M500-100 SHARPS CONTAINER

K980003 · Imagination Medical, Inc. · FMI · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K980003
• Device Name: M500-100 SHARPS CONTAINER
• Applicant: Imagination Medical, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.

Device Story

M500-100 Sharps Container; polyethylene plastic construction; molded without side or bottom seams; includes locking polyethylene lid. Designed for disposal of up to 30 syringes (1-5cc) placed vertically, sharp-side down; accommodates other sharps via top opening. Used in medical clinics by trained personnel. Features flat bottom for table stability; compatible with wall brackets. Includes black fill-line indicator to prevent overfilling. Locking lid prevents leakage and loss of contents. Benefits include safe containment of hazardous sharps, reducing risk of accidental injury.

Clinical Evidence

Bench testing only. Testing conducted per American and British standards. Evaluations included leak testing (filled with water) and drop testing (3-foot drop onto hard floor while filled with syringes). Results showed no leakage, no lid opening, and no protrusion of contents.

Technological Characteristics

Polyethylene plastic construction; molded seamless design; locking polyethylene lid; flat-bottom form factor; wall-bracket compatible; manual operation; no energy source; no software.

Indications for Use

Indicated for the safe disposal of hazardous sharps, specifically syringes sized 1 to 5 cc (up to 30 count), for use by trained medical personnel in clinical settings.

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

• B.D. Home Sharps Container (K943575)
• Sage Sharps Phiebotomy Confiner (# 8900MW)

Submission Summary (Full Text)

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K980003

MAR 1 3 1998

## 510(k) Summary

| Company: | Imagination Medical Inc.<br>12855 Phillips Highway<br>Jacksonville, Fl. 32256<br>[phone] |
|-----------------|-------------------------------------------------------------------------------------------------|
| Contact: | Mr. Tim Weist |
| Device Name: | M500-100 Sharps Container |
| Common Name: | 1 QT Sharps Container |
| Classification: | 21 CFR 880 Type II |

The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.

The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.

The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.

There is a black line on this container to notify the user not to overfill .

Predicate Devices:

- B.D. Home Sharps Container K943575 1
- 2 Sage Sharps Phiebotomy Confiner # 8900MW

Conclusions of Testing:

In all rest, the M500-100 sharps container met or exceeded the criteria set as pass. These test were conducted using the quidelines of the American Standards for Testing and the British Standards of Testing. This container when filled with water and allowed to stand

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showed no signs of leaksge from the container. With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom. Since syringes are placed into this container sharp side down always in a vertical position, it is unlikely that a sharp could of would protrude through the top.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Mr. Tim Weist Director of Safety and Compliance Imaqination Medical Incorporated 12855 Phillips Highway 32256 Jacksonville, Florida

K980003 Re: M500-100 Sharps Container Trade Name: Regulatory Class: II Product Code: FMI February 17, 1998 Dated: February 17, 1998 Received:

Dear Mr. Weist:

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 The general controls provisions of the Act 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 requlations 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 Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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. Weist

through 542 of the Act for devices under the Electronic enroagn Siz Or on 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 asboring 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 [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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510(k) NUMBER (IF KNOWN): K980003

_M500-100 Sharps Container DEVICE NAME:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental Infection Control

Division of Dental Infection Control, and General Hospital Devices

510(k) Number K980003

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use
(Optional Format 1-2-96)