(85 days)
CombiSets Hemodialysis Blood Tubing Set: The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis, They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Venous Blood Tubing Set: The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Arterial Blood Tubing Set: The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.
The Split Septum Injection Sites are designed for use during hemodialysis with either a 21 gauge metal needle or plastic needles that have a 19% priming volume. The injection site plug features a tapered split to accommodate either needle described above. This is the only change to the Fresenius Hemodialysis Blood Tubing Sets currently offered. The housing and septa are identical to that of the current standard injection site.
This document, K041042, is a 510(k) premarket notification for "Split Septum Injection Sites," which are components of Fresenius Bloodlines used in hemodialysis. This is a submission for a minor device modification to existing Fresenius Hemodialysis Blood Tubing Sets.
The document does not describe a study that uses acceptance criteria in the way typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC). This is a traditional medical device submission, focusing on physical and functional equivalence to predicate devices, and demonstrating that a minor design change (the split septum injection site) does not adversely affect safety and performance.
Therefore, many of the requested categories for AI/ML device studies (sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and specific types of ground truth like pathology or outcomes data) are not applicable to this submission.
Here's a breakdown based on the information provided, highlighting the differences from an AI/ML context:
Acceptance Criteria and Device Performance (for a traditional medical device modification)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence | "The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate device." |
| Design Control Compliance | "Fresenius Medical North America has provided certification of compliance to 21 CFR 820.30 - Design Control requirements." |
| Performance Testing (Validation) | "A summary of the results of validation testing (performance testing) for the minor device modification" was provided. |
| Needle Compatibility | Designed for use with either a 21 gauge metal needle or plastic needles with a 19% priming volume. |
| Injection Site Design | Tapered split to accommodate specified needles; housing and septa identical to current standard injection site. |
| Intended Use Equivalence | Maintains the intended use as extracorporeal blood circuits for hemodialysis (single-use, with conventional and high flux negative pressure hemodialyzer equipment). |
Note: Specific quantitative performance metrics (e.g., flow rates, leak testing results, material compatibility data) are implied by "validation testing" and "summary of the results," but the detailed data and specific acceptance thresholds are not provided in this 510(k) summary. The summary focuses on substantiating substantial equivalence, not on presenting raw performance data.
Information Typically Associated with AI/ML Studies (and why they are not applicable here):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device modification, not a data-driven algorithm. Testing would involve engineering validation and verification (e.g., mechanical stress tests, leak tests, biocompatibility, flow dynamics).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering specifications, material standards, and functional requirements, not expert interpretation of data.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. There is no "human reader" or "AI assistance" involved in the function of this split septum injection site.
- 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, material standards, validated manufacturing processes, and functional performance requirements as an extracorporeal blood circuit component. The key "ground truth" for this modification is that the new split septum maintains the safety and effectiveness of the previous design and functions as intended with standard needles, without introducing new risks.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
Summary regarding the device and its assessment:
This 510(k) submission for the Fresenius Split Septum Injection Sites is a "Special 510(k)," which is used for minor modifications to marketed devices where the modification does not affect the intended use or fundamental scientific technology. The primary 'study' proving acceptance criteria is the design control process and validation testing that demonstrates the modified device remains substantially equivalent to its predicate devices in terms of safety and effectiveness. The acceptance criteria are implicit in meeting the requirements for substantial equivalence and compliance with relevant regulations (e.g., 21 CFR 820.30 for Design Control). The performance data cited are from internal validation testing, but the specifics are not detailed in this summary.
§ 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.