(147 days)
The HookSafe™ U-100 Insulin Syringe; models 0.5cc/ml and 1cc/ml, serves as the vehicle in which medication, insulin can be injected into the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
The HookSafe™ U-100 Insulin Syringe is the Safety Syringe with the following functional advantage:
Single use, completely non-reusable, all parts and components can be safely discarded.
Fully meets anti-needlestick requirements and incorporates anti-reuse functionality. After the injection of insulin, it is at this stage where the anti-reuse function of our syringe begins, a mechanism within our syringe engages the needle hub and forms a lock. At this point, one simply needs to pull the syringe plunger back and the needle will be completely retracted into the barrel of the syringe. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.
The provided text is a 510(k) summary for the HookSafe™ U-100 Insulin Syringe. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new device.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies are not available in the provided document.
Here's an attempt to answer the questions based only on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The primary "acceptance criteria" presented is substantial equivalence to the predicate device K041970. | The device models 0.5cc/ml and 1cc/ml "maintain the same safety and effectiveness as that of cleared device" (K041970). The device is single-use, non-reusable, fully meets anti-needlestick requirements, and incorporates anti-reuse functionality (needle retraction into the barrel after use). |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, particularly for devices demonstrating substantial equivalence to a predicate, the "acceptance criteria" largely revolve around showing that the new device is as safe and effective as the predicate. This often involves demonstrating compliance with relevant standards and functional equivalence. Explicit quantitative performance metrics are less common in the summary itself, unless the modifications significantly alter performance.
Study Details
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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 Available. The document states "verification and validation tests contained in this submission," but does not detail the sample sizes for these tests or their provenance.
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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 Available. This type of information is typically relevant for studies involving diagnostic or interpretive tasks. This submission concerns a physical medical device (syringe) where ground truth would relate to its mechanical function, safety features, and compliance with standards, rather than expert interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. See above.
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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. This is not an AI-assisted diagnostic or interpretive device, so an MRMC study is not relevant or mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied Functional/Mechanical Performance and Safety Compliance. For a syringe, "ground truth" would likely involve verifying proper mechanical function (e.g., plunger movement, needle retraction), integrity (no leaks), and successful activation of safety features (anti-needlestick and anti-reuse mechanisms) as per engineering specifications and relevant standards. The document states compliance to applicable standards and "verification and validation tests," but does not detail the specific "ground truth" methods used in those tests.
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The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in this context.
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How the ground truth for the training set was established
- Not Applicable. See above.
§ 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).