(162 days)
The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy.
The provided text for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930) discusses performance in terms of adherence to various standards rather than specific quantitative acceptance criteria and device performance values. It is a submission for a medical device that outlines its equivalence to a predicate device based on similar intended use and technological characteristics. The document does not describe a study comparing the device's performance against specific, pre-defined quantitative acceptance criteria in a clinical setting in the way an AI/ML device would be.
Therefore, many of the requested categories for AI/ML device studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this 510(k) summary for a physical medical device.
However, I can extract the information that is present and indicate where the requested information is not provided or applicable.
Acceptance Criteria and Device Performance for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930)
This 510(k) summary for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET does not present quantitative acceptance criteria or corresponding device performance results in the format typically seen for AI/ML diagnostic devices. Instead, the performance is demonstrated through conformance to established national and international standards for physical medical devices. The core argument for acceptance is substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Standards Complied With) | Reported Device Performance (Conformance) |
|---|---|
| Physical Specification | Conforms to applicable standards |
| Chemical Specification | Conforms to applicable standards |
| Biological Specification | Conforms to applicable standards (e.g., ISO 10993 series, USP Pyrogenic standards) |
| Sterilization Specification | Conforms to applicable standards (e.g., ISO 11607-1, ISO 11135) |
| Intended Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device |
Study Proving Device Meets Acceptance Criteria:
The study described is primarily a bench testing and comparison to predicate device approach, rather than a clinical trial with quantitative endpoints in the context of AI/ML performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing," which implies laboratory-based evaluations of the physical device components. Specific sample sizes for these tests are not provided in this summary.
- Data Provenance: Not applicable in the context of patient data for an AI/ML device. The testing would have been conducted in a laboratory setting by the manufacturer, BIOTEQUE CORPORATION, likely in Taiwan (R.O.C.), given the submitter's address.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., radiologists reviewing images to establish ground truth). For a physical medical device like blood tubing, "ground truth" is typically established through validated laboratory tests against defined physical, chemical, and biological specifications, not through expert consensus on observational data.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth from observational data. This is not relevant for bench testing of a physical product.
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 is a physical medical device (blood tubing), not an AI/ML diagnostic algorithm. Therefore, an MRMC study and the concept of human reader improvement with/without AI assistance do not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Standards Conformance: The "ground truth" for this device is based on conformance to established national and international standards for medical device physical, chemical, biological, and sterilization properties (e.g., ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards). The absence of safety and effectiveness concerns compared to a predicate device (K853851) also serves as a benchmark for acceptability.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.
§ 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.