(128 days)
Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.
The Hospira Blood Sets with Secure Lock are intended for use as gravity sets. Hospira Blood sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly / blood pump assembly / or blood cylinder assembly, and injection site assembly. Blood sets are configured to ensure the intended use of the device is met. Hospira Blood 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.
The Hospira Blood Sets are being compared to a predicate device, the Hospira Infusion Blood Sets (K101677), due to a modification to the Secure Lock Male Luer and a change in the male luer adapter material. The study aims to demonstrate substantial equivalence to the predicate device.
The document provides information on non-clinical and performance testing to ensure the modified device meets the required standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (Hospira Blood Sets) |
|---|---|
| Materials of Construction meet ISO 10993 applicable requirements | New data generated showing all materials (including alternate acrylic male luer adapter) meet ISO 10993 applicable requirements. |
| Material Biocompatibility: | Material Biocompatibility: |
| Cytotoxicity (ISO 10993-5) | Meets Cytotoxicity (ISO 10993-5) |
| Sensitization (ISO 10993-10) | Meets Sensitization (ISO 10993-10) |
| Intracutaneous Reactivity (ISO 10993-10) | Meets Intracutaneous Reactivity (ISO 10993-10) |
| Systemic Toxicity (ISO 10993-11) | Meets Systemic Toxicity (ISO 10993-11) |
| Subacute Toxicity (ISO 10993-11) | Meets Subacute Toxicity (ISO 10993-11) |
| Subchronic Toxicity (ISO 10993-11) | Meets Subchronic Toxicity (ISO 10993-11) |
| Pyrogenicity (ISO 10993-11) | Meets Pyrogenicity (ISO 10993-11) |
| Hemocompatibility (ISO 10993-4) | Meets Hemocompatibility (ISO 10993-4) |
| Device Performance (per ISO 1135-4, ISO 594-1, ISO 594-2): | Device Performance (per ISO 1135-4, ISO 594-1, ISO 594-2): |
| Product Sterility Assurance Level 10-6 | Product Sterility Assurance Level 10-6 |
| Particulate Contamination (ISO 1135-4:2012) | Meets Particulate Contamination |
| Leakage (ISO 1135-4:2012) | Meets Leakage |
| Tensile Strength (ISO 1135-4:2012) | Meets Tensile Strength |
| Closure-piercing pin (ISO 1135-4:2012) | Meets Closure-piercing pin requirements |
| Tubing (ISO 1135-4:2012) | Meets Tubing requirements |
| Blood Filter (ISO 1135-4:2012) | Meets Blood Filter requirements |
| Drip chamber and drip tube (ISO 1135-4:2012) | Meets Drip chamber and drip tube requirements |
| Flow Regulator (ISO 1135-4:2012) | Meets Flow Regulator requirements |
| Flow Rate (ISO 1135-4:2012) | Meets Flow Rate requirements |
| Injection Site (ISO 1135-4:2012) | Meets Injection Site requirements |
| Male Conical Fitting (ISO 1135-4:2012) | Meets Male Conical Fitting requirements |
| Protective Caps (ISO 1135-4:2012) | Meets Protective Caps requirements |
| Gauging (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Gauging requirements |
| Liquid Leakage (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Liquid Leakage requirements |
| Air Leakage (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Air Leakage requirements |
| Separation Force (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Separation Force requirements |
| Stress Cracking (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Stress Cracking requirements |
| Unscrewing Torque (ISO 594 Part 2:1998) | Meets Unscrewing Torque requirements |
| Ease of Assembly (ISO 594 Part 2:1998) | Meets Ease of Assembly requirements |
| Resistance to Overriding (ISO 594 Part 2:1998) | Meets Resistance to Overriding requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each test in the non-clinical and performance evaluations. It states that "New data has been generated" for these tests. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
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 is a medical device for fluid delivery, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for this device is based on objective measurements and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of device and testing described. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts in medical imaging). The tests mentioned here are objective chemical, physical, and functional performance tests.
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
No, an MRMC comparative effectiveness study was not done. This is a traditional medical device (blood sets) and not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI device. The performance is of the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for the Hospira Blood Sets is defined by the objective pass/fail criteria established by recognized international standards (ISO 10993 for biocompatibility and ISO 1135-4, ISO 594-1, ISO 594-2 for performance). The results of these tests, demonstrating compliance with these standards, constitute the "ground truth" for the device's acceptable performance.
8. The sample size for the training set
This is not an AI or machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as it is not an AI/ML 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.