(90 days)
The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
The Gambro medical lines QuickSet® are tubing sets (bloodlines) employed in the hemodialysis equipments extracorporeal circulation: they convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line). The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
Here's a breakdown of the acceptance criteria and study information for the Gambro QuickSet® Bloodlines, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary focuses on demonstrating substantial equivalence through non-clinical bench testing. It does not list specific numerical acceptance criteria for each test in a dedicated table, but rather states that the tests were "successful" in demonstrating safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | Successful |
| Biocompatibility | Successful |
| Sterilization Process Validation | Successful |
| Sterility Testing | Successful |
| Flow Rate Testing | Successful |
| Validation of Needle and Needle-less System Injection Ports | Successful |
| Compatibility with Hemodialysis Machines | Successful |
| Testing for Mechanical Hemolysis | Successful |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of bloodlines tested for flow rate, number of samples for biocompatibility).
- Data Provenance: The data provenance is from non-clinical bench testing. The country of origin is not explicitly stated, but the submission is to the US FDA by Gambro Renal Products, a US-based company, suggesting the testing was likely conducted in the US or in compliance with US regulatory standards. The testing is prospective in nature, as it was conducted to support the 510(k) submission for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a non-clinical bench test, not a study involving human or image-based ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a non-clinical bench test, not a study involving human readers or expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical bloodline system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical component, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by engineering specifications, recognized standards, and established laboratory methods for evaluating the performance, safety, and compatibility of medical devices like bloodlines. For example:
- Biocompatibility: Complies with ISO standards for biological evaluation of medical devices.
- Sterility: Absence of microorganisms, confirmed by validated sterility tests.
- Flow Rate: Meeting predefined flow rate specifications.
- Mechanical Hemolysis: Meeting acceptable levels of red blood cell damage.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.