(71 days)
Hospira Latex-Free Advanced Sensor Catheters:
Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling, A secondary indication is for the therapeutic infusion of solutions.
Hospira Latex-Free Critical Care Catheters:
Indicated for the assessment of hemodynamic status through right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling.
Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters:
Indicated for temporary transluminal ventricular pacing a temporary ventricular pacing lead.
The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters have multi-Iumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvO2), and access ports for drug delivery or blood sampling. In addition, the HOSPIRA Latex-Free Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the latex-free balloon.
The provided text describes a 510(k) summary for the HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the proposed device itself. The key study mentioned relates to the material of the new balloon.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific device performance acceptance criteria for the overall catheter system with corresponding reported results. Instead, it describes tests performed on the gamma sterilized Polyisoprene-Polyurethane balloon material.
| Acceptance Criteria (for the balloon) | Reported Performance (for the balloon) |
|---|---|
| Biocompatibility | Passed |
| Expansion Symmetry | Passed |
| Over Inflation | Passed |
| Multiple Inflations | Passed |
| Deflation Time | Passed |
| Burst Strength | Passed |
The overall device is stated to "meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate catheters." This statement implies an equivalency review rather than a direct performance study against novel criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the tests conducted on the Polyisoprene-Polyurethane balloon.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these would typically be lab-based, pre-clinical tests for a material change, not human clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study involving human readers. This type of study is not relevant for the described material and device equivalency assessment.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
There is no mention of a standalone performance study. This type of study is typically relevant for AI/software devices, which this is not. The described tests are material/physical performance tests.
7. Type of Ground Truth Used
For the balloon material tests, the ground truth would be based on engineering specifications and established test methodologies for biocompatibility, mechanical properties (expansion symmetry, over inflation, multiple inflations, deflation time, burst strength). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense for these specific tests as described.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are for material and device physical integrity.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" to establish ground truth for.
In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence of the new latex-free catheters to previously cleared predicate devices, primarily by showing that the new balloon material (Polyisoprene-Polyurethane) meets established performance and safety criteria, and that manufacturing process changes (gamma sterilization) are acceptable. The study highlighted is a set of laboratory tests on the balloon component, not a clinical study of the entire device's performance in humans against specific numerical clinical efficacy acceptance criteria.
§ 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).