(241 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical design of a sharps container, with no mention of AI or ML.
No
The device is described as a "Sharps Safe" designed for the disposal of contaminated needles, and its function is to prevent needle penetration and contain sharps waste. It does not provide any treatment or therapy to a patient.
No
Explanation: The device is described as a "Sharps Safe" designed for the disposal of contaminated needles. Its function is to provide a safe container for sharps, not to diagnose any medical condition or disease. The performance studies focus on physical integrity (impact resistance, puncture resistance, etc.), not diagnostic accuracy.
No
The device description clearly outlines a physical product made of plastic tubes, caps, and a vinyl cover, with performance studies focused on mechanical properties like impact and puncture resistance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the disposal of contaminated needles by paramedics or home care providers in remote locations. This is a physical containment and disposal function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is a container designed for the safe disposal of sharps. It does not involve any reagents, assays, or procedures for analyzing biological specimens.
- Performance Studies: The performance studies focus on the physical properties of the container (impact resistance, puncture resistance, leakproofness, etc.), which are relevant to its function as a sharps disposal unit, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the device described is a medical device for sharps disposal, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.
Product codes (comma separated list FDA assigned to the subject device)
80MMK 880.5570
Device Description
The device is comprised of a 1.5 inch diameter plastic tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Securely attached to each end is a plastic cap. Secured inside the cap attached to the bottom end is a hard plastic disc designed to prevent needle penetration. The cap on the top end has a ¼ inch hole in the center. Radiating from the hole are slits cut in the plastic which form flaps through which a sharps can be inserted. A vinyl cover is provided for the top to provide a moisture tight seal.
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
Paramedics or Home Care Providers / remote locations
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)
Non Clinical Tests:
- Impact Resistance: No needle ejection when dropped from eight (8) feet onto concrete. No damage to container.
- Puncture Resistance: 1.5 - 5.12 lb. average for sides. 6.56 lb. average for bottom. 2.0 - 5.80 lb average for sides. 6.99 lb. average for bottom.
- Wall Thickness: l.5 - .072 inches average for sides. .1174 inches average for bottom. 2.0 -.078 inches average for sides. .1125 inches average for bottom.
- Sharps Closure - Pull Test - 45 lb. for 24 hours.
- Capacity: 1.5 - 15.8 cu. in./6.75 oz. 2.0 - 28.2 cu. in./12.30 oz.
- Leakproof Test: The bottom is leakproof. The top is also leakproof when the vinyl cover is in place.
- Disposal: Sharps Safes contain no heavy metals and can be incinerated.
- Attachment Strap Test: A Sharps Safe will support 45 pounds when secured to a surface by the attachment straps.
Clinical Tests: Not required.
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.
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
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
Image /page/0/Picture/0 description: The image shows a logo for "DURA-VAC" with a caduceus symbol to the left of the text. Below the text is a drawing of a medical equipment case. The address "4464 McGrath STREET" is to the right of the case. The logo appears to be for a medical equipment or supply company.
4464 McGRATH STREET #114 • VENTURA, CA 93003 • (805) 658-7768
AUG - 1 1996
REVISION OF 510K SUMMARY (as required by 807.92 (c)) May 20, 1996
Submitted by: Neal Shults (owner) 4464 McGrath Street #114 Ventura, CA 93003 (805) 658-7768 (805) 658-8353 (FAX) November 27, 1995
Trade name - Sharps Safe 1.5 Sharps Safe 2.0 Common name - Sharps Container Classification name - Sharps Container 80MMK 880.5570
Equivalent device being legally marketed: Trade name - Sharps A Gator Manufactured by: Devon Industries, Inc. 510K Approval Number: K943892
Description :
The device is comprised of a 1.5 inch diameter plastic tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Securely attached to each end is a plastic cap. Secured inside the cap attached to the bottom end is a hard plastic disc designed to prevent needle penetration. The cap on the top end has a ¼ inch hole in the center. Radiating from the hole are slits cut in the plastic which form flaps through which a sharps can be inserted. A vinyl cover is provided for the top to provide a moisture tight seal.
Intended Use :
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.
Technological Characteristics:
Predicate devices which we surveyed all had some They were either too large, too small, shortcomings. wouldn't contain the sharps if mishandled, blood could leak out,would shatter if struck, couldn't be attached to the outside of a drug box, or the contents couldn't be seen.
All of these failings were addressed when designing the Sharps Safe and eliminated.
1
Image /page/1/Picture/1 description: The image shows the logo for DURA-VAC, which includes a caduceus symbol, the text "DURA-VAC" in bold font, and a line drawing of a rectangular device. Below the logo is the address "4464 McGrath STREET". The logo appears to be for a medical or healthcare-related product or service, given the presence of the caduceus symbol.
4464 McGRATH STREET #114 • VENTURA, CA 93003 • (805) 658-7768
Non Clinical Tests: The summary data derived from mechanical testing are as follows : No needle ejection when dropped l)Impact Resistance: from eight (8) feet onto concrete. No damage to container. 2)Puncture Resistance: 1.5 - 5.12 lb. average for sides. 6.56 lb. average for bottom. 2.0 - 5.80 lb average for sides. 6.99 lb. average for bottom. 3)Wall Thickness: l.5 - .072 inches average for sides. .1174 inches average for bottom. 2.0 -.078 inches average for sides. .1125 inches average for bottom. 4)Sharps Closure - Pull Test - 45 lb. for 24 hours. 5)Capacity: 1.5 - 15.8 cu. in./6.75 oz. 2.0 - 28.2 cu. in./12.30 oz. 6)Leakproof Test: The bottom is leakproof. The top is also leakproof when the vinyl cover is in place. 7)Disposal: Sharps Safes contain no heavy metals and can be incinerated. 8)Attachment Strap Test: A Sharps Safe will support 45 pounds when secured to a surface by the attachment straps .
2
K45514
Image /page/2/Picture/1 description: The image shows the logo for DURA-VAC, which is written in bold, black letters. To the left of the company name is a medical symbol. Below the company name is the address, 4464 McGrath Street, and an image of a piece of equipment.
4464 MeGRATH STREET #114 • VENTURA, CA 93003 • (805) 658-7768
Clinical Tests :
Not required.
Conclusions :
It is very clear that there is a real need for a sharps container that is designed specifically for Paramedics and Home Health Care Professionals.
All of the existing devices on the market have shortcomings which make them unsuitable for Paramedic use. Sharps Safes were designed to fill this void.
The nonclinical tests provided us with the design and materials to be used, and the clinical tests refined the parameters of the materials. These tests also revealed that a better system was needed to secure the container to the drug box. It also became apparent that two sizes would be beneficial (2 inch and l.5 inch).
The combined talents of sixty (60) fire department Paramedics were used to develop Sharps Safes.
We feel that they meet the need.