(140 days)
Medical device to enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
The Medigard Blood Collection Device Consists of two Parts 1) a blood collection tube holder and 2) an evacuated sharps collection tube Netther part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures The device is intended to be used to provide a safe and reliable method of collection of blood samples from a patient using standard evacuated blood collection tubes The device is designed to prevent accidental needle stick injury At the end of the procedure, the needle is retracted into the Medigard evacuated sharps collection tube
The Medigard Blood Collection Device is a medical device designed to provide a safe and reliable method for collecting blood samples from a patient using standard evacuated blood collection tubes. Its primary function is to prevent accidental needle stick injuries to healthcare workers during and after the blood collection procedure. The device achieves this by retracting the needle into an evacuated sharps collection tube at the end of the procedure, making the needle inaccessible.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state quantitative acceptance criteria or detailed performance metrics. However, it indicates that the device must demonstrate safety and effectiveness, specifically in preventing needle sticks. The performance is assessed relative to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Prevention of accidental needle stick injuries. | Designed to prevent accidental needle stick injuries. Needle retracted via vacuum and cannot be accessed after retraction. (Demonstrated through Bench Testing and Simulated Use testing) |
| Effectiveness: Ability to enable withdrawal of blood samples. | Facilitates blood withdrawal from a patient into evacuated blood collection tubes. (Demonstrated through Bench Testing and Simulated Use testing) |
| Equivalence to Predicate Device: Similar intended use, materials, design (retraction of needle), where used, and target population. | Confirmed similar intended use, materials (plastic vs. plastic/metal), design (retraction of needle), healthcare facilities, and healthcare professionals. The difference in retraction mechanism (vacuum vs. spring) did not raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Bench Testing and Simulated Use testing were performed." However, it does not provide details on the sample size used for these tests.
The data provenance is not explicitly mentioned (e.g., country of origin). The testing type ("Bench Testing and Simulated Use testing") suggests controlled experimental conditions rather than real-world patient data. It is highly likely these were prospective tests designed for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing ground truth. Since the device's primary function is mechanical (needle retraction), ground truth would likely be established through objective observation and measurement of the retraction mechanism's functionality and the safe containment of the needle, rather than subjective expert interpretation, as would be the case for diagnostic imaging.
4. Adjudication Method for the Test Set:
Given the nature of the device (mechanical function for safety), there is no indication of an adjudication method like 2+1 or 3+1. Performance would likely be determined by direct observation of successful needle retraction and secure containment, with pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation is a critical component, to assess the impact of AI on reader performance. The Medigard Blood Collection Device is a mechanical safety device, not a diagnostic one.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The concept of "standalone performance" typically applies to AI algorithms that operate without human intervention. While the Medigard device's safety feature (needle retraction) is activated by the user, the retraction mechanism itself operates independently once triggered. The "Simulated Use testing" would assess this standalone mechanical performance. However, there's no explicit mention of an "algorithm only" study as that term is specific to AI. The testing performed focused on the device's mechanical function and safety features.
7. Type of Ground Truth Used:
The ground truth for this type of device would primarily be established through objective observation of the device's mechanical function and safety features. This would involve:
- Successful needle retraction: Verifying that the needle retracts fully and effectively.
- Secure containment: Confirming that the retracted needle is inaccessible and cannot cause a stick injury.
- Usability: Assessing if the device can be used successfully for blood collection.
This is not a diagnostic device, so ground truth would not be pathology, outcomes data, or expert consensus on clinical findings.
8. Sample Size for the Training Set:
The document discusses "Bench Testing and Simulated Use testing" which are verification and validation tests, not machine learning model training. Therefore, there is no concept of a "training set" in the context of this device.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this device (it's a mechanical device, not an AI/ML algorithm), this question is not applicable.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).