(90 days)
BMW's CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.
BMW Medical has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong PIC catheter on an open-ended midline catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter.
BMW Medical, Inc.'s midline catheters are single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in diameter to accommodate specific patient populations.
A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting.
The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the female luer of the proximal hub during aspiration of blood samples.
Here's a breakdown of the acceptance criteria and the study information for the BMW Medical, Inc.'s Clampless Valved Catheter-Midline (CVC-ML) as described in the provided text:
Important Note: The provided text is a 510(k) Premarket Notification summary, not a detailed study report. As such, many of the specific details usually found in a comprehensive clinical or performance study (like exact sample sizes, detailed ground truth establishment, expert qualifications, or MRMC study results) are not present in this summary. The information below reflects what can be extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Valve Function | Minimize potential for air embolism and bleedback. | "The valve included in the hub of the BMW CVC Midline catheter is at least as effective in minimizing these potentials as are the predicate devices, even when a guide wire or stylet stiffener is passed through the valve." |
| "Studies have shown that repeated insertion and removal of the guide wires or stylet through the valve does not compromise its function." | ||
| "The valve remains closed when the catheter is not in use. The valve opens inward... when fluids are infused... and it opens outward... during aspiration of blood samples." | ||
| Hemolysis | No hemolysis of blood. | "no hemolysis of blood is observed when aspirating blood through BMW's valve" |
| Aspiration Pressures | Low aspiration pressures. | "aspiration pressures are low." |
| Biocompatibility (Hub Material) | Meets biocompatibility requirements for the intended application. | "Published biocompatibility flow chart requirements indicate that BMW's hub material meets biocompatibility requirements, and is therefore acceptable for use in this catheter application." |
| Stiffness | Substantially equivalent to predicate devices. | "test data collected on the stiffness... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
| Elongation at Break | Substantially equivalent to predicate devices. | "test data collected on the... elongation at break... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
| Radiopacity | Substantially equivalent to predicate devices (visible). | "test data collected on the... radiopacity... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." (Also: "homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity.") |
| Flow Rate | Substantially equivalent to predicate devices. | "test data collected on the... flow rate... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
| Tensile Strength | Substantially equivalent to predicate devices. | "test data collected on the... tensile and burst strength... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
| Burst Strength | Substantially equivalent to predicate devices. | "test data collected on the... tensile and burst strength... demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
| Leak Test Data | No leaks. | "test data collected on the... leak test data demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "test data" and "studies" but doesn't quantify the number of catheters or tests conducted for each performance characteristic.
- Data Provenance: Not specified. It's implied to be internal testing by BMW Medical, Inc. The text does not mention country of origin, nor whether the data is retrospective or prospective. Given the nature of a premarket notification for a physical device, these would almost certainly be prospective lab/bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's likely that internal engineers or quality control personnel performed the tests. The "Published biocompatibility flow chart requirements" would have been established by external, recognized standards bodies, not individual experts for this specific submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. The performance tests described (e.g., stiffness, flow rate, leak tests, hemolysis observation) are objective, quantitative measurements or observations that do not typically involve human adjudication in the sense of consensus on an interpretation.
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
- MRMC Study: No. This is a physical medical device (catheter), not an AI diagnostic or image interpretation system. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for most performance claims appears to be:
- Predicate Device Performance: Direct comparison to the established performance characteristics of the Bard Groshong PIC catheter and the HDC V-Cath® Midline catheter. The goal is "substantial equivalence," meaning its performance is "at least as effective" or "substantially equivalent" to legally marketed predicate devices.
- Biocompatibility Standards: "Published biocompatibility flow chart requirements." These are established industry or regulatory standards.
- Direct Physical Measurement/Observation: For characteristics like hemolysis, aspiration pressures, stiffness, radiopacity, flow rate, and strength, the ground truth is derived from direct measurements and observations during bench testing.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning. The reference to "test data collected" implies performance testing, not model training.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment relevant to that context.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”