(526 days)
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.
The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set. The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access.
This document describes the premarket notification (510(k)) for the CombiSet Hemodialysis Blood Tubing Set. It does NOT describe a study involving an AI device or algorithm. Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness with AI.
The document focuses on the substantial equivalence of the CombiSet Hemodialysis Blood Tubing Set to a predicate device (CombiSet SMARTECH Hemodialysis Blood Tubing Sets, K201207) through various performance, sterilization, and biocompatibility tests.
Here's the relevant information about the non-AI device's performance testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Test Objective (Acceptance Criteria Implicit) | Reported Device Performance |
|---|---|---|
| Structural Integrity | Demonstrate that the bloodline can withstand 1.5X the labeled maximum positive and negative pressures | Met criteria |
| Pump Segment Performance | Evaluate performance characteristics of the bloodline over the range of the inlet pressures (normally 0 mmHg to -250 mmHg). Flow rate settings will cover up to 600 mL/min. | Met criteria |
| Visual Inspection for Endurance and Simulated Use Tests | Endurance: Demonstrate that bloodlines perform with no tubing failures (kinking, collapsing, or disconnection) at the maximum labeled flow rate and pressures for not less than 18 hr. Simulated Use: Demonstrate that bloodlines perform with no tubing failures (kinking, collapsing, or disconnection) under simulated use conditions for not less than 4 hr. | Met criteria |
| Needle Access Port Test | Demonstrate that the needle access ports can withstand 1.5X the labeled pressures after being punctured with the largest gauge needle recommended in the labeling (21 gauge) - 6X for maximum positive pressure, 11X for maximum negative pressure per ISO 8638:2010. | Met criteria |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to fluid pressure of 300-330 kPa. | Met criteria |
| Male and Female Luer Connectors Tests | Demonstrate that the applicable components of the bloodline meet the dimensional and performance requirements of ISO 80369-7 2016 (Sections 5 and 6). | Met criteria |
| Visual Inspection for Packaging (Shipping study) | Demonstrate that the shipping case, packaging configuration, and palletization pattern maintain the product's structural integrity during manual handling and motorized freight. | Met criteria |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodline between components, and between components and tubing can withstand a tensile force of 15 lbf. | Met criteria |
| Spike Flow Rate | Demonstrate that the spike, a component of the bloodline, can deliver not less than 1000 mL of a sodium chloride solution in 10 min under a static head of 1 m. | Met criteria |
| Spike Insertion Force | Demonstrate that the spike, a component of the bloodline, is capable of piercing and penetrating the closure of an infusion device without coring and with force not exceeding 200 N, when inserted at a rate of 500 mm/min. | Met criteria |
| Spike Leak Test | Demonstrate that the spike, a component of the bloodline, will not leak after piercing an infusion device, remaining pierced for 5 hr, and then having an applied internal pressure of 20 kPa for 15 sec. | Met criteria |
| Spike Disconnection Force | Demonstrate that the spike, a component of the bloodline, is capable of being removed from the insertion point when a removal force is applied at a rate of 100 mm/min. Establish the removal force value. | Met criteria |
| Labeling Content per FDA Guidance (Blood Tubing Set) and ISO 8638 | Verify the Instructions for Use, color-coded components, unit labels, shipping carton graphics, and case labels for the bloodline meet the requirements of ISO 8638:2010 and FDA Guidance. | Met criteria |
| Readability of Barcode with Human Readable Identification Codes | Demonstrate that the barcode information on the outer container labels and unit labels for the bloodlines is capable of being scanned. | Met criteria |
| Level Detector Test | Demonstrate that the venous chamber of the bloodline interfaces correctly with the hemodialysis machine (2008 series) such that the venous clamp will activate (close) when the fluid level inside the venous chamber falls below the sensor heads. | Met criteria |
| Air-Capture Chamber Fill Level | Demonstrate that the recommended fill level of the air-capture chambers is marked. | Met criteria |
| Blood Filter Retention Test | Demonstrate that the blood filter of the bloodline remains in the assembly position after tests at 1.5X the maximum recommended positive pressure, with a flow rate of 600 mL/min for not less than 18 hr. | Met criteria |
| Transparency of Transducer Protectors | Demonstrate that the machine side of the TPs is clear to allow for visual inspection of blood contamination during use. | Met criteria |
| Transducer Protector Leak Test | Demonstrate that the TP is capable of maintaining a secure and leak-free connection to the hemodialysis machine. | Met criteria |
| Structural Integrity (Vented Caps) | Demonstrate that the vented caps can withstand 1.5X the labeled maximum positive and negative pressures. | Met criteria |
| Viral Retentiveness Test for Transducer Protectors | Demonstrate that the membrane inside the transducer protector prevents the passage of bacteriophage (Φ X174) from the patient side to the machine side up to a pressure of 750 mmHg for 1 hr. | Met criteria |
| Tubing Compliance Test | Demonstrate that tubing is capable of being occlusively clamped by the venous line clamp of the dialysis machine. | Met criteria |
| Clamp Occlusion Test | Demonstrate that tubing is capable of being occlusively clamped by the bloodline clamps. | Met criteria |
Note: The document explicitly states: "All testing met predetermined acceptance criteria."
2. Sample size used for the test set and the data provenance:
The document does not provide specific sample sizes (e.g., number of units tested) for each performance or biocompatibility test. It mentions that "samples" were tested.
- Data Provenance: The studies were conducted by Fresenius Medical Care Renal Therapies Group, LLC, likely internally or through contracted labs, as part of their 510(k) submission to the FDA. The country of origin for the data is not specified beyond being part of a US FDA submission. It is implicitly prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes performance testing of a physical medical device (blood tubing set), not an AI device requiring expert ground truth for classification or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes performance testing of a physical medical device. The results of the physical tests (e.g., pressure resistance, leak tests) are objective measurements.
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 document is for a physical medical device (blood tubing set), not an AI device. No human reader studies or AI assistance were involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a physical medical device, not an AI device or algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established engineering standards and regulatory requirements (e.g., ISO 8638:2010, ISO 80369-7:2016, AAMI/ANSI/ISO 10993-7:2008, ANSI/AAMI/ST72:2019, ISO 10993-1:2018, ASTM F1671-13). The device's ability to resist pressure, prevent leaks, sustain flow rates, and demonstrate biocompatibility according to these standards serves as the ground truth.
8. The sample size for the training set:
Not applicable. This document describes the testing of a physical medical device, not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. See point 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.