← Product Code LXQ · K151575 # Dynarex Eye Cups (K151575) _Dynarex Corporation · LXQ · Sep 1, 2015 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K151575 ## Device Facts - **Applicant:** Dynarex Corporation - **Product Code:** LXQ - **Decision Date:** Sep 1, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP ## Intended Use 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 Story The Dynarex Eye Cup is a 17ml, non-sterile, reusable polyethylene cup. It is designed to be filled with an eyewash solution and placed over the eye to facilitate irrigation or flushing. The device is intended for over-the-counter use by patients or caregivers in home or emergency settings. The user fills the cup, positions it over the eye, and performs the wash. The device provides a simple mechanical means to contain liquid for ocular irrigation, aiding in the removal of debris or irritants from the eye. ## Clinical Evidence No clinical data. Evidence consists of bench testing, specifically biocompatibility testing including Acute Systemic Toxicity, In-Vitro Cytotoxicity, Ocular Irritation, and Maximization. Results showed no evidence of cellular or systemic toxicity, ocular irritation, or sensitization. ## Technological Characteristics Material: LDPE (Sinopec Yangzi Petrochemical Co. Ltd. No. 2426H). Dimensions: 1.732 in x 1.062 in. Volume: 17ml. Form factor: Cup. Sterilization: Non-sterile. Reusable. No software or electronic components. ## Predicate Devices - Flents Plastic Eye Wash Cup ([K140409](/device/K140409.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is written in a simple, sans-serif font. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K151575 Device Name Dynarex Eye Cup Indications for Use (Describe) 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. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY Page 1 of 3 ## 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 {4}------------------------------------------------ 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 Device
Dynarex CPR Shield | 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
Instructions | "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" | {5}------------------------------------------------ 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 Page 3 of 3 ### 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. --- **Source:** [https://fda.innolitics.com/device/K151575](https://fda.innolitics.com/device/K151575) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com