Red2Green Reusable Sharps Container

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the figure in a circular pattern. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 26, 2016 Triumvirate Environmental, Inc. % Allison C. Komiyama, Ph.D., R.A.C. Representative/Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104 Re: K153363 Trade/Device Name: Red2Green Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 23, 2016 Received: June 24, 2016 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, 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 {1}------------------------------------------------ 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 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/Resourcesfor You/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 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, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K153363 Device Name Red2Green Reusable Sharps Container #### Indications for Use (Describe) Red2Green Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps. Type of Use (Select one or both, as applicable) - Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Druq 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Triumvirate Environmental. The logo consists of a light green triangle on the left and the words "TRIUMVIRATE" and "ENVIRONMENTAL" in dark green on the right. The word "TRIUMVIRATE" is above the word "ENVIRONMENTAL". #### DATE PREPARED July 26, 2016 #### MANUFACTURER AND 510(k) OWNER Triumvirate Environmental, Inc. 200 Inner Belt Road, Somerville, MA 02143, USA Telephone: (888) 834-9697 Fax: (617) 628-8099 Official Contact: Steve Todisco, Corporate Healthcare Director #### REPRESENTATIVE/CONSULTANT Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies 2834 Hawthorn Street, San Diego, CA 92104, USA Telephone: Email: akomiyama@acknowledge-rs.com #### PROPRIETARY NAME OF SUBJECT DEVICE Red2Green Reusable Sharps Container #### COMMON NAME Container, Sharps #### DEVICE CLASSIFICATION Hypodermic single lumen needle (21 CFR 880.5570, Product Code MMK, Class II) #### PREMARKET REVIEW ODE/DAGRID/INCB General Hospital Panel {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Triumvirate Environmental. The logo consists of a light green triangle pointing to the left, followed by the words "TRIUMVIRATE" in bold, dark green letters, and "ENVIRONMENTAL" in smaller, dark green letters below it. The logo is simple and professional, and the colors are calming and natural. ## INDICATIONS FOR USE Red2Green Reusable Sharps Containers and accessories are 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, storage and transportation of hazardous sharps. ### DEVICE DESCRIPTION Red2Green Reusable Sharps Containers are reusable sharps containers designed for 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. Device configurations are as follows: | Part # | Part Name | Associated Lids | Aperture Dimensions | Optional Accessories | |--------|--------------------------------------------------------|------------------------------------------------------|----------------------------|--------------------------------------------------------------------------| | 2-001 | 2 Gallon Container Body (Red)<br>6.3" x 12.8" x 10.4" | 2-002 Vertical Drop Lid<br>2-003 Horizontal Drop Lid | 2.25" Φ<br>1.75" x 9.375" | 2-004 Wall Enclosure<br>2-006 Metal Wall Bracket<br>2-005 Stabilizer | | 3-001 | 3 Gallon Container Body (Red)<br>6.3" x 12.8" x 15.3" | 2-002 Vertical Drop Lid<br>2-003 Horizontal Drop Lid | 2.25" Φ<br>1.75" x 9.375" | 3-002 Wall Enclosure<br>2-006 Metal Wall Bracket<br>2-005 Stabilizer | | 4-001 | 4 Gallon Container Body (Red)<br>6.3" x 12.8" x 20.1" | 2-002 Vertical Drop Lid<br>2-003 Horizontal Drop Lid | 2.25" Φ<br>1.75" x 9.375" | 4-002 Wall Enclosure<br>2-006 Metal Wall Bracket<br>2-005 Stabilizer | | 8-001 | 8 Gallon Container Body (Red)<br>13" x 13" x 17.4" | 8-002 Vertical Drop Lid<br>8-003 Gallon Lab Lid* | 2.25" Φ<br>6.5" × 7" | 8-004 Stabilizer<br>8-005 Basic Rolling Dolly<br>8-006 Foot Pedal Dolly | | 8-007 | 8 Gallon Container Body (Yellow)<br>13" x 13" x 17.4" | 8-002 Vertical Drop Lid<br>8-003 Gallon Lab Lid* | 2.25" Φ<br>6.5" × 7" | 8-004 Stabilizer<br>8-005 Basic Rolling Dolly<br>8-006 Foot Pedal Dolly | | 10-001 | 10 Gallon Container Body (Red)<br>13" x 13" x 22.3" | 8-002 Vertical Drop Lid<br>8-003 Gallon Lab Lid* | 2.25" Φ<br>6.5" × 7" | 8-004 Stabilizer<br>8-005 Basic Rolling Dolly<br>10-002 Foot Pedal Dolly | | 10-003 | 10 Gallon Container Body (Yellow)<br>13" x 13" x 22.3" | 8-002 Vertical Drop Lid<br>8-003 Gallon Lab Lid* | 2.25" Φ<br>6.5" × 7" | 8-004 Stabilizer<br>8-005 Basic Rolling Dolly<br>10-002 Foot Pedal Dolly | | 17-001 | 17 Gallon Container Body (Red)<br>13" x 17" x 24.7" | 17-002 Transportation Lid* | 13" x 17" | 17-003 Basic Rolling Dolly<br>17-004 Foot Pedal Dolly | | 17-005 | 17 Gallon Container Body (Yellow)<br>13" x 17" x 24.7" | 17-002 Transportation Lid* | 13" x 17" | 17-003 Basic Rolling Dolly<br>17-004 Foot Pedal Dolly | * For commercial or healthcare users: for use only in areas with no unsupervised patient/customer access. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Triumvirate Environmental. The logo consists of a light green triangle on the left and the words "TRIUMVIRATE" and "ENVIRONMENTAL" in a dark green font on the right. The word "TRIUMVIRATE" is above the word "ENVIRONMENTAL". ## PREDICATE DEVICE IDENTIFICATION The Red2Green Reusable Sharps Container is substantially equivalent to the following predicates: | 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate | |---------------|-----------------------------------------------------------------------------------|-------------------| | K132007 | Stericycle Sharps Management Service Reusable Sharps Container / Stericycle, Inc. | ✓ | | K950897 | Biobox TrapTop / Biosystems | | | K950898 | Biobox with Funnel Top / Biosystems | | ## SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the Red2Green Reusable Sharps Container. The following tests were performed to demonstrate safety based on current industry standards and predetermined acceptance criteria. Puncture resistance (per ASTM F2132): This test was performed by selecting sections from each area of the container or lid and subjecting them to a 21 gage needle advancing at a rate of 4″/min. Per the acceptance criteria, the average puncture force was no less than 3.4 lbf with no one value from any region being less than 2.8 lbf. All containers and lids were tested. lmpact with Leak test (per ISO 23907): Containers were filled with representative sharps material and 1% volume of water. The lid was closed and the container was placed 1 m from the impact surface. The container was allowed to free fall and on its base, side wall, and adjacent side wall. Additionally, the 2 and 3 gallon containers were allowed to free fall and land on their lids as specified in the standard. Per the acceptance criteria, there was no loss of container integrity and no evidence of leakage. All containers and lids were tested in each possible configuration. Stability test (per ISO 23907): One container was filled with representative sharps material and placed on a surface with a 15° incliner lid was left open and was tested in both orientations. Per the acceptance criteria, the device did not topple. lmpact test (per 49 CFR 178.603): Five containers were filled with representative sharps material to a gross mass of 50 lbs and conditioned at 0° F for at least 24 hours. The container was allowed to free fall from a height of 1.2 m and land on its base, top, side wall, adjacent side wall, and bottom corner. Per the acceptance criteria, there was no damage to the outer packaging and no leakage of the filling substance. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for Triumvirate Environmental. The logo consists of a light green triangle on the left and the words "TRIUMVIRATE" and "ENVIRONMENTAL" in green on the right. The word "TRIUMVIRATE" is in a larger font than the word "ENVIRONMENTAL". The logo is simple and clean, and the colors are calming and professional. Stacking test (per 49 CFR 178.606): Five containers were filled with representative sharps material to a gross mass of 50 lbs and then subjected to a static load of 250 lbs. Per the acceptance criteria, the load was sustained for 24 hours at a temperature of 23° C and 50% relative humidity. No damage, leakage or deterioration that could adversely affect transportation safety was observed. Vibration test (per 49 CFR 178.608): Three containers were filled with representative sharps material to a gross mass of 50 lbs and then subjected to vibration at 278 cpm for 1 hour. Per the acceptance criteria, there was no damage to the outer packaging and no leakage of the filling substance. Accessory strength test: The strength of Wall Enclosures and Metal Wall Bracket were tested by filling their associated sharps container with water. The filled container was placed into one of each of the respective wall mounted accessories. After 48 hours the containers were removed and the accessories were inspected for any loss of integrity. There was no evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms. Repeated opening test: To demonstrate that repeated opening and closing of the device does not negatively affect performance, three samples of the Horizontal Drop Lid were manually opened and closed for 1000 repetitions. The device was inspected for any damage or loss of functionality to the container or lid. For all three samples, the device remained undamaged and there were no signs of malfunction of the lid. Life cycle test: Five representative sharps containers were filled with representative sharps material, tipped, dumped, disinfected, washed, dried and processed 400 times. There was no evidence of discoloration, cracks, breaks or other deficiencies (such as deterioration to the label) that would prevent the containers from operating normally. After 400 cycles, the devices were subjected to vibration simulation per ISTA Procedure 3E, one round of leak testing, impact testing per 49 CFR 178.603, and then a second round of leak testing. One sharps container was then subjected to puncture resistance testing per ASTM F2132. After reprocessing, the integrity of the device endured, and no changes to the performance or technical characteristics were visible. #### EQUIVALENCE TO PREDICATE DEVICES The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K132007, K950897, and K950898. The colors and lid configurations are similar to those cleared in K132007. The subject device has the same intended use and similar technological characteristics (i.e. the lid closure) to the devices cleared in K132007, K950897, and K950898. The device has similar accessories to the devices cleared in K950897, and K950898. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Triumvirate Environmental. The logo consists of a light green triangle on the left and the words "TRIUMVIRATE" and "ENVIRONMENTAL" in dark green on the right. The word "TRIUMVIRATE" is above the word "ENVIRONMENTAL". Triumvirate Environmental, Inc. believes that the Red2Green Reusable Sharps Container is substantially equivalent to the predicate devices based on the information summarized in the table below. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Triumvirate Environmental. The text is in a sans-serif font and is green in color. The word "TRIUMVIRATE" is in a larger font than the word "ENVIRONMENTAL". To the left of the text is a geometric shape that is also green. | | Subject Device | | Predicate Device | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Triumvirate Environmental, Inc. | Stericycle, Inc. | Biosystems | Biosystems | | | Red2Green Reusable Sharps<br>Container | Stericycle Sharps Management<br>Service Reusable Sharps<br>Container | Biobox TrapTop (Small, Medium,<br>Large and X-Large) | Biobox with Funnel Top (Small,<br>Medium, Large and X-Large) | | | K153363 | K132007 | K950897 | K950898 | | Indications for Use | Red2Green Reusable Sharps<br>Containers and accessories are<br>intended to be used in healthcare<br>facilities including nursing stations,<br>medication carts, laboratories,<br>dental offices, emergency rooms,<br>surgical rooms, treatment rooms,<br>emergency vehicles, veterinarian<br>offices and other small quantity<br>waste generators for the safe<br>disposal, storage and<br>transportation of hazardous<br>sharps. | The Stericycle Sharps<br>Management Service Reusable<br>Sharps Container is intended<br>for use in health care facilities<br>for the storage and transport<br>for disposal of syringes and<br>other medical sharps waste. | Unknown | Unknown | | Device Design | Reusable containers designed for<br>the safe disposal of sharps, i.e.<br>articles that can penetrate human<br>skin. The base of the container is<br>rectangular in shape. Different<br>base dimensions and various lid<br>designs are available based on the<br>amount and type of waste that is<br>generated in a specific healthcare<br>location. | Reusable containers designed<br>for the safe disposal of sharps,<br>i.e. articles that can penetrate<br>human skin. The base of the<br>container is rectangular in<br>shape. Different base<br>dimensions and various lid<br>designs are available based on<br>the amount and type of waste<br>that is generated in a specific<br>healthcare location. | Containers designed for the safe<br>disposal of sharps, i.e. articles that<br>can penetrate human skin. The<br>base of the container is rectangular<br>in shape. Different base dimensions<br>and various lid designs are available<br>based on the amount and type of<br>waste that is generated in a specific<br>healthcare location. | Containers designed for the safe<br>disposal of sharps, i.e. articles that<br>can penetrate human skin. The<br>base of the container is<br>rectangular in shape. Different<br>base dimensions and various lid<br>designs are available based on the<br>amount and type of waste that is<br>generated in a specific healthcare<br>location. | | | Subject Device | Predicate Device | | | | ProCodes / Reg # | MMK / 21 CFR 880.5570 | MMK / 21 CFR 880.5570 | MMK / 21 CFR 880.5570 | | | Model Types | 2 gallon<br>3 gallon<br>4 gallon<br>8 gallon<br>10 gallon<br>17 gallon | 2 gallon<br>4 gallon | 8 gallon<br>17 gallon | | | Physical Properties | | | | | | Material | Medium density polyethylene | Polypropylene copolymer | Polypropylene copolymer | | | Color | Red or yellow | Red or yellow | Red | | | Dimensions<br>L x W x H (inches) | 2 gallon: 6.3 x 12.8 x 10.4<br>3 gallon: 6.3 x 12.8 x 15.3<br>4 gallon: 6.3 x 12.8 x 20.1<br>8 gallon: 13 x 13 x 17.4<br>10 gallon: 13 x 13 x 22.3<br>17 gallon: 13 x 17 x 24.7 | 2 gallon: 6.9 x 12.3 x 13.9<br>4 gallon: 6.9 x 12.3 x 21.9 | 8 gallon: 11.3 x 13 x 19.7<br>17 gallon: 13.3 x 17.5 x 24.8 | | | Container Closure | Vertical and horizontal drop, lab<br>lid, transportation lid | Vertical and horizontal drop | Horizontal drop, lab lid,<br>transportation lid | | | Technological Properties | | | | | | Reusable or Single-use | Reusable | Reusable | Unknown | | | Container<br>Accessories | Stabilizing tray, wall enclosure,<br>wall bracket, rolling dolly, foot<br>pedal dolly | Unknown | Stabilizing tray, wall enclosure, wall<br>bracket, rolling dolly, foot pedal<br>dolly | | | Needle Removal<br>Mechanism | No | No | No | | | Non-Clinical Testing | | | | | | Performance testing | ● Puncture resistance<br>● Impact w/ leak<br>● Stability<br>● Impact<br>● Stacking<br>● Vibration<br>● Accessory strength<br>● Repeated opening<br>● Life cycle | ● Puncture resistance<br>● Leak<br>● Stability<br>● Impact<br>● Stacking<br>● Vibration | Unknown | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Triumvirate Environmental. The logo consists of a geometric shape on the left and the company name on the right. The company name is written in green, with "TRIUMVIRATE" on top of "ENVIRONMENTAL". {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Triumvirate Environmental. The logo consists of a light green triangle on the left and the words "TRIUMVIRATE ENVIRONMENTAL" in dark green on the right. The word "TRIUMVIRATE" is on top of the word "ENVIRONMENTAL". ## CONCLUSION Based on the testing performed, including puncture resistance, impact with leak, stability, impact, stacking, vibration, accessory strength, repeated opening, and life cycle testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. Based on the intended use, technological characteristics, performance data, and non-clinical tests performed, the subject devices (Red2Green Reusable Sharps Containers) are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate devices.