(252 days)
The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples.
BMW's Needlefree Valved Connector is a rigid plastic adapter with a male luer port on the distal end for attachment to I.V. access systems (e.g., catheters). The proximal end terminates in a female luer lock fitting which may be attached to any I.V. administration set terminating in a standard male luer. The female luer is capped when napt in use to minimize the potential for contamination.
The plastic adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve is normally closed when it is not in use. The valve opens towards the I.V. access system when fluids are infused into the patient and it opens away from the I.V. access system to permit 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 by a bond between the proximal and distal pieces of the adapter. The connector valve is packaged in a sterile blister pack with male luer cap(s). The caps will also be packaged and sold individually.
This device is a physical medical device (Needlefree Valved Connector and Cap), not an AI/ML powered software, therefore, many of the requested categories are not applicable. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria typical for novel devices or software.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as might be expected for an AI/ML device or a device with new performance claims. Instead, the performance is described in terms of substantial equivalence to existing predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs the same intended functions as predicate devices. | The valve remains closed when not in use. The valve opens toward the distal end of the I.V. administration system (catheter) when fluids are infused. The valve opens away from the I.V. device to permit aspiration of blood samples. |
| Physical Equivalence: Physical characteristics are substantially equivalent to a predicate device, with differences not raising new safety or efficacy questions. | Physical characteristics are substantially equivalent to the hub of BMW's Clampless Valued Catheter, except for attachment mechanisms (male luer lock vs. tapered barbed extension). The male luer lock attachment meets ANSI standards. |
| Safety and Efficacy: No new questions of safety and efficacy are raised compared to predicate devices. | The male luer lock attachment of the Needle Free Connector meets ANSI standards and "poses no new questions of safety and efficacy to the user." Offers the same needlefree access features as Braun's Safsite, reducing accidental stick risk. Both must be capped when not in use to minimize contamination. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. Given this is a physical device submission focused on substantial equivalence, the "test set" would likely refer to engineering verification and validation testing (e.g., flow rate, pressure, material compatibility, leak testing, functional cycling), rather than a clinical dataset in the AI/ML context. The document does not detail specific sample sizes for these tests or their provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. For a physical medical device like this, "ground truth" as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant. Performance is typically assessed against engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are common in clinical studies where expert disagreement needs to be resolved for ground truth establishment. This type of submission relies on engineering testing and comparison with predicate devices.
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. This is a physical medical device, not an AI/ML software, and therefore, an MRMC study related to human readers improving with AI assistance would not be performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on:
- Engineering Specifications: Adherence to design requirements (e.g., luer lock meeting ANSI standards).
- Functional Performance Comparison: Demonstrating that the device performs functionally identically to the predicate device (e.g., valve opening/closing as intended for infusion and aspiration).
- Safety Profile: Assurance that design differences do not introduce new safety concerns, implicitly relying on established safety profiles of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.