(125 days)
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.
The proposed set consists of non-DEHP PVC (
The provided text describes the regulatory filing for a medical device called a "Blood Administration Set" (K210335) by Baxter Healthcare Corporation. It details the device's indications for use, technological characteristics, and substantial equivalence to a predicate device, as well as a list of nonclinical tests performed to support its safety and effectiveness.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector | ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5 | Met acceptance criteria (all tests). |
| ISO 80369-7 Luer Tests on female Luer Lock Connector | ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5 | Met acceptance criteria (all tests). |
| Tensile Strength Test | ISO 1135-4:2015, Clause 5.3 | Met acceptance criteria. |
| Leak Test (Pressure Test) | ISO 1135-4:2015, Annex A.2 | Met acceptance criteria. |
| Notch Clamp Activation Force Test | Activation force ≤50N | Met acceptance criteria. |
| Notch Clamp Shut-Off Test | No liquid or air leakage when subjected to 50kPa for 15 sec | Met acceptance criteria. |
| Non-DEHP Claim Verification | Met acceptance criteria. | |
| Flow Rate Testing | ISO 1135-4:2015, Section 5.9 | Met acceptance criteria. |
| ISO 1135-4 Blood Component Compatibility Test | ISO 1135-4, Clause 7.6 and 7.7 | Met acceptance criteria. |
Biocompatibility Tests:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Supported biocompatibility. |
| Sensitization | ISO 10993-10 | Supported biocompatibility. |
| Intracutaneous (Irritation) Reactivity | ISO 10993-10 | Supported biocompatibility. |
| Acute Systemic Toxicity | ISO 10993-11 | Supported biocompatibility. |
| 30 Day Systemic Repeat Dose Toxicity Study | ISO 10993-11 | Supported biocompatibility. |
| Material Mediated Pyrogen | ISO 10993-11 | Supported biocompatibility. |
| Hemocompatibility | ISO 10993-4 | Supported biocompatibility. |
Sterility Tests:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility | 10⁻⁶ Sterility Assurance Level (SAL) per ANSI/AAMI/ISO 11137-2, with MSDs between 14.2 - 25.0 kGy. Confirmed by periodic dose audit studies. | Met SAL. |
| Bacterial Endotoxins | Endotoxin limit of 20 EU/device per USP . | In conformance to USP . |
| Pre-sterilization Bioburden | Routine periodic testing performed. | Performed. |
Shelf-Life:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life | 3 (three) years | Supported. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each of the nonclinical tests. It refers to "risk analyses and design verification tests" and "bench tests" conducted by Baxter Healthcare Corporation. The data provenance is internal to Baxter Healthcare Corporation, indicated by "Baxter Healthcare Corporation conducts risk analyses and design verification tests". There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective, as these are nonclinical bench tests on the device itself.
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 section is not applicable as the studies described are nonclinical (bench) tests on the device's physical and functional properties, not clinical studies involving human patients or expert interpretation of medical data. Therefore, no "ground truth" was established by experts in a healthcare context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where human interpretation or expert consensus is required for complex outcomes.
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 section is not applicable as the device is a "Blood Administration Set," a physical medical device, not an AI software/algorithm requiring human reader evaluation. There is no mention of AI or human reading in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical tests, the "ground truth" or reference standards are the specified international and national standards (e.g., ISO 80369-7, ISO 1135-4, USP , USP , USP , ISO 10993 series, ANSI/AAMI/ISO 11137 series) that the device must comply with. These standards define the acceptable performance parameters.
8. The sample size for the training set
This section is not applicable. The context is the regulatory filing for a physical medical device, not a machine learning model. There is no concept of a "training set" for the type of nonclinical tests performed for this device.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.