(27 days)
The AccuCath™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath™ IV Catheter is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
The AccuCath™ Intravascular Catheter has usable length catheters of 1.25 and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The AccuCath™ IV Catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. The AccuCath™ IV Catheter is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, and a guidewire within the lumen of the needle which is connected to a slider, spring and release button.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Length of Catheter | Test and report catheter length | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
| Safety Activation | After deployment of the needle safety feature, the needle tip shall be sub-flush with the distal end of the housing | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
| Gravity Flow | Test and report gravity flow rate with a 1000mm head pressure of water | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
| Bleedback | No egress of blood over a period of 15 seconds | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
| Guidewire Deployment/Retraction | Guidewire to deploy and retract smoothly per predetermined force requirements | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
| Catheter Flashback | Flash is visible inside the catheter within a predetermined amount of time | The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set. However, it indicates that "Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30." The data provenance is implied to be from in-house testing conducted by Bard Access Systems, Inc., as the tests were performed "in conjunction with in-house protocols." The country of origin of the data is not explicitly stated. It is a prospective study as tests were actively performed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described appears to be primarily laboratory-based performance testing rather than studies requiring expert interpretation or ground truth establishment based on clinical data.
4. Adjudication Method for the Test Set
This information is not provided in the document, as the described tests are objective performance evaluations rather than judgmental assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes engineering and performance verification tests for the medical device itself, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device (AccuCath™ Intravascular Catheter) is a physical medical device, not an algorithm or AI system. The tests performed are on the physical properties and functionality of the catheter.
7. The Type of Ground Truth Used
For the performance tests conducted, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO, ASTM), and in-house protocols by which the device's physical and functional characteristics were objectively measured and compared. It is not an expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical catheter, not an AI or machine learning model that requires a training set. The "training" in the context of device development would refer to the iterative design and development process, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this physical medical device. The "ground truth" for the device's design and manufacturing would be established through engineering principles, regulatory standards, and established material science, which guided its development.
§ 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).