(80 days)
The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts.
The REVOLUTION Holder should be used by health care workers experienced in phlebotomy.
At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick.
The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.
The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collection Needles during blood drawing procedures, and to allow blunting of PUNCTUR-GUARD® needles prior to removal from the patient. Blunting reduces the probability of accidental needle sticks which are a major risk for infection with HIV or hepatitis. Blunting is performed by turning the dial at the holder's end.
The REVOLUTION Holder is non-sterile and can be used for up to 100 blood draws, including 20 cleanings. Contaminated needles can be released quickly in a one-handed operation by a manual push on the release button.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PUNCTUR-GUARD REVOLUTION™ Blood Collection Needle Holder:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Aspect) | Reported Device Performance |
|---|---|
| Holder Integrity: Retains integrity under expected forces. | Retains its integrity under forces that can be expected to occur in practical use. |
| Needle Insertion: Allows needle insertion in an acceptable torque range. | Allows needle insertion by the health care worker in an acceptable torque range. |
| Blood Draws: Allows blood draws reliably. | Allows blood draws in a reliable fashion. |
| Safety Feature Activation: Performs activation of the PUNCTUR-GUARD® safety feature consistently and fault-free. | Performs activation of the safety feature of PUNCTUR-GUARD® Blood Collection Needles in a consistent and fault-free manner. |
| Needle Disposal: Allows needle disposal by pushing a release button. | Allows needle disposal by pushing a release button. |
| Reusability: Can be used for up to 100 uses, including 20 cleanings. | Can be used for up to 100 uses, including 20 cleanings. |
| Substantial Equivalence: Quantitative test values demonstrate substantial equivalence to the predicate device (DROP-IT® holder). | Quantitative test values demonstrated the substantial equivalence of the REVOLUTION holder to the predicate device, the DROP-IT holder. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document states, "Sample sizes reflected the significance of the particular functions, expressed in appropriate AQL levels." It does not provide specific numerical sample sizes for each test.
- Data Provenance: The tests were conducted internally by Bio-Plexus technical staff and externally by "outside health care workers." The country of origin is not explicitly stated, but Bio-Plexus, Inc. is located in Vernon, CT, USA, suggesting the testing was likely conducted in the US. The testing appears to be prospective as it's part of the development and validation of the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document mentions "outside health care workers" participated in "complete functional testing in blood drawing procedures."
- Number of Experts: Not specified.
- Qualifications of Experts: The term "health care workers" is broad. More specific qualifications (e.g., phlebotomists with X years of experience, nurses, physicians) are not provided.
4. Adjudication Method for the Test Set
- The document describes "pass/fail evaluations" and mentions "functional testing." It does not provide details on an adjudication method like 2+1 or 3+1 for resolving discrepancies in evaluations. It implicitly suggests that the tests were designed with clear pass/fail criteria, possibly eliminating the need for complex adjudication for objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was NOT performed. The tests focused on the performance of the device itself and its equivalence to a predicate, not on how human readers (or users) improve their performance with or without AI assistance. The device is a mechanical blood collection holder, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a form of standalone testing was done. The device itself was tested for its mechanical and functional performance (holder integrity, needle insertion torque, safety feature activation, reusability) separate from a human operator, with human users primarily verifying the functionality during simulated use. Since this is a mechanical device and not an algorithm, "standalone" here refers to the device's inherent function rather than an algorithm's performance.
7. The Type of Ground Truth Used
- The ground truth was established through objective measurements (force and torque measurements), pass/fail evaluations against predefined design specifications, and simulated use testing verified by technical staff and healthcare workers. This constitutes a combination of engineering specifications and direct observational evidence of function. It does not involve "expert consensus" in the sense of interpreting medical images or pathology.
8. The Sample Size for the Training Set
- Not Applicable. The device is a mechanical blood collection holder, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (as there is no training set for a mechanical device).
§ 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).