(249 days)
The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.
The Amuchina ARM Automatic [Dialyzer] Reprocessing Machine is a stand alone device designed for the automated reprocessing of hemodialyzers for reuse and for the pre-processing of hemodialyzers prior to first use. The ARM Unit has 4 stations which can sequentially process up to 4 dialyzers at one time. The ARM Unit has no direct or indirect patient contact. The ARM Unit uses a peracetic acid/hydrogen peroxide based disinfectant as both a cleaning solution and a disinfectant. The disinfectant concentrate is diluted to the inuse strength with AAMI quality water. When reprocessing dialyzers, the ARM Unit uses the following cycles: Rinse, Cleaning, Flush, Volume & Leak Test, and Disinfection. When pre-processing dialvzers, the following cycles are used: Flush, Volume & Leak Test (only if instructed for by the user), and Disinfection. For regularly scheduled maintenance, the ARM Unit has the following system cycles: System Rinse, System Disinfect, and System Self Test. Other cycles which are included in the ARM Unit include: Prime Pump for priming the chemical pump with the disinfecting agent, Line Volume Calibration for use in determining the total cell volume of the dialyzer, and System Void to purge fluids from the circuits prior to moving the machine. The ARM Unit incorporates the feature of including a patient photograph on the dialyzer label, thus reducing the possibility of reused dialyzers being used on the wrong patient.
Here's an analysis of the provided 510(k) summary regarding the Amuchina ARM Automatic Reprocessing Machine:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Amuchina ARM Automatic Reprocessing Machine (K013713) does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance metrics with associated thresholds (e.g., sensitivity > 90%, specificity > 85%). Instead, the "acceptance criteria" are implied by the comparative features and the results of the non-clinical performance and in-vitro testing.
The primary acceptance criterion appears to be functional equivalence to the predicate device (Seratronic DRS-4 Dialyzer Reprocessing System, K860674) for the intended uses of reprocessing and pre-processing dialyzers. The device's performance is demonstrated by functionality tests and in-vitro testing confirming proper dilution of the disinfectant.
| Feature | Acceptance Criteria (Implied by Predicate & Intended Use) | Reported Device Performance (Amuchina ARM) |
|---|---|---|
| Intended Use | Reprocessing hemodialyzers for reuse | Reprocessing hemodialyzers for reuse on the same patient. |
| Pre-processing hemodialyzers prior to first use | Pre-processes hemodialyzers prior to first use. | |
| Number of Stations | 4 | 4 |
| Cleaning Solutions | Capable of using Peracetic Acid/Hydrogen Peroxide | Uses Peracetic Acid/Hydrogen Peroxide. |
| Disinfectants | Capable of using Peracetic Acid/Hydrogen Peroxide | Uses Peracetic Acid/Hydrogen Peroxide. |
| Cycles | Expected cycles for reprocessing (Clean, Disinfect, Test) | Rinse, Cleaning, Flush, Volume & Leak Test, Disinfection (reprocessing). Flush, Volume & Leak Test (optional), Disinfection (pre-processing). System Rinse, System Disinfect, System Self Test, Prime Pump, Line Volume Calibration, System Void (maintenance/utility). |
| Test Cycle Contents | Pressure Leak Test, Total Blood Cell Volume | Pressure Leak Test, Total Blood Cell Volume. |
| Dialyzer Labeling | Comprehensive patient/dialyzer information for reuse safety | Bar Code, Patient Name, Patient Photograph (digital), Dialyzer Lot Number, Dialyzer Serial Number, Number times reprocessed, Number times reused, Test Results, Dialyzer Status. |
| Microprocessor Control | Yes | Yes |
| Interactive Touch Screen | Yes | Yes |
| Operator Defined Parameters | Yes | Yes |
| Patient Photograph Feature | (Not applicable to predicate, but an added feature for safety) | Yes (reduces possibility of wrong patient use). |
| Water Quality | AAMI Quality | AAMI Quality |
| Functionality | Perform all intended/programmed functions as designed. | "Each individual function of the ARM Unit was tested to see if they performed as intended/programmed. No errors or failures either-were detected." |
| Dilution Accuracy | Properly dilute cleaner/disinfectant concentrate. | "In-vitro testing was performed to assure the ARM Unit properly diluted the cleaner/disinfectant concentrate to the in-use concentrations of active ingredients. The results from these tests show that the ARM Unit performed as expected." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical study or a large-scale data analysis. The testing described is "Non-Clinical Performance Data" and "In-vitro testing."
- Test Set Sample Size: Not specified in terms of number of dialyzers or patient cases. The description implies a series of functional tests on the device itself and in-vitro tests on the dilution capabilities.
- Data Provenance: The testing is described as non-clinical and in-vitro, meaning it was likely conducted in a controlled laboratory environment by the manufacturer (Amuchina International, Inc.). There is no mention of country of origin for data specifically, beyond the company's address in Gaithersburg, MD, USA. It is retrospective in the sense that the testing was completed before the 510(k) submission. No prospective clinical data is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For non-clinical and in-vitro functional testing of a device like this, ground truth is typically established by engineering specifications, chemical analysis, and adherence to established standards (e.g., AAMI quality water). There's no mention of human experts interpreting results for a test set in the way a radiologist might for medical images.
4. Adjudication Method for the Test Set
This is not applicable as there's no mention of human interpretation of results requiring adjudication (e.g., by multiple experts). The tests described are objective functional and chemical tests.
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
No MRMC comparative effectiveness study was done, nor is it applicable. This device is an automated reprocessing machine; it does not involve human "readers" or AI assistance for diagnostic interpretation. Its function is to mechanically and chemically prepare dialyzers for reuse.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance was demonstrated through the non-clinical and in-vitro testing. The device's "individual functions" and its ability to "properly dilute the cleaner/disinfectant concentrate" were tested as an automated system without human intervention influencing the core performance metrics. The machine itself is designed to operate without a "human-in-the-loop" for its primary reprocessing functions, beyond operator setup and maintenance.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily based on:
- Engineering Specifications and Design Requirements: Ensuring each function performs "as intended/programmed."
- Chemical Analysis: Verifying "in-use concentrations of active ingredients" following dilution.
- Comparison to Predicate Device's Performance Characteristics: Demonstrating substantial equivalence to the Seratronic DRS-4.
- Adherence to Standards: Implicitly, AAMI quality water standard.
There is no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. The Sample Size for the Training Set
There is no mention of a training set in this 510(k) summary. This type of device does not utilize machine learning or AI models that require a "training set." Its functionality is based on programmed logic and mechanical/chemical processes.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or applicable for this device, this question is not applicable.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.