(129 days)
Not Found
No
The device description focuses on mechanical features for sharps disposal and does not mention any computational or learning capabilities.
No
The device is described as a container for the storage and disposal of used sharps, which is a waste management tool, not a device used for medical treatment or therapy.
No
The intended use states the device is for storage and disposal of used sharps devices, which is not a diagnostic function.
No
The device description clearly describes a physical, molded plastic container with various mechanical features for sharps disposal, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For storage and disposal of used sharps devices." This is a physical containment and disposal function, not a diagnostic test performed on biological samples.
- Device Description: The description details a container for holding sharps, focusing on features for safe handling and disposal. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on biological analysis.
The device is clearly designed for the safe management of medical waste (sharps), which is a different category of medical device than an IVD. The predicate device (K901321 Sharp-Safe Sharps disposal Box) also confirms its classification as a sharps disposal container, not an IVD.
N/A
Intended Use / Indications for Use
For storage and disposal of used sharps devices
Product codes
MMK
Device Description
The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures.
The Safety Cradle sharps container utilizes a unique two part design that provides the following features:
-
Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge.
-
A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container.
-
Permanent closure when container is full.
-
Highly absorbent pad with gelling compound for fluid control.
-
Left handed and right handed phlebotomy needle extractors.
-
Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container.
-
Safety Cradle feature provides a unique means for a horizontal drop of a sharp.
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
Not Found
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)
Reference Device(s)
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
OCT 11 1005
Safety and Effectiveness Summary
for 510(k) Premarket Notification K962149 for Safety Cradle® sharps container
| The manufacturer
of record is: | Specialized Health Products Incorporated
655 E. Medical Drive
Bountiful, Utah 84010 |
|-----------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use: | For storage and disposal of used sharps devices |
| Classification Number: | 80MMK |
| Classification Name: | Sharps Container |
| Regulation Number:
Class: | 880.5570
Class II |
| Common/Usual Name: | Sharps Container |
| Commercial Name: | Safety Cradle® |
| Performance Standards: | None established under section 514. |
| Substantial Equivalence: | |
The Safety Cradle sharps container is substantially Equivalent in function to:
Specialized Health Products Incorporated 655 E. Medical Drive Bountiful, Utah Sharp-Safe Sharps disposal Box K901321 (5/11/90)
In developing the information for this submission, the CDRH draft Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers was_referenced.
1
DEVICE DESCRIPTION
The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures.
The Safety Cradle sharps container utilizes a unique two part design that provides the following features:
-
Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge.
-
A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container.
-
Permanent closure when container is full.
-
Highly absorbent pad with gelling compound for fluid control.
-
Left handed and right handed phlebotomy needle extractors.
-
Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container.
-
Safety Cradle feature provides a unique means for a horizontal drop of a sharp.
2
PRODUCT COMPARISON
Safety Cradle vs. Sharp Safe
| FEATURE | Predicate Device
Sharp Safe
K901321 | Proposed Device
Safety Cradle®
K962149 |
|---------------------------------------------------------------------|-------------------------------------------|----------------------------------------------|
| 510(k) Clearance | yes | yes |
| Puncture resistance meets ASTM standards | yes | yes |
| Horizontal drop of sharps | yes | yes |
| Stable in free standing position | yes | yes |
| Leak proof in upright position | yes | yes |
| Potential for fingers to accidentally slip into
container | yes | no |
| Injection molded parts | no | yes |
| Fill indicator line | no | yes |
| Instructions on container | no | yes |
| Phlebotomy needle extractor(s) | no | yes |
| Nestable | no | yes |
| Sufficient clarity to view fill level
(Meets ECRI standards) | no | yes |
| Closure Mechanisms:
Automatic closure between disposal of sharps | yes | yes |
| Permanent closure when container is full | with tape | yes |
| Handle | no | yes |
| Absorbent pad to resist leakage in positions
other than upright | yes | yes |
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ י
ﺳﻤﺴ