(57 days)
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.
The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.
The provided text is a 510(k) summary for a medical device (Blood Tubing Lines for Hemodialysis AV06C-E). It details the device's characteristics, intended use, and comparison to a predicate device, focusing on demonstrating substantial equivalence based on recognized standards and bench testing.
However, the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this document.
This document outlines various tests conducted (sterilization, biological safety, bench performance) to support the device's safety and effectiveness compared to a predicate, but it does not provide explicit acceptance criteria with numerical values or detailed study designs for those criteria as you've requested. It indicates what tests were done (e.g., Cytotoxicity, Structural Integrity, Pump Segment Performance) but not the specific thresholds for acceptance or the methodology of the associated studies in the depth you're looking for.
Therefore, I cannot populate the table or answer most of your detailed questions from the provided text.
Here's what I can extract and state explicitly from the document regarding the information you asked for:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated in the document with specific numerical criteria and outcomes against those criteria. The document states "Sterilization validation and Shelf Life test were completed using the subject device," "Biological safety testing was completed to confirm the safety of the subject device," and "Bench testing was completed to confirm the subject device is substantially equivalent to the predicate device in performance." It then lists the types of tests performed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's evaluation is primarily based on bench testing, sterilization, and biological safety, not expert interpretation of diagnostic images or clinical outcomes.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: For biological safety, it's based on standard biological safety tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemocompatibility). For bench performance, it's based on engineering and performance standards relevant to blood tubing lines (e.g., structural integrity, pump segment performance, tensile strength, flow dynamics).
- The sample size for the training set: Not applicable (not an AI/learning algorithm).
- How the ground truth for the training set was established: Not applicable.
The document emphasizes that the device is "substantially equivalent" to a predicate device, meaning it has similar intended use, design, configuration, scientific technology, and principles of operation, with only minor differences that do not raise new questions of safety and effectiveness. The demonstration of this equivalence relies on a series of validations and bench performance tests listed by appendix number.
§ 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.