(286 days)
The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use, portable transportable sharps container. Its permanent closure system protects the user prior to disposal via incineration.
The North American Rescue Sharps Shuttle is approximately 6.41" in length, with a sharps aperture of approximately 1" in diameter.
The North American Rescue Sharps Shuttle are injected or blow molded single use, non-sterile disposable, transportable sharps collectors and transport containers intended for use where standard sharps containers are not conveniently accessible. The North American Rescue Sharps Shuttle is a portable collector that provides an alternate to resheathing a needle with its original protective cover. The North American Rescue Sharps Shuttle is designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes.
The North American Rescue Sharps Shuttle is cylindrical, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal via incineration. In addition to the temporary closing mechanism, the North American Rescue Sharps Shuttle has a locking mechanism designed with a locking tab to permanently close the container.
The North American Rescue Sharps Shuttle is a non colored, translucent plastic and is approximately 6.41 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap, which is snapped and locked close contains the biohazardous sharps. Each North American Rescue Sharps Shuttle is individually labeled with a biohazard symbol and fill line. The North American Rescue Sharps Shuttle is available as a single device or as a kit of six (6).
This document is a 510(k) Summary for a medical device called the "North American Rescue Sharps Shuttle." This type of document is generally for substantial equivalence determinations, not for proving a device meets specific clinical acceptance criteria in the same way an AI/ML algorithm might. Instead, it demonstrates that the new device is as safe and effective as a legally marketed predicate device.
Therefore, the following information about acceptance criteria and study design is interpreted within the context of a 510(k) submission for a non-active medical device (a sharps container), rather than an AI/ML diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Material Properties: | |
| * Material: Polypropylene | * Device is made of polypropylene. (Demonstrates equivalence to predicate) |
| Functional Safety (Puncture Resistance): | |
| * Conformity to ASTM F2132-01 (2008)e1 "Puncture of Materials used in Resistance of Materials containers for discarded used in containers for medical needles and other Sharps" (Puncture Resistance Standard) | * The North American Rescue Sharps Shuttle was tested for puncture resistance per ASTM F2132-01 (2008)e1. The conclusion is that it is "substantially equivalent" to the predicate, which also met this standard. Therefore, it implicitly meets the standard, as the predicate was also tested via bench testing per the same standard. |
| * Conformity to ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods - Sharps containers for puncture resistance section 5.3 (Puncture Resistance Standard) | * The North American Rescue Sharps Shuttle was tested for puncture resistance per ISO 23907, section 5.3. The conclusion is that it is "substantially equivalent" to the predicate. |
| Functional Safety (Resistance to Damage and Leakage after Dropping): | |
| * Conformity to ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods - Sharps containers for resistance to damage and leakage after dropping, section 5.4 (Drop Test Standard) | * The North American Rescue Sharps Shuttle was tested for resistance to damage and leakage after dropping per ISO 23907, section 5.4. The conclusion is that it is "substantially equivalent" to the predicate. |
| Dimensional & Design Equivalences: | |
| * Similar dimensions (length, width, volume) to predicate device (Sage Sharps Shuttle K972279) | * NA Rescue Sharps Shuttle: Approx. 6.41" (H) x 1.33" (W I.D.), |
§ 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).