(35 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 Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks.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 Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997 and the 1cc Allergy and Insulin Syringes were introduced in November 1997. 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.
The provided text describes a 510(k) submission for the VanishPoint® Syringe, a safety syringe designed to prevent needlestick injuries. However, the document does not contain specific acceptance criteria or the details of a study with numerical performance data for this device.
Instead, the submission primarily focuses on establishing "substantial equivalence" of the 1cc Tuberculin VanishPoint® Syringe to previously marketed versions of the VanishPoint® Syringe (3cc, 5cc, 10cc, 1cc Allergy and Insulin). This is a common pathway for medical devices seeking FDA clearance, where the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.
Based on the available information, here's what can be gathered, with many fields explicitly marked as "Not provided in the text" due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not formally stated. The submission focuses on substantial equivalence to predicate devices. | The device functions like a conventional hypodermic syringe but with the added ability to retract the contaminated needle inside the syringe immediately after use, activated by the user. This retraction is intended to protect the user from accidental needlesticks that would occur between removing the needle from the patient and disposing of the syringe. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not provided in the text.
- Data provenance: Not provided in the text. The submission relies on the established safety and effectiveness of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of experts: Not applicable/Not provided in the text. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.
- Qualifications of experts: Not applicable/Not provided in the text.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided in the text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC study: Not provided in the text. This type of study is more common for diagnostic imaging AI systems comparing human reader performance.
- Effect size: Not applicable/Not provided.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone performance study: Not applicable/Not provided in the text. This device is a mechanical syringe, not an algorithm. Its operation inherently involves human interaction.
7. The Type of Ground Truth Used
- Type of ground truth: Not applicable in the context of this 510(k) summary. For devices relying on substantial equivalence, the "ground truth" is essentially the demonstrated safety and effectiveness of the predicate device(s) as cleared by the FDA. The safety claim for this specific device is "protection from accidental needlesticks" through needle retraction.
8. The Sample Size for the Training Set
- Training set sample size: Not applicable/Not provided in the text. This is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
- Ground truth for training set: Not applicable/Not provided in the text.
Study Description (as inferred from the 510(k) Summary):
The "study" that proves the device meets its (unstated) acceptance criteria is based on the concept of Substantial Equivalence. The submission argues that the 1cc Tuberculin VanishPoint® Syringe is simply a "smaller version" of existing, previously cleared VanishPoint® syringes (3cc, 5cc, 10cc, and 1cc Allergy and Insulin versions). The implicit assumption (and the basis of the FDA clearance) is that if the design and function are sufficiently similar to devices already on the market and deemed safe and effective, then the new device also meets those standards without requiring new, extensive performance studies.
The document states: "No new issues of safety or effectiveness when prepared. The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint®... the 5cc and 10cc VanishPoint® Syringes... and the 1cc Allergy and Insulin Syringes..."
This indicates that the "proof" is a comparative analysis to already-cleared devices, rather than a de novo performance study with specific acceptance criteria and detailed quantitative results.
§ 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).