(263 days)
The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.
The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.
The provided text is a 510(k) Premarket Notification for the RAPIDO BLS HOLLOW-FIBRE DIALYZER. It describes the device, its intended use, and comparative testing against predicate devices to demonstrate substantial equivalence, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.
However, I can extract the relevant information regarding the acceptance criteria and the study type used for this medical device, which is an in-vitro performance study.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these tests met established specifications." However, the specific numerical acceptance criteria for each performance parameter are not provided in this summary. The reported performance is implicitly that the device performs substantially equivalently to the predicate devices.
| Acceptance Criteria (General) | Reported Device Performance (Implicit) |
|---|---|
| Meets established specifications for mechanical integrity | Met established specifications |
| Meets established specifications for priming volume | Met established specifications |
| Meets established specifications for pressure drop | Met established specifications |
| Meets established specifications for ultrafiltration rate | Met established specifications |
| Meets established specifications for sieving coefficient | Met established specifications |
| Meets established specifications for hemolysis | Met established specifications |
| Compliant with safety and effectiveness requirements | Demonstrated substantial equivalence and compliance |
| Biocompatible for intended use (ISO 10993-1) | Demonstrated biocompatibility |
| Sterile and non-pyrogenic | Demonstrated effectiveness of production techniques |
| Package integrity testing met specifications | Met established specifications |
| Shipping carton provides adequate protection | Passed basic testing and provided adequate protection |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing mentioned is "in vitro test results" and refers to "the device" (singular) implying testing on a sample, but the specific number of units tested is not given.
- Data Provenance: In vitro test results. The device manufacturer is Bellco Srl, located in Mirandola (MO), Italy. The tests were conducted internally or by a contracted lab. The document describes these as "non-clinical" and "in vitro" tests, not involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an in-vitro performance study for a physical medical device, not an AI/algorithm-based device relying on expert-annotated ground truth.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm. However, the performance described is of the device itself (standalone), not in conjunction with a human operator making clinical decisions based on its output (beyond operating the dialysis machine it connects to).
7. The type of ground truth used
- Established Specifications/Predicate Device Performance: The "ground truth" or reference for evaluating the RAPIDO BLS was its ability to meet established specifications for various performance parameters and to demonstrate substantial equivalence to legally marketed predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H). This relied on comparing the numerical values obtained from the in-vitro tests against these benchmarks.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was an in vitro and non-clinical performance evaluation comparing the RAPIDO BLS HOLLOW-FIBRE DIALYZER to existing predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H).
The testing included:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1.
- Sterility, pyrogenicity, EtO residual, and package integrity testing.
- In vitro functional performance testing:
- Mechanical integrity
- Priming volume
- Blood side pressure drop
- Ultrafiltration rate
- Sieving coefficient
- Hemolysis
For comparative purposes, the same in-vitro functional performance tests were also conducted on the predicate devices where applicable.
Conclusion of the Study:
The document concludes that the results from these in vitro studies demonstrate that the RAPIDO BLS performs in a manner substantially equivalent to the predicate devices and that it is biocompatible and safely manufactured (sterile, non-pyrogenic). All tests "met established specifications." This substantial equivalence argument is the basis for FDA clearance.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”