(514 days)
Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result failure when conservative therapy is judged to be inadequate.
The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.
The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.
A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.
The provided text describes a 510(k) summary for the Altra Nova® 200 Hemodialyzer with multiple-use labeling. It focuses on demonstrating equivalence to an existing single-use device rather than performing a typical clinical study with acceptance criteria and reported device performance in the way a new diagnostic or AI-driven device would.
Therefore, many of the requested categories (e.g., AI integration, expert consensus, MRMC studies, training set details) are not applicable to this type of submission. The document is a regulatory submission for a medical device (hemodialyzer) seeking clearance for reuse, not a study evaluating software performance or diagnostic accuracy.
Here's a breakdown based on the information available, highlighting what is applicable and what isn't:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with performance metrics like sensitivity or specificity. Instead, the acceptance criteria for this device (a reusable hemodialyzer) revolve around demonstrating that the reprocessed device is as safe and effective as the single-use predicate device. The "performance" is implicitly tied to maintaining the original device's characteristics after reprocessing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reprocessed device is as safe as single-use. | "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." (No specific safety metrics provided in this summary) |
| Reprocessed device is as effective as single-use. | "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." (No specific efficacy metrics provided in this summary, but implies maintenance of the original device's filtration capabilities). |
| Reprocessing method maintains device integrity. | "Reprocessing between uses was performed according to the Renatron® operator's manual." (This indicates a validated reprocessing method was used, implying device integrity was maintained). |
| Device characteristics (materials, design) remain unchanged. | "The product drawings, material list, chemical structure, production process flow for the membrane or dialyzer, and physical characteristics of the Altra Nova® 200 reusable hemodialyzer is identical to the currently marketed Altra Nova 200 single use hemodialyzer..." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this 510(k) summary. The summary refers to "Testing performed on reprocessed devices," but the number of devices or cycles tested is not disclosed.
- Data Provenance: Not specified, but likely proprietary internal testing conducted by Althin Medical, Inc. (the manufacturer) in the USA. It would be retrospective in the sense that the testing was performed on devices that were then reprocessed according to a defined protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is Not Applicable (N/A). This submission is for a physical medical device (hemodialyzer), not an AI-driven or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set:
- This is Not Applicable (N/A). No adjudication method is described because the testing doesn't involve subjective interpretations or expert consensus. It likely involved objective measurements of device performance parameters (e.g., clearance rates, ultrafiltration rates, material integrity) after reprocessing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- This is Not Applicable (N/A). This is a physical medical device, not an AI or diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is Not Applicable (N/A). This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth," in this context, is the original performance specifications and safety profile of the single-use Altra Nova® 200 Hemodialyzer. The study's goal was to demonstrate that the reprocessed device met these same predefined engineering and functional standards. This would involve objective measurements (e.g., chemical analysis, physical integrity tests, performance characteristics like solute clearance and ultrafiltration coefficient) against established benchmarks for the fresh device.
8. The sample size for the training set:
- This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set.
9. How the ground truth for the training set was established:
- This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set or ground truth establishment relevant to AI.
§ 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.”