(65 days)
This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.
This device is intended for injection of insulin. The needle protection device is an integral pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the desired 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 needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles.
The provided text is a 510(k) summary for a medical device (Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in performance studies for diagnostic or AI-driven devices.
Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study
The provided document does not describe an acceptance criteria table or a study designed to prove the device meets specific performance criteria in the way requested (e.g., sensitivity, specificity, or similar metrics for diagnostic tools). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against predefined metrics.
The document states:
- "NON-CLINICAL DATA: The descriptive characteristics of this device are precise enough to ensure equivalence."
- "CLINICAL DATA: Not applicable"
- "CONCLUSION: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device."
This indicates that the "study" conducted for this 510(k) was primarily a comparative analysis of the device's characteristics against a predicate device to establish substantial equivalence. Performance criteria related to safety and effectiveness are inferred through this equivalence, rather than direct measurement against numerical targets.
Breakdown of Requested Information:
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A table of acceptance criteria and the reported device performance
- Not provided. The document does not define specific quantitative acceptance criteria or report performance metrics in this format. The basis for approval is substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. Since no specific clinical or performance study with a "test set" was described, this information is absent. The assessment relied on comparison with a predicate device.
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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 / Not provided. No ground truth establishment by experts for a test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
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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
- Not applicable / Not provided. This device is an insulin syringe with a needle protection mechanism, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For this type of device and submission, "ground truth" as typically understood in performance studies (especially for diagnostics) is not used. The "truth" or benchmark is the predicate device's substantial equivalence in design, materials, and intended use.
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The sample size for the training set
- Not applicable / Not provided. No training set, as understood for AI or complex statistical models, is mentioned.
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How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.
Summary of the Document's Approach to Demonstrating Safety and Effectiveness:
The document leverages the concept of substantial equivalence to a predicate device (K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device). Instead of conducting a new study with explicit performance criteria, the manufacturer demonstrates that their proposed device is:
- Comprised of identical or similar components and materials as the predicate device.
- Has the same intended use (injection of insulin; needle protection after use).
- Has similar technical characteristics.
- Doesn't raise new questions of safety or effectiveness.
This approach, common for Class II medical devices in 510(k) submissions, assumes that if a new device is sufficiently similar to a previously cleared device, it is also safe and effective. No clinical data, performance studies with acceptance criteria, or expert evaluations for a test set were deemed necessary or were documented in this summary.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).