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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the DeRoyal Industries, Inc. TRACECART SHARPS COLLECTION CONTAINER, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device. 510(k)s evaluate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through clinical trials with strict acceptance criteria and ground truth. Therefore, many of the requested data points (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not typically applicable or provided in a 510(k) submission like this. Instead, the emphasis is on demonstrating that the new device performs as safely and effectively as existing, legally marketed devices.

However, we can extract the acceptance criteria and the type of study conducted to show that these criteria were met, which are primarily engineering and performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Method)	Reported Device Performance
Impact resistance	Passed
Puncture resistance	Passed
Overfill detection	Passed
Leak resistance	Passed
Stack test	Passed
Stability	Passed
Volume capacity	Passed
Wall material thickness	Passed

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for each test. It simply states that the "DeRoyal TraceCart Sharps Collection Container passed the following test methods." For engineering tests like these, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but are not usually detailed in a 510(k) summary.
Data Provenance: Not explicitly stated, but these types of tests are typically conducted prospectively by the manufacturer (DeRoyal Industries, Inc.) in their own testing facilities or by accredited laboratories, following specified test protocols. The country of origin of the data would likely be the USA, where DeRoyal Industries is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable / Not specified. For engineering performance tests of a sharps container (e.g., measuring puncture resistance, leak resistance), "experts" in the sense of medical professionals establishing a ground truth are not relevant. The ground truth is established by objective physical measurements and adherence to engineering specifications for materials and design. The "experts" would be the engineers or technicians performing the tests, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple expert readers in interpreting complex data (e.g., medical images). For objective engineering tests, the outcome is typically a pass/fail based on predetermined thresholds, so no human adjudication is needed to establish "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is typically performed for diagnostic or AI-assisted devices to assess the impact of the device on human reader performance. A sharps collection container is a physical containment device, not a diagnostic tool, so an MRMC study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This concept pertains to artificial intelligence algorithms operating independently. The DeRoyal TraceCart Sharps Collection Container is a physical medical device; thus, standalone algorithm performance is not relevant. The device's standalone performance is effectively demonstrated by the engineering tests described.

7. The Type of Ground Truth Used

The ground truth for these tests is based on objective engineering standards and physical properties. For example:
- Puncture resistance: Ground truth is the material's ability to resist penetration by a defined force from a sharp object (e.g., a needle), as measured against industry standards.
- Leak resistance: Ground truth is the container's ability to hold liquids without leakage under specified conditions.
- Wall material thickness: Ground truth is a direct physical measurement.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an artificial intelligence or machine learning model. This device is a physical container, not an AI system. Its design and material selection would be based on engineering principles and material science, not a "training set" of data in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As established in point 8, there is no "training set" for this device in the context of AI/ML. The "ground truth" for its design and manufacturing would be established through material specifications, engineering drawings, and quality control standards.

Summary

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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: (423) 938-7828 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

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(HDPE)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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1

K983750

510(k) Number (if known):

Device Name:

DeRoyal Industries Inc. TraceCart Sharps Collection Container

Indications for Use:

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

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

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).