SHARPS PLUS 5 GALLON SHARPS CONTAINER

K980179 · Rotonics Mfg., Inc. · FMI · Apr 13, 1998 · General Hospital

Device Facts

• Record ID: K980179
• Device Name: SHARPS PLUS 5 GALLON SHARPS CONTAINER
• Applicant: Rotonics Mfg., Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps. Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities. Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.

Device Story

Sharps Plus 5 Gallon Reusable Container is a heavy-duty, rotationally molded linear low-density polyethylene container for collecting contaminated disposable sharps. Used in healthcare facilities at point-of-disposal; features horizontal drop lid opening to reduce needle exposure; includes integrated needle unwinder. Containers are locked within wall safes; keys managed by nursing/housekeeping. Once full, containers are transported to regional treatment facilities, where lids are removed via mechanical arm; containers are emptied, cleaned, and disinfected using automated washers. A 'Reuse Tracking Label' monitors wash cycles; containers discarded after 12 months. Semi-translucent walls allow visual monitoring of waste levels. Device benefits include safe containment of infectious sharps and durability for repeated transport and processing cycles.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included Free Fall Drop (ASTM D5276-94), Stacking (49 CFR 173.465(d)), Penetration (49 CFR 173.465(e)), Vibration (49 CFR 173.608), and Puncture (Health Devices 22).

Technological Characteristics

Rotationally molded linear low-density polyethylene; wall thickness .125"; semi-translucent. Features horizontal drop lid with tongue and groove track; integrated needle unwinder. Complies with OSHA Bloodborne Pathogens Standard. Testing standards: ASTM D5276-94 (Drop), 49 CFR 173.465(d) (Stacking), 49 CFR 173.465(e) (Penetration), 49 CFR 173.608 (Vibration), Health Devices 22 (Puncture).

Indications for Use

Indicated for use in healthcare settings by healthcare providers for the collection of contaminated disposable sharps at the point of disposal.

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

• BioSystem The Sharps I (K980179)

Reference Devices

• Devon Industries
• Sage Products
• Becon Dickinson

Submission Summary (Full Text)

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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center, HFZ-401 1390 Piccard Drive Rockville, MD 20850

Kg80179

APR 1 3 1998

Re: Sharps Plus 5 Gallon Reusable Container Rotonios Manufacturing Bensenville, IL

## 510(k) Summary

The Sharps Plus 5 Gallon Reusable Container is substantially equivalent to the BioSystem The Sharps I result sharps container. The Sharps Plus 5 Gallon Reusable Container meets and exceed the primary design characteristics needed to comply with the OSHA Bloodborne Pathogens Standard as well as the American Society for Testing & Maserials. Data for the following tests have been provided; Free Fall Drop (ASTM DS276-944), Stacking (49 CFR 173.465(d), Penetration (49 CFR 173.465(e), Vibration (49 CFR 173.608, Puncture (Health Devices 22). In each of these tests, the Sharps Plus container passed the test criteria.

The Sharps Plus 5 Gallon Reusable Container has a wall thickness of . 125", approximately twice the thickness of most single use primary sharps containers ( 07" to .05"). The testing data illustrates the highly resilies of linear low-density polyethylene. The container is molded rotationally by building up layers of plastic. Each container is equipped with a needleunwinder. Containers remain locked within the Wall Safe when in use within the healthcare facility. Keys are kept with housekeeping and unit nursing station.

The Sharps Plus 5 Gallon Rousable Container is marketed to medical waste transporters and regional treatment facilities, handling the destruction of infectious waste. The Sharps Plus 5 Gallon Reusable Container is used solely as a primary container when being shipped over the road. It is common for these facilities to have a unique waste dumping/loading configuration. The Sharps Plus 5 Gallon Reusable Contamer is designed to be opened, emptied and cleaned mechanically, as per the OSHA Bloodborne Pathogens Standard. As with the prodicate device the lid is designed to slide on and off the container via a tongue and groove track. A mechanical arm is used to slide the lid off of the container. Regional treatment facilities handling reusable medical waste are required to use automated container washers. Containers are washed to remove gross contamination and disinfected with a low-level disinfectant. A "Reuse Tracking Label" is used to track the number of cycles and the length of time, containers are used in the field. The Tracking Label is marked after each wash out cycle. After 12 months of use the containers are discarded.

The use of a "horizontal drop" lid opening reduces exposure to needles improperly discarded. Needles are less likely to be onented with the needle face up towards the opening. Other products on the market, such as Devon Industries, Sage Products and Becon Dickinson, all feature a horizontal drop lid opening. The containers are manufactured with natural linear lowdensity polyethylene and are semi-translucent. This makes viewing the waste level through the cabinet window easier.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1998

Mr. Ed Krausse Divisional Vice President Rotonics Manufacturing, Incorporated 736 Birginal Drive Bensenville, Illinois 60106

Re : K980179 Sharps Plus Reusable 5 Gallon Sharps Trade Name: Container Requlatory Class: II Product Code: FMI Dated: January 8, 1998 Received: January 20, 1998

Dear Mr. Krausse:

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 Requlations, Title 21, Parts_800 to 895. _ A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Krausse

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA assoirson in postantial 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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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Indications for use:

510(k) Number: 980179

Device Name: Sharps Plus 5 Gallon Reusable Container

The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps.

Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities.

Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.

Qian S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use Or Over the Counter Use