(69 days)
Baxter Two Gallon Chemotherapy Container
Not Found
Based on the provided text, there is no indication that the Bemis Two Gallon Chemotherapy Container contains an AI model.
The document describes a physical sharps disposal container with features related to its construction, safety, and intended use. It mentions materials, dimensions, labeling, stability, and testing for puncture resistance, leakproofness, and impact resistance.
There are no mentions of AI, machine learning, deep neural networks, image processing, or any other terms typically associated with AI models. The device's function is purely mechanical and passive.
No
This device is a container for the safe disposal of chemotherapy waste and sharps, not a device used for therapy or treatment of a disease or condition.
No
The device is a sharps disposal container for chemotherapy waste, and its intended use is for safe disposal, not for diagnosing medical conditions.
No
The device description clearly details a physical container made of polypropylene plastic with specific dimensions, weight, and features like a gasketed lid and screw-on cap. It also describes physical testing for puncture resistance, leakproofness, toppling, and impact resistance. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the safe disposal of chemotherapy waste, specifically sharps like needles and syringes. This is a waste management function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the container (material, size, puncture resistance, leakproofness, labeling) and its function as a disposal unit. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of Diagnostic Elements: The document does not describe any process for analyzing a sample, detecting a substance, or providing information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function. It is a container for disposing of medical waste.
N/A
Intended Use / Indications for Use
The Bemis Two Gallon Chemotherapy Container is a sharps disposal container. It is intended for the safe disposal of needles, syringes, and other chemotherapy waste in clinical areas which, for example, include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.
Product codes
FMI
Device Description
The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with I the Isemis Two Gallon Chemonerapy Commacies, and chemo treatment rooms. They feature a gasketed lid and screw-on plastic cap.
The Temis Two Gallon Chemotherapy Containers bave a volume of 6 qt. and weigh 1 lb. The neinis I wo Gallon Chemos.crc.pp of the Sallon Chemotherapy 2 07. Will officers are injections of polypropylene plastic and are available in translucent white. These containers are NOT reusable.
Remis Two Gallon Chemotherapy Containers are puncture resistant with integral Isemis I wo Gallon Chellouncilly of Childreness 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 containers shall not be contact areas of each region of samanan 2.8 lb./ft." according to ECRI Puncture icss than 374 10.71. Will no one variable on the Bemis Two Gallon Chemo Containers using Kesistance chieria. Testing was done on the Duncture tests, however, Bemis will reject any parts with wall thicknesses less than .055".
The containers are leakproof on the sides and bottom. The lids are gasketed to guard I he containers are teasproof on the sacs are sessionce criteria "... there shall against spills. According to 24 hour period when filled with water and positioned oe no leakage of the contents over a Ever a Ever Section Sharps Containers passed this requirement when tested using this method.
The Two Gallon Chemotherapy Containers are labeled with the Biohazard warning The Two Gellon Chemotherspy Containers and relov, with dre Bovy, with lettering and symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol that is 1½" in helght. The laber one is one us of SSA regulations. The labels are symbol in contrasting color in accordance was one one one of any and esseen admissive. The labels attached directly to the surface of the container by a permanders exist for alleched directly to the sufface of the consiness of a pointents exist for overfill boldly indicate fill level of three-quarer capacity. While no standards exist for overfil boldly indicate fill level of thee-quarter capacity. which the some of the many and detection, FCRI OverJill Warning Chiefia specifics that continent white, therefore, fill level. Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level.
The Benis Two Gallon Chemotherapy Container is designed for use in areas with The Benis Two Gallon Chemonetapy Colnama Closure Charcoteristics criteria, the interio controlled access. According to rich mith one-handed operation. There is no limitation should access for this containct as the opening is designed to accept other objects related to hand access for this containcr as are opening is conginer remains closed during normal handling.
FCRI Freestanding Capability criteria specifies that the container should be stable in it's FCRT Freestanding Capability Cities specifical when in the closed position, contents unright position when topped to 20 Tegrees, and on the Bemis Two Gallon Chemon should not spill out when toppled. Testing done on the Boured the container retaining its solid contents.
No standards exist for impact resistance of sharps containers. The proposed Conndiners, when in the No standards exist for impact resistance states that containers, when in the Sinniard CAN/CSA - Z310.6 on Impact Resistance of 24 inches, remain intest (Lid final closure position and dropped from a discuss of Drimation Chemo Containers passed this test.
There are no features to bend, break, or shear the needle.
Two Gallon Chemotherapy Containers can be used freestanding or locked on wall Two Gallon Chemotherspy Conamens can be assessed as unlock containers from mounted brackets. A key that is unique to uns ordest to essues 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
nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.
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)
Baxter Two Gallon Chemotherapy Container
Reference Device(s)
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
FEB 11 1997
K964858 510K SUMMARY
| Submitter's Name: | Bemis Manufacturing Company |
|---|---|
| Address: | 300 Mill Street |
| Sheboygan Falls, WI 53085 | |
| Telephone: | 414-467-4621 |
| 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 Chemotherapy Container |
Sharps Disposal Container Classification Name: K964858 510(k) Number:
Baxter Two Gallon Chemotherapy Container Predicate Device:
Description of the Device
The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with I the Isemis Two Gallon Chemonerapy Commacies, and chemo treatment rooms. They feature a gasketed lid and screw-on plastic cap.
The Temis Two Gallon Chemotherapy Containers bave a volume of 6 qt. and weigh 1 lb. The neinis I wo Gallon Chemos.crc.pp of the Sallon Chemotherapy 2 07. Will officers are injections of polypropylene plastic and are available in translucent white. These containers are NOT reusable.
Remis Two Gallon Chemotherapy Containers are puncture resistant with integral Isemis I wo Gallon Chellouncilly of Childreness 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 containers shall not be contact areas of each region of nominal saman 2.8 lb./ft." according to ECRI Puncture icss than 374 10.71. Will no one variable on the Bemis Two Gallon Chemo Containers using Kesistance chieria. Testing was done on the Duncture tests, however, Bemis will reject any parts with wall thicknesses less than .055".
The containers are leakproof on the sides and bottom. The lids are gasketed to guard I he containers are teasproof on the sacs are sessionce criteria "... there shall against spills. According to 24 hour period when filled with water and positioned oe no leakage of the contents over a Ever a Ever Section Sharps Containers passed this requirement when tested using this method.
1
The Two Gallon Chemotherapy Containers are labeled with the Biohazard warning The Two Gellon Chemotherspy Containers and relov, with dre Bovy, with lettering and
symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol that is 1½" in helght. The laber one is one us of SSA regulations. The labels are symbol in contrasting color in accordance was one one one of any and esseen admissive. The labels
attached directly to the surface of the container by a permanders exist for alleched directly to the sufface of the consiness of a pointents exist for overfill
boldly indicate fill level of three-quarer capacity. While no standards exist for overfil boldly indicate fill level of thee-quarter capacity. which the some of the many and detection, FCRI OverJill Warning Chiefia specifics that continent white, therefore,
fill level. Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level.
The Benis Two Gallon Chemotherapy Container is designed for use in areas with The Benis Two Gallon Chemonetapy Colnama Closure Charcoteristics criteria, the interio controlled access. According to rich mith one-handed operation. There is no limitation should access for this containct as the opening is designed to accept other objects related
to hand access for this containct as the opening is designed to sed during to hand access for this container as are opening is conginer remains closed during normal handling.
FCRI Freestanding Capability criteria specifies that the container should be stable in it's FCRT Freestanding Capability Cities specifical when in the closed position, contents unright position when topped to 20 Tegrees, and on the Bemis Two Gallon Chemon should not spill out when toppled. Testing done on the Boured the container retaining its solid contents.
No standards exist for impact resistance of sharps containers. The proposed Conndiners, when in the No standards exist for impact resistance states that containers, when in the Sinniard CAN/CSA - Z310.6 on Impact Resistance of 24 inches, remain intest (Lid final closure position and dropped from a discuss of Drimation Chemo Containers passed this test.
There are no features to bend, break, or shear the needle.
Two Gallon Chemotherapy Containers can be used freestanding or locked on wall Two Gallon Chemotherspy Conamens can be assessed as unlock containers from mounted brackets. A key that is unique to uns ordest to essues and require assembly by the user. Instructions are included in every case.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HL. 'AN SERVICES-USA".
FEB 11 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John B. Howell General Counsel General Manufacturing Company . ............ 300 Mill Street " P.O. Box 901 P.O. Box 901
Sheboygan Falls, Wisconsin 53085-0901
K964858 Re : Bemis Two Gallon Chemotherapy Container Trade Name : Regulatory Class: II Product Code: FMI November 26, 1996 Dated: December 4, 1996 Received:
Dear Mr. Howell:
We have reviewed your Section 510(k) notification of intent to We have reviewed your secced above and we have determined the market the device ference above (for the indications for device is subscancially called (ces marketed in interstate use stated in the encrosule, or che enactment date of the Commerce prior to May 20, or to devices that have been Medical Device Amendments, circe be provisions of the Pederal Food, Drug, and Cosmetic Act (Act). You may, therefore, Food, Drug, and Coametic nee (ibe, general controls provisions The general controls provisions of the Act of the Act. of the Act. Inc. Inc. annual registration, listing of Incides, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back in your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with She Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (SMP) regaracions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP verrif on may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Mr. Howell
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally ... ...... marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices) , please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification® (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
A. Timot Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
...
Device Name: Beinis Two Gallon Chemotherapy Container
Indications for Use:
SAMBAND STATES AND ASSESS
The Bemis Two Gallon Chemotherapy Container is a sharps disposal container. It is intended for the safe disposal of needles, syringes, and other chemotherapy waste in Intended for the sate disposal of neceies, 577.1555, include nurse's stations, oncology, pharmacies, and chemotherapy treament rooms.
(PI.EASE DO NOT WRITE BP.LOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
(Division Sign-Off) Division of Dental, In and General Hos 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)