The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The Flents Plastic Eye Wash Cup is non-sterile and is reusable.

AI/ML Overview

This document describes a 510(k) premarket notification for the Flents Plastic Eye Wash Cup, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for a novel diagnostic or therapeutic device. Therefore, many of the requested elements for describing a study proving performance against acceptance criteria are not directly applicable or present in this submission.

However, I will extract the relevant information where available and explain why other sections are not filled based on the provided text.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the Flents Plastic Eye Wash Cup does not present a study with specific performance acceptance criteria in the format typically seen for novel medical devices (e.g., diagnostic accuracy, efficacy endpoints). Instead, it demonstrates substantial equivalence to a previously cleared predicate device, K051414 (Tollot Pty. Ltd. (Aaxis Pacific) Eye Cup), primarily through biocompatibility testing and comparison of fundamental attributes.

The "acceptance criteria" are effectively the demonstration that the new device is as safe and effective as the predicate device such that no new questions of safety or effectiveness are raised. The "study" performed is biocompatibility testing of the materials and a comparison of design and intended use to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a relatively low-risk device, the "acceptance criteria" are implicitly met by demonstrating that the materials are biocompatible and the design and intended use are comparable to a legally marketed predicate.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Findings)
Biocompatibility: No evidence of cellular or systemic toxicity, ocular irritation, or sensitization response for materials in contact with eyewash solutions and the eye.	Biocompatibility testing (Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation, Maximization Sensitization) showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials demonstrated safety for intended use.
Intended Use: Device holds liquids such as eye wash solutions to flush out the eye, similar to the predicate.	The Flents Plastic Eye Wash Cup's intended use is identical to the predicate device: "intended to hold liquids such as eye wash solutions, used to flush out the eye."
Design: Similar design to predicate, an ABS plastic receptacle for eyewash solutions.	Design is "similar" to the predicate, being an ABS Plastic receptacle for eyewash solutions. Dimensions and volume are specified.
Safety and Effectiveness: No new questions of safety or effectiveness raised compared to the predicate device.	Based on biocompatibility testing and comparison of attributes, the device is considered substantially equivalent in safety and effectiveness. Instructions for reusable, non-sterile use (washing before use) address a key difference.

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

Test Set Sample Size: For the biocompatibility testing, the sample size is not explicitly stated in the provided text (e.g., number of animals for in-vivo tests, number of cell cultures for in-vitro tests). It generally refers to the samples of the "Chi Mei ABS PA-757 White plastic" material itself, and possibly its colorant.
Data Provenance: The biocompatibility testing was "performed by third-party laboratories." The country of origin for the data is not specified. The studies are assumed to be prospective in nature, meaning they were conducted specifically for this submission.

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

Number of Experts: This information is not explicitly provided. Biocompatibility studies are typically conducted by qualified laboratory personnel following established standards (e.g., ISO 10993). The interpretation of results and overall conclusion of safety would be overseen by toxicologists or similar experts.
Qualifications of Experts: Not specified in detail, but implied to be qualified personnel within the third-party laboratories performing the tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the context of biocompatibility testing. The "ground truth" for biocompatibility is determined by the results of the standardized biological tests themselves against accepted cytotoxicity, irritation, and sensitization criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic aids where human readers interpret output, and the goal is to quantify the improvement in human performance with AI assistance. The Flents Plastic Eye Wash Cup is a simple mechanical device; such a study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance Study: No, a standalone performance study (in the context of an algorithm's performance without human intervention) was not done. This is not an AI/algorithm-driven device. The "standalone performance" of the device itself relates to its physical properties and material safety, which was assessed through biocompatibility testing.

7. The Type of Ground Truth Used

Ground Truth: For the "study" (biocompatibility testing), the ground truth is based on standardized biological test results and accepted criteria for biocompatibility (e.g., ISO 10993 standards). For the comparison to the predicate, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

Summary

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othecary Products, Inc.®

JUL 0 9 2014

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: __ K 1 4 0 4 0 9

Applicant: Apothecary Products, Inc. 11750 12th Avenue South Burnsville, MN 55337 FDA Establishment Registration Number: 2183416

Flents Plastic Eye Wash Cup

Contact person: James Jenkins Sr. Regulatory Affairs Specialist Phone: 952.808.8364 Fax: 952.890.0418

Date prepared: June 12, 2014

Name of Device:

Device Classification Name:	Cup, Eye
Common or usual name:	Eye Cup
Classification:	Ophthalmic - Unclassified - Pre-Amendment
Product Code:	LXQ
Predicate Device information:	K051414

Device Description:

intended Use: The Flents Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.

,""

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pothecary Products, Inc.®

Comparison to Predicate Device:

The Flents Plastic Eye Wash Cup has the same intended use and a similar design as the predicate device and is 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 material is safe for use in contact with solutions used to wash the affected eye.

Attribute	Applicant Device; FlentsPlastic Eye Wash Cup	Predicate Device; TollotPty.Ltd.(Aaxis Pacific), Non-sterile K051414
ClassificationName	Cup, Eye	Cup, Eye
Intended Use	The Flents Plastic Eye WashCup is intended to hold liquidssuch as eye wash solutions,used to flush out the eye.	A cup that holds liquids, such aseye wash solution, used to flushout the eye.
Design	ABS Plastic receptacle foreyewash solutions.	Similar
Colors	TZE Kun Plastic Materials, No.216941 White	Unknown
Dimensions	1.903 in x 1.353 in	Similar from redacted drawings
Volume	0.65 fl. oz. (19 mL)	Unknown
Materials	Chi Mei ABS PA-757	Unknown
Sterile	Non-sterile	Sterile/Non-sterile
Reuse	Reusable	Sterile Cup not reusable

Comparison to Predicate Device

Differences:

The Flents Plastic Eye Wash Cup is a non-sterile reusable device. The predicate device includes a sterile and non-sterile configuration that may not be reusable. The Flents Plastic Eye Wash Cup provides instructions to "Wash cup thoroughly with soap and warm water before use. Rinse well and dry" to ensure eye wash cup is not contaminated with any previous liquids or materials prior to each use. The Flents Plastic Eye Wash Cup is not packaged as sterile, however if cleaned as directed prior to each use, the eye cup is safe and effective "to hold liquids such as eye wash solutions used to flush out the eye" for its intended use, and is substantially equivalent with

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pothecary Products, Inc.®

regards to safety and effectiveness as the predicate device based on our eye cup material biocompatibility testing.

Summary of Safety and Effectiveness of Applicant Device

Biocompatibility testing of the applicant material and colorant included Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation and Maximization Sensitization. Studies were performed to assess the biocompatibility of the Flents Plastic Eye Wash Cup. Results of the biocompatibility testing show no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials used in the manufacture of the Flents Plastic Eye Wash Cup have demonstrated to be substantially equivalent with regards to safety and effectiveness, to their predicate devices and safe for its intended use.

Conclusion:

The Flents Plastic Eye Wash Cup is substantially equivalent to the predicate device in regards to intended use, design, and substantially equivalent with regards to safety and effectiveness. All the materials used in the Flents Plastic Eye Wash Cup have passed the relevant biocompatibility tests and have demonstrated to be safe and effective for the applicant intended use.

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Truthful and Accuracy Statement

Truth and Accuracy Statement : ... ・、 1 : : : : : : : :

I certify that, in my capacity as Senior Regulatory Specialist of Apothecary Products Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and no material fact has been omitted (as required by 21 CFR 807.87(k)).

ﺮﺡ

(Signature)

James Jenkins

February 12, 2014

(Premarket Notification [510(k)] Number)

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G649 Silver Spring, MD 20993-0002

July 9, 2014

Apothecary Products, Inc. Mr. James Jenkins Senior Regulatory Specialist 11750 12th Avenue South Burnsville, MN 55337-1295

Re: K140409

Trade/Device Name; Flents Plastic Eye Wash Cup Regulation Number: None Regulation Name: Eye Cup Regulatory Class: Unclassified Product Code: LXQ Dated: 06/12/2014 Received: 06/19/2014

Dear Mr. Jenkins:

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.

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Page 2 - Mr. James Jenkins

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/dcfault.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, 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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r Product 11750 12th Avenue South

690-1940 FAX (952) 890

Indications for Use

510(k) Number (if known): _K140409

Device Name: Plastic Eye Wash Cup

Indications for Use:

The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Naima B. Jacobs-el -S 2014.07.09 10:08:29 -04'00'

Regulation Number and Section

N/A