(101 days)
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira infusion sets are disposable devices for single patient use.
The provided text is related to a 510(k) premarket notification for a medical device called "Hospira Extension Set." This is an IV administration set. The document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the specific information requested in the prompt concerning acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a software algorithm or AI device.
The document discusses:
- Device Name: Hospira Extension Set
- Regulation Number: 21 CFR 880.5440
- Regulation Name: IV Administration Sets
- Regulatory Class: II
- Product Code: FPA
- Indications for Use: "Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system."
- Predicate Devices: LifeShield Vision Infusion Sets - K113683, Hospira Infusion Blood Sets - K101677, LifeShield Latex Free Microbore Set - K052722
- Reason for 510(k) submission: Modification to Secure Lock Male Luer
- Summary of non-clinical tests: Stated that "All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993."
- Summary of Performance Testing: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable. The product Sterility Assurance Level is $10^{-6}$."
The information requested in the prompt (acceptance criteria table, sample sizes for test/training, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, etc.) is typically associated with studies for AI/ML-enabled devices involving diagnostic or predictive tasks. The Hospira Extension Set is a physical medical device (IV administration set), and its 510(k) submission primarily relies on demonstrating substantial equivalence to predicates through material compatibility, physical performance testing, and sterility, rather than clinical studies with human readers or AI algorithms as described in your request.
Therefore, I cannot extract the requested information from the provided document as it is not relevant to this type of device and submission.
§ 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.