(210 days)
The FirmGrip 101 Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.
The FirmGrip™ peripherally inserted catheter includes a typical midline catheter encapsulated in a specially designed protective sleeve, to produce a self-contained clean catheter insertion field. The catheter contains a stiffening guidewire for additional contribution to ease of insertion and for catheter's internal air volume reduction. Both the catheter and guidewire remain protected throughout the entire catheter insertion procedure and is not exposed to the outer environment or to any hand contact. The protective sleeve back side is closed with a Tortuous Path Disc (TP Disc) which closed it and provides additional protection. Being the catheter protected by the sleeve, may save the need of using a sterile sheet since the sleeve may replace it. The protective sleeve enables manipulation and insertion of the catheter without interfering the protective sleeve's internal clean field. Once the catheter is properly placed in the blood vessel, both protective sleeve and the guidewire are removed and discarded. The FirmGrip™ is packed in an individual sterile pack and is sterilized by EtO. A needle assembly unit contains a specially designed adapter, called "PeelGuard", and a PeelAway needle introducer is supplied with the FirmGrip or separately. The needle assembly unit has its own individual package and is sterilized by EtO as well. The operation mechanism for the modified device is the same as the original device. The protective sleeve's handgrip portion, in its front side, has an accordion-shape which helps to promote the catheter with each intermittent grasping and pushing it forward. Once both the sleeve and the wire are removed, the catheter remains inside the vein. The catheter luer connector and a short portion of the catheter remain outside of the body and used as an access port for the medical treatment. The soft materials used for the catheter and PeelGuard make the connections more flexible, easy to use for the medical staff and more convenient for the patient.
The provided document describes a 510(k) submission for the FirmGrip™ Peripherally Inserted Catheter Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through extensive clinical trials as might be seen for a new drug or a PMA device.
Therefore, the information regarding acceptance criteria and study details will be limited to what is relevant for establishing substantial equivalence for a Class II device of this nature.
Here's an analysis of the provided text with respect to your requested information:
1. A table of acceptance criteria and the reported device performance
The document states: "The modified device was tested with according to Flexicath's legally marketed device specification and all acceptance criteria were met."
However, no specific acceptance criteria or detailed reported device performance are provided within this document. This is typical for a 510(k) summary, which generally does not include proprietary testing details or internal specifications. The conclusion paragraph indicates that nonclinical tests demonstrated the device's safety and effectiveness compared to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | All acceptance criteria were met as per Flexicath's legally marketed device specifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "New device verification and validation tests" and "nonclinical performance data," but it does not specify the sample size used for the test set, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). Given that this is a nonclinical performance study for a device, the "data provenance" would typically refer to the testing lab and the conditions under which the tests were performed (e.g., in-house, third-party lab).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information (experts for ground truth) is not relevant for a nonclinical performance study of a peripherally inserted catheter device. Ground truth established by experts is typically a concept applied to diagnostic devices or AI algorithms that interpret medical images or data. For a catheter, performance is evaluated through engineering tests, biocompatibility tests, and potentially animal or human cadaver studies, not by expert consensus on clinical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, adjudication methods are not applicable to the nonclinical performance testing described for this device. Adjudication is used to resolve disagreements in interpretations, often in clinical trials or studies involving human judgment (e.g., reading medical images).
5. 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
No MRMC comparative effectiveness study was done, nor would it be expected for this type of medical device. MRMC studies are specific to diagnostic imaging devices or AI-powered interpretative tools where human "readers" (e.g., radiologists) review cases. This device is a catheter, not an interpretive tool. No mention of AI assistance is made.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the FirmGrip™ Peripherally Inserted Catheter Device. This device is a physical medical instrument, not an algorithm or an AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, "ground truth" would refer to the established engineering specifications and performance benchmarks for catheter functionality (e.g., tensile strength, flow rate, insertion force, biocompatibility, sterility). The document states testing was done "according to Flexicath's legally marketed device specification," implying that the ground truth was established by these internal specifications and relevant industry standards for catheter performance and safety. It would not be based on expert consensus, pathology, or outcomes data in the same way an imaging or diagnostic device would.
8. The sample size for the training set
There is no "training set" for this device in the context of machine learning or AI. Training sets are used to develop and refine algorithms. This is a physical medical device, and its development involves engineering design, material science, and manufacturing processes, not algorithmic training.
9. How the ground truth for the training set was established
As there is no "training set" for this device, this question is not applicable.
§ 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).