(391 days)
To Administer Blood to the patient's vascular system.
To administer Blood and Blood Derivatives into a patient's vascular system
The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.
The provided document describes the PENTATRASFU™ Blood Transfusion Sets and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device. Therefore, the information required for this request (AI/ML acceptance criteria, study details, expert involvement, etc.) is not present in the provided text.
However, I can extract the information related to the performance testing and compliance with standards as described for this medical device.
Here's the information as best as can be extracted from the provided text, focusing on the performance criteria and testing mentioned for the PENTATRASFU™ Blood Transfusion Sets:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance based on ISO 1135-4 Second Edition 1998-03-15 Transfusion Equipment for Medical Use - Part 4 Transfusion Sets for Single Use | The results of the Performance Testing showed that these Blood Transfusion Sets met the testing requirements as described on the ISO 1135-4 Recognized Guidance Document. |
| Biocompatibility based on FDA recognized standard 10993 | Biocompatibility testing of these Blood Transfusion Sets showed the materials to be biocompatible for their intended use. |
| Sterility | The device is described as Sterile. |
| Non-Pyrogenic | The device is described as Non-Pyrogenic. |
| Non-toxic | The device is described as Non-toxic. |
| Mechanical Properties and Functioning | The PENTATRASFU™ blood Transfusion Sets have been subjected to performance and safety testing to verify mechanical properties and functioning. |
| Substantial Equivalence to Predicate Devices | Substantially equivalent based on same intended use, instructions, biocompatible materials (PVC tubing, Polyethylene, White PVC, Natural Rubber), similar design, same principle of operation, and no new or different characteristics that affect safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance Testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The testing mentioned refers to compliance with a standard (ISO 1135-4) and biocompatibility, which typically involve laboratory testing, not expert-adjudicated ground truth as would be relevant for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The assessment of this medical device is based on compliance with recognized standards and laboratory testing, not a human reader adjudication process.
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/not provided. This device is a blood transfusion set, not an AI/ML-driven diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through compliance with recognized international standards (ISO 1135-4 for performance, ISO 10993 for biocompatibility) and direct physical/material testing, rather than clinical outcomes or expert consensus on diagnostic interpretations.
8. The sample size for the training set
This information is not applicable/not provided. This device is a physical product and does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This device is a physical product and does not have a "training set" or "ground truth" in the context of AI/ML.
§ 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.