(157 days)
The Pinnacle™ TPN Management System Transfer Set is to be used with the Pinnacle TPN Management System, a gravimetric pharmacy compounding device.
The Pinnacle™ TPN Management System Transfer Set is intended to be used with the Pinnacle TPN Management System gravimetric pharmacy compounding device in the pharmacy to provide a sterile fluid path for the compounding of ingredients from multiple source containers into a final container.
The Pinnacle™ TPN Management System Transfer Set is available in a 6-lead or a 9- lead configuration with vented or non-vented spikes. The detachable lipid line may be used when compounding lipid formulations into a dual-chambered final container.
The provided text describes a medical device, the Pinnacle™ TPN Management System Transfer Set, and its 510(k) submission for regulatory clearance. However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed performance studies with acceptance criteria as typically found in clinical trials or dedicated performance validation reports. The FDA's letter states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is based on the device being "similar in intended use, operation and function" to the identified predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text, as this information is not present.
Here's a breakdown of why the requested information is absent and what types of information are provided:
- Acceptance Criteria & Reported Performance: Not present. The document focuses on showing similarity to predicate devices rather than independent performance against predefined criteria.
- Study Details: There is no description of a study designed to statistically prove performance against acceptance criteria. The 510(k) process primarily relies on demonstrating substantial equivalence, which often involves testing to ensure the new device functions similarly to the predicate, rather than a standalone clinical or performance study establishing new efficacy or safety thresholds.
- Sample Size (Test Set), Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: All of these details are typically associated with performance studies, especially for AI/ML devices or diagnostics where quantifiable metrics like sensitivity, specificity, or accuracy are established. Since no such performance study is detailed in this 510(k) summary, these points cannot be addressed.
The document primarily provides:
- Submitter and Device Information: Name, contact, device name, classification.
- Intended Use: The purpose of the device.
- Predicate Devices: Identification of existing devices to which the new device is compared for substantial equivalence.
- Description: Physical characteristics and configurations of the transfer set.
- FDA Communication: The FDA's letter confirming substantial equivalence and providing regulatory guidance.
To find the type of information you are requesting, one would typically look for a dedicated performance study report or clinical trial documentation, which is not part of this 510(k) summary.
§ 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.