(27 days)
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.
This 510(k) premarket notification for the "Optimum™ Cleaning, Disinfecting and Storage Solution" does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The provided document, K014162, is a 510(k) summary and the FDA's clearance letter for a contact lens care solution. This type of submission primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Therefore, the document does not include the detailed study information you've requested regarding acceptance criteria, performance metrics, sample sizes, expert qualifications, or ground truth establishment. These types of details are more common in clinical study reports for devices undergoing Premarket Approval (PMA) or for devices where clinical data is explicitly required to establish substantial equivalence beyond technological characteristics.
Here's why the requested information is not present in this document and what one might typically find in a 510(k) for a contact lens solution:
- Acceptance Criteria and Device Performance Table: Not applicable in this context. Substantial equivalence is the primary criterion. For cleaning and disinfecting solutions, performance is generally assessed through microbiological and cleaning efficacy studies, often compared directly to the predicate device or against industry standards. The summary states, "The product formulation, solubility, cleaning effectiveness and disinfection properties are similar to the predicate product." This implies such tests were likely conducted and showed comparable results, but the detailed criteria and results are not in this public summary.
- Sample Size, Ground Truth, Expert Qualifications, Adjudication, MRMC, Standalone Performance, Training Set: These are concepts typically associated with imaging or diagnostic algorithms where human interpretation plays a role, or where a "ground truth" needs to be established for classification performance. For a contact lens solution, "ground truth" would relate to laboratory measurements of microbial kill rates, cleaning efficacy (e.g., protein removal), and lens compatibility, rather than expert interpretation of images or clinical outcomes in humans as described in your questions.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the performance of AI in assisting human readers, typically in interpreting medical images.
- Standalone performance: While the device itself has a standalone performance (how well it cleans and disinfects), the document doesn't detail this in the format you've requested, as its purpose is to show equivalence.
- Type of ground truth: For a contact lens solution, ground truth would be established through laboratory methods (e.g., standardized microbiological assays to count viable organisms after disinfection, optical density measurements for protein removal, and material compatibility tests).
- Sample size for training set, how ground truth for training set was established: These relate to AI/machine learning models and are not relevant to a contact lens cleaning solution.
In summary, the provided document (K014162) is a 510(k) notification for a contact lens solution. It establishes substantial equivalence to a predicate device and does not contain the detailed performance study information, acceptance criteria, or statistical details typically found in submissions for AI/ML-driven medical devices or those requiring extensive clinical trials for efficacy.
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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.
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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.
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. . . . . . . . . . . . . .
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
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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)
§ 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.”