(49 days)
The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.
B. Braun Medical's Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury. The Ultrasite Valve is designed to provide needle-free access on I.V. pump sets, gravity sets, and extension sets. The Ultrasite Valve is a needle-free, capless positive displacement valve to be used in place of needles for the administration of fluids. The Ultrasite Valve may be accessed with standard male luer connectors and requires no special accessory devices.
The provided text describes a 510(k) premarket notification for the "Ultrasite® Valve" and its substantial equivalence to a previously marketed device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in the way typically expected for an AI/ML medical device.
The document is a regulatory submission for a physical medical device (needle-free injection site), not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance, training sets, ground truth establishment, expert adjudication, and multi-reader multi-case studies are not applicable to this submission.
The "study" mentioned is a "Functional testing" which was performed to support that there are "no new issues of safety or effectiveness raised by the expanded indications for use for power injectors." The document does not provide details of this functional testing, such as specific acceptance criteria or performance metrics.
Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on substantial equivalence to a predicate device.
- Reported Device Performance: The document states that "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for power injectors." However, specific performance metrics from this testing are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Functional testing indicated no new safety/effectiveness issues for expanded indications (power injectors). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any functional testing.
- Data Provenance: Not applicable as it's a physical device and not relying on a dataset from specific countries for analysis. The testing would have been conducted on the device itself.
- Retrospective/Prospective: Not specified, but likely refers to lab/bench testing of the physical device.
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. The device is a physical medical device (needle-free injection site), not an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication method for the test set
- This question is not applicable. As above, it's a physical device, not an AI/ML algorithm.
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 question is not applicable. The device is a physical medical device and does not involve AI assistance or human readers in an MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical device.
7. The type of ground truth used
- This question is not applicable in the context of AI/ML ground truth (expert consensus, pathology, outcomes data). For a physical device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks for the physical device. The document implies comparison to the predicate device's performance and standard safety/effectiveness as per regulatory requirements.
8. The sample size for the training set
- This question is not applicable. The device is a physical medical device and AI/ML training sets are not relevant.
9. How the ground truth for the training set was established
- This question is not applicable. The device is a physical medical device and AI/ML training sets are not relevant.
§ 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.