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510(k) Data Aggregation
(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.), <0.75l capacity. * Sage Sharps Shuttle: Approx. 6.385" (H) x 1.11" (W I.D.), <0.75l capacity. (Deemed substantially equivalent) |
| * Similar weight to predicate device (Sage Sharps Shuttle K972279) | * NA Rescue Sharps Shuttle: Approx. 1.5oz. * Sage Sharps Shuttle: Approx. 1.5oz. (Deemed substantially equivalent) |
| * Similar closure mechanism (temporary and permanent locking tab) to predicate. | * Device has cylindrical shape, conical taper, temporary closure, and a permanent locking mechanism with a locking tab, similar to the predicate. (Deemed substantially equivalent) |
| Intended Use & Patient Population: | |
| * Non-sterile, single use, portable transportable sharps container with permanent closure system, protecting user prior to disposal via incineration. Accepts blood needles, lancets, small syringes. Used in point-of-procedure, non-clinical conditions (first responders, battlefield medics). | * The device matches this description and intended use, and is deemed substantially equivalent to the predicate which also has a similar intended use (EMS, home health care, accepting angio-caths, blood needles, lancets, small syringes). The environments of use are comparable (non-clinical, portable). |
| Biocompatibility: | |
| * Biocompatibility not applicable per ISO 10993 (implied acceptance criteria for non-patient contact device) | * Biocompatibility not applicable per ISO 10993. (Deemed substantially equivalent to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size in the conventional sense of clinical trials or AI/ML evaluations. The testing described (impact resistance, puncture resistance, resistance to damage and leakage after dropping) involves physical product samples, not patient data.
- Sample Size: The document does not explicitly state the number of units tested for each non-clinical performance test. It only states that the device "was tested." Standard practice for such tests, governed by the cited ASTM and ISO standards, would involve a statistically relevant number of samples, but the exact count is not given here.
- Data Provenance: The "data" (test results) are from non-clinical laboratory testing of the manufactured device. There is no patient or clinical data involved in this specific 510(k) submission. Therefore, it is not applicable to discuss country of origin or retrospective/prospective nature of data as these are physical device tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device and submission. "Ground truth" in the context of expert consensus is typically for diagnostic assessments (e.g., image interpretation). For a sharps container, the "ground truth" is established by adherence to performance standards (e.g., material does not puncture under specified force, container does not leak after specific drops). These are objective physical tests, not subjective expert evaluations. The qualifications would be of the laboratory technicians performing the tests and the engineers interpreting the results against the standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication in the sense of reconciling differing expert opinions, as the tests are objective physical measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical sharps container, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical sharps container, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by objective performance standards defined by organizations like ASTM and ISO. Specifically:
- ASTM F2132-01 (2008)e1 for puncture resistance.
- ISO 23907 (First edition 2012-09-01) sections 5.3 (puncture resistance) and 5.4 (resistance to damage and leakage after dropping).
Meeting these predefined, measurable criteria serves as the "ground truth" for the device's acceptable safety and efficacy properties in a non-clinical setting.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. There is no "training set" of data in this context. The manufacturing process itself (injection or blow molding) produces the devices, and quality control ensures consistency, but this is not a data "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set as understood for AI/ML, there is no ground truth established for it. The ground truth for the device's performance is established by the aforementioned industry standards, which inform the design and testing of the product.
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