(84 days)
BMW's central venous catheters are designed for the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as for blood withdrawal.
BMW Medical has developed a central venous catheter that provides the clampless valve features of the Groshong catheter on an open-ended Hickman catheter. The BMW valve is external to the central venous system and is protected inside an adapter attached to a Hickman-type catheter. This configuration provides the advantages of a normally closed three-way valve while avoiding the influences of the central venous system and continuous direct blood contact that can potentially interfere with the function of the Groshong three-way valve.
BMW Medical, Inc.'s central venous catheters are configured as long-term 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 length and diameter, specific sizes designed for pediatric and adult populations.
A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the barbed end of 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 proximal hub during aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position and bonded between the proximal (female luer) and distal (barbed) pieces.
In addition to central venous catheters. BMW intends to market a surgical tunneler which is used to form a subcutaneous tunnel from the catheter exit site, in the area just below the patient's nipple, to the entrance site near the patients mid-clavicular area.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BMW Medical Inc. Clampless Valved Catheter:
Lack of Specific Acceptance Criteria and Dedicated Study:
It's important to note that the provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove a device meets specific, pre-defined performance acceptance criteria through an independent study in the traditional sense of a clinical trial for a novel device. The document primarily relies on comparison to predicate devices and bench testing to show similar or superior performance.
Therefore, many of the requested elements (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and ground truth for training data) are not applicable or not explicitly detailed in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary focused on substantial equivalence through comparison, "acceptance criteria" here are implicitly linked to the performance of the predicate devices according to FDA guidance.
| Acceptance Criterion (Implicitly based on Predicate Devices and FDA Guidance) | Reported Device Performance (BMW Clampless Valved Catheter) |
|---|---|
| Physical Characteristics: | |
| - Dimensions (length, diameter) | - Identical to Hickman/Broviac predicate devices for all items in FDA Guidance on Premarket Notification for Intravascular Catheters. Minor difference in priming volume for 2.7F catheter (greater than Broviac due to hub size). |
| - Radiopacity (presence of BaSO2) | - Composed of silicone rubber mixed with barium sulfate (BaSO2) to impart radiopacity. |
| - Valve mechanism (three-way valve functionality) | - Valve located in adapter (proximal end), external to central venous system. Remains closed when not in use. Opens inward for infusion, outward for aspiration. |
| - Tunneler design | - Shorter than Hickman/Broviac tunneler. No new safety or effectiveness issues. |
| Functional Performance (Bench Testing): | |
| - Infusion Direction (e.g., resistance, flow, air embolism prevention) | - Superior performance compared to Groshong predicate devices. Retains a greater column of water before opening, minimizing potential for air embolism. |
| - Aspiration Direction (e.g., blood sample withdrawal, bleedback prevention) | - Superior performance compared to Groshong predicate devices. Effectively prevents bleedback, but negative aspiration pressures are not so great that they cause blood damage. |
| - No new safety or effectiveness issues | - External location of BMW three-way valve and shorter tunneler pose no new safety or effectiveness issues. |
| Overall Performance: | - Performed identically to, or better than, the predicate devices for all performance characteristics studied. |
Details on the "Study" (Assessment of Performance Data)
The "study" referred to is primarily an assessment of performance data from bench tests comparing the BMW catheter to predicate devices, rather than a singular, large-scale, standalone study with human subjects.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "performance test results" and "comparisons." These typically involve a statistically relevant number of devices or components undergoing bench testing, but the exact N is not provided.
- Data Provenance: The tests were conducted internally by BMW Medical Inc. as part of their 510(k) submission. No country of origin for observational data is mentioned, as it primarily involves bench testing. It is inherently retrospective in the sense that the data supports a pre-existing design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not specified. "Ground truth" in this context would typically refer to expert consensus on clinical outcomes or image interpretations. Since this is primarily bench testing for substantial equivalence, such a concept isn't directly relevant or detailed in the submission. The "truth" is based on established engineering and medical device performance standards.
4. Adjudication Method for the Test Set
- Not applicable / None specified. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. This document focuses on physical and functional bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was NOT done. MRMC studies are specific to evaluating diagnostic algorithms or imaging interpretation by multiple human readers. This submission is for a physical medical device (catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This question is relevant for AI/software devices. The BMW catheter is a physical medical device; its performance is standalone in the sense that it functions physically but not "algorithm-only."
7. The Type of Ground Truth Used
- The "ground truth" for the performance comparisons was based on bench testing standards and established performance characteristics of the predicate devices (Hickman/Broviac and Groshong catheters) as outlined in the "FDA Guidance on Premarket Notification [(510(K)] Submission for Short-Term and Long-Term Intravascular Catheters."
8. The Sample Size for the Training Set
- Not applicable / Not specified. There isn't a "training set" in the context of a new algorithm. The BMW catheter's design and manufacturing processes would have been developed through R&D, but this isn't analogous to an algorithm's training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8. The "truth" for the design would be based on engineering principles, material science, and the known characteristics of successful existing catheters.
§ 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.”