	"no significant difference between KARATS and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses."
Surface Analysis (XPS): No significant changes to the lens surface.	"no significant changes to the surface of the Focus NIGHT & DAY lens as analyzed by XPS testing."
In Vitro Cleaning Efficacy: Substantially equivalent to currently marketed products in daily protein removal.	"KARATS is substantially equivalent to currently marketed products in terms of daily protein removal."
Cytotoxicity: Non-cytotoxic and non-irritant.	"KARATS is non-cytotoxic and is a non-irritant."
Microbiological Efficacy: Meets stand-alone criteria of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.	"KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."
Clinical Performance: Substantially equivalent to predicate solutions.	"Data from the clinical studies supported the substantial equivalence of KARATS."

Note: The document frequently refers to "substantial equivalence" and meeting "guidelines" without providing the specific numerical or qualitative targets for these criteria. The "reported device performance" directly quotes or paraphrases the document's findings.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Silicone Hydrogel Lens Compatibility: Not explicitly stated, but implies multiple lenses were tested for "measured properties."
- Surface Analysis (XPS): Not explicitly stated, but mentions "lens samples were processed and analyzed."
- In Vitro Cleaning Efficacy: Not explicitly stated.
- Cytotoxicity: Not explicitly stated.
- Microbiology: Not explicitly stated.
- Clinical Testing: Not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data. The studies were pre-clinical and clinical, indicating both laboratory and human subject studies. No information is given about whether the studies were retrospective or prospective, though clinical studies are generally prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention using experts to establish ground truth for any of the studies described. The assessments appear to be based on laboratory measurements (e.g., optical/physical changes, XPS, in vitro efficacy, cytotoxicity, microbiological testing) and clinical observations, not expert consensus on an annotated dataset.

4. Adjudication Method for the Test Set

None stated or implied. As ground truth was not established by human experts, there would be no need for an adjudication method.

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

No. The document describes studies for a contact lens solution, not an AI-assisted diagnostic device. A MRMC study with human readers and AI assistance is not applicable here.

6. Standalone Performance Study

Yes, for microbiological efficacy. The document explicitly states: "These studies demonstrate that KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." This indicates the solution's performance was assessed independently against established criteria. Other pre-clinical studies (e.g., cytotoxicity, in vitro cleaning) also represent standalone assessments of the product's properties.

7. Type of Ground Truth Used

The "ground truth" for KARATS Multi-purpose Solution appears to be:

Laboratory Measurements/Analytical Standards: For silicone hydrogel compatibility (optical/physical changes), XPS (surface changes), in vitro cleaning efficacy (protein removal), cytotoxicity (cell viability/irritation), and microbiology (disinfection efficacy against specific organisms). These are typically quantitative or qualitative outcomes measured in a controlled lab setting against predefined success criteria (e.g., "no significant difference," "non-cytotoxic," "meets stand-alone criteria").
Clinical Observations/Outcomes: For clinical testing, data likely involved patient reported outcomes, adverse event rates, and physician assessments to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

Not applicable / Not stated. This is a pre-AI era medical device submission (2003) for a chemical solution, not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The studies involved testing the solution directly.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided document.

Summary

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K031957

AUG 1 4 2003

PART IX. 510(k) SUMMARY

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 Multi-purpose Solution

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Telephone No.

Steven Dowdley 678-415-3897

2. Device Name

Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution KARATS Multi-purpose Solution

3. Predicate Device(s)

KARATS Multi-purpose Solution

4. Description of the Device

ട. Indications for Use

Karats Multi-Purpose Solution is indicated for cleaning, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

6. Description of Safety and Substantial Equivalence

A series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K021635. The non-clinical studies were completed to demonstrate the substantial equivalence of KARATS to other currently marketed 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.

Silicone Hydrogel Lens Compatibility Data

A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with KARATS Multi-purpose Solution. The study showed there was no significant difference between KARATS and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. KARATS Multi-purpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products.

Surface Analysis by XPS

X-Ray Photoelectron Spectroscopy (XPS) was used to analysis the surface of the lenses to determine if the surface coating was compromised by the solution. Following cycling in the solution, lens samples were processed and analyzed. The kinetic energy of the photoelectrons

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was measured and the binding energy of the photoelectron was calculated. The results showed that there were no significant changes to the surface of the Focus NIGHT & DAY lens as analyzed bv XPS testing.

In Vitro Cleaning Efficacy

Results of the study showed that KARATS is substantially equivalent to currently marketed products in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K021635.

Cytotoxicity

A series of cytotoxicity studies were previously conducted to demonstrate the safety of KARATS. Results of the testing demonstrated that KARATS is non-cytotoxic and is a non-intitant. This data was previously submitted and reviewed in original 510(k) submission - K021635.

Microbiology

A series studies were previously completed to demonstrate the microbiological efficacy of KARATS. These studies were previously submitted under 510(k) K021635. These studies demonstrate that KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

Clinical Testing

A series of clinical studies have been conducted, submitted and reviewed in 510(k) submission K021635. Data from the clinical studies supported the substantial equivalence of KARATS.

7. Substantial Equivalence

The data provided in this 510(k) submission concludes that Karats Multi-Purpose Solution is substantially equivalent to Karats Multi-Purpose Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

AUG 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIBA Vision Corporation c/o Steven Dowdley, RAC 11460 Johns Creek Pkwy. Duluth, GA 30097

Re: K031957

Trade/Device Name: Karats Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: June 23, 2003 Received: July 21, 2003

Dear Mr. Dowdley:

We 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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Page 2 - Steven Dowdley, RAC

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Réti korenthal

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: (Number to be assigned)

Device Name: KARATS Multi-purpose Solution

Indications for Use:

Kants Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or over-the-counter:

(Division Sign-Off)
Division of Ophthalmia Fou

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K031957

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.”