(64 days)
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System consists of two distinct components:
- the 2008 Machine, and .
- . the SORB™ Module.
The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.
During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
The provided text describes a Special 510(k) submission for an updated version of a hemodialysis system, the 2008 Sorbent System. This type of submission focuses on demonstrating substantial equivalence to a predicate device (an already legally marketed device) through verification testing for modifications that do not significantly alter the device's fundamental technology, indications for use, or safety and effectiveness.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense of a performance study with specific outcome measures and thresholds. Instead, it describes a "verification testing summary" aimed at demonstrating that the modified device meets its design requirements and is substantially equivalent to the predicate device.
The "performance" is implicitly defined by the successful completion of these verification activities, indicating that the modified device functions as intended and safely.
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by verification testing) |
|---|---|
| 2008 System Software/Hardware Functionality | Success: Meets performance specifications (Functional SW Verification, Disinfection, Infusate Delivery, Modes of Operation, Alarms testing). |
| HISORB+ Cartridge Performance & Equivalence | Success: Dialysate chemistries are comparable, performance (modified cartridge) is acceptable, and passes shipping test. |
| Substantial Equivalence to Predicate Device (K093362) | Success: Design verification testing demonstrates that the device meets design requirements and supports substantial equivalence. (Implies all functional aspects are comparable). |
| General Safety and Effectiveness (no new questions raised) | Success: Performance and technological characteristics are equivalent, raising no new safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of a clinical study. The testing described is non-clinical verification testing (e.g., software testing, hardware testing, cartridge performance), not a study involving human patients. Therefore, the "sample size" would refer to the number of test runs, prototypes, or cartridges used to perform the verification, which is not detailed.
- Data Provenance: The data is likely internal to the manufacturer, Renal Solutions, Inc., and represents retrospective (or in-house) testing focusing on engineering and performance verification of the device itself, rather than prospective clinical data from patients. There is no information regarding the country of origin of data, as it's not a clinical data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for non-clinical verification testing is typically established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel within Renal Solutions, Inc., responsible for design, testing, and regulatory affairs. Their specific numbers and qualifications are not detailed here, as this is not a study requiring expert clinical review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple human readers assess cases and discrepancies need to be resolved. This submission describes non-clinical verification testing of a device's functionality and performance against engineering requirements and established safety standards.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a hemodialysis system, not an imaging or diagnostic AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a hemodialysis machine with a sorbent system. It is a physical medical device for treatment, not an algorithm or AI system for standalone performance evaluation. Its operation still requires a healthcare practitioner ("human-in-the-loop") as stated in its Indications for Use.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The device was tested to ensure it met its own defined performance parameters.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate device (2008 Sorbent System, K093362). The modified device's performance was compared to, and intended to be equivalent to, that of the predicate.
- Regulatory Standards: Implicitly, the verification testing would also adhere to relevant industry standards and regulatory guidance for hemodialysis devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical hemodialysis system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a)
Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.(b)
Classification. Class II (performance standards).