The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

Device Description

The API Soft Grip Contact Lens Cases and Deluxe Contact Lens Cases are designed for storage of contact lenses with adjoining dual wells that have screw top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The Econo-Mate Contact Lens Cases have two adjoining wells with integral hinged, self-sealing caps in which respective contact lenses are immersed. The cases are also labeled with an 'R' or 'L' to distinguish right and left lenses. The cases are available in a variety colors.

AI/ML Overview

The document provided is a 510(k) Summary for a contact lens case, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance, are not applicable.

However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Attribute	Acceptance Criteria (from "test plan")	Reported Device Performance
Leak Test	Effective against leaking	All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria and have demonstrated to be effective against leaking.
Biocompatibility	Safe for use in contact lens storage and disinfection	Demonstrated the materials are safe for use in contact lens storage and disinfection.

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

Sample Size: Not explicitly stated. The document mentions "All Soft Grip, Deluxe, and Econo-Mate contact lens cases" were subjected to the leak test, implying a representative sample of each model, but the exact number is not provided.
Data Provenance: The document does not specify country of origin for the test data. The tests were performed by "third-party laboratories" for biocompatibility and presumably internally or by a third party for the leak test. The study appears to be prospective testing of newly manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is Not Applicable as the device is a contact lens case, not an AI/ML device requiring expert ground truth for image or data interpretation. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus in the typical sense of AI/ML evaluation.

4. Adjudication Method for the Test Set

This question is Not Applicable. Performance (e.g., leak integrity, biocompatibility) is determined through empirical testing and analytical methods, not through an adjudication process like those used for expert review of AI/ML output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is Not Applicable. MRMC studies are used for evaluating diagnostic or prognostic devices often involving human readers and AI assistance. This device is a contact lens case for storage.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is Not Applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through physical and chemical testing standards.
- For the leak test: The "ground truth" is whether the case physically leaks under specified conditions.
- For biocompatibility: The "ground truth" is adherence to established biocompatibility standards and tests (e.g., ISO 10993 series or equivalent) to determine material safety.

8. The Sample Size for the Training Set

This question is Not Applicable. This device is a manufactured product, not an AI/ML model that requires a training set.

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

This question is Not Applicable. As stated above, this is a physical product, not an AI/ML model requiring a training set.

Summary

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pothecary Products, Inc.°

JUL 1 4 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 (c)

The assigned 510(k) number is: _K111856

Applicant:	Apothecary Products, Inc.11750 12th Avenue SouthBurnsville, MN 55337
Contact person:	James JenkinsSr. Regulatory Affairs SpecialistPhone: 952.808.8364Fax: 952.890.0418
Date prepared:	March 11, 2011
Name of Device:	Contact Lens Case,
	Model: Soft Grip Contact Lens Case; 68013, 68012
	Model: Econo-Mate Contact Lens Case: K1010
	Model: Deluxe Contact Lens Case; K1020
Device Classification Name:	Soft (hydrophilic) contact lens care products
Common or usual name:	Contact Lens Case
Classification:	Class II, 21 CFR 886.5928
Product Code:	LRX
Predicate Device information:	K093377; K991206; K042578
Device Description:	The API Soft Grip Contact Lens Cases and DeluxeContact Lens Cases are designed for storage ofcontact lenses with adjoining dual wells that havescrew top caps. The cases are labeled with an 'R' or'L' to distinguish right and left lenses. The Econo-MateContact Lens Cases have two adjoining wells withintegral hinged, self-sealing caps in which respectivecontact lenses are immersed. The cases are alsolabeled with an 'R' or 'L' to distinguish right and leftlenses. The cases are available in a variety colors.

disinfection.

The applicant devices are not sterile and not for heat-

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Image /page/1/Picture/0 description: The image shows the logo for Apothecary Products, Inc. The logo features a symbol resembling a mortar and pestle enclosed within a circle, followed by the text "Apothecary Products, Inc." The "Inc." is followed by the registered trademark symbol. The text is in a serif font and appears to be a professional logo design.

Intended Use: The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

Comparison to Predicate Devices:

The API devices have the same intended use, similar design and materials as the predicate devices and are substantially equivalent with regards to safety and effectiveness.

Discussion of Non-Clinical Tests Performed in Determination of Substantial Equivalence:

Biocompatibility testing performed by third party laboratories demonstrated the materials are safe for use in contact lens storage and disinfection.

The applicant contact lens cases were subjected to an 8 hour leak test to ensure devices are effective against leaking. All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria per test plan and have demonstrated to be effective against leaking.

Attribute	API Contact Lens CaseApplicant Device; Soft GripModel 68012 & 68013	Reliance Design & Mfg Corp,Polaris Contact Lens Case,Model #201 (K093377)
ClassificationName	Contact Lens Case	Contact Lens Case
Intended Use	The API Soft Grip, 68012,68013; Contact Lens Cases areintended for the storage of soft(hydrophilic), rigid gaspermeable (RGP), or hardcontact lenses during chemicaldisinfection. For use in storageduring chemical disinfectiononly. Do not use during heatdisinfection.	Polaris Contact Lens Case is forthe storage of soft (hydrophilic),rigid gas permeable or hardcontact lenses. It is to be usedwith chemical disinfectants only.It is not to be used in heatdisinfection.
Disinfection Type	Chemical(Not Heat)	Chemical(Not Heat)
Design	Two adjoining wells with screwtop caps into which respectivelenses are immersed.	Two adjoining wells screwedwith screw top into whichrespective lenses are immersed.

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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Apothecary Products, Inc. c/o Mr. Bhavesh Sheth Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, OH 44087

JUL 1 4 2011

Re: K111856

Trade/Device Name: Soft Grip Contact Lens Case (Models 68012 and 68012); Deluxe Contact Lens Case (Model K1020), Econo-Mate Contact Lens Case (Model K1010) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: June 28, 2011 Received: June 29, 2011

Dear Mr. Sheth:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm1.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and · Radiological Health

RE
RE
RE

Enclosure

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Indications for Use

510(k) Number (if known): KIII956

Device Name: Contact Lens Case

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE).

Denise Hayle

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111856

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.”