(194 days)
The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements.
PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.
The pressure injectable EOCVC Oligon catheters are indicated for short term (
The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.
The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.
The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties.
Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood.
The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane.
A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician.
The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.
The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission.
This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.
The provided text is a 510(k) summary for the Edwards Oximetry Central Venous Catheter (EOCVC), Edwards Oligon Oximetry Central Venous Catheter, and PediaSat Oximetry Catheters. The submission aims for clearance of proposed modifications to accessories (suture loop, box clamp, and dilator) for use with previously cleared catheters. The study described focuses on demonstrating the substantial equivalence of these modified accessories to predicate device accessories.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Accessories' Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence (Accessories perform their intended function similarly to predicate devices) | Testing was conducted to compare the performance and functionality of the EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter accessories to the predicate device accessories. |
| Safety Equivalence (Accessories are as safe as predicate devices) | The accessories to the EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheters were shown to be safe... and substantially equivalent to the predicate device for its intended use. Functional and performance testing included biocompatibility. |
| Performance Testing Requirements (Specific tests verifying accessory function and integrity) | The accessories to the EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheters have successfully passed functional and performance testing, including: visual inspection, tensile strength, retention force, insertion test, guidewire passage, and dimensional verifications. Test data established that the proposed modifications to accessories have been shown to be equivalent to the predicate devices for their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the functional and performance testing of the accessories. It only mentions that "Testing was conducted." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These studies are typically conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The testing described appears to be primarily bench testing and performance verification against engineering specifications, rather than clinical studies requiring expert ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective evaluations (e.g., image interpretation). The tests described are objective engineering and performance verification tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device on human reader performance, usually in diagnostic imaging. The submission focuses on the substantial equivalence of modified catheter accessories through bench and performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical catheter and its accessories, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for these tests would primarily be engineering specifications and established performance benchmarks derived from the predicate devices and industry standards. For example, "tensile strength" would be compared against a defined maximum or minimum force, and "dimensional verifications" against specified measurements.
8. The Sample Size for the Training Set
Not applicable. The described study is not a machine learning study requiring a training set. It involves physical product testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device submission.
§ 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).