ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER

{0}------------------------------------------------ 510(k) Summary Ecoship Disposable Sharps Container JAN 3 1 2014 #### 510(k) Summary # Daniels Sharpsmart, Inc. Ecoship Disposable Sharps Container K132792 #### December 30, 2013 ## ADMINISTRATIVE INFORMATION Manufacturer Name Official Contact Representative/Consultant Daniels Sharpsmart, Inc. 111 W Jackson Blvd., Suite 720 Chicago, IL 60604 Telephone: +1 (312) 546-8925 Fax: +1 (312) 276-4714 Alan Larosee Director of Compliance Allison C. Komiyama, Ph.D. Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: akomiyama@paxmed.com flarson@paxmed.com #### DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name Common Name Classification Name Classification Regulations Product Code Classification Panel Reviewing Branch Ecoship Disposable Sharps Container Container, sharps Hypodermic single lumen needle 21 CFR 880.5570, Class II MMK General Hospital Infection Control Devices Branch {1}------------------------------------------------ #### INTENDED USE Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Overthe-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles. ### DEVICE DESCRIPTION Ecoship Disposable Sharps Containers are single-use sharps containers designed for point-first disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes. The containers are intended to be used in supervised areas of human and veterinary healthcare facilities. These areas may include nursing stations, laboratories, dental offices, physician offices, clinics, emergency rooms, surgical rooms, treatment rooms, research facilities, veterinarian practices and other small quantity waste generators. The devices are also intended to be used in healthcare facility mail-back programs and in home healthcare by clinical staff. Two Ecoship Disposable Sharps Container models are described in this submission: - D2-ES is 2 liters with fill capacity of 1.5 liters . - o Tare: 192 grams (6.77 oz) - o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm - D4-ES is 4 liters with fill capacity of 3 liters . - o Tare: 304 grams (10.72 oz) - Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o #### EQUIVALENCE TO MARKETED DEVICE Daniels Sharpsmart, Inc. Ecoship Disposable Sharps Container is substantially equivalent in indications and design principles to the following predicate devices: - Daniels Corporation PTY, INC., Sharpsmart S2 Disposable Sharps Container (K091736) . - Sharps Compliance, Inc., Sharps Compliance Container (K083129) . - Oak Ridge Products L.L.C., Oak Ridge Products Sharps Containers (K130281) . The D2-ES (2 liter) and D4-ES (4 liter) Ecoship Disposable Sharps Containers have a similar design and dimensions, use similar materials, and are similar in color to those cleared under K091736. K083129 and K130281. The subject device has similar fill capacity and locking {2}------------------------------------------------ mechanisms to those cleared in K091736 and K130281. The access opening is similar in size and shape to K091736 and K083129. A return mail-back carton is provided similar to K083129. No FDA performance standards for Ecoship Disposable Sharps Container have been established. The following tests were performed to ensure that the performance of the subject device meets Daniels Sharpsmart, Inc. requirements. ### Pucture Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste) Needle puncture resistance was measured by taking various sections of a container and subjecting them to penetration with a 0.8 mm diameter needle. The force required to puncture the container was measured. The puncture resistance of each section of the container was greater than 20 N and the passing criterion was met. ### Toppling Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste) Toppling resistance was measured by filling a container to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and tilting it to a 15° angle. The container remained standing after being tilted, and the passing criterion was met. ## Toppling Resistance (per ISO 23907 Sharps injury protection - Requirements and test methods -Sharps containers) Toppling resistance was measured by filling a container to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and tilting it to a 15° angle using the worst case challenge configurations. The container did not slide, and remained standing after being tilted, and the passing criteria were met. ### Impact Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste) Impact resistance was measured by filling five containers to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and surfactant solution equal to 6% of the nominal capacity. The containers were then conditioned at 23°C and dropped in a specific orientation from a height of no less than 1 meter. The containers did not rupture, tear, crack, open, or leak, and the passing criteria were met. ### Cold Impact Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste) Cold impact resistance was measured by filling five containers with representative sharps material with a bulk density of 0.2 kg/liter. The containers were then conditioned at -18°C and dropped in a specific orientation from a height of no less than 1.2 meters. The containers did not rupture, tear, crack, open, or leak, and the passing criteria were met. {3}------------------------------------------------ ### Handle Strength (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste) Handle strength was measured by filling a container to nominal capacity with material with a bulk density of 1 kg/liter and suspending it from the handle for 1 hour. The container remained intact and the handle did not rupture, tear, crack, or separate from the container. Therefore, the passing criteria were met. Drop Test (per United Nations Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6, "Requirements For the construction and testing of packagings, intermediate bulk containers (IBCs), large packagings and portable tanks) This test was performed by filling six containers with no less than 1.2 kg of polycarbonate granules to a minimum of 95% capacity and prepared as they would be used in transport. The containers were then conditioned at -18°C and dropped in one of two specific orientations from a height of no less than 1.2 meters. The containers were not damaged, and the passing criterion was met. Stacking Test (per United Nations Recommendations on the Transport of Dangerous Goods -Model Regulations, Part 6, "Requirements For the construction and testing of packagings, intermediate bulk containers (IBCs), large packagings and portable tanks) This test was performed by stacking three empty containers and prepared as they would be used in transport. A mass of 81 kg was then applied to the top of the stack for 24 hours at room temperature. The containers were not damaged, and the passing criterion was met. #### Vibration Test (per 49 CFR Part 178.608 Specifications for Packagings - Vibration Standard) This test was performed by filling three containers with polycarbonate granules to a minimum of 95% capacity, prepared as they would be used in transport. The containers were then vibrated (25 mm peak to peak at a frequency that induces displacement of 1.6 mm from the vibration plate) for 60 minutes at room temperature. The containers did not rupture, leak or deteriorate, and the passing criteria were met. All testing demonstrated that the subject device is safe and effective for its intended use. The devices conform to regulations per US OSHA 29 CFR 1910.1030 Bloodborne Pathogens. Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis and dimensional analysis. Clinical data were not submitted in this premarket notification. {4}------------------------------------------------ The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including fill capacity and access opening size. The subject and predicate devices are packaged in similar materials. Any differences in the technological characteristics do not raise new issues of safety or efficacy. The device is safe and effective for its intended use and performs as well as or better than the predicate devices. Overall, the Ecoship Disposable Sharps Container has the following similarities to the predicate devices: - has the same intended use, . - . uses the same operating principle, - incorporates the same basic design, - incorporates the same or very similar materials, and . - has similar packaging. . Therefore, the information provided within the 510(k) is sufficient to demonstrate that the subject device is substantially equivalent to the predicates. {5}------------------------------------------------ aditional 510(k) Premarket Notification : ummary: Table of Substantial Equivalenc | Subject Device<br>Ecoship Disposable<br>Sharps Container | | Sharpsmart™ S2<br>Disposable Sharps<br>Container | Daniels Corporation PTY,<br>INC.<br>K091736 | Predicate Devices<br>Sharps Compliance<br>Container | Sharps Compliance, Inc.<br>K083129 | Oak Ridge Products Sharps<br>Containers | Oak Ridge Products L.L.C.<br>K130281 | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------| | Indications<br>for Use | Daniels Sharpsmart, Inc. | | Sharpsmart™ S2 disposable<br>sharps container are intended to<br>be used in healthcare facilities,<br>including nursing stations,<br>medication carts, laboratories,<br>dental offices, emergency rooms,<br>surgical rooms, treatment rooms,<br>emergency vehicles, veterinarian<br>office and other small quantity<br>waste generators for the safe<br>disposal of hazardous sharps. This<br>device is intended for "Over-the-<br>Counter" use.<br>Physical Attributes: S2 model is a<br>1 quart size. The container has a<br>volume of 1.6 quarts, fill capacity<br>of 1.16 quarts and an empty<br>weight of 0.95 lb.<br>S2 model Color - Red with<br>translucent lid or yellow with<br>translucent lid.<br>S2 model outer dimensions of<br>7.50 "h x 4.50"w x 5.50 "d.<br>(190mm x 115mm x 140mm). | The Sharps Compliance<br>Container is a disposable<br>infectious waste container in 1<br>gallon, 2 gallon and 3 gallon<br>sizes, intended for use by<br>laypersons or health<br>professionals, in small usage<br>areas in clinical and non-<br>clinical settings, such as:<br>phlebotomy, nursing homes,<br>homes, isolation, doctors office,<br>clinics, labs, or school nurses<br>office. The Sharps Compliance<br>Container is eventually<br>disposed of through a mail-<br>back system or otherwise in<br>accordance with local<br>regulations. | Oak Ridge Products Sharps containers<br>are single-use, disposable, non-sterile<br>containers intended to be used for<br>healthcare purposes for safe disposal<br>of hazardous sharps such as<br>hypodermic needles, syringes, lancets,<br>and blood needles. The target<br>population is for trained healthcare<br>professionals.<br>The 1 quart Phlebotomy container is<br>intended to be used with an<br>appropriate mounting device.<br>The 5.4 quart is intended to be used<br>with an appropriate mounting device.<br>The 2 gallon container is intended to<br>be used in areas where there is no<br>unsupervised patient access. | | | | | Ecoship Disposable Sharps<br>Container is intended to be used<br>in healthcare facilities,<br>including nursing stations,<br>medication carts, laboratories,<br>dental offices, emergency<br>rooms, surgical rooms,<br>treatment rooms, emergency<br>vehicles, veterinarian offices<br>and other small quantity waste<br>generators for the safe disposal<br>of hazardous sharps. The device<br>is intended for "Over-the-<br>Counter" use. The container is<br>eventually disposed of through<br>a mail-back system or<br>otherwise in accordance with<br>local regulations. | | | | | | | . : {6}------------------------------------------------ Traditional 510(k) Premarket Notificatio Ecoship Disposable Sharps Contain | | Subject Device<br>Ecoship Disposable<br>Sharps Container | Daniels S2 Disposable<br>Sharps Container | Predicate Devices<br>Sharps Compliance<br>Container | Oak Ridge Products Sharps<br>Containers | |--------------------------------|----------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | | Daniels Sharpsmart, Inc. | The Daniels Corporation<br>K091736 | Sharps Compliance, Inc.<br>K083129 | Oak Ridge Products L.L.C.<br>K130281 | | Size (model) | 2 liter (D2-ES)<br>4 liter (D4-ES) | 1.6 quart (S2) | 1 gallon<br>2 gallon<br>3 gallon | 1 quart (Phlebotomy red)<br>5.4 quart (Universal clear)<br>5.4 quart (Universal red)<br>2 gallon (Nestable red) | | Material | Polypropylene | Polypropylene | Polypropylene | Polypropylene | | Color of base | Red | Red or yellow | Red | Red or clear | | Fill Line<br>Capacity | 1.5 liters (D2-ES)<br>3 liters (D4-ES) | 1.51 liters (1.6 quarts) | 3.79 liters (1 gallon)<br>7.57 liters (2 gallon)<br>11.36 liters (3 gallon) | 0.76 liters (1 quart)<br>4.07 liters (5.4 quart)<br>6.8 liters (2 gallon) | | Size (mm)<br>L x W x H | 142 x 142 x 151 (D2-ES)<br>142 x 142 x 303 (D4-ES) | 190 x 115 x 140 | 222 x 140 x 178 (1 gal)<br>222 x 140 x 273 (2 gal)<br>222 x 140 x 426 (3 gal) | 115 x 115 x 190 (1 quart)<br>280 x 115 x 267 (5.4 quart)<br>262 x 178 x 257 (2 gallon) | | Container<br>closure | Screw-on cap | Hinged friction fit door | Snap-on cap | Slide or rotating door | | Locking<br>mechanism | Yes | Yes | No | Yes | | Access opening<br>size | 45 mm (diameter) | 31.75 mm (diameter) | Unknown | 50.8 x 38.1 mm<br>203.1 x 35.6 mm<br>142.2 x 58.4 mm | | Needle<br>Removal<br>Mechanism | No | Yes | No | No | | Brackets | Available but not<br>necessary for use | Available but not<br>necessary for use | Not available | Available and necessary<br>for 1 quart and 5.4 quart models | | Return shipping<br>provided | Yes | No | Yes | No | Page 13 of 40 {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 31, 2014 Daniels Sharpsmart, Incorporated Dr. Allison Komiyama Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Re: K132792 Trade/Device Name: Ecoship Disposable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single-Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 30, 2013 Received: December 31, 2013 Dear Dr. Komiyama: 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. Iisting 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. {8}------------------------------------------------ Page 2 - Ms. Komiyana 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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/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.htm. Sincerely yours, for Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Ecoship Disposable Sharps Container IFU Statement ### Indications for Use K132792 510(k) Number: Device Name: Ecoship Disposable Sharps Container Model D2=ES: 2 liters with fill capacity of 1.5 liters Model D4-ES: 4 liters with fill capacity of 3 liters Indications: Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment. rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Over-the-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles. 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 IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) Page I of I Digitally signed by Sreekanth U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000 540490-cn=Sreekanth Gutala -S Date: 2014.01.28 13:08:15 -05'00'