(425 days)
The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.
The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. 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.
The BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems are closed system IV catheters designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing (4.0 IN), and a Luer connector. The 24G and 26G products are also provided with 2.8 IN extension tubing. The system incorporates an integrated extension set which is available in multiple configurations: 1) Y connection (dual port) with a PRN adapter or needleless connector (MaxZero) and end cap; 2) Y connection (dual port) with two PRN adapters or two needleless connectors (MaxZero); 3) Y connection (dual port) with one PRN adapter and one needleless connector (MaxZero); and 4) Straight connection (single port) with a PRN adapter or needleless connector (MaxZero). The Luer connectors are color-coded to indicate catheter gauge size.
This is a 510(k) premarket notification for a medical device (intravascular catheter), not an AI/ML device. Therefore, the requested information categories concerning AI/ML device performance (such as sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this document.
However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets them for the BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."
The acceptance criteria are implicitly derived from the types of tests conducted, which are standard for intravascular catheters and needleless connectors. The "reported device performance" is a general statement of compliance rather than specific numerical results.
| Acceptance Criteria Category (Derived from Tests) | Reported Device Performance (Summary from Document) |
|---|---|
| Needleless Connector Performance | Met predetermined design requirements. |
| Needleless Connector Removal Torque | Met predetermined design requirements. |
| Needleless Connector Leakage Pressure | Met predetermined design requirements. |
| Needleless Connector Microbial Ingress | Met predetermined design requirements. |
| Needleless Connector EtO Sterilization Compatibility | Met predetermined design requirements. |
| Catheter System Performance | Met predetermined design requirements. |
| Flow rate | Met predetermined design requirements. |
| Back pressure | Met predetermined design requirements. |
| Insertion force | Met predetermined design requirements. |
| Droplet size | Met predetermined design requirements. |
| Droplet separation | Met predetermined design requirements. |
| Activations | Met predetermined design requirements. |
| Shelf-Life | Met predetermined design requirements. |
| Qualification of 26G catheters | Met predetermined design requirements. |
| Lie distance (ISO 10555-1, §4.4.2) | Met predetermined design requirements. |
| Needle tip sharpness (ISO 10555-5, §4.3.3.2) | Met predetermined design requirements. |
| Joint strength (ISO 10555-5, §4.3.3.4) | Met predetermined design requirements. |
| Flow rate (ISO 10555-1, §4.9) | Met predetermined design requirements. |
| Pressure Withstand (300psi for specific configs) | Verified to withstand pressure up to 300psi. |
| Burst and leaking testing (ISO 10555-1, §4.10) | Met predetermined design requirements. |
| Material/Biocompatibility | Met predetermined design requirements. |
| Particulate Matter testing per USP | Met predetermined design requirements. |
| Microbial Ingress testing | Met predetermined design requirements. |
| MR Compatibility per ASTM F2182-19 | Met predetermined design requirements. |
| Biocompatibility (various ISO 10993-1 tests) | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. It generally refers to "performance tests" being completed.
The data provenance is internal to Becton Dickinson, as indicated by "BD internal" next to several tests. The studies are prospective in the sense that they are conducted to verify design changes for market approval. The country of origin is not explicitly stated for the test execution, but the submitter is based in Sandy, Utah, USA.
The studies relate to the subject devices (BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System with new configurations and modifications) in comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics defined by engineering specifications and international standards (e.g., ISO, ASTM, USP).
4. Adjudication method for the test set
Not applicable in the context of this device type. Performance is measured against predefined engineering and regulatory specifications, not subject to human adjudication for accuracy or diagnosis.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth used for these performance tests is based on:
- Established engineering specifications and design requirements for the device's physical and functional performance.
- International standards such as ISO 10555-1, ISO 10555-5, ASTM F2182-19.
- Pharmacopeial standards such as USP for particulate matter testing.
- Biocompatibility standards guidance from ISO 10993-1:2009 and FDA guidance.
These are objective, measurable outcomes rather than expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of AI/ML.
§ 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).