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510(k) Data Aggregation
(235 days)
HAEMOPHARM BIOFLUIDS SRL
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
The HBiofluids HMB32 is a bicarbonate based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is broken, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment.
The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500+4500 ml and 500+1500 ml.
The provided text describes the HBiofluids HMB32 dialysis solution and its substantial equivalence to a predicate device (Accusol, K041428) for use in Continuous Renal Replacement Therapy. This is a medical device submission based on substantial equivalence, not typically one that relies on clinical performance studies with specific accuracy metrics in the way AI/ML devices do. Therefore, many of the questions regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.
However, I can extract information related to the device's characteristics and the nonclinical testing performed to establish its safety and effectiveness.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for a dialysis solution based on substantial equivalence, the "acceptance criteria" are primarily established by demonstrating similarity to a legally marketed predicate device and meeting relevant standards for manufacturing, biocompatibility, and sterility. There are no specific performance metrics like sensitivity, specificity, or AUC that would be generated from a clinical study for this type of device.
Instead, the comparison focuses on key parameters and chemical composition.
| Parameter | Predicate Device (ACCUSOL, K041428) | HMB32 (Reported Performance) | Acceptance/Comparison Outcome |
|---|---|---|---|
| Indication for Use | For use as a dialysis solution in continuous renal replacement therapy | For use as a dialysis solution in continuous renal replacement therapy | Substantially Equivalent |
| Overall Design | Two units of 5 liter double chamber non-PVC bags, over-wrapped, clear/colorless solution | Two units of 5 liter or four units of 2 liter double chamber PVC free bags, over-wrapped, clear/colorless solution | Similar/Equivalent (PVC free noted for HMB32) |
| Ionic Composition of Final Solution (mmol/l): | Acceptance is based on close numerical values and clinical equivalence for use as a dialysis solution. | ||
| Na+ | 140.00 | 140.00 | Match |
| K+ | 2.00 | 2.50 | Close/Clinical Equivalence |
| Ca++ | 1.75 | 1.50 | Close/Clinical Equivalence |
| Mg++ | 0.50 | 0.75 | Close/Clinical Equivalence |
| HCO3- | 35.00 | 32.00 | Close/Clinical Equivalence |
| Cl- | 111.30 | 115.00 | Close/Clinical Equivalence |
| Glucose | 5.55 | 5.55 | Match |
| Theoretical Osmolarity | 296 mOsm/l | 297 mOsm/l | Close/Clinical Equivalence |
| Solution container components and materials | Two chamber container system, administration site with membrane tube and pull-ring closure, medication port | Two chamber container system, administration tube with luer lock, second tube for optional insertion | Similar functionality and design logic |
| Biocompatibility of patient contacting container/closure components | Established via testing per ISO 10993-1 | Established via testing per ISO 10993-1 | Same standard, assumed equivalent |
| Sterilization | Moist heat | Moist heat | Match |
| Shelf life | 12 months | 12 months | Match |
| Additional Nonclinical Testing | (Not detailed for predicate) | Acceptance based on meeting standards. | |
| - Biocompatibility | N/A (but similar standard) | Components found in human plasma, complies with European Pharmacopeia 8.0. Materials of container/closure system are medical grade, meet ISO 10993-1 and USP Class VI. | Met standards (ISO 10993-1, USP Class VI, EP 8.0) |
| - Sterilization Validation | N/A (but "moist heat") | Steam sterilization validated to SAL of 10^-6 per EN ISO 17665-1:2007 | Validated (EN ISO 17665-1) |
| - Pyrogenicity Testing | N/A | LAL test confirmed non-pyrogenic | Confirmed non-pyrogenic |
| - Stability Testing | N/A (but "12 months") | Real-time aging out to 18 months confirmed integrity, labeled with 12-month shelf life. | Confirmed (18-month stability for 12-month shelf life) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This device is a dialysis solution, and its performance is evaluated primarily through chemical composition analysis, material testing (biocompatibility, sterility), and stability studies, rather than a "test set" of patient data or images.
- Data Provenance: Not applicable in the context of clinical "data" for a test set. The validation is based on laboratory testing of the solution and its components, and comparison to the predicate device's established characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no concept of "ground truth" derived from expert consensus in the context of chemical composition, sterility, or biocompatibility testing for a dialysis solution.
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. This device is not an AI/ML diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the conventional sense. The "ground truth" for this device's safety and effectiveness is established by:
- Chemical Analysis: Direct measurement of ionic composition and osmolarity.
- International Standards: Compliance with ISO 10993-1, USP Class VI, European Pharmacopeia 8.0, and EN ISO 17665-1 for biocompatibility, material safety, and sterilization.
- Material Science: Testing of container/closure materials.
- Stability Studies: Experimental data from real-time aging.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable.
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