(72 days)
The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..
The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes.
The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance.
Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab.
Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste.
The provided document, a 510(k) summary for the Sharps Shuttle, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical AI/software device.
This 510(k) is for a physical medical device (a sharps container) and thus its "acceptance criteria" are related to product performance and safety, demonstrated through physical tests rather than a study with a test set, ground truth, or statistical performance metrics.
Therefore, many of the requested elements for an AI/software device study are not applicable to this document. I will extract the relevant information where possible and indicate when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Design Features" and their "Safety and Effectiveness Basis." These "Design Features" serve as the de facto acceptance criteria for this physical device, outlined by reference to OSHA regulations and general safety principles. The document describes the features but does not provide specific quantitative acceptance criteria values or detailed test results, only the basis for needing these features.
| Design Feature | Acceptance Criteria (Basis) | Reported Device Performance |
|---|---|---|
| Impact Resistance | The container's ability to retain solid contents, following lid closure and locking, in the event it is dropped during handling/transport. | Not specified in this document. |
| Puncture Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are puncture resistant. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii) | Not specified in this document. |
| Overfill Detection | During use, containers for contaminated sharps shall be replaced routinely and not be allowed to overfill. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii) | Not specified in this document. ("non-colored translucent plastic" might imply visibility for overfill) |
| Leak Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are Leak Proof on sides and bottom. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii) | Not specified in this document. |
| Sharps Access & Closure | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are closable. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i) | Not specified in this document. ("hinged cap which when snapped closed contains the biohazardous sharps") |
| Stability | During use, containers for contaminated sharps shall be maintained upright throughout use. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, ii) | Not specified in this document. ("cylindrical for rigidness") |
| Mounting Accessories | During use, containers for contaminated sharps shall be easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i) | Not specified in this document. |
| Handling | Sharps containers should be safe and easy to handle in transport. | Not specified in this document. |
| Capacity | This value gives the user an estimate or comparison of volume. | "approximately 6 inches long by 1 inch in diameter" |
Details of the "Study" (as applicable to a physical device 510(k)):
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2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. For a physical device, this would typically involve testing a sample of manufactured units. The document only lists design features and their safety basis.
- Data provenance: Not applicable. This is not a data-driven device; its performance is assessed via physical testing against FDA/OSHA requirements for sharps containers. The document originates from Sage Products Inc. (Crystal Lake, IL, USA) and is a pre-market notification to the FDA in the USA.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the regulatory requirements for sharps containers (OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030), rather than expert consensus on interpretive data. The document implies compliance with these established regulations.
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4. Adjudication method for the test set:
- Not applicable. Performance is likely determined by meeting defined physical test specifications, not by subjective expert adjudication.
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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 is a physical device, not an AI/software device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an AI/software device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the requirements of this device is based on regulatory standards and safety guidelines (specifically OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030) for physical sharps containers.
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8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/software device that requires a training set.
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9. How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI/software device.
§ 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).