(91 days)
BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have 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.
These devices are 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.
These devices are 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). These devices are not made with natural rubber latex.
The provided document is a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to specifically answer questions about acceptance criteria and comprehensive study details like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for AI/human performance studies.
The document focuses on demonstrating substantial equivalence to a predicate device (K192443) for minor modifications, primarily the introduction of 16 GA configurations and updates to specifications and instructions for use. It primarily relies on leveraging data from the predicate device and internal BD studies for specific performance tests.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."
However, the specific "predetermined acceptance criteria" and the "reported device performance" are not explicitly listed in a table format in the provided text. The tests performed are:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Force to break adhesion between catheter unit and needle (initial adhesion) meets specifications | Met predetermined design requirements |
| Force to remove needle from catheter unit (average system drag) meets specifications | Met predetermined design requirements |
| Catheter separation force meets specifications | Met predetermined design requirements |
| Blood escape time meets specifications | Met predetermined design requirements |
| Procedural leak time meets specifications | Met predetermined design requirements |
| Testing per ISO 10555-1:2014 meets specifications | Met predetermined design requirements |
| Testing per ISO 10555-5:2013 and ISO 23908:2011 meets specifications (leveraged from predicate) | Met predetermined design requirements |
| EO residuals per ISO 10993-7:2008 meets specifications (leveraged from predicate) | Met predetermined design requirements |
| Sterilization validation per ISO 11135:2014 meets specifications (leveraged from predicate) | Met predetermined design requirements |
| Biocompatibility in accordance with ISO 10993-1:2018 and FDA guidance meets specifications (leveraged from predicate) | Met predetermined design requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "BD Internal Studies" for some tests, but details about sample size or data provenance (retrospective/prospective, country of origin) are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. This device is a physical medical device (intravascular catheter), not an AI-powered diagnostic or decision support system that typically requires expert-established ground truth for its performance evaluation (e.g., in reading medical images). The testing involves physical properties and performance characteristics of the catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As mentioned above, this type of testing is not relevant for the evaluation of a physical medical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This device is a physical invasive medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests conducted, the "ground truth" would be defined by engineering specifications, industry standards (e.g., ISO), and known physical properties of materials. For example, the "ground truth" for "force to break adhesion" would be a specific measurable force value derived from engineering design and safety requirements. Biocompatibility relies on well-established testing protocols and standards.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical product, not an AI system that requires a "training set" in the machine learning sense. The term "training set" is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As stated above, the concept of a "training set" and its "ground truth" is not relevant to the evaluation of this physical medical device.
§ 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).