(182 days)
The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.
Stat Medical Pen Needle
This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results and acceptance criteria in the way a clinical study report would. Therefore, much of the requested information regarding detailed acceptance criteria and study particulars will not be found directly in this document.
However, I can extract the information that is present and indicate where the document is silent on certain points.
Acceptance Criteria and Device Performance Table:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | For subcutaneous injection of insulin with a pen injector device (single-use). | "The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin." (This is its stated intended use, implying it meets this foundational criteria for equivalence). |
| Material | Not specified in this document. | Not specified in this document. |
| Dimensions (Gauge, Length) | Not specified in this document. | Not specified in this document. |
| Sterility | Must be sterile. | As a hypodermic single lumen needle, sterility is a fundamental requirement and implied by the classification (21 CFR 880.5570) and general GMP principles. Specific acceptance criteria (e.g., SAL) are not detailed here. |
| Biocompatibility | Must be biocompatible (no adverse reactions). | Implied by the device type and FDA regulations, but specific criteria and performance are not detailed here. |
| Needle Tip Sharpness/Penetration Force | Not specified in this document. | Not specified in this document. |
| Compatibility with Pen Injectors | Compatible with "a pen injector device." | Stated as "intended for use with a pen injector device." Specific compatibility tests or quantitative results are not in this summary. |
| Performance in Use (e.g., ease of attachment, fluid flow) | Not specified in this document. | Not specified in this document. |
Additional Information based on the provided document:
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in this document. 510(k) summaries for Class II devices demonstrating substantial equivalence often rely on comparison to a predicate and adherence to recognized standards, rather than new, extensive clinical trials with specified sample sizes for "test sets" in the context of AI.
- Data Provenance: Not applicable. This document is related to a medical device (a pen needle), not an AI device or a study involving data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a physical medical instrument, not an AI or diagnostic tool requiring expert ground truth for a test set.
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Adjudication Method for the Test Set:
- Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI-assisted diagnostic device.
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Standalone (Algorithm Only) Performance:
- Not applicable. This is not an algorithm.
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Type of Ground Truth Used:
- Not applicable. The "ground truth" for a pen needle would be its physical and functional specifications meeting standards and equivalence to a predicate.
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Sample Size for the Training Set:
- Not applicable. This device does not use a "training set" in the context of AI or machine learning.
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How the Ground Truth for the Training Set was Established:
- Not applicable.
Summary of the Document's Purpose:
This document is an FDA 510(k) clearance letter for the "Stat Medical Pen Needle." Its primary purpose is to inform the manufacturer (Emergo Group, Inc. c/o BSI, Inc.) that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination allows the manufacturer to market the device.
The letter explicitly states that the review determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976 (or devices that do not require PMA approval), based on the "indications for use stated in the enclosure" (which is page {2} in your input).
The 510(k) process for devices like a pen needle typically relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as a legally marketed predicate device. The "study" in this context would be the information provided in the 510(k) submission, which would include engineering drawings, material specifications, performance testing data (e.g., sterilization validation, biocompatibility, force testing, flow rates, dimensions), and a comparison to the predicate device. These details are not typically summarized in the final FDA clearance letter provided here.
§ 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).