(90 days)
The Devon SafeTip Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.
The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.
Here's an analysis of the provided text regarding the Devon SafeTip Safety Syringe, focusing on its acceptance criteria and the study that proves its performance:
The provided text describes a 510(k) premarket notification for the Devon SafeTip Safety Syringe. It highlights the device's description, indications for use, and a summary of testing. However, the document does not explicitly state specific numerical acceptance criteria or detail a comprehensive study to prove the device meets such criteria. It references adherence to "internationally recognized standards" and FDA Guidance but doesn't provide the quantitative results or the methodology of the study.
Based on the provided information, I can answer some of your questions and identify the information that is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics within the provided text. The text indicates general compliance with "internationally recognized standards for syringe performance and labeling characteristics" and reliability of the safety feature. | "Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." |
Missing Information: Specific numerical thresholds for performance (e.g., success rate of needle cover deployment, force required for activation, leakage rates, etc.) are not provided. The term "demonstrated performance" is qualitative.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document states "Simulated clinical use testing" but provides no details on the sample size (number of syringes tested, number of simulated injections), the country of origin of the data, or whether the study was retrospective or prospective.
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)
Missing Information: This information is entirely absent. The testing described is for a physical device (syringe, safety feature), not one that requires expert interpretation for "ground truth" in the way an AI diagnostic tool would. "Simulated clinical use testing" would likely involve objective measurements rather than expert consensus on subjective findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Adjudication methods are typically relevant for studies involving subjective human assessment or disagreement, particularly in diagnostic imaging or clinical trials. Since the testing is for the performance of a physical device and its safety mechanism, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned.
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/Missing Information: An MRMC comparative effectiveness study is used for evaluating human reader performance, often with and without AI assistance, particularly in diagnostic fields. This is not relevant to a physical medical device like a safety syringe. The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Missing Information: This question applies to AI algorithms. The Devon SafeTip Safety Syringe is a physical device, not an AI algorithm, so the concept of "standalone performance" for an algorithm is not relevant here. The device itself (the safety mechanism) acts "standalone" in its deployment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would likely be objective physical measurements and observations of the syringe's functional performance and safety feature deployment. For example:
- Successful deployment of the sheath: Yes/No
- Completeness of sheath coverage over the needle: Yes/No
- Force required to activate the safety feature (if applicable)
- Integrity of the syringe body and needle after use
- Absence of leakage
However, the document does not explicitly state the specific types of "ground truth" or measurement criteria used beyond mentioning "performance of the SafeTip syringe and reliability of the safety feature."
8. The sample size for the training set
Not Applicable/Missing Information: The concept of a "training set" applies to machine learning or AI models. This is a physical device and does not have a training set in that sense. Any manufacturing or design validation would involve internal testing and iteration, but not a "training set" in the context of AI.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As mentioned above, a training set is not applicable to this physical device.
Summary of what is known from the provided text:
- Device: Devon SafeTip Safety Syringe, a piston syringe with a passive sharp safety feature.
- Purpose of Safety Feature: Automatically deploys a plastic cover (sheath) over the needle after injection to prevent accidental needle sticks.
- Indications for Use: Administration of intramuscular (IM) injections.
- Testing Performed: "Simulated clinical use testing" was conducted.
- Compliance: The testing demonstrated performance and reliability in accordance with "internationally recognized standards for syringe performance and labeling characteristics" and the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005.
Key Missing Information: The provided text lacks the detailed, quantitative information typically found in a comprehensive study report, such as specific acceptance criteria values, sample sizes, detailed methodology, and the actual results of the "simulated clinical use testing." It acts more as a high-level summary of compliance.
§ 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).