LogoFDA 510(k) Search
K Number
K131452
Device Name
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
Manufacturer
ST. JUDE MEDICAL SYSTEMS AB
Date Cleared
2013-09-05

(108 days)

Product Code
DXO,DQX,DRG
Regulation Number
870.2870
Type
Traditional
Panel
CV
Reference & Predicate Devices
K113584
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

Device Description

The modified PressureWire™ is essentially a modification of the previously cleared PressureWire™ (K113584). The subject device, The subject and predicate device, PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris. PressureWire is available in different lengths.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (PressureWire™) and does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document states:

  • "A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission."
  • "The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
  • "Based on passing verification specification criteria for mechanical and signal testing along with chemical characterization and biocompatibility, PressureWire™ performs substantially equivalent to predicate devices."

However, the actual acceptance criteria, the specific studies performed, sample sizes, ground truth establishment methods, or expert involvement are not detailed in this public 510(k) summary. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113584) based on minor modifications.

Therefore, I cannot complete the table or answer the specific questions about the study within the provided text.

§ 870.2870 Catheter tip pressure transducer.

(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).