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510(k) Data Aggregation
(347 days)
QAX
The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.
The Theranova 400 and 500 Dialyzers (referred to collectively as Theranova Dialyzers) are hollow fibers dialyzers that are intended for use in the treatment of chronic renal failure by intermittent hemodialysis. The hollow fiber membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP). The membrane surface area for the Theranova 400 Dialyzer is 1.7 m2. while that for the Theranova 500 Dialyzer is 2.0 m². Theranova Dialyzers are intended to be used as part of a high permeability hemodialysis system (such as those regulated under 21 CFR §876.5860). Theranova Dialyzers should be used with blood tubing sets with connectors that comply with ISO 8637 and a monitor that controls and monitors the ultrafiltration rate. Theranova Dialyzers are not intended to be used for hemofiltration or hemodiafiltration. Thev are steam-sterilized, single use only devices.
Theranova Dialyzers are intended to treat chronic renal failure by removal of solutes and plasma water from the blood when used with a hemodialysis monitor capable of ultrafiltration control. The blood travels through the hollow fibers and exits via a blood exit port. Plasma water and certain low and middle molecular weight solutes pass through the hollow fiber membrane and into the countercurrent flowing dialysis solution, removing uremic toxins and waste products by means of diffusion and convection. In addition to the typical removal of small solutes and plasma water, Theranova Dialyzers can remove greater amounts of larger solutes (up to 45 kDa) due to the membrane design.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Theranova Dialyzers (Theranova 400, Theranova 500) - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document outlines bench performance testing and clinical study endpoints which function as acceptance criteria for the device. Many bench tests are characterized as "N/A; device performance characteristic," meaning an explicit numeric acceptance criterion isn't stated but rather the performance is reported for characterization. For the clinical study, specific non-inferiority and superiority margins serve as acceptance criteria.
Table: Acceptance Criteria and Reported Device Performance
| Test/Endpoint | Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Bench Performance Testing | |||
| Ultrafiltration Coefficient | N/A; device performance characteristic | Theranova 400: 48 mL/h/mmHg, Theranova 500: 59 mL/h/mmHg | Bench |
| Pressure drop -blood compartment (various QB) | N/A; device performance characteristic | See Table 2 (e.g., Theranova 400: ≤90 mmHg @ 200 mL/min, Theranova 500: ≤80 mmHg @ 200 mL/min etc.) | Bench |
| Pressure drop -dialysate compartment (various QD) | N/A; device performance characteristic | See Table 2 (e.g., Theranova 400: ≤20 mmHg @ 300 mL/min, Theranova 500: ≤15 mmHg @ 300 mL/min etc.) | Bench |
| Clearance of Urea | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 191 mL/min @ QB 200, QD 300; Theranova 500: 192 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Phosphate | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 179 mL/min @ QB 200, QD 300; Theranova 500: 182 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Creatinine | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 184 mL/min @ QB 200, QD 300; Theranova 500: 186 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Vitamin B12 | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 148 mL/min @ QB 200, QD 300; Theranova 500: 152 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Inulin | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 119 mL/min @ QB 200, QD 300; Theranova 500: 124 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Cytochrome C (marker molecule) | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 109 mL/min @ QB 200, QD 300; Theranova 500: 114 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Myoglobin | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 93 mL/min @ QB 200, QD 300; Theranova 500: 98 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Chitinase-3-like protein 1 YKL-40 | Mean clearance of YKL-40 is ≥ 22 mL/min (± 20%) | Pass (Mean clearance value for Theranova 400 and 500 at QB/QD 400/700 mL/min = 30 mL/min) | Bench |
| Sieving coefficient of Chitinase-3-like protein 1 YKL-40 | Sieving coefficient of YKL-40 ≥30% (± 20%) | Pass | Bench |
| Protein Loss Test | In-vitro protein loss ≤1.13 g/L | Pass | Bench |
| Endotoxin retention testing | Patient exposure to endotoxin is below 5 EU/kg/hr | Pass | Bench |
| Drug removal testing | N/A; comparative testing of device drug removal to other high-flux dialyzers | Representative drugs were not removed significantly differently by Theranova Dialyzers as compared to other high-flux dialyzers | Bench |
| Mechanical hemolysis testing | NA; comparative testing of mechanical hemolysis testing to other high-flux dialyzers | Results establish that Theranova Dialyzers are comparable to other high-flux dialyzers | Bench |
| Clinical Study Endpoints (Theranova 400 vs. Elisio-17H) | |||
| Primary Safety: Pre-dialysis Serum Albumin (non-inferiority) | Lower bound of two-sided 95% CI > -0.1765 g/dL | Lower bound of two-sided 95% CI was -0.098 g/dL (met non-inferiority) | Clinical Trial |
| Primary Efficacy: Reduction Ratio (RR) of λFLCs (superiority) | Lower bound of two-sided 95% CI around the difference > 0 | Mean Estimated Treatment Difference = 14.828; 95% CI (10.501, 19.156) (demonstrated superiority) | Clinical Trial |
| Secondary Efficacy: λFLC RR (4 weeks) | N/A (evaluated for performance) | Significantly higher in Theranova group | Clinical Trial |
| Secondary Efficacy: CFD RR (4 & 24 weeks) | N/A (evaluated for performance) | Significantly larger reduction ratios in Theranova group | Clinical Trial |
| Secondary Efficacy: κFLC RR (4 & 24 weeks) | N/A (evaluated for performance) | Significantly larger reduction ratios in Theranova group | Clinical Trial |
| Secondary Efficacy: IL-6, TNFα, ß2m RR (4 & 24 weeks) | N/A (evaluated for performance) | Not significantly different between groups | Clinical Trial |
| Secondary Efficacy: Change in pre-dialysis ß2m (24 weeks) | N/A (evaluated for performance) | No significant difference | Clinical Trial |
| Secondary Efficacy: Urea Clearance (Kt/Vurea) (every 4 weeks) | N/A (evaluated for performance) | No significant change in Kt/V (urea) between the two study groups over the course of the study | Clinical Trial |
| Secondary Safety: Pre-dialysis serum albumin (trends) | N/A (evaluated for trends) | Small, but statistically significant reduction at Weeks 4 and 8. Changes from baseline not significantly different between groups at Week 12 and thereafter. | Clinical Trial |
| Secondary Safety: Factor VII, Protein C, Factor II (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: Vitamin A (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: nPNA (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: Chemistry, hematology, coagulation lab tests | N/A (evaluated for changes) | Some small, statistically significant changes in electrolytes/hematology, but remained within normal/expected ranges and clinically insignificant. No significant changes for coagulation. | Clinical Trial |
| Secondary Safety: Adverse Events | N/A (evaluated for incidence) | No significant differences in total AEs, SAEs, or device-related AEs. | Clinical Trial |
| Exploratory: hs-CRP | N/A (evaluated for differences) | No significant differences | Clinical Trial |
| Exploratory: KDQOL-36, EQ-5D-5L | N/A (evaluated for differences) | No significant differences | Clinical Trial |
2. Sample size used for the test set and the data provenance
For Bench Testing:
The document does not explicitly state the sample sizes for each specific bench test (e.g., number of dialyzers tested for ultrafiltration coefficient). However, it implies testing was conducted according to various ISO standards and established protocols.
- Data Provenance: In-vitro testing (laboratory setting). No country of origin is specified for these bench tests, but the sponsor is Baxter Healthcare Corporation, based in Illinois, USA.
For Clinical Study (Theranova 400 Randomized Controlled Trial [NCT03257410]):
- Test Set Sample Size:
- Enrolled patients: 172
- Randomized patients: 172 (86 to Theranova 400 group, 86 to Elisio-17H group) - This forms the Full Analysis Set (FAS).
- Completed the trial: 130 patients (65 in each group). This forms the basis for the Per-Protocol Set (PPS).
- Data Provenance: Prospective, multicenter, randomized controlled open-label trial conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not directly applicable in the traditional sense of a diagnostic device where experts label "ground truth" for interpretations (e.g., radiologists for medical images).
- For Bench Testing: The "ground truth" is established by direct physical or chemical measurements according to standardized methods (e.g., ISO 8637, ISO 10993) using laboratory equipment. No human experts are "labeling" the ground truth in this context.
- For Clinical Study: The "ground truth" (i.e., patient outcomes, lab results like serum albumin, λFLC reduction ratios) is established through medical laboratory assays and clinical assessments performed by trained medical personnel and technicians at the participating clinical sites. These are objective measurements rather than subjective expert interpretations requiring adjudication. The study involved a multi-center team of clinicians (treating physicians) and study staff for patient care and data collection.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For Bench Testing: No adjudication method is applicable as these are objective measurements.
- For Clinical Study: The "ground truth" for patient outcomes (laboratory values, adverse events) is based on direct measurements and clinical observation, not subjective interpretation requiring "adjudication" in the sense of multiple readers agreeing on a finding. Adverse events were likely recorded by site investigators and potentially reviewed by a central safety committee, but this is not an "adjudication method" for establishing ground truth like in image analysis.
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 a hemodialyzer, not an AI software for diagnostic interpretation. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical device (hemodialyzer), not an algorithm. Its performance is tested directly (bench testing) and through its effect on patients (clinical trial), not through an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Bench Testing: Physical and chemical measurements (e.g., concentrations, volumes, pressures) and standardized biological assays (e.g., cytotoxicity, endotoxin levels).
- For Clinical Study:
- Primary Safety Endpoint: Pre-dialysis serum albumin levels (objective laboratory measurement).
- Primary Efficacy Endpoint: Pre- versus post-dialysis Reduction Ratio (RR) of λFLC (objective laboratory measurement).
- Other Endpoints: Other objective laboratory measurements (e.g., B2m, Kt/Vurea, CFD, kFLC, IL-6, TNFα, electrolytes, hematology, coagulation, Vitamin A), and documented adverse events.
- Patient Reported Outcomes (PROs): Standardized questionnaires (KDQOL-36, EQ-5D-5L) provided patient perspectives.
8. The sample size for the training set
- Not applicable. This device is a hemodialyzer. There is no concept of a "training set" in the context of device development as there would be for an AI/ML algorithm. The clinical trial serves as the primary evaluation of the device's performance in a human population.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this type of device, this question is not relevant.
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