(52 days)
The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.
The BEC Shrouded Plastic Cannula consists of a shrouded blunt tubular cannula at one end and a female luer attachment at the other. This luer attachment is designed to connect to a male luer lock or luer slip connector of a tubing set, syringe, or other intravascular administration device. The cannula end of the body is designed to penetrate a pre-slit, natural rubber septum and latch with the BEC, MED-NET or IMED Needleless Injection Site or Y-site.
The provided document is a 510(k) Summary for a medical device called the "BEC Shrouded Plastic Cannula." This type of document is part of a premarket submission to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.
It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way that an AI/ML device submission would. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Therefore, for your request, the best I can do is explain why the information isn't available in this document and extract what little pertains to "performance" in the context of a 510(k) for a physical medical device.
Explanation regarding absence of requested information:
This document is a 510(k) Summary for a physical medical device (BEC Shrouded Plastic Cannula), not an AI/ML-driven diagnostic or treatment device. The regulatory pathway for this device is based on demonstrating substantial equivalence to an existing, legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a clinical study with typical metrics (e.g., sensitivity, specificity, AUC).
For a device like this, "performance data" typically refers to engineering tests to ensure physical integrity, material compatibility, and similar attributes, not diagnostic accuracy or patient outcomes from a clinical study as would be seen for an AI product.
Here's how the provided information relates to your request, with most items being "Not Applicable" or "Not Provided" given the nature of the document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (If typically applicable) | Reported Device Performance (as per document) |
|---|---|
| Not explicitly stated (e.g., accuracy, sensitivity) in this document for a direct comparison study. | - Identity to predicate devices: "identical to Medical Network Associates, Incorporated's Shrouded Plastic Cannula reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510(k) #K945070." |
- Material Identity: "made of the same material by the same foreign manufacturer."
- Safety Goal: "intended to provide additional protection against inadvertent 'needlestick' injuries to health care providers."
- Functionality Goal: "provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle."
- Sterilization: "performed in-house using a validated ethylene oxide process."
- Packaging: "consistent with those generally used by the medical device industry." |
Explanation: The "acceptance criteria" for a 510(k) on a physical device like this primarily revolve around demonstrating that it is as safe and effective as a predicate device. The "performance data" mentioned refers to the data submitted for the predicate device (IMED), implying that since this device is identical in material and design, similar performance is expected. No specific quantitative performance metrics (like those for an AI/ML device) are provided for a direct comparison in this summary.
Regarding the study that proves the device meets the acceptance criteria:
Based on the document, the "study" is implicitly the demonstration of substantial equivalence to a predicate device, which itself would have undergone testing and regulatory review. The key points are:
- Reliance on Predicate Device: The document explicitly states: "This Shrouded Plastic Cannula is identical to Medical Network Associates, Incorporated's Shrouded Plastic Cannula reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510(k) #K945070."
- Predicate Device Data: "Technological data and performance data were submitted for the IMED predicate device." This indicates that the IMED device's data is leveraged for the current submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. This document refers to the substantial equivalence to a predicate device. If human clinical data were part of the predicate device submission, the details are not summarized here. The "performance data" mentioned likely refers to engineering or materials testing, not a clinical "test set" in the AI/ML sense.
- Data Provenance: Not applicable/Not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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 medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a physical device, "ground truth" would relate to material properties, sterility, and mechanical function, validated through engineering standards and testing, not clinical diagnosis.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this type of 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).