(274 days)
The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.
The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).
The document provided is a 510(k) summary for the Dimesol Tubing Sets for Hemodialysis. It establishes substantial equivalence to predicate devices rather than proving the device meets explicit acceptance criteria through a standalone study. Therefore, some information typically found in a study demonstrating such criteria (like sample sizes for test/training sets, expert qualifications, or adjudication methods) is not applicable or not provided in the context of this 510(k) submission.
Here is a summary based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit quantitative acceptance criteria with reported numerical performance values in a distinct table, the document refers to compliance with established international standards for various performance characteristics and biocompatibility. The "acceptance criteria" are implied by adherence to these standards and by demonstrating equivalence to predicate devices.
| Aspect | Acceptance Criteria (Implied by Standards & Predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993 Series (e.g., Cytotoxicity, Sensitization, Hemolysis) | "Compatible with ISO 10993 series standards" |
| Biocompatible for listed tests (see TABLE 5) | ||
| Performance - General | Conforms to ISO 8638:2010 (General requirements for hemodialysis blood line systems) | "Conforms to ISO 8638: 2010" |
| Performance - Structural | Conforms to ISO 594-2:1998 (Luer conical fittings with 6% (Luer) taper for syringes, needles, and certain other medical equipment) | "Conforms to ISO 594-2: 1998" |
| Specific Performance Tests | (e.g., Structural Integrity, Connectors, Tubing Compliance, Priming Volume, Tensile Strength, Simulated Operation, Endurance Testing) | Tests performed, found to be "within the accepted test parameters" of ISO 8638 and ISO 594-2 (see TABLE 6) |
| Material Equivalence | Equivalent materials to predicate devices (PVC, PP, PC, ABS, PE) | Uses PVC, PP, PC, ABS, PE (see TABLE 3) |
| Sterilization Method | Electron beam (SAL 10-6) | Electron beam (SAL 10-6) |
| Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the tests conducted to demonstrate compliance with ISO standards. It states that tests were performed but does not detail the number of units tested.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. The manufacturing entity is Bain Medical Equipment (Guangzhou) Co., Ltd. in Guangzhou, China. The testing was conducted to international standards (ISO), which are globally recognized.
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 a 510(k) submission for a hemodialysis tubing set, as it is a medical device and not an AI/software device that typically requires expert consensus for ground truth establishment. The "ground truth" for demonstrating the safety and effectiveness of this device comes from compliance with recognized performance and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable for this type of medical device submission. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, often seen in diagnostic imaging or AI performance evaluations.
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. The Dimesol Tubing Sets for Hemodialysis are physical medical devices, not an AI or software product. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device and not an algorithm or AI product.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by compliance with recognized international standards (ISO 10993 for biocompatibility, ISO 8638 and ISO 594-2 for performance) and by demonstrating substantial equivalence to legally marketed predicate devices that have already met these standards.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical medical device.
§ 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.