(127 days)
The STA Cath® Attachable Infusion Catheter is intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The STA Cath Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.
The STA Cath® Attachable Infusion Catheter is an open end style catheter similar to the Alpha Cath™ Infusion Catheter. This catheter consists of a length of PVC tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked.
The distal end of the catheter has a short length of tubing attached to it. A loop of monofilament extends beyond both ends of this attached tube, and is used by the physician to draw a 4-0 suture, placed at an attachment site in the patient, through the attached tube in order to temporarily hold the catheter in place.
The provided document is a 510(k) summary for the STA Cath® Attachable Infusion Catheter. This document is a regulatory submission to the FDA, detailing the device's characteristics and its substantial equivalence to existing predicate devices. It does not contain acceptance criteria for performance studies, nor does it describe specific studies proving a device meets such criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity).
The document's purpose is to establish "substantial equivalence" to predicate devices, which means demonstrating the new device is as safe and effective as a legally marketed device. This is typically achieved through comparisons of technological characteristics, intended use, and sometimes non-clinical performance data (e.g., biocompatibility, sterilization validation, mechanical testing), rather than clinical efficacy studies with acceptance criteria as one would find for an AI/ML medical device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are also not applicable or present in this type of regulatory submission for a physical medical device.
To directly answer your request based on the provided document:
- A table of acceptance criteria and the reported device performance: Not applicable. The document establishes substantial equivalence to predicate devices, not discrete acceptance criteria for performance metrics.
- Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study with sample sizes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set with ground truth established by experts.
- Adjudication method 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. This is not an AI/ML device, and no MRMC study is described.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
The "study" presented here is essentially the argument for substantial equivalence based on comparing the device's design and intended use to existing, legally marketed devices.
Key points from the document related to "proving" the device:
- Technological Comparison: The document states, "There is no new technology added in the construction of the STA Cath® Attachable Infusion Catheter compared to the Alpha Cath Infusion Catheter." The difference is an "attachment feature" which allows the catheter to be temporarily attached to body tissues.
- Substantial Equivalence Argument: The attachment feature is compared functionally to similar retention features on other catheters like "suture holes on the connectors of hemodialysis catheters, the implantable cuffs on hemodialysis and central venous catheters, the balloons on Foley catheters, and the pigtails on urethral catheters."
- Conclusion: "The STA Cath® Attachable Infusion Catheter is substantially equivalent to the existing Alpha Cath™ Infusion Catheter in design and operation and is substantially equivalent to other catheters such as Foley catheters which use a temporary means to hold the catheter in place during use."
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).