DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER

K983750 · Deroyal Industries, Inc. · FMI · Nov 30, 1998 · General Hospital

Device Facts

• Record ID: K983750
• Device Name: DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
• Applicant: Deroyal Industries, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

The DeRoyal Industries, Inc. TraceCart Sharps Collection Container is intended for use during the generation of medical waste by providing a means of containment prior to disposal of contaminated medical waste and sharps used in various types of medical settings.

Device Story

The TraceCart Sharps Collection Container is a passive containment system for medical waste and sharps (syringes, needles, laparoscopic devices). Constructed from high-density polyethylene (HDPE) with an opaque polypropylene lid, the device provides a puncture-resistant and leak-resistant vessel for waste disposal. It is used in various healthcare settings by clinical staff to safely store contaminated items prior to final disposal. The device does not perform active processing; it serves as a physical barrier to prevent accidental injury during waste management. It is available in 15, 30, and 40-gallon capacities.

Clinical Evidence

Bench testing only. The device was validated through performance testing including impact resistance, puncture resistance, overfill detection, leak resistance, stack testing, stability, volume capacity, and wall material thickness measurements.

Technological Characteristics

Materials: High-density polyethylene (HDPE) container, opaque polypropylene lid. Form factor: 15, 30, and 40-gallon capacities. Features: Puncture-resistant, leak-resistant, non-sterile. No energy source or software components.

Indications for Use

Indicated for use by medical waste generators in healthcare settings, including hospitals and doctors' offices, for the safe collection and containment of contaminated medical waste and sharps.

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 Sage Products
• Devon Industries

Submission Summary (Full Text)

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NOV 30 1998

## DeRoyal Industries, Inc. TRACECART SHARPS COLLECTION CONTAINER

**Revised 510(k) Summary** K98375

# SUMMARY OF THE SAFETY AND EFFECTIVENESS IN UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

## SUBMITTER INFORMATION

DeRoyal Industries, Inc. NAME: 200 DeBusk Lane ADDRESS: Powell, TN 37849

TELEPHONE: CONTACT: DATE OF PREPARATION: [phone] Camille Matlock November 16, 1998

## DEVICE NAMES

| NAME: | DeRoyal Industries, Inc. TraceCart Sharps Collection Container |
|---------------------------------|----------------------------------------------------------------|
| COMMON/USUAL NAME: | Sharps Collection and Disposal Systems |
| CLASSIFICATION NAME (if known): | Accessory: Hypodermic Single Lumen Needle |

#### PREDICATE OR LEGALLY MARKETED DEVICES

Baxter Sage Products Devon Industries

## DEVICE DESCRIPTION

The DeRoyal Industries, Inc. TraceCart Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices to provide the safe collection and containment of various types of contaminated waste and sharps such as syringes, needles, and laparoscopic devices.

Device Design/Materials UsedPhysical Progetties: The proposed device is comprised of high-density polyethylene (HDPE). The lid is comprised of opaque polypropylenc. The DeRoyal TraceCart Sharps Collection Container passed the following test methods: impact resistance, puncture resistance, overfill detection, leak resistance, stack test, stability, volume capacity, and wall material thickness.

#### DEVICE INTENDED USE

The DeRoyal Industries, Inc. TraceCart Sharps Collection Container is intended for use during the generation of medical waste by providing a means of containment prior to disposal of contaminated medical waste and sharps used in various types of medical settings.

| Characteristic | DeRoyal Device | Other Devices |
|----------------------|---------------------------------------------------------------------------------|---------------|
| Material Description | Container: High-density polyethylene<br>(HDPE)<br>Lid: Opaque polypropylene lid | Similar |
| Sizes | 15 gallon, 30 gallon, and 40 gallon | Yes |
| Puncture Resistant | Yes | Yes |
| Leak Resistant | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Ms. Camille Matlock Regulatory Affairs DeRoy Industries, Incorporated 200 DeBusk Lane 37849 Powell, Tennessee

Re : K983750 DeRoyal Industries, Incorporated TraceCart Trade Name: Sharps Collection Container Requlatory Class: II Product Code: FMI Dated: October 22, 1998 Received: October 23, 1998

Dear Ms. Matlock:

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 legally marketed predicate 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. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 - Ms. Matlock

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 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" (21CFR 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/dsma/dsmamaip.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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K983750

510(k) Number (if known):

Device Name:

DeRoyal Industries Inc. TraceCart Sharps Collection Container

#### Indications for Use:

The DeRoyal Industries Inc. TraceCart Sharps Collection Container is to be used by generators of medical waste in any health care setting where the safe collection and disposal of contaminated waste and medical sharps is required, such as in hospitals, doctors' offices, and other health care settings.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qim S. Lim

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

Over-The-Counter Use

Prescription Use (Per 21 CFR § 801.109) OR