BEMIS TWO GALLON CHEMOTHERAPY CONTAINER

K964858 · Bemis Mfg. Co. · MMK · Feb 11, 1997 · General Hospital

Device Facts

• Record ID: K964858
• Device Name: BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
• Applicant: Bemis Mfg. Co.
• Product Code: MMK · General Hospital
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended 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 areas with controlled access which typically include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.

Device Story

Bemis Two Gallon Chemotherapy Container is a single-use, puncture-resistant, leakproof receptacle for chemotherapy waste; designed for controlled access areas like nurse's stations and oncology rooms. Device consists of injection-molded polypropylene container with gasketed lid and screw-on cap. Features translucent walls for visual fill-level monitoring; labeled with OSHA-compliant biohazard warnings. Operates as a passive collection vessel; no mechanical needle-shearing features. Can be used freestanding or secured via wall-mounted bracket with unique key lock. Provides safe containment of sharps and chemotherapy-related waste; prevents spills during handling and toppling. Benefits healthcare staff by providing a secure, stable, and visible disposal method for hazardous medical waste.

Clinical Evidence

Bench testing only. No clinical data. Testing included puncture resistance per ECRI criteria (minimum 3/4 lb./ft.), leak resistance per ECRI criteria (no leakage over 24 hours), and impact resistance per CAN/CSA-Z316.6 (remained intact after 24-inch drop).

Technological Characteristics

Injection-molded polypropylene plastic; translucent white. Dimensions: 8.5"H x 11.5"W x 7.6"D; volume: 6 qt. Wall thickness: minimum 0.055". Features gasketed lid and screw-on cap. Puncture resistance tested per ECRI criteria; leak resistance tested per ECRI criteria; impact resistance tested per CAN/CSA-Z316.6. Standalone or wall-mounted with bracket.

Indications for Use

Indicated for the safe disposal of needles, syringes, and other chemotherapy waste in controlled access clinical environments such as nurse's stations, oncology units, pharmacies, and chemotherapy treatment rooms.

Regulatory Classification

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.

Predicate Devices

• Baxter Two Gallon Chemotherapy Container

Submission Summary (Full Text)

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JAN-24-97 FRI 10:21 AM BEMIS MFG./PLANT N FAX NO. 414 467 0868 P. 3
FEB 11 1997
510K SUMMARY K964858

Submitter's Name: Bemis Manufacturing Company
Address: 300 Mill Street
Sheboygan Falls, WI 53085
Telephone: [phone]
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
Classification Name: Sharps Disposal Container
510(k) Number: K964858

Predicate Device: Baxter Two Gallon Chemotherapy Container

Description of the Device

The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with
controlled access such as nurse's stations, pharmacies, and chemo treatment rooms. They
feature a gasketed lid and screw-on plastic cap.

The Bemis Two Gallon Chemotherapy Containers have a volume of 6 qt. and weigh 1 lb.
2 oz. with dimensions of 8.5"H x 11.5"W x 7.6"D. Two Gallon Chemotherapy
Containers are injection molded of polypropylene plastic and are available in translucent
white. These containers are NOT reusable.

Bemis Two Gallon Chemotherapy 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 lb./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 Chemo 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. The lids are gasketed to guard
against spills. 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.

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JAN-24-97 FRI 10:22 AM BEMIS MFG./PLANT N FAX NO. 414 467 0868 P. 4

The Two Gallon Chemotherapy Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The labels boldly indicate fill level of three-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 Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level.

The Bemis Two Gallon Chemotherapy 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 related to chemotherapy waste. Following final closure, the container remains closed during normal handling.

ECRI Freestanding Capability criteria specifies that the container should be stable in it's upright position when tipped to 20 degrees, and when in the closed position, contents should not spill out when toppled. Testing done on the Bemis Two Gallon Chemo 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 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 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. John B. Howell
General Counsel
Bemis Manufacturing Company
300 Mill Street
P.O. Box 901
Sheboygan Falls, Wisconsin 53085-0901

FEB 11 1997

Re: K964858
Trade Name: Bemis Two Gallon Chemotherapy Container
Regulatory Class: II
Product Code: FMI
Dated: November 26, 1996
Received: December 4, 1996

Dear Mr. Howell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K964858

Device Name: Bemis Two Gallon Chemotherapy Container

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 areas with controlled access which typically include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Chris S. Lam
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K 964858

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)