K Number
K014162
Device Name
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
Date Cleared
2002-01-15

(27 days)

Product Code
Regulation Number
886.5918
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses
Device Description
The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.
More Information

Not Found

No
The summary describes a chemical solution for cleaning contact lenses and does not mention any computational or data-driven components indicative of AI/ML.

No
The device is described as a cleaning, disinfecting, and storage solution for contact lenses, which does not inherently qualify it as a therapeutic device.

No

Explanation: The "Intended Use / Indications for Use" section clearly states that this product is "To clean, disinfect and store" contact lenses, which are maintenance activities, not diagnostic. There is no mention of identifying, detecting, or measuring a disease, condition, or physiological state.

No

The device is a sterile solution, which is a physical 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 to "clean, disinfect and store... rigid gas permeable (RGP) and hard contact lenses." This is a direct interaction with a medical device (contact lenses) for maintenance purposes, not for diagnosing a condition or examining a specimen taken from the human body.
  • Device Description: The description details the chemical composition of a cleaning and storage solution. This aligns with a product used for maintaining medical devices, not for in vitro diagnostic testing.
  • Lack of IVD Characteristics: The document lacks any mention of:
    • Analyzing specimens from the human body (blood, urine, tissue, etc.).
    • Providing information for diagnosis, monitoring, or treatment decisions based on biological samples.
    • Any processes related to laboratory testing or analysis of biological materials.

Therefore, this device falls under the category of a contact lens care product, which is regulated as a medical device but not as an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Optimum Cleaning, Disinfecting and Storage Solution is intended to clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses.

Product codes

MRC; HPX

Device Description

The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

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)

The product formulation, solubility, cleaning effectiveness and disinfection properties are similar to the predicate product.

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.

K001964

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.

Not Found

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

§ 886.5918 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

K 014162

510(k) Summary

JAN 1 5 2002

Daniel J. Manelli Submitted by: Manelli, Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

100 02 102 2000 000

"

202-261-1000

On behalf of Lobob Laboratories, Inc.

510(k) Submission: Optimum™ Cleaning, Disinfecting and Storage Solution

January 10, 2002

Optimum Cleaning, Disinfecting and Storage Solution is intended to clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses. The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

The product is substantially equivalent to the currently marketed Lobob Optimum™ Cleaning, Disinfecting and Storage Solution (K001964). The product formulation, solubility, cleaning effectiveness and disinfection properties are similar to the predicate product. Labeling and indications for use are identical.

1

Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Lobob Laboratories, Inc. c/o Mr. Daniel J. Manelli Manelli Denison & Selter PLLC 2000 M Street, N.W. 7th Floor Washington, D.C. 20036-3307

Re: K014162

Trade/Device Name: Optimum Cleaning, Disinfecting and Storage Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC; HPX Dated: December 19, 2001 Received: December 19, 2001

Dear Mr. Manelli:

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.

2

. . . . . . . . . . . . . .

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin maxioung of substantial equivalence of your device to a legally premaired notification: "The PDF missification 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 If you desire specific acrise to for in vitro diagnostic devices), please contact the Office of additionally 21 CF F at 607.10 for questions on the promotion and advertising of Compliance at (301) 597-1019 Times of Compliance at (301) 594-4639. Also, please note the your deviol, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation entities, "Pisoralians of responsibilities under the Act may be obtained from the Division Official 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

3

Exhibit D

Page __ 1 __ of __ 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Lobob Optimum Cleaning, Disinfecting and Storage Solution Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K014162

Prescription Use __

OR

Over-The-Counter Use

(Per 21 CFR 801.109)