The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene 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.

Device Description

The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.

AI/ML Overview

The provided document describes the Dynarex Eye Cup (K151575) and its equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, a specific study proving those criteria, or details regarding sample sizes, expert involvement, ground truth, or comparative effectiveness studies.

The document makes a claim of "substantial equivalence" based on similar intended use, design, and biocompatibility testing. The "biocompatibility testing" is presented as the study proving safety and effectiveness, but no detailed results or comparative data against specific acceptance criteria for performance are provided.

Here's a breakdown of the information that is and is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's function (washing/flushing the eye). The equivalence is largely based on material safety and basic design.
Reported Device Performance: No quantitative performance metrics are provided. The "performance" is implicitly tied to its function of holding eyewash solution and being placed over the eye.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an eye cup, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used: Not explicitly stated, as no performance study is detailed. The "ground truth" for the substantial equivalence claim relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set: Not applicable, as this is a physical device and not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

Summary of Bio-compatibility Testing (as presented as the "study"):

The document states one "study" was conducted, focusing on biocompatibility.

Study Name/Type: Biocompatibility testing.
Tests Performed: Acute Systemic Toxicity, In-Vitro Cytotoxicity, Ocular Irritation, and Maximization (sensitization).
Results: "Results of the biocompatibility testing showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response."
Conclusion: "All materials used in the manufacture of the Dynarex Eye Wash Cup have demonstrated to be substantially equivalent in regards to safety and effectiveness to the predicate device and are safe for its intended use."

Comparison Table as provided in the document (illustrates equivalence, not performance against criteria):

Characteristic	Applicant Device Dynarex Eye Cup	Predicate Device Flents Plastic Eye Wash Cup
Classification Name	Cup, Eye	Cup, Eye
Intended Use	The Dynarex Eye Cup is a non-sterile device is placed over the eye to allow the solution to wash out or flush the affected eye.	The Flents Eye Wash Cup is intended to hold liquids such as eye wash solution, used to flush out the eye.
Design	Polyethylene	ABS Plastic
Color	Natural molded color - no colorant - whitish/opaque	TZE Kun Plastic Materials. No. 216941 White
Volume	17ml	0.65 fl. Oz. (19ml)
Dimensions	1.732 in x 1.062 in	1.903 in x 1.353 in
Materials	Sinopec Yangzi Pertrochemical Co. Ltd. LDPE - No. 2426H	Chi Mei ABS No. PA-757
Sterility	Non Sterile	Non Sterile
Reuse	Reusable	Reusable
Labeling / Cleaning	"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"	"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 document focuses on demonstrating that the Dynarex Eye Cup is substantially equivalent to a predicate device, as opposed to providing detailed performance data against specific, quantitatively defined acceptance criteria for its function. The "study" mentioned pertains solely to the biocompatibility of the materials.

Summary

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

September 1, 2015

Dynarex Corporation Mr. James Hurlman Manager, Regulatory Affairs 10 Glenshaw Street Orangeburg, NY 10962

Re: K151575

Trade/Device Name: Dynarex Eye Cups Regulation Number: None Regulation Name: Eye Cup Regulatory Class: Unclassified Product Code: LXQ Dated: May 30, 2015 Received: June 29, 2015

Dear Mr. Hurlman:

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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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 801and Part 809); medical device reporting of medical 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 and Part 809), 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" (21 CFR 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 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 -A

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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Indications for Use

510(k) Number (if known) K151575

Device Name Dynarex Eye Cup

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

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THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICES ACT OF 1990.

Assigned 510(k) number is: K151575

Submitter Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10962 USA Phone: 845-365-8200 845-680-6717 Fax: Contact Person James Hurlman Date of Summary 05/30/2015 Trade Name Dynarex Eye Cup, Model 3380 Device Classification Name Cup. Eye

Common Name Eye cup Classification Opththalmic - Unclassified - Pre-Amendment Product Code LXQ Predicate Device Flents Plastic Eye Wash Cup 510(k) #: K140409 Device Description The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or

Comparison to Predicate Device The Dynarex Eye Cup has the same intended use and similar design as the predicate device and is substantially equivalent with regards to safety and effectiveness.

flush the affected eye. The cup is non-sterile and is re-usable.

510(K) SUMMARY

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K151575

CORPORATION 10 Glenshaw Street, Orangeburg, N.Y. 10962

The Dynarex Eye Cup is a non-sterile device made of opaque Intended Use Polyethylene 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. Differences: The design differences include the products material where our device is made of LDPE and the predicate device is made of ABS plastic. The color of the predicate device is white due to an added colorant and the Dynarex version is naturally whitish and/or opaque with no colorant added. The predicate device has a 2mL greater fluid capacity. Both devices are sold non-sterile and are reusable. Neither Dynarex nor the predicate device have established a patient population for the use of the product, in an emergency situation the product can be used effectively, with care, on any age.

Table of Comparison

Characteristic	Applicant DeviceDynarex CPR Shield	Predicate DeviceFlents Plastic Eye Wash Cup
Classification Name	Cup, Eye	Cup, Eye
Intended Use	The Dynarex Eye Cup is a non-sterile device is placed over theeye to allow the solution to washout or flush the affected eye.	The Flents Eye Wash Cup isintended to hold liquids such aseye wash solution, used to flushout the eye.
Design	Polyethylene	ABS Plastic
Color	Natural molded color - nocolorant - whitish/opaque	TZE Kun Plastic Materials. No.216941 White
Volume	17ml	0.65 fl. Oz. (19ml)
Dimensions	1.732 in x 1.062 in	1.903 in x 1.353 in
Materials	Sinopec Yangzi PertrochemicalCo. Ltd.LDPE - No. 2426H	Chi Mei ABS No. PA-757
Sterility	Non Sterile	Non Sterile
Reuse	Reusable	Reusable
Labeling / CleaningInstructions	"Wash cup thoroughly with soapand warm water before use.Rinse well and dry to ensure eyewash cup is not contaminatedwith any previous liquids ormaterials prior to each use"	"Wash cup thoroughly with soapand warm water before use.Rinse well and dry to ensure eyewash cup is not contaminatedwith any previous liquids ormaterials prior to each use"

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Image /page/5/Picture/1 description: The image shows the word "dynarex" in a bold, sans-serif font. The letters are black and have a slight drop shadow effect, giving them a three-dimensional appearance. The word is presented against a white background, which makes the text stand out.

CORPORATION 10 Glenshaw Street, Orangeburg, N.Y. 10962

510(K) SUMMARY

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Summary of Safety and Effectiveness of Applicant Device

Biocompatibility testing of the applicant material includes Acute Systemic Toxicity, In-Vitro Cytotoxicity, Occular Irritation and Maximization. Results of the biocompatibility testing showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials used in the manufacture of the Dynarex Eye Wash Cup have demonstrated to be substantially equivalent in regards to safety and effectiveness to the predicate device and are safe for its intended use.

Conclusion

The Dynarex Eye Wash Cup is substantially equivalent to the predicate device with regards to intended use, design and substantially equivalent as it relates to safety and effectiveness to the predicate device via biocompatibility testing.

Regulation Number and Section

N/A