(90 days)
The Intradyn Pediatric Hemostasis Introducers are designed to facilitate percutaneous introduction of catheters into the vascular system of pediatric patients while minimizing blood loss.
Hemostasis introducers are used to insert catheters into the vascular system without significant blood loss. The hemostasis valve attached to the sheath is the method of achieving the prevention of blood loss. The valve allows for the introduction of a catheter and provides a tight seal around the catheter being introduced, thus preventing excessive leakage of blood. A procedure to use this device would typically begin with a clinician using an introducer needle to create a puncture hole and then introducing a guidewire into the vasculature. A dilator and sheath are then threaded over the guidewire, and the dilator is removed and discarded. The clinician can then use the introducer sheath with the hemostasis valve to pass catheters through while minimizing blood loss. The introducers are to be used with a catheter of the same size as the designated sheath size, however a catheter one French size smaller may be used with all 4 French and larger introducers.
The pediatric introducer sets consist of a Teflon introducer sheath, hemostasis valve with a side port extension tube bonded to a three-way stopcock, polyethylene or nylon (3 Fr. Size) dilator and optional guidewire. The pediatric hemostasis introducer sheaths will range in size from 3 - 6 French and will have a sheath length of 7 cm. The guidewire sizes for use with these introducers will be 0.018 -0.021 inches.
The provided text is a 510(k) summary for the Intradyn™ Pediatric Hemostasis Introducers. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically seen with performance data for AI/ML-enabled devices or other complex systems.
Instead, this 510(k) focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through similarities in materials, functionality, design, manufacturing, sterilization processes, and indications for use.
Therefore, for most of your requested points, the information is not available in the provided document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics against defined acceptance criteria for the new device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of submission. This 510(k) does not describe a clinical performance study with a test set of data. It relies on the established safety and efficacy of the predicate devices.
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)
Not applicable. No ground truth establishment related to clinical performance data is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This device is not an AI/ML-enabled medical device, nor does the document describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it's a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth related to performance data is mentioned. The "ground truth" in a 510(k) for substantial equivalence often refers to the regulatory precedent and established safety/effectiveness of predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" described in this 510(k) is a comparison to predicate devices to demonstrate substantial equivalence, not a performance study measuring specific acceptance criteria.
- Rationale: The manufacturer asserts that the Intradyn™ Pediatric Hemostasis Introducers are "identical in materials, functionality, design and manufacturing and sterilization processes" to previously cleared B. Braun Medical Inc. Hemostasis Introducers (K894446 and K955820). They also state the pediatric introducers are "similar in indications for use and size" to the Fast-Cath introducers by Daig Corporation (K910861), and that the slightly smaller French size "does not raise any new issues of safety and efficacy."
- Outcome: The FDA concurred with the substantial equivalence determination, allowing the device to be marketed.
This approach is common for devices seeking 510(k) clearance when they are similar enough to existing devices that new clinical performance data is not deemed necessary to establish safety and efficacy.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).