(90 days)
The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.
The provided text is a 510(k) Summary for the Transonic Flow-QC® Sets, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a medical device with an algorithm.
Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample sizes, ground truth, experts, adjudication), and multi-reader multi-case (MRMC) or standalone studies is not explicitly available in the provided document. This document emphasizes material testing, compliance with standards, and comparison to a predicate device, which is a common approach for certain classes of medical devices.
Here's a breakdown based on the provided text, indicating where information is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Testing (as defined by Quality Control Test Procedure documents ensuring conformance to product design specifications) | All finished products are tested and must meet all required release specifications before distribution. These tests are established to ensure the product's performance parameters conform to the product design specifications. |
| Visual Examination (in-process and finished product) | All finished products are tested and must meet all required release specifications before distribution. |
| Material Compliance (ISO Standard 10993) | The Transonic Flow-QC® Sets are made of materials which have been tested in accordance with the ISO Standard 10993 and therefore suitable for the intended use of this product. |
| Design and Production Standard Compliance (ANSI/AAMI RD17-1994) | The ANSI/AAMI standard "American National Standard for Hemodialyzer Blood Tubing" RD17-1994 was followed for the design and will continue to be followed for the production and quality assurance testing of this device. |
Study Details
Below is a response to each specific point, indicating that the information is not present in the provided 510(k) summary for the Transonic Flow-QC® Sets. This type of 510(k) submission, particularly for accessories, often relies on material compliance and comparison to a predicate rather than extensive clinical performance studies as would be seen for a diagnostic algorithm.
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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):
- Information Not Provided. The document describes manufacturing quality control and material testing, not a clinical performance study with a "test set" in the context of an algorithm.
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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):
- Information Not Provided. No "ground truth" establishment by experts is mentioned, as this is not a diagnostic device or an algorithm requiring such validation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Provided. No adjudication method is mentioned, as there is no "test set" in the context of a diagnostic performance study.
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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:
- Information Not Provided. No MRMC study was performed or is relevant, as this device is a hemodialysis accessory, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information Not Provided. This device does not involve an algorithm, hence no standalone performance study was conducted or is applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information Not Provided. "Ground truth" in the context of diagnostic accuracy is not addressed. The "truth" for this device relates to manufacturing specifications and material compliance.
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The sample size for the training set:
- Information Not Provided. There is no "training set" as this device does not involve machine learning or an algorithm.
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How the ground truth for the training set was established:
- Information Not Provided. Not applicable, as there is no 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.