SAFETY CRADLE

K962149 · Specialized Health Products, Inc. · FMI · Oct 11, 1996 · General Hospital

Device Facts

• Record ID: K962149
• Device Name: SAFETY CRADLE
• Applicant: Specialized Health Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

For storage and disposal of used sharps devices.

Device Story

Molded plastic sharps container; provides safe disposal of used sharps; features biased flap 'Safety Cradle' mechanism, living hinge, and depressible cover for automatic closure; includes secondary temporary closure with lock and handle; incorporates absorbent pad with gelling compound for fluid control; includes integrated left/right-handed phlebotomy needle extractors; supports wall, table, or free-standing mounting; provides horizontal drop path for sharps; prevents accidental finger contact; includes fill indicator line and instructions on container; nestable design; permanent closure mechanism for final disposal; used by clinicians/staff to mitigate needlestick injury risk during sharps disposal.

Clinical Evidence

Bench testing only. Device performance verified against ASTM puncture resistance standards and ECRI standards for fill level visibility.

Technological Characteristics

Molded plastic construction; mechanical biased flap and living hinge closure system; absorbent pad with gelling compound; integrated needle extractors; nestable form factor; wall/table/free-standing mounting options.

Indications for Use

Indicated for the storage and disposal of used sharps devices in clinical or healthcare settings.

Regulatory Classification

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.

Predicate Devices

• Sharp-Safe Sharps disposal Box (K901321)

Submission Summary (Full Text)

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OCT 11 1996

K962149

# 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:

880.5570

## Class:

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.

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# 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:

1. 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.
2. 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.
3. Permanent closure when container is full.
4. Highly absorbent pad with gelling compound for fluid control.
5. Left handed and right handed phlebotomy needle extractors.
6. Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container.
7. Safety Cradle feature provides a unique means for a horizontal drop of a sharp.

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# PRODUCT COMPARISON
Safety Cradle vs. Sharp Safe

| FEATURE | Predicate Device
Sharp Safe | Proposed Device
Safety Cradle® |
| --- | --- | --- |
| 510(k) Clearance | K901321 | K962149 |
| 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 |