(72 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and safety features of a sharps container, with no mention of AI or ML technology.
No
This device is a sharps container designed for the safe disposal of medical sharps, primarily to prevent injuries and the spread of infection, not to treat or diagnose a medical condition.
No
Explanation: The device described is a sharps container designed for the safe disposal of medical waste. Its function is to contain sharps, not to diagnose medical conditions or provide any diagnostic information.
No
The device description clearly describes a physical container made of polypropylene plastic for the disposal of sharps. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a strong indicator that the device is not intended for diagnostic purposes.
- Device Description: The description clearly states the device is a "Sharps Container" designed for the disposal of sharp medical waste. Its features relate to containment, puncture resistance, and secure closure, not to the analysis of biological samples.
- No mention of biological samples or analysis: The description focuses on the physical characteristics and function of a container for sharps, not on any process involving biological specimens for diagnostic purposes.
- Intended User/Care Setting: While used in labs and pharmacies, the purpose is for waste disposal within these settings, not for performing diagnostic tests.
- Performance Studies: The performance studies described relate to the physical integrity of the container (puncture resistance, leak resistance, impact resistance), not to the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is also a "Sharps Container," further confirming the device's function as a waste disposal product.
IVD devices are specifically designed to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This sharps container does not perform any such function.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The Demis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure.
The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"II x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable.
Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". ASTM proposed standard for puncture resistance states "...the average puncture force for the sharps contact areas of each region of nominal uniform thickness of the container shall not be less than 3,4 1b./ft. with no one value less than 2.8 lb./ft." according to ECRI Puncture Resistance criteria. Testing was done on the Bemis Two Gallon Sharps Containers using this standard. All wall thicknesses of .050" will pass the puncture tests, however, Bemis will reject any parts with wall thicknesses less than .055".
The containers are leakproof on the sides and bottom. According to ECRI Health Devices Leak Resistance criteria "...there shall be no leakage of the contents over a 24 hour period when filled with water and positioned in an upright position." The Bemis Two Gallon Sharps Containers passed this requirement when tested using this method.
The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSIIA regulations. The labels are attached directly to the conor in accordance will of a promanent adhesive. The labels boldly indicate fill level of shree-quarter capacity. While no standards exist for overfill detection, ECRI Overfill Warning criteria specifies that contents be viewed to determine fill level. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels.
The Demis Two Gallon Sharps Container is designed for use in areas with controlled access. According to ECRI Inlet and Closure Characteristics criteria, the inlet should accept sharps safely and easily with one-handed operation. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling.
ECRI Freestanding Capability criteria specifies that the container should be stable in it's unright position when tipped to 20 degrees, and when in the temporary closed position, contents should not spill out when toppled. Testing done on the Bemis Two Gallon Sharps Container at a topple angle of greater than 20 degrees, showed the container retaining its solid contents.
No standards exist for impact resistance of sharps containers. The proposed Canadian Standard CAN/CSA - Z316.6 on Impact Resistance states that containers, when in the final closure position and dropped from a distance of 24 inches, remain intact (lid remains on container) and sharps do not escape. Bemis Two Gallon Sharps Containers passed this test.
There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the necdle is inserted into the slotted opening and slid to the left or right until firmly seated. It is then turned counter-clockwise to unscrew the needle from the tube holder.
Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Baxter Two Gallon Sharps Container
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510K SUMMARY K965248
| Submitter's Name: | Bemis Manufacturing Company |
|---|---|
| Address: | 300 Mill Street |
| Sheboygan Falls, WI 53085 | |
| Telephone: | 414-467-4621 ext. 2273 |
| Contact Person: | John B. Howell |
| Date Submitted: | November 26, 1996 |
| Revised January 17, 1997 | |
| Name of Device | |
| Common Name: | Sharps Disposal Container |
| Tradename: | Bemis Two Gallon Sharps Container |
| Classification Name: | Sharps Disposal Container |
| Predicate Device: | Baxter Two Gallon Sharps Container |
Description of the Device
The Demis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure.
The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"II x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable.
Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". ASTM proposed standard for puncture resistance states "...the average puncture force for the sharps contact areas of each region of nominal uniform thickness of the container shall not be less than 3,4 1b./ft. with no one value less than 2.8 lb./ft." according to ECRI Puncture Resistance criteria. Testing was done on the Bemis Two Gallon Sharps Containers using this standard. All wall thicknesses of .050" will pass the puncture tests, however, Bemis will reject any parts with wall thicknesses less than .055".
The containers are leakproof on the sides and bottom. According to ECRI Health Devices Leak Resistance criteria "...there shall be no leakage of the contents over a 24 hour period when filled with water and positioned in an upright position." The Bemis Two Gallon Sharps Containers passed this requirement when tested using this method.
1
The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSIIA regulations. The labels are attached directly to the conor in accordance will of a promanent adhesive. The labels boldly indicate fill level of shree-quarter capacity. While no standards exist for overfill detection, ECRI Overfill Warning criteria specifies that contents be viewed to determine fill level. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels.
The Demis Two Gallon Sharps Container is designed for use in areas with controlled access. According to ECRI Inlet and Closure Characteristics criteria, the inlet should accept sharps safely and easily with one-handed operation. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling.
ECRI Freestanding Capability criteria specifies that the container should be stable in it's unright position when tipped to 20 degrees, and when in the temporary closed position, contents should not spill out when toppled. Testing done on the Bemis Two Gallon Sharps Container at a topple angle of greater than 20 degrees, showed the container retaining its solid contents.
No standards exist for impact resistance of sharps containers. The proposed Canadian Standard CAN/CSA - Z316.6 on Impact Resistance states that containers, when in the final closure position and dropped from a distance of 24 inches, remain intact (lid remains on container) and sharps do not escape. Bemis Two Gallon Sharps Containers passed this test.
There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the necdle is inserted into the slotted opening and slid to the left or right until firmly seated. It is then turned counter-clockwise to unscrew the needle from the tube holder.
Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.