(38 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and containment capabilities of a sharps collection container, with no mention of AI or ML.
No
The device is a sharps collection container, designed for the safe disposal of medical waste and sharps, not for treating a disease or condition.
No
The device is a sharps collection container, designed for the safe disposal of contaminated waste and medical sharps, not for diagnosing medical conditions.
No
The device description explicitly states the device is comprised of physical materials (high-density polyethylene and polypropylene) and passed physical performance tests, indicating it is a hardware device.
Based on the provided information, the DeRoyal Industries Inc. TraceCart Sharps Collection Container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the safe collection and disposal of contaminated waste and medical sharps. This is a containment and safety function, not a diagnostic one.
- Device Description: The device is described as an accessory to a hypodermic needle for collecting and containing waste and sharps. It doesn't perform any tests on biological samples.
- Performance Studies: The performance studies listed focus on physical properties like impact resistance, puncture resistance, and leak resistance. These are relevant to the container's function as a safe disposal unit, not to diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. The TraceCart Sharps Collection Container does not perform any of these functions.
N/A
Intended Use / 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.
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.
Product codes
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
PAGE છવ
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
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 | |
| (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)
1
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
2
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
3
Page 1 of 1
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.
(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