(249 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device, specifically the Red2Green Reusable Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical safety and efficacy through human trials. Therefore, the information requested in your prompt related to clinical studies, human readers, ground truth established by experts, etc., is not typically found in this kind of document for a device like a sharps container.
However, the document does detail non-clinical performance testing and acceptance criteria. Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Puncture Resistance (ASTM F2132) | Average puncture force 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. Implicitly, the device met these criteria, as the conclusion states the device does not raise new issues of safety or efficacy and is substantially equivalent. |
| Impact with Leak (ISO 23907) | No loss of container integrity and no evidence of leakage. | All containers and lids were tested in each possible configuration. Implicitly, the device met these criteria. |
| Stability (ISO 23907) | Device did not topple. | One container was tested in both orientations (lid open). Implicitly, the device met these criteria. |
| Impact (49 CFR 178.603) | No damage to the outer packaging and no leakage of the filling substance. | Five containers were subjected to the test on base, top, side wall, adjacent side wall, and bottom corner. Implicitly, the device met these criteria. |
| Stacking (49 CFR 178.606) | 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. | Five containers were subjected to a static load of 250 lbs for 24 hours. Implicitly, the device met these criteria. |
| Vibration (49 CFR 178.608) | No damage to the outer packaging and no leakage of the filling substance. | Three containers were subjected to vibration at 278 cpm for 1 hour. Implicitly, the device met these criteria. |
| Accessory Strength Test | No evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms. | The strength of Wall Enclosures and Metal Wall Bracket was tested with associated sharps containers filled with water for 48 hours. Implicitly, the device met these criteria. |
| Repeated Opening Test | Device remained undamaged and there were no signs of malfunction of the lid. | Three samples of the Horizontal Drop Lid were manually opened and closed for 1000 repetitions. Implicitly, the device met these criteria. |
| Life Cycle Test | 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 integrity of the device endured, and no changes to the performance or technical characteristics were visible after subsequent vibration, leak, and impact testing, and then puncture resistance testing on one container. | Five representative sharps containers were subjected to 400 cycles of filling, tipping, dumping, disinfecting, washing, drying, and processing, followed by vibration, leak, impact, and puncture resistance testing. Implicitly, the device met these criteria. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Puncture Resistance: "All containers and lids were tested." (Specific number of units not given, but implies comprehensive testing across product variations).
- Impact with Leak: "All containers and lids were tested in each possible configuration." (Specific number of units not given, but implies comprehensive testing across product variations and configurations).
- Stability: "One container."
- Impact: "Five containers."
- Stacking: "Five containers."
- Vibration: "Three containers."
- Accessory Strength: "One of each of the respective wall mounted accessories." (Number depends on accessories available).
- Repeated Opening: "Three samples of the Horizontal Drop Lid."
- Life Cycle: "Five representative sharps containers." (One of these was then used for puncture resistance).
Data Provenance: This document describes non-clinical laboratory testing performed by the manufacturer, Triumvirate Environmental, Inc. The location of the testing is not explicitly stated but is assumed to be internal to the company or through a contracted lab. This is retrospective data collected specifically for this 510(k) submission. There is no information regarding country of origin of data for clinical data as none was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. The ground truth for this device's performance is based on meeting engineering and performance standards outlined by ASTM, ISO, and CFR, not on expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. For this device, performance is measured against objective laboratory criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance
This information is not applicable. This device is a physical sharps container and does not involve AI or human interpretation for its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical sharps container and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Red2Green Reusable Sharps Container is established by adherence to recognized national and international performance standards (e.g., ASTM F2132, ISO 23907, 49 CFR 178.603, 178.606, 178.608) and predetermined acceptance criteria set forth by the manufacturer to demonstrate substantial equivalence to predicate devices. These standards define objective, measurable physical properties expected of sharps containers.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical device. The non-clinical tests described are performance verification tests.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated above.
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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
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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
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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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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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)6.3" x 12.8" x 10.4" | 2-002 Vertical Drop Lid2-003 Horizontal Drop Lid | 2.25" Φ1.75" x 9.375" | 2-004 Wall Enclosure2-006 Metal Wall Bracket2-005 Stabilizer |
| 3-001 | 3 Gallon Container Body (Red)6.3" x 12.8" x 15.3" | 2-002 Vertical Drop Lid2-003 Horizontal Drop Lid | 2.25" Φ1.75" x 9.375" | 3-002 Wall Enclosure2-006 Metal Wall Bracket2-005 Stabilizer |
| 4-001 | 4 Gallon Container Body (Red)6.3" x 12.8" x 20.1" | 2-002 Vertical Drop Lid2-003 Horizontal Drop Lid | 2.25" Φ1.75" x 9.375" | 4-002 Wall Enclosure2-006 Metal Wall Bracket2-005 Stabilizer |
| 8-001 | 8 Gallon Container Body (Red)13" x 13" x 17.4" | 8-002 Vertical Drop Lid8-003 Gallon Lab Lid* | 2.25" Φ6.5" × 7" | 8-004 Stabilizer8-005 Basic Rolling Dolly8-006 Foot Pedal Dolly |
| 8-007 | 8 Gallon Container Body (Yellow)13" x 13" x 17.4" | 8-002 Vertical Drop Lid8-003 Gallon Lab Lid* | 2.25" Φ6.5" × 7" | 8-004 Stabilizer8-005 Basic Rolling Dolly8-006 Foot Pedal Dolly |
| 10-001 | 10 Gallon Container Body (Red)13" x 13" x 22.3" | 8-002 Vertical Drop Lid8-003 Gallon Lab Lid* | 2.25" Φ6.5" × 7" | 8-004 Stabilizer8-005 Basic Rolling Dolly10-002 Foot Pedal Dolly |
| 10-003 | 10 Gallon Container Body (Yellow)13" x 13" x 22.3" | 8-002 Vertical Drop Lid8-003 Gallon Lab Lid* | 2.25" Φ6.5" × 7" | 8-004 Stabilizer8-005 Basic Rolling Dolly10-002 Foot Pedal Dolly |
| 17-001 | 17 Gallon Container Body (Red)13" x 17" x 24.7" | 17-002 Transportation Lid* | 13" x 17" | 17-003 Basic Rolling Dolly17-004 Foot Pedal Dolly |
| 17-005 | 17 Gallon Container Body (Yellow)13" x 17" x 24.7" | 17-002 Transportation Lid* | 13" x 17" | 17-003 Basic Rolling Dolly17-004 Foot Pedal Dolly |
- For commercial or healthcare users: for use only in areas with no unsupervised patient/customer access.
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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.
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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.
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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.
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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 SharpsContainer | Stericycle Sharps ManagementService Reusable SharpsContainer | Biobox TrapTop (Small, Medium,Large and X-Large) | Biobox with Funnel Top (Small,Medium, Large and X-Large) | |
| K153363 | K132007 | K950897 | K950898 | |
| Indications for Use | Red2Green Reusable SharpsContainers and accessories areintended to be used in healthcarefacilities including nursing stations,medication carts, laboratories,dental offices, emergency rooms,surgical rooms, treatment rooms,emergency vehicles, veterinarianoffices and other small quantitywaste generators for the safedisposal, storage andtransportation of hazardoussharps. | The Stericycle SharpsManagement Service ReusableSharps Container is intendedfor use in health care facilitiesfor the storage and transportfor disposal of syringes andother medical sharps waste. | Unknown | Unknown |
| Device Design | Reusable containers designed forthe safe disposal of sharps, i.e.articles that can penetrate humanskin. The base of the container isrectangular in shape. Differentbase dimensions and various liddesigns are available based on theamount and type of waste that isgenerated in a specific healthcarelocation. | Reusable containers designedfor the safe disposal of sharps,i.e. articles that can penetratehuman skin. The base of thecontainer is rectangular inshape. Different basedimensions and various liddesigns are available based onthe amount and type of wastethat is generated in a specifichealthcare location. | Containers designed for the safedisposal of sharps, i.e. articles thatcan penetrate human skin. Thebase of the container is rectangularin shape. Different base dimensionsand various lid designs are availablebased on the amount and type ofwaste that is generated in a specifichealthcare location. | Containers designed for the safedisposal of sharps, i.e. articles thatcan penetrate human skin. Thebase of the container isrectangular in shape. Differentbase dimensions and various liddesigns are available based on theamount and type of waste that isgenerated in a specific healthcarelocation. |
| Subject Device | Predicate Device | |||
| ProCodes / Reg # | MMK / 21 CFR 880.5570 | MMK / 21 CFR 880.5570 | MMK / 21 CFR 880.5570 | |
| Model Types | 2 gallon3 gallon4 gallon8 gallon10 gallon17 gallon | 2 gallon4 gallon | 8 gallon17 gallon | |
| Physical Properties | ||||
| Material | Medium density polyethylene | Polypropylene copolymer | Polypropylene copolymer | |
| Color | Red or yellow | Red or yellow | Red | |
| DimensionsL x W x H (inches) | 2 gallon: 6.3 x 12.8 x 10.43 gallon: 6.3 x 12.8 x 15.34 gallon: 6.3 x 12.8 x 20.18 gallon: 13 x 13 x 17.410 gallon: 13 x 13 x 22.317 gallon: 13 x 17 x 24.7 | 2 gallon: 6.9 x 12.3 x 13.94 gallon: 6.9 x 12.3 x 21.9 | 8 gallon: 11.3 x 13 x 19.717 gallon: 13.3 x 17.5 x 24.8 | |
| Container Closure | Vertical and horizontal drop, lablid, transportation lid | Vertical and horizontal drop | Horizontal drop, lab lid,transportation lid | |
| Technological Properties | ||||
| Reusable or Single-use | Reusable | Reusable | Unknown | |
| ContainerAccessories | Stabilizing tray, wall enclosure,wall bracket, rolling dolly, footpedal dolly | Unknown | Stabilizing tray, wall enclosure, wallbracket, rolling dolly, foot pedaldolly | |
| Needle RemovalMechanism | No | No | No | |
| Non-Clinical Testing | ||||
| Performance testing | ● Puncture resistance● Impact w/ leak● Stability● Impact● Stacking● Vibration● Accessory strength● Repeated opening● Life cycle | ● Puncture resistance● Leak● Stability● Impact● Stacking● Vibration | Unknown |
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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".
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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.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).