(207 days)
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
Intravascular catheters are single use devices which provide access to veins or arteries.
The provided text describes a 510(k) summary for Johnson & Johnson Medical's intravascular catheters, specifically addressing an additional indication for use with power injectors.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence for an additional indication for use (power injectors) for existing intravascular catheters. Therefore, the "acceptance criteria" are implied by whether the device performs comparably to predicate devices for this new use case, and whether it aligns with the power injector specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Appropriateness for use with power injectors rated for a maximum of 300 psi | Bench data demonstrates that the 16 to 24 gauge JJM catheters are appropriate for use with power injectors rated for a maximum of 300 psi. |
| Technological characteristics are the same as predicate devices for this new indication | The Johnson & Johnson Medical (JJM) catheters have the same technological characteristics as the predicate devices. No changes (materials, specifications, manufacturing and sterilization processes) have been made to the currently-marketed catheters. |
| Use with power injectors claim is the same as predicate Becton-Dickinson catheters' claim. | The use with power injectors claim is the same as the Becton-Dickinson catheters claim for use with power injectors. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "bench data," which implies testing was performed on a sample of the 16 to 24 gauge JJM catheters. The exact number of catheters tested is not provided.
- Data Provenance: The data is generated from "bench data," indicating laboratory or engineering testing. The country of origin is not specified, but the applicant is Johnson & Johnson Medical in Arlington, TX, USA, suggesting the testing was likely conducted in the US or under their supervision. The study is prospective in the sense that new testing was performed to support the additional indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This submission describes physical performance testing ("bench data") rather than a study requiring expert interpretation of medical images or clinical outcomes. Therefore, there is no "ground truth" established by experts in the typical sense for a diagnostic device. The ground truth for performance would be based on engineering specifications and measurement devices.
4. Adjudication Method for the Test Set
N/A. This is not applicable to bench testing of physical device performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an intravascular catheter, and the evaluation focused on its physical performance with power injectors, not on diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done in the form of "bench data." This tested the device's physical capabilities (specifically, catheter integrity and suitability) with power injectors without human intervention in the performance measurement.
7. The Type of Ground Truth Used
The ground truth used was engineering specifications and physical measurement data. The "bench data" would have involved measuring the catheter's ability to withstand pressure, maintain integrity, and facilitate flow under conditions mimicking power injector use, compared against established engineering standards or predicate device performance.
8. The Sample Size for the Training Set
N/A. Since this involves physical device performance testing ("bench data") to support an additional indication, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
N/A. This concept is not applicable as there is no training set mentioned or implied for this type of device evaluation.
§ 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).