SURE-WAY REUSABLE SHARPS CONTAINER

K992626 · Sure-Way Systems, Inc. · FMI · Dec 16, 1999 · General Hospital

Device Facts

• Record ID: K992626
• Device Name: SURE-WAY REUSABLE SHARPS CONTAINER
• Applicant: Sure-Way Systems, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Sure-Way Reusable Container is intended to be used for the disposal of contaminated medical sharps in health care facilities.

Device Story

Sure-Way Reusable Sharps Container is a receptacle designed for the collection and disposal of contaminated medical sharps within healthcare facilities. The device provides a secure, puncture-resistant enclosure to prevent accidental needle sticks or sharps injuries during disposal processes. It is intended for use by healthcare personnel in clinical settings. The container is reusable, requiring appropriate decontamination protocols between uses. By safely containing hazardous sharps, the device minimizes the risk of bloodborne pathogen exposure to staff and patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable sharps container for medical waste. Puncture-resistant construction. Designed for healthcare facility environment.

Indications for Use

Indicated for the disposal of contaminated medical sharps in health care facilities.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1999

Mr. Gary Chilcott, President Sure-Way Systems, Incorporated 310 East Harry Bridges Boulevard Wilmington, California 90744

K992626 Re : Sure-Way Reusable Sharps Container Trade Name: Requlatory Class: II Product Code: FMI Dated: October 7, 1999 Received: October 25, 1999

## Dear Mr. Chilcott:

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 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Chilcott

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq of substantial equivalence of your device to a leqally 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,

Susan Runner

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 Statement Revised 11/10/99 ම අඩි පිටිමේ නිල . අමාත්‍ය ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..

Verl 3 - 4/24/96

Applicant: Sure-Way Systems, Inc.

510(k) Number (if known): _K992626

Device Name: Sharps Container

Indications For Use:

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The Sure-Way Reusable Container is intended to be used for the disposal of contaminated medical sharps in health care facilities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Qhin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 儿 i umber