K Number
K031957
Device Name
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
Date Cleared
2003-08-14

(50 days)

Product Code
Regulation Number
886.5928
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
More Information

No
The device is a contact lens cleaning solution, and the description focuses on its chemical composition and performance in cleaning and disinfecting lenses. There is no mention of AI or ML.

No.
This device is a multi-purpose solution for cleaning, disinfecting, and storing soft contact lenses, which are medical devices, but the solution itself is not a therapeutic device designed to treat a medical condition. Its purpose is to maintain and prepare other medical devices (contact lenses).

No

This device is a multi-purpose solution for cleaning and storing contact lenses, not for diagnosing medical conditions.

No

The device is a sterile aqueous solution, which is a chemical substance, 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 test performed on a biological sample from the human body to provide information about a physiological state, disease, or condition.
  • Device Description: The description lists the chemical components of a solution designed for contact lens care.
  • 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.)
    • Providing diagnostic information
    • Measuring analytes or biomarkers
    • Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.

The device is clearly a contact lens care product, which falls under a different regulatory category than IVDs.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LPN

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

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 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.

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 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.

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.

KARATS Multi-purpose Solution

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.

K021635

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.”

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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

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

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

1

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.

2

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