(87 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 Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hospira Extension Sets, formatted to answer your specific questions.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical effectiveness study of a new AI-powered medical device. Therefore, many of your questions regarding AI-specific studies, such as effect size of human readers with AI, training set details, and specific expert qualifications for ground truth in AI, are not applicable to this document. This device is a physical medical device (intravascular administration set), not an AI/software device.
Acceptance Criteria and Device Performance for Hospira Extension Sets
This document describes a 510(k) submission for Hospira Extension Sets, a physical medical device. The "acceptance criteria" here refer to performance standards and substantial equivalence claims, not diagnostic performance of an AI model.
The study presented focuses on demonstrating that the revised Hospira Extension Sets (with modifications to the Secure Lock Male Luer) perform comparably to previously cleared predicate devices and meet relevant performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance |
|---|---|---|
| Functional Claims / Intended Use | "meet the functional claims and intended use as described in the product labeling" | The device "meets the functional claims and intended use as described in the product labeling." |
| Material Equivalence | Materials of construction for the proposed device are the same as predicate (with specified exceptions). | Male luer adapter material changing to an alternate acrylic material. |
| Design Equivalence | Design remains the same as predicate (with specified exceptions). | Minor dimensional modifications to the male luer adapter to enhance connection with female luers. |
| Performance Testing | Device performs as intended in accordance with applicable standards. | New performance data generated to ensure device performs as intended in accordance with: |
- ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements)
- ISO 594-2 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings)
- ISO 8536-4 (Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed)
- ISO 8536-10 (Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment)
"All testing is acceptable." |
| Sterility Assurance Level (SAL) | SAL of 10⁻⁶ | Product Sterility Assurance Level is 10⁻⁶. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices. | The device is declared "substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683 and Hospira Infusion Blood Sets cleared under K101677." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this summary. The summary refers to "performance testing" and "new performance data" under various ISO standards, which would imply defined sample sizes for physical testing, but these specifics are not provided in the publicly available 510(k) summary.
- Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a manufacturing change to an existing device, it's highly likely this "new performance data" would come from laboratory testing conducted by or for Hospira. There is no indication of retrospective or prospective clinical data in the traditional sense for this type of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device is a physical, non-diagnostic medical device. The "ground truth" here is adherence to engineering standards and functional performance, not human expert interpretation of medical images or data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies (e.g., radiology reads). This document describes the testing of a physical medical device against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not applicable to this physical medical device. This type of study is specifically designed for assessing the diagnostic performance of software or imaging systems, often with and without AI assistance to human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This question applies to AI algorithms. The Hospira Extension Set is a physical medical device with no AI component. The performance discussed is the standalone performance of the physical device according to engineering and functional standards.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to international engineering standards (ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-10) and the functional claims outlined in the product labeling. This is determined through physical and mechanical testing, not by expert consensus on clinical findings or pathological outcomes.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI component, there is no training set or ground truth established for it.
§ 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.