SHARPTRACK REUSABLE SHARPS CONTAINER

K981184 · Bfi- Medical Waste Systems · FMI · Jun 22, 1998 · General Hospital

Device Facts

• Record ID: K981184
• Device Name: SHARPTRACK REUSABLE SHARPS CONTAINER
• Applicant: Bfi- Medical Waste Systems
• Product Code: FMI · General Hospital
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Used within health care settings (i.e., medical, dental, veterinarian, or other health care facility) for the collection of used disposable sharps. Containers are supplied to the health care facilities by BFI representatives. Containers are used by health care providers at the point of disposal where potentially infectious sharps' waste is generated.

Device Story

SharpTrack™ Reusable Sharps Container; designed for collection/containment of used disposable sharps in healthcare settings (medical, dental, veterinary). Device placed at point-of-care for immediate disposal of potentially infectious sharps. System involves BFI representatives supplying containers to facilities. Serves as physical containment vessel to mitigate sharps injury risk and manage infectious waste. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable sharps container for infectious waste. Physical containment vessel. No electronic, software, or energy-based components. Materials and construction specifications not detailed in provided text.

Indications for Use

Indicated for use in medical, dental, veterinary, or other healthcare facilities for the collection of used disposable sharps by healthcare providers 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of what appears to be an abstract caduceus, a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1998

BFI Waste Systems of North America, Incorporated ·C/O Mr. A. Wes Siegner Law Offices of Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005

Re : K981184 SharpTrack™ Reusable Sharps Container Trade Name: Requlatory Class: II Product Code: FMI Dated: April 1, 1998 Received: April 1, 1998

Dear Mr. Siegner:

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, Druq, 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 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 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 requlation 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

{1}------------------------------------------------

Page 2 - Mr. Siegner

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 described in your sie in privalence 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 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

{2}------------------------------------------------

510(k) Number (if known): K981184

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

- Used within health care settings (i.e., medical, dental, -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------veterinarian, or other health care facility) for the collection of used disposable sharps.
- Containers are supplied to the health care facilities by BFI -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------representatives.
- Containers are used by health care providers at the point of -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------disposal where potentially infectious sharps' waste is generated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chân Sơn

(Division Sign-Off) Division of Dontal, Infection Control, and General Hospital Devices

510(k) Number K981184

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)