(288 days)
Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
The document describes a 510(k) premarket notification for Hospira Sapphire Sets, an accessory for infusion pumps. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based only on the provided text. Many of the requested details about acceptance criteria and study specifics are not explicitly stated in this type of regulatory document, which focuses on demonstrating equivalence rather than a full clinical trial.
1. Table of acceptance criteria and the reported device performance:
The document outlines a series of tests performed to establish substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to the predicate device. Specific numerical acceptance criteria are generally not provided in this summary. Instead, it states that "All testing is acceptable."
| Acceptance Criteria Category | Reported Device Performance (Hospira Sapphire Sets) |
|---|---|
| Biocompatibility (ISO 10993) | Meets applicable material test requirements for ISO 10993 (Hemocompatibility, Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Subacute Toxicity, Pyrogenicity). |
| Particulate Contamination (ISO 8536-4, 6.1) | Meets the requirements. |
| Leakage (ISO 8536-4, 6.2) | Meets the requirements. |
| Tensile Strength (ISO 8536-4, 6.3) | Meets the requirements. |
| Tensile Strength (ISO 1135-4, 5.3) | Meets the requirements. |
| Flow Rate Accuracy | Testing conducted using the proposed Hospira Sapphire Sets and the Sapphire Infusion System was acceptable. |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for any of the tests (biocompatibility, particulate contamination, leakage, tensile strength, or flow rate accuracy).
- Data Provenance: The tests were conducted to demonstrate substantial equivalence of the "Hospira Sapphire Sets," which are described as a "combination of Hospira IV set components with the Sapphire Cassette." The testing was performed for the new device as part of the 510(k) submission. It relates to the safety and performance of the device itself and its interaction with the Sapphire Infusion System. This would be considered prospective testing conducted by the manufacturer for regulatory submission. Country of origin of the data is not specified, but the applicant is Hospira, Inc. in Lake Forest, Illinois, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this type of device submission. The "ground truth" for infusion pump accessories, in this context, is established through adherence to recognized international standards (e.g., ISO) and engineering performance specifications. There is no concept of expert "ground truth" establishment in the way it might apply to diagnostic AI or imaging devices.
4. Adjudication method for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs independent review to establish a consensus ground truth. For an infusion set, performance is measured against objective physical and chemical standards.
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 is not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where human "readers" (e.g., clinicians interpreting images) are part of the diagnostic process and their performance might be augmented by AI. The Hospira Sapphire Sets are infusion pump accessories, not diagnostic imaging devices or AI-powered tools for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an infusion set, not an algorithm or an AI-powered system. The tests described are for the physical and functional performance of the medical device itself.
7. The type of ground truth used:
The "ground truth" for the performance claims of the Hospira Sapphire Sets is based on adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 1135-4) and the engineering specifications and performance characteristics demonstrated to be "acceptable" through the conducted tests. It's essentially "compliance with established safety and performance benchmarks."
8. The sample size for the training set:
This is not applicable. The device is a physical medical device (infusion set), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).