(364 days)
The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a container to a patient's vascular system. These devices may be used for any adult or pediatric patient, greater than 28 days old and greater than 3kg, with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy.
The delivery of blood products is intended for patients requiring volume replacement for hemorrhagic shock or life-threatening bleeding.
*Capable of rates greater than 100ml/min
The LifeFlow® Blood System is a single use, disposable, intravenous administration set that is intended to deliver blood, blood components (red blood cells or plasma), and IV fluids from a container to a patient's vascular system rapidly using a hand pump. The set includes the handle, syringe, and tubing. The blood tubing features two IV spikes with roller clamps, blood filter chamber, force reduction tubing, and luer connector.
This is a 510(k) premarket notification for the LifeFlow® Blood System, an intravenous administration set. The provided text describes the device, its intended use, and a summary of performance testing to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance." However, it describes several performance aspects the device was tested against, primarily to demonstrate substantial equivalence to the predicate and compliance with relevant standards. These can be inferred as the "acceptance criteria" for the device's functionality.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance | Study that Proves the Device Meets Acceptance Criteria |
|---|---|---|
| Rapid Delivery Capability | Rates greater than 100ml/min (for blood, blood components, crystalloid, and colloid fluids) | Functional testing: "Flow rate with LifeFlow® Handle activation" |
| Mechanical Hemolysis | Compared to reference device | "Mechanical Hemolysis in comparison to the reference device" |
| Component Reliability | - | Functional testing: "reliability" |
| Human Packed Red Blood Cell Infusion Capability | - | Functional testing: "human packed red blood cell infusion capability" |
| Biocompatibility | Complies with ISO 10993-1, passed tests for cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, acute systemic toxicity, hemocompatibility, particulates, and risk assessment | Biocompatibility evaluation per ISO 10993-1 |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Sterilization testing according to ANSI/AAMI/ISO 11137-2:2013 |
| Pyrogenicity | - | Sterilization testing (including pyrogenicity testing) |
| Packaging and Shelf Life | - | Sterilization testing (including packaging and shelf life testing) |
| Luer Taper Conformity | Compliant with ISO 594-1:1986 and ISO 594-2:1998 | Design verification in compliance to ISO 594-1:1986 and ISO 594-2:1998 |
| Transfusion Set Standards | Compliant with ISO 1135-4:2015, specifically section 5.6 for blood filters | Design verification in compliance to ISO 1135-4:2015 |
| Air Embolism Prevention (AirCheck™) | Ball float descends and forms a seal if ~20mL of air enters, stopping flow and indicating to user. | Device description and implicitly, functional testing. |
| Force Reduction | Allows for consistent fluid flow, decreases peak force and peak pressure. | Device description and implicitly, functional testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample sizes used for any of the specific tests (e.g., mechanical hemolysis, flow rate determination, reliability testing). It also does not specify the provenance of the data (country of origin, retrospective or prospective). All testing appears to be bench testing, which typically involves laboratory conditions rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to bench testing of an administration set for fluid delivery. The "ground truth" for performance is established by objective measurements against engineering specifications and international standards, not by expert interpretation of patient data or images.
4. Adjudication Method for the Test Set
Not applicable, as the acceptance criteria are based on objective engineering measurements and compliance with standards, not on subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess improvement with AI assistance. The LifeFlow® Blood System is an intravenous administration set, not a diagnostic AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The LifeFlow® Blood System is a physical medical device, not an algorithm or AI system. It is designed for human operation (hand pump activation).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned (e.g., flow rate, hemolysis, biocompatibility), the ground truth is established by:
- Objective engineering measurements: Data collected from bench tests related to fluid dynamics, material strength, etc.
- Compliance with international standards: Verification against recognized standards like ISO 594-1, ISO 594-2, ISO 1135-4, and ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. The LifeFlow® Blood System is a physical medical device and does not involve machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this device.
§ 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.