(174 days)
Vacutainer® Needle Disposal Container 367201
Not Found
No
The device description is for a simple, non-electronic container for needle disposal and there are no mentions of AI, ML, or related concepts.
No
The device is a needle disposal container, which is used for the safe disposal of medical sharps to prevent injuries and the spread of infection, not for treating diseases or conditions.
No
The device description clearly states it is a "Needle Disposal Container" and is intended for waste management, not for diagnosing medical conditions. Its function is to safely contain medical waste.
No
The device description clearly states it is a physical container made of plastic, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions based on in vitro examination of specimens.
- Device Description: The description clearly states it's a "Needle Disposal Container," designed for the safe disposal of needles. This is a physical containment device, not a device that performs tests on biological samples.
- Lack of IVD-related information: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting analytes or markers
- Performing diagnostic tests
- Any of the typical performance metrics associated with IVDs (Sensitivity, Specificity, AUC, etc.)
The device's function is purely for the safe handling and disposal of medical waste, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids. The BIO-PLEXUS™ Needle Disposal Container performs the same function as other legally marketed sharps containers, for example, the Vacutainer® Needle Disposal Container 367201. Specifically, this is to receive and accumulate contaminated blood collection needles and accessories in a puncture resistant container until final disposal can occur.
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
healthcare workers in healthcare facilities and in the home healthcare setting
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)
Not Found
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.
Vacutainer® Needle Disposal Container 367201
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
K960933
Bio-Plexus, Inc. 384 Merrow Road Tolland, CT 06084
CONTACT: Carl R. Sahi (President) March 6, 1996 Prepared:
July 9, 1996 Revised:
Proprietary Name: Generic Name: Classification Name:
Class: Panel Code: Product Code: Reason for submission: Bio-Plexus Inc. Registration Number: BIO-PLEXUS™ Needle Disposal Container Sharps Container Accessory to Blood Collection Needles, Winged Sets and Catheters of Appropriate Size II 80 FMI new device 1224632
The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids. The BIO-PLEXUS™ Needle Disposal Container performs the same function as other legally marketed sharps containers, for example, the Vacutainer® Needle Disposal Container 367201. Specifically, this is to receive and accumulate contaminated blood collection needles and accessories in a puncture resistant container until final disposal can occur. The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories.