(66 days)
The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected form accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997.
The provided text is a 510(k) submission for a medical device, the VanishPoint™ Syringe, seeking clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics as might be found for a novel device.
Therefore, the information required for items 1 through 9 in your request is largely not present in the provided document, as it's not typically part of a 510(k) summary focused on substantial equivalence for a Class II device like a syringe.
Here's a breakdown based on the given text:
1. A table of acceptance criteria and the reported device performance
- Absent. This document does not detail specific acceptance criteria or quantitative performance metrics for the device. The "Safety and Effectiveness" section states: "No new issues of safety or effectiveness when prepared. The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997." This indicates a claim of equivalence rather than a report of specific test results against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Absent. No information is provided regarding a test set, sample sizes, or data provenance. The substantial equivalence argument relies on the existing predicate devices.
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)
- Absent. Ground truth establishment by experts is not described, as the submission does not detail a clinical study where such an assessment would be necessary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Absent. No adjudication method is 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
- Absent. This is not relevant to a syringe device. MRMC studies are typically for diagnostic imaging devices involving interpretation by multiple readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Absent. This is not relevant to a syringe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Absent. No ground truth is described for the device performance. The "ground truth" for this submission concerns the functionality and safety profile of similar, already cleared devices, suggesting that the new device has "no new issues of safety or effectiveness."
8. The sample size for the training set
- Absent. No training set is mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Absent. Not applicable.
Summary of what the document does provide regarding acceptance/equivalence:
The core of this 510(k) submission is the assertion of substantial equivalence to existing predicate devices.
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Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria in a 510(k) relevant to device safety and effectiveness are that the new device (1cc VanishPoint™ Syringe) does not raise new issues of safety or effectiveness compared to its predicate devices, and that it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
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Study Proving Equivalence (Described implicitly): The "study" is the comparison to the predicate devices.
- The 1cc VanishPoint® Syringe is stated to be a "smaller version" of the original 3cc VanishPoint® (introduced Dec 1995), and also compared to 5cc and 10cc VanishPoint® Syringes (introduced May 1997).
- The document states: "No new issues of safety or effectiveness when prepared."
In essence, for this type of device and submission, the "proof" is the demonstrated similarity and lack of new risks compared to already cleared devices on the market. Clinical trials or detailed performance studies with explicit acceptance criteria are generally not required for such 510(k) submissions unless the device has novel technology or raises new safety/effectiveness concerns.
§ 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).