(142 days)
The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired.
The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and for fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing
The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615). The tubing pathway can be split up in to five separate sections: Access Blood path (Red), Return Blood path (Dark Blue), Filtrate (Effluent) path (Yellow), Dialysate Solution path (Green), Replacement (Substitution) path (Light Blue). The Edwards AqualineS Tubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters. The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing. The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
The provided text describes a 510(k) premarket notification for the "Edwards Aqualine Sterile Tubing Set" and its accessories. This is a medical device submission, and the content focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical or algorithmic study.
Therefore, many of the requested elements for describing an acceptance criteria study (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable (N/A) in this context. The submission's goal is to demonstrate that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with functional bench testing.
Here's a breakdown of the information as it relates to the provided document:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The device performance is assessed through bench testing to ensure basic functionality and equivalence in critical parameters.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Bench Testing) |
|---|---|
| Material Equivalence: Same materials as predicate devices. | The Edwards Aqualine Tubing Sets are made of the same materials as the Baxter Accura Tubing Set (K021615), with the exception of one pressure transducer membrane (EPDM rubber instead of butyl rubber). |
| Process Equivalence: Same manufacturing processes. | The Edwards Aqualine Tubing Sets are manufactured by the same processes and sterilized under the same conditions as the Baxter Accura Tubing Set (K021615). |
| Design Equivalence: Similar design to predicate devices. | Similar design, with differences noted for the "S" version (total volume, length, diameters) to allow for lower flow rates/priming volumes. |
| Intended Use Equivalence: Same intended use as predicate devices. | Indicated for use with Baxter Accura System for continuous solute/fluid removal in acute renal failure/fluid overload, and TPE, similar to predicate devices. |
| Functional Equivalence: Performs like predicate devices. | Functional testing conducted on the Baxter Accura System. |
| Mechanical Resistance: Withstands pump action. | Rolling tests conducted on Edwards Aqualine, AqualineS, and Baxter Accura (K021615) Tubing Sets. |
| Shelf-Life/Sterility Maintenance: Maintains integrity over time. | Expiration date established by real-time tests over a 5-year period. Tensile Strength Testing conducted as part of expiration date tests. |
| Safety - Pressure Transducer: Safe material for pressure sensing. | Use of EPDM rubber for all pressure transducer membranes, which is a material also used in the predicate device (Baxter Accura K021615). |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The "test set" for this type of submission refers to the physical devices undergoing bench testing. The document states "Functional testing has been conducted with the Edwards Aqualine Tubing Sets" and "Rolling tests (mechanical resistance during the rolling pump action) have been conducted with the Edwards Aqualine, Edwards AqualineS and Baxter Accura (K021615) Tubing Sets." No specific number of units tested is provided.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by the manufacturer or a contracted lab. The manufacturing entity, Haemotronic S.p.A., is in Italy, and the applicant is in Germany. It would be prospective testing on manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. The "ground truth" for this device comes from engineering specifications and performance standards for hemodialysis tubing sets, established by the manufacturer and validated through the testing performed. There is no mention of external human experts establishing ground truth in the context of a diagnostic or interpretative study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for studies involving human interpretation or uncertain outcomes. Bench testing for medical device functionality typically relies on objective measurements against predetermined engineering specifications, not expert adjudication.
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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:
- N/A. This device is a sterile tubing set, not an AI-powered diagnostic tool. Therefore, MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a physical medical tubing set, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" is defined by engineering specifications and established performance standards for hemodialysis tubing sets. This includes parameters like material properties (tensile strength), mechanical resistance to pumping, and sterile shelf-life. The predicate device's performance also serves as a de facto benchmark for substantial equivalence.
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The sample size for the training set:
- N/A. This is a hardware medical device, not a machine learning algorithm. There is no concept of a "training set."
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How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this type of 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.