(383 days)
The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.
The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro. The components of the Oxyless Blood Tubing Set include pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines and tubing clamps. Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free. Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.
This document is a 510(k) Premarket Notification for a medical device, the Oxyless Blood Tubing Set. It details the device's comparison to a predicate device to establish substantial equivalence, rather than a study proving the device meets acceptance criteria based on performance metrics against a clinical ground truth.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of the requested AI/algorithm evaluation. The "acceptance criteria" discussed in this document refer to engineering and biocompatibility testing for a physical medical device, not performance metrics of an AI model against a diagnostic or predictive ground truth.
However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as the "study" in this context.
Here's a breakdown of what can be derived from the provided text, reinterpreting the request for AI-specific criteria to fit the presented information about a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" here refer to engineering performance and biocompatibility standards for a physical medical device. The "reported device performance" indicates that these criteria were met, not specific quantitative results for each test.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Bench Performance Testing | Pressure Leak Testing | Device does not leak under specified pressure conditions. | Met acceptance criteria. |
| Pump Segment Endurance Testing | Device withstands prolonged use with pump action. | Met acceptance criteria. | |
| Injection Port Endurance Testing | Injection ports withstand repeated access without failure. | Met acceptance criteria. | |
| Priming Volume Assessment | Priming volume is within specified limits. | Met acceptance criteria. | |
| Tensile Testing of Joints/Materials | Components maintain structural integrity under tension. | Met acceptance criteria. | |
| Pressure Transducers Leak Testing | Transducers do not leak under specified pressure conditions. | Met acceptance criteria. | |
| Clamp Performance Testing | Clamps effectively occlude tubing as intended. | Met acceptance criteria. | |
| Tubing Kink Resistance | Tubing resists kinking during typical use. | Met acceptance criteria. | |
| Blood Tubing Set Operational Testing (with blood analog fluid for 4 hours at 37°C) | Device functions as intended for specified duration/conditions. | Met acceptance criteria. | |
| Biocompatibility Testing | Cytotoxicity | No evidence of cytotoxic effects. | Biocompatible for intended use. |
| Sensitization | No evidence of sensitization. | Biocompatible for intended use. | |
| Irritation or Intracutaneous Reactivity | No evidence of irritation or intracutaneous reactivity. | Biocompatible for intended use. | |
| System Toxicity (Acute) | No evidence of acute systemic toxicity. | Biocompatible for intended use. | |
| Genotoxicity | No evidence of genotoxicity. | Biocompatible for intended use. | |
| Hemocompatibility and Hemolysis | Acceptable haemocompatibility and no significant hemolysis. | Biocompatible for intended use. | |
| Pyrogenicity | Device is non-pyrogenic. | Biocompatible for intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a single number. The testing included multiple specific tests (pressure, endurance, tensile, etc.) for which a sample size would have been used for each. The document states "Bench performance testing of the Oxyless Blood Tubing Set was conducted and compared to the predicate device."
- Data Provenance: Not applicable in the traditional sense of a clinical or imaging dataset. The "data" here are the results from in-vitro (bench) and material (biocompatibility) tests performed on the physical device. The testing was conducted to "the predicate device for its 501(k) submission" and "in accordance with the performance testing described in the FDA Guidance for Hemodialysis Blood Tubing Sets."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive clinical diagnosis or label. For this physical blood tubing set, the verification is against engineering specifications and biocompatibility standards, not against "ground truth" established by human experts in the diagnostic sense. The "ground truth" are the test specifications themselves, likely set by engineering and regulatory standards.
4. Adjudication method for the test set
Not applicable. This is not a study involving human adjudication of results for a diagnostic or predictive task. Test results are objective measurements against defined criteria.
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 algorithm or a diagnostic assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a physical medical device submission, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation consists of:
- Established engineering specifications and performance criteria for hemodialysis blood tubing sets (e.g., specific pressure limits, endurance cycles, tensile strengths).
- Biocompatibility standards as outlined in "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
- The performance characteristics of the legally marketed predicate device (Nipro Blood Tubing Set) with which it claims "substantial equivalence."
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, there is no ground truth established for one.
§ 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.