(290 days)
The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.
The MAKY 21.1 Dialyzer Reprocessing System is designed and manufactured to reprocess standard, high efficiency, and high flux hollow-fiber dialyzers. Each type of dialyzer can be processed by one of two pre-programmed cycles, or by a custom cycle configured by HDC Maquinolas, LLC. Custom cycles meet the same minimum requirements as the pre-programmed cycles. The MAKY 21.1 may be configured to utilize one of two approved cleaning agents (peracetic acid, bleach), and one of three approved disinfection agents (peracetic acid, glutaraldehyde, formaldehyde). The MAKY 21.1 will automatically dilute the cleaning and disinfection agents, with the exception of glutaraldehyde, which must be diluted by the user.
The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics in the way typically expected for a medical device efficacy study (e.g., sensitivity, specificity, accuracy, or expert agreement).
Instead, the document is a 510(k) summary and an FDA clearance letter for a medical device (MAKY 21.1 Dialyzer Reprocessing System), focusing on substantial equivalence to predicate devices rather than a de novo clinical performance study.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "must achieve 90% cleaning efficiency"). The criteria are implicitly tied to performing "as intended" and being "substantially equivalent" to predicate devices.
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Reported Device Performance:
- "Each function of the MAKY 21.1 System was tested to see if it performed as intended."
- "In-vitro testing was also performed to assure the MAKY 21.1 properly diluted the cleaner/disinfectant concentrate to the in-use concentrations of active ingredients."
- "All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling."
- "The results from these tests show that the MAKY 21.1 performed as expected."
Table (based on available information):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| System functions as intended | Each function of the MAKY 21.1 System was tested to see if it performed as intended. Any errors or failures detected during testing were corrected. |
| Proper dilution of cleaner/disinfectant concentrate | In-vitro testing was performed to assure the MAKY 21.1 properly diluted the cleaner/disinfectant concentrate to the in-use concentrations of active ingredients. |
| Material compatibility with chemicals | All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling. |
| Substantial equivalence to predicate devices | The information and data provided in this 510(k) Notification establish that the MAKY 21.1 Dialyzer Reprocessing System is substantially equivalent to the legally marketed predicate devices (Minntech Corporation Renatron II Dialyzer Reprocessing System (K904210) and Mesa Medical, Inc. Echo MM1000 Dialyzer Reprocessing System (K834447)). |
| Compliance with AAMI Recommended Practice for Reuse of Hemodialyzers | The device is indicated for use "in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers." (Implied performance is to meet these guidelines, but specific test results are not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only references "testing" and "in-vitro testing" without detailing the number of dialyzers, tests performed, or the duration/scope of these tests.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This type of information is typically for studies involving human interpretation or subjective assessments. The testing described is functional and chemical, not involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used when multiple human experts interpret data to establish ground truth, which is not the nature of the described testing.
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 reprocessing system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated in these terms. The document describes the system performing its functions ("automating the in-vitro rinsing, cleaning, testing and disinfection"). The "testing" mentioned is likely functional testing of the device's automated processes itself, rather than an "algorithm only" performance evaluation against an external benchmark. The closest concept is the "in-vitro testing" to assure proper dilution, which would be a standalone test of that function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the functional tests seems to be the expected operational parameters of the device (performing as intended, accurate dilution) and adherence to established standards/specifications (e.g., "in-use concentrations of active ingredients," "material compatibility"). For the substantial equivalence claim, the ground truth is the performance and characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI that would typically require such a data set.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as #8.
§ 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.