For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only, Not to be used with heat.

Device Description

The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.

AI/ML Overview

This document describes the regulatory submission for the "i-Promotions Contact Lens Case" and does not contain information about the acceptance criteria or a study that proves a device meets such criteria in the context of advanced medical technologies or AI/ML.

The provided text focuses on the device's classification, intended use, and summary of safety testing carried out for regulatory clearance. It benchmarks the device against predicate devices based on design and materials, rather than performance metrics.

Therefore, I cannot provide the information requested in your bullet points (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details) because the document does not discuss these aspects in the context of device performance or clinical studies. The "Summary of Safety Testing" section only mentions cytotoxicity testing to demonstrate the product is safe for its intended use, but doesn't provide specific performance acceptance criteria or detailed study results beyond a general statement of safety.

Summary

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Amended 510(k) K042578 Page #5 January 14, 2005

XII. Summary of Safety and Effectiveness

Date of Preparation:	September 20, 2004
Device Name:	i-Promotions Contact Lens Case
Classification Name:	Contact Lens Case
Manufacturer:	i-Promotions, Inc.9522 Gravois Rd.St. Louis, MO 63123
Contact:	Charlotte SlankardPresidenti-Promotion, Inc.
Predicate Device:	Pelican Contact Lens Case K030987And OptiLens™ Contact Lens Case K920064
Device DescriptionAnd Intended Use:	The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.The i-Promotions Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. Not to be used with heat disinfection. Use only with chemical disinfection.
Summary of SafetyTesting:	NAMSA preformed cytotoxicity testing on six completed i-Promotions Contact Lens Cases. The six cases tested were created using the correct proportion of Dow Chemical Company Low Density Polyethylene Product #9931 and one of five Carolina Color Corporation (listed on page 15). One case was created using no colorant. Five cases were created using one of each colorant. NAMSA took an equal sampling from each of the six cases and combined the sampling to perform one cytotoxicity test.The six completed contact lens cases were tested using the biological and toxicology tests recommended by the USPXXII and the results of these studies show that the product is safe for its intended use.

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Table I
Summary of Equivalences and Differences
510(k) Device and Predicate Devices
(Amended 1-14-05)

Device Name	510(k) i-PromotionsContact Lens Case	Pelican ContactLens Storage Case(K030987)Item #600	Opti-LensTMContact Lens Case(K920064)
Indications	Storage andDisinfection of Soft,Rigid GasPermeable or HardLenses	Storage andDisinfection of Soft,Rigid GasPermeable or HardLenses	Storage andDisinfection of Soft,Rigid GasPermeable or HardLenses
Disinfection Type	Chemical(Not Heat)	Chemical(Not Heat)	Chemical(Not Heat)
Design	Two AdjoiningWells With IntegralHinged Caps IntoWhich RespectiveLenses areImmersed	Two AdjoiningWells With IntegralHinged Caps IntoWhich RespectiveLenses areImmersed	Two AdjoiningWells With ScrewTop Caps IntoWhich RespectiveLenses areImmersed
Materials	-Dow ChemicalCompany LowDensityPolyethyleneDow Product #9931-One of the CarolinaColor CorporationColorants listed inList of MaterialsPage15	-Dow ChemicalCompany LowDensityPolyethyleneDow Product #9931See 510(k)(K030987)Item #600	-M.A. Industries,Inc. #PO011ALPolypropylene
Labeling	Refers to product asi-Promotionscontact lens case;instructs patient toclean lens case witha disinfectingsolutionrecommended forthis purpose	See 510(k)(K030987)Item #600	Refers to product asOpti-Lens contactlens case; instructspatient to clean lenscase with Opti-FreeDaily Cleaner

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized wing or feather shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

i-Promotions, Inc. c/o Ms. Charlotte Slankard 9522 Gravois Rd. St. Louis, MO 63123

Re: K042578

Trade/Device Name: i-Promotion Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Storage Case Regulatory Class: Class II Product Code: LRX Dated: December 27, 2004 Received: December 30, 2004

Dear Ms. Slankard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for acce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered province that 20, 2017 - ) 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 If your device 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 - Ms. Charlotte Slankard

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,

Ahalpi forentthal

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

Enclosure

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Amended 510(k) K042578 Page #7 January 14, 2005

Indications for Use

510 (k) Number: K042578

Device Name: i-Promotions Contact Lens Case

Indications for Use:

For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.

For use during chemical disinfection only, Not to be used with heat.

Over the Counter Use (21 CFR 801 Subpart C)

Over-the-Counter Use

Firdak Lee Cohen, MD

(Division Sign Division of Ophthalmic E Nose and Throat Devise

510(k) Number 042578

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.”