(31 days)
Hypodermic Needle-Pro® EDGE" Safety Device: This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
Hypodermic Needle-Pro® EDGE" Safety Device with Syringe: This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
This device is intended for injection or aspiration of fluids into the body. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "onepiece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap", the needle protection sheath for needles equal to or less than !" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The device is then discarded into a sharps container.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smiths Medical ASD, Inc. Hypodermic Needle-Pro® EDGE™ Safety Device.
Acceptance Criteria and Device Performance (Implicit)
The document doesn't explicitly list quantifiable "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating conformance to established industry standards and through a simulated clinical use study. For medical devices like this, regulatory acceptance often hinges on:
- Safety: The device effectively prevents needle sticks after use.
- Effectiveness: The device performs its intended function (injection/aspiration, covering the needle).
- Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices.
- Compliance with Standards: Meeting recognized national and international standards applicable to hypodermic needles and syringes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Prevent Needle Sticks (Primary Safety Function) | The device features a "one-piece" design where the needle is pressed into the sheath using a one-handed technique. Lugs on the needle hub snap into clips ("bottom snap"), and additional needle retaining hooks secure the needle within the sheath. The simulated clinical use studies confirmed that the device could be used effectively, with the needle shielded inside the protection device after use. This directly addresses the aim of preventing needle sticks. |
| Effective Injection/Aspiration | The device is intended for injection or aspiration of fluids. While not explicitly detailed, the design (Luer lock/slip syringe compatibility, permanent needle fixation) and conformance to ISO standards (ISO 594/1, ISO 594-2, ISO 7864, ISO 7886-1) imply its functional effectiveness for these tasks. |
| Conformance to Industry Standards | Met: Conformance was declared for: |
- ISO 594/1:1986(E): Conical fittings with 6% (Luer) taper - General requirements.
- ISO 594-2:1998(E): Conical fittings with 6% (Luer) taper - Lock Fittings.
- ISO 7864:1993(E): Sterile hypodermic needles for single use.
- ISO 7886-1:1993: Sterile hypodermic syringes for single use. |
| Substantial Equivalence to Predicate Devices | The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." The technological characteristics are noted as "the same hinged style protective sheath that is manually activated after use" as the predicate devices. |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The document states "Simulated clinical use studies were conducted," but it does not specify the sample size (e.g., number of devices tested, number of simulated uses).
- Data Provenance: The study was conducted by Smiths Medical ASD, Inc., and is presumably internal to the company. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a "simulated clinical use study," it would inherently be prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a simulated use study of a physical device like this, "ground truth" would likely involve objective observation of device function (e.g., successful activation of safety mechanism, no needle exposure). It's possible the "experts" were the study designers or trained observers, but their number and qualifications are not disclosed.
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Adjudication method for the test set:
- This information is not provided. Given the nature of observing a mechanical safety mechanism, formal adjudication (like 2+1 reads) might not have been deemed necessary, or the method was not explicitly documented in the summary.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic tools where human "readers" (e.g., radiologists) interpret images. This device is a physical medical device (safety hypodermic needle).
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the sense that the device's mechanical function was tested on its own. The "Simulated clinical use studies" would primarily assess the device's ability to shield the needle after use, which is its standalone function without direct human "performance" being the primary variable, beyond successful activation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would have been objective observation of the device's mechanical function in the simulated clinical use. For example, did the needle successfully retract/shield? Was it securely contained? Was there any accidental needle exposure after activation? This is a direct observation of the device's intended safety outcome.
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The sample size for the training set:
- Not applicable / Not provided. For a physical medical device, there isn't typically a "training set" in the computational sense. Device design and engineering are based on principles and iterative testing, not machine learning training data.
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How the ground truth for the training set was established:
- Not applicable. As above, there's no "training set" with ground truth in the context of this device. Design validation and verification for a mechanical device involve engineering specifications and tests, rather than labeled training data.
§ 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).