(88 days)
BD Cathena™ Safety IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
BD Cathena™ Safety IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ catheter, a needle, a grip, a passive safety needle shield, and a flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. BD Cathena™ Safety IV Catheter has BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
BD Cathena™ Safety IV Catheter is available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.
BD Cathena™ Safety IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).
The FDA 510(k) clearance letter for the BD Cathena™ Safety IV Catheter (K251155) indicates that the submission is for manufacturing changes (new colorant supplier, new needle lubricant supplier) and the creation of new performance specifications for existing indications for use (blood sampling and blood pressure monitoring) rather than a novel AI/ML device. Therefore, a traditional acceptance criteria and study proving device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or standalone algorithm performance, as typically understood in AI/ML medical devices, is not applicable here.
However, based on the provided document, the acceptance criteria and supporting studies are related to demonstrating that the modified device maintains substantial equivalence to its predicate for its stated indications for use, including the new performance specifications.
Here's an interpretation of the relevant information provided:
I. Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally understood as the "predetermined design requirements" that the device must meet. The document states that the subject device met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but the successful completion of these tests serves as evidence of meeting those criteria.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Blood Fill Time | Met predetermined design requirements (new performance specifications created and tested). |
| Frequency Response | Met predetermined design requirements (new performance specifications created and tested). |
| Catheter Kink Resistance | Met predetermined design requirements (new performance specifications created and tested). |
| Average System Drag | Met predetermined design requirements (tested). |
| Air Vent Time | Met predetermined design requirements (tested). |
| Procedural Leak Time | Met predetermined design requirements (tested). |
| Instaflash Time | Met predetermined design requirements (tested). |
| Biocompatibility | Assessed and adopted from a representative BD device (K201075) utilizing the same intended use, device materials, and manufacturing processing, implying acceptance criteria for biocompatibility were met. |
| Sterilization (ISO 11135 & ISO 10993-7) | Met applicable standards requirements (tested). |
| Luer Connections (ISO 80369-7) | Met applicable standards requirements (tested). |
| Material Equivalence (Colorant & Lubricant) | Design verification testing performed to demonstrate equivalence after supplier changes, implying acceptance criteria for material performance were met. |
II. Sample Size and Data Provenance for Test Set
The document does not specify exact sample sizes for each performance test (e.g., number of catheters tested for Blood Fill Time, Kink Resistance, or Frequency Response). However, it implies that sufficient samples were tested to "ensure that the subject device meets pre-determined design requirements."
The "test set" in this context refers to the samples of the subject device used for physical and functional testing. The provenance of these samples would be prospective, as they are newly manufactured devices undergoing verification for the submission. No information is provided regarding the country of origin of this test data, but it would typically be generated at the manufacturer's testing facilities or authorized contract labs.
III. Number of Experts and Qualifications for Ground Truth
This question is not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic or predictive performance requiring expert interpretation for ground truth. The "ground truth" for the performance tests (e.g., Blood Fill Time, Kink Resistance) is established through standardized laboratory measurement methods and engineering specifications, not expert consensus on medical images or clinical outcomes.
IV. Adjudication Method for Test Set
Not applicable. As described above, the tests are objective physical and functional performance assessments, not subjective interpretations requiring adjudication.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is typically conducted for diagnostic imaging devices or AI tools where human readers are interpreting cases. This submission is for an intravascular catheter, a physical medical device. The "new performance specifications" are related to the physical and functional characteristics of the catheter (e.g., how quickly blood fills, how well it resists kinking for pressure monitoring), not to aiding human interpretation of medical data. Therefore, a study comparing human readers with and without AI assistance is not relevant or reported here.
VI. Standalone (Algorithm Only) Performance
Not applicable. The BD Cathena™ Safety IV Catheter is a physical medical device and is not an AI algorithm. Its performance is assessed through physical and functional bench testing.
VII. Type of Ground Truth Used
The "ground truth" here is based on engineering specifications and standardized test methods. For example:
- Blood Fill Time: Measured against a specific time objective.
- Frequency Response: Measured against a defined physiological frequency range for accurate blood pressure monitoring.
- Kink Resistance: Measured against criteria for maintaining lumen patency under stress.
- Biocompatibility: Assessed against ISO 10993 standards.
- Sterilization: Assessed against ISO 11135 standards.
- Luer Connections: Assessed against ISO 80369-7 standards.
These are objective, quantitative measurements derived from established industry standards and internal design requirements, not from clinical outcomes, pathology, or expert consensus in a diagnostic sense.
VIII. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
IX. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).