(348 days)
The SANSIN 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 propose device, SANSIN Tubing Sets for Hemodialysis, is used to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The proposed devices are provided sterile and single use.
The proposed device is intended to be used with Fresenius 2008K Home Hemodialysis manufactured by Fresenius Medical Care North America, which is a hemodialysis delivery system being submitted to FDA for premarket notification (K124035).
The proposed device mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessories such as priming piece, drain bag, priming needle, fluid replacement tube, connecting tube, monitor and transducer protector.
The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN.
This document describes the non-clinical performance evaluation of the SANSIN Tubing Sets for Hemodialysis for its 510(k) submission (K202796).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by a combination of internal test methods, recognized consensus standards, and specific performance attributes compared against the predicate device. The document explicitly states that the non-clinical tests were conducted to verify that the proposed device met "all design specifications" and was "Substantially Equivalent (SE) to the predicate device."
| Test/Performance Characteristic | Acceptance Criteria (Derived from standards/predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993 Series (specifically, no cytotoxicity, no intracutaneous reactivity, no systemic toxicity, no chronic toxicity, no hemolysis, no complement activation, no significant difference in prothrombin time and partial thromboplastin time, no genotoxicity, no potential febrile reaction). | Cytotoxicity: No cytotoxicity. |
| Intracutaneous Reactivity Test: No intracutaneous reactivity. | ||
| Acute Systemic Toxicity Test: No systemic toxicity. | ||
| Sub chronic Toxicity Study: No chronic toxicity. | ||
| Hemolysis Study: No hemolysis. | ||
| Complement Activation: No complement activation. | ||
| Prothrombin Time: Not significant statistically different compared to negative control. | ||
| Partial Thromboplastin Time Study: Not significant statistically different compared to negative control. | ||
| Genotoxicity (Bacterial Reverse Mutation, In Vitro Mammalian Chromosome Aberration Test): No genotoxicity. | ||
| Pyrogenicity: No potential febrile reaction. | ||
| Sterilization Assurance Level (SAL) | 10^-6 | SAL (10^-6) (Achieved via EO sterilization) |
| Repeated Closing Test | Ability to meet maximum closing time (Specific quantitative criteria likely defined in internal test protocol). | Demonstrated that the proposed device is able to meet the maximum closing time. |
| Tensile Strength Test | Any connections between components (excluding protective caps) shall withstand a static tensile force (Specific quantitative criteria likely defined in internal test protocol). | Demonstrated that any connections between the components of the transfusion set of the proposed device, excluding protective caps, shall withstand a static tensile force. |
| Endurance Pump Test | Ability to meet endurance requirements (Specific quantitative criteria likely defined in internal test protocol). | Demonstrated that the proposed device is able to meet the endurance requirements. |
| Stimulated Operation Test (Compatibility with Fresenius 2008K Home Hemodialysis System) | Good compatibility performance in hemodialysis treatment conditions. | Demonstrated good compatibility performance in hemodialysis treatment conditions with specific hemodialysis delivery system (Fresenius 2008K Home Hemodialysis System). |
| Pressure Leak Test | (Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics"). | Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics. |
| Priming Volume Test | (Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics" despite differences from predicate). | Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics. |
| Tubing Compliance Test | (Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics"). | Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics. |
| Mechanical Hemolysis Test | (Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics"). | Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics. |
| Endurance Pump Test after Aging | Ability to maintain safety and effectiveness under -300 pressure. | Approved that the product can maintain the safety and effectiveness of the product under -300 pressure. |
| Blood Flow | Meet blood flow requirements (Specific quantitative criteria likely defined in internal test protocol, especially concerning differences in negative pressure and inner diameter from predicate). | Stimulated operation test conducted, approved that the proposed device meets the requirements of blood flow. |
| Seal Strength | ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials requirements. | Complies with ASTM F88/F88M-15. |
| Seal Leaks (Dye Penetration) | ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration requirements. | Complies with ASTM F1929-15. |
| Bacterial Endotoxins Test | USP 42-NF 37:2019 <85> Bacterial Endotoxins Test requirements. | Complies with USP 42-NF 37:2019 <85>. |
| Luer Lock Fittings | ISO 594-2:1998 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2 Lock fittings requirements. | Complies with ISO 594-2:1998. |
| Cardiovascular Implants and Extracorporeal Blood Circuit | ISO 8638:2010 Cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters requirements. | Complies with ISO 8638:2010. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical performance test. It mentions that tests were performed on "proposed device" or "relevant device configurations," implying that samples of the SANSIN Tubing Sets were used.
Data provenance: Given that the manufacturer is Jiangxi Sanxin Medtec Co., Ltd. in Nanchang, Jiangxi, China, and the listed contact person is in Shanghai, China, the data provenance is China. All tests appear to be retrospective (performed on completed devices or materials) and conducted by the manufacturer or a third-party testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies described are non-clinical (bench testing) rather than clinical studies involving expert interpretation of patient data. The "ground truth" for these tests is based on objective, quantifiable measurements against established standards and design specifications.
4. Adjudication Method for the Test Set
This section is not applicable as no adjudication method is mentioned or required for non-clinical bench testing. The results are based on objective test measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The SANSIN Tubing Sets are physical medical devices used for delivering hemodialysis, and their performance is evaluated through non-clinical bench tests and compatibility assessments, not human reading studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is not an algorithm or AI system. It is a physical medical device. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is predominantly:
- Established consensus standards: Such as various parts of ISO 10993, ISO 11135, ASTM F88, ASTM F1929, USP, ISO 594-2, and ISO 8638.
- Internal design specifications: For tests like Repeated Closing, Tensile Strength, Endurance Pump, Pressure Leak, Priming Volume, Tubing Compliance, Mechanical Hemolysis, and Stimulated Operation where specific quantitative thresholds would be defined internally by the manufacturer to ensure functional performance and equivalence to the predicate.
- Predicate device characteristics: For comparison of physical performance parameters (e.g., length, priming volume, negative pressure, inner diameter), although the proposed device did not always match the predicate, the testing demonstrated that the proposed device's different characteristics did not raise new safety or effectiveness concerns.
8. The Sample Size for the Training Set
This section is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the device is not an AI/ML algorithm that requires a training set.
§ 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.