(104 days)
The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for direct measurement and monitoring of fluid pressure.
Indications for the Transpac® III DSPT include: Intracranial Pressure Monitoring. Intrauterine Pressure Monitoring, or Compartmental (Intramuscular) Pressure Monitoring.
In addition, indications for the Transpac® III DSPT include: Direct arterial blood pressure monitoring - central and peripheral, Pulmonary artery monitoring, Venous pressure monitoring, Left atrial monitoring when used with an air eliminator filter, or Cardiac catheterization.
The Transpac III DSPT is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the Transpac® III DSPT include:
- the Transpac® III Disposable Straight Pressure Transducer module that houses a ceramic . transducer,
- . a luer connector with locking collar that can connect to an intravascular catheter,
- a transducer cable that can connect to a compatible pressure monitor using a hooded RJ-11 . connector,
- . A stopcock for altering direction of fluid flow.
The Transpac® III DSPT can be pole-mounted or patient mounted and is provided sterile and nonpyrogenic and is intended for one-time use.
The document provided is a 510(k) summary for a medical device called the Transpac® III Disposable Straight Pressure Transducer (DSPT). It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information on the acceptance criteria, the specific results of a study proving the device meets these criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods typically found in studies for AI/ML-based devices.
The relevant section, "Statement of Safety and Effectiveness," simply states: "The Transpace III DSPT has been tested for biocompatibility and physical and electrical requirements and has passed all acceptance criteria. The Transpac® III DSPT meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Transpac® II Disposable Transducer and predicate Disposable Transpac® III IT devices."
This statement confirms that testing was done and acceptance criteria were met, but it does not provide the details of those criteria or the study results themselves. This type of information is usually detailed in a separate test report or technical documentation, which is not part of this 510(k) summary.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).