(167 days)
The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.
The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.)
This is a medical device 510(k) premarket notification summary for the PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, and the provided text focuses on the device's technical characteristics and non-clinical performance data. There is no information in the provided text that describes a study comparing the device's performance against acceptance criteria using patient data or expert assessments. The information primarily covers device description, intended use, and a comparison of features with predicate devices.
Therefore, the following information is not available in the provided text:
- Acceptance criteria table and reported device performance based on a study of that nature.
- Sample size used for the test set and data provenance specific to such a study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a performance study.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on non-clinical performance testing and biocompatibility, as stated:
"The successful results of the key tests involving dynamic response, fiber optics, flow rates, leakage, force at break, lead tubing, markings, priming volumes, radiopacity, needlefree connector compatibility, and catheter to introducer fitment demonstrate that the proposed PICCOx Peripherally Inserted Central Venous Oximetry Catheter has met the pre-determined acceptance criteria applicable to the safe use of the devices."
This indicates that internal performance specifications were met through non-clinical bench testing, but these acceptance criteria and results are not detailed in a way that allows for filling out the requested table. The summary confirms that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, the device "has been tested in accordance with its performance specification which accommodates known functional requirements."
Without further details on these specific "performance specifications" and their corresponding results, the requested table and other study-related information cannot be generated from the given text.
§ 870.1230 Fiberoptic oximeter catheter.
(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).