(157 days)
passive anti-needle stick device to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components
The Introcan Safety I.V. Catheter which is a passive antineedle stick device. The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.
Based on the provided text, the device in question is the Introcan Safety I.V. Catheter, which is a passive anti-needle stick device. The document is a 510(k) summary indicating its substantial equivalence to a previously cleared device, the "Microcath"™ Intravenous Catheter Placement Unit and Catheter (K801941).
Here's the analysis of acceptance criteria and the study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Composed of materials tested in accordance with ISO Standard 10993 and determined to be suitable for intended use. |
| Functional Integrity (General) | "All finished products are tested and must meet all required release specifications before distribution." |
| Physical Testing | "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." (No specific parameters or numerical results are provided in this summary.) |
| Visual Examination | "Visual examination (in process and finished product)" is performed. (No specific criteria or results are provided.) |
| Substantial Equivalence | The device is similar in materials, form, and intended use to the predicate device (Microcath™) and raises no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any specific test set or clinical study. The testing described appears to be manufacturing quality control and component testing rather than a clinical trial or performance study against pre-defined acceptance criteria with clinical endpoints.
The data provenance is implied to be internal testing by B. Braun Medical, Inc., rather than external clinical data or country-specific data. It's retrospective in the sense that it refers to internal testing of finished products, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The "ground truth" for the internal quality control tests would be the established product design specifications and testing procedures, not expert consensus on diagnostic or clinical outcomes.
4. Adjudication Method for the Test Set:
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study is more common for diagnostic imaging devices or software. The device here is an I.V. catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a physical medical device (an I.V. catheter), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The described testing (physical, visual) is standalone performance for the device itself.
7. The Type of Ground Truth Used:
The "ground truth" for the described testing appears to be:
- Established engineering/design specifications: For physical testing.
- ISO Standard 10993 requirements: For biocompatibility.
- cGMP (Current Good Manufacturing Practices) for quality control: For manufacturing and release procedures.
There is no mention of pathology, outcomes data, or expert consensus as a ground truth for this specific device's performance. The comparison is to a predicate device for "substantial equivalence" based on materials, form, and intended use, implying that its safety and effectiveness are derived from its similarity to an already approved device.
8. The Sample Size for the Training Set:
This information is not applicable or provided. The device is a physical I.V. catheter, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this physical device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).