(84 days)
A properly placed MDC Safe Step Safety Blood Collection Needle System incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples.
The Safe Step Safety Blood Collection Needle System consists of four separate components: a blood collection needle assembly; an evacuated tube adapter; a front protective cap; and a rear protective cap.
The Safe Step Safery Blood Collection Needle System is a standard Blood Collection Needle System with the additional feature of a retractable needle. The needle safety mechanism can be activated by lifting the thumb pad (located on the rear piece of the tube adapter) upwards and forward, relative to the two finger tabs on the tube adapter front piece, after removing the last blood sample tube.
After needle retraction, the device is disposed of according to routine procedure in a sharps container.
The provided text describes a traditional medical device (a blood collection needle system) and its regulatory clearance process, not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable or mentioned in this document.
However, I can extract information related to the device's acceptance criteria and how "performance data" proved it met them, based on the provided text.
Acceptance Criteria and Device Performance for Safe Step Safety Blood Collection Needle System
The "Safe Step Safety Blood Collection Needle System" is a blood collection needle system with an added safety feature: a retractable needle mechanism designed to minimize needle stick injuries.
The document indicates that the device's acceptance was based on demonstrating substantial equivalence to a predicate device and meeting functional requirements and specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Intended Use | Substantially equivalent to existing blood collection needle systems for: |
- Providing vein access for blood specimen collection using an evacuated blood collection tube.
- Incorporating a safety feature to cover the needle after use. | - "The Safe Step Safety Blood Collection Needle System is substantially equivalent to other Blood Collection Needle Systems currently in commercial distribution by BioPlexus, Inc. in terms of the intended use as a Blood Collection Needle System, providing vein access for the purpose of obtaining blood specimens using an evacuated blood collection tube, and the incorporation of a safety feature to cover the needle after use." (Section 10.5)
- The device incorporates "a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples." (Section 10.6) |
| Technological Characteristics | Similar to the predicate device (Bio-Plexus, Inc. Punctur-Guard Blood Collection Needle System) in terms of: - Providing vein access to collect blood specimens.
- Including a user-activated feature to cover the needle after use.
- Differences in physical appearance and materials not affecting relative safety or effectiveness. | - "The Safe Step Safety Blood Collection Needle System has the same technological characteristics as the Punctur-Guard Blood Collection Needle System. Both devices provide vein access to collect blood specimens and include a user activated feature to cover the needle after use." (Section 10.7)
- "Differences that exist between these systems relating to physical appearance and materials do not affect the relative safety or effectiveness of the devices." (Section 10.5) |
| Functional Requirements & Specifications | The device must meet its defined functional requirements and specifications. (Specific functional details are not provided in the summary, but are implied.) | - "Performance data indicate that the Safe Step Safety Blood Collection Needle System meets the functional requirements and specifications of this device." (Section 10.8) (Note: The specific performance data, test methods, or quantified results are not detailed in this summary document.) |
Since this is a medical device clearance and not an AI/ML device, the following points are not applicable or the information is not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable; this is for a physical device, not an AI model. Performance data is only vaguely mentioned as being present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; ground truth in the AI sense is not relevant here. The "ground truth" for this device would be its ability to perform its mechanical function (retraction, blood collection) reliably, which would be measured through engineering performance tests.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: 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).