(246 days)
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-102DB、BT-102DC、BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-102DA 、BT-102DB、BT-102DC、BT-102DD)
This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way requested for AI/diagnostic devices. The information provided heavily emphasizes physical, chemical, biological, and sterilization specifications rather than clinical performance metrics often associated with "device performance" in the context of diagnostic or AI-driven tools.
Therefore, the requested table of acceptance criteria and reported device performance, and several other points (2, 3, 4, 5, 6, 7, 8, 9), cannot be directly extracted or are not applicable from the provided text in the way they would be for a typical AI/diagnostic device study. The text primarily focuses on conformity to standards and substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Applicable Standards/Specifications) | Reported Device Performance (as stated in the document) |
|---|---|
| Physical Specification | Conforms to applicable standards |
| Chemical Specification | Conforms to applicable standards |
| Biological Specification | Conforms to applicable standards (including ISO 10993 series, USP Pyrogenic standards) |
| Sterilization Specification | Conforms to applicable standards (including ISO 11607-1, ISO 11135) |
| Substantial Equivalence to Predicate Device | Bench testing demonstrates that differences in technological characteristics do not raise new questions of safety or effectiveness, making it substantially equivalent to Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench testing," but it does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood tubing pack, and its evaluation relies on engineering, material, and sterility testing against established standards, not expert interpretation of outputs like an AI diagnostic tool.
4. Adjudication method for the test set
Not applicable. The evaluation is based on conformance to engineering and safety standards, not a diagnostic interpretation process requiring adjudication.
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 not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation focuses on the physical and biological characteristics of the blood tubing pack itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established international and national standards for medical device safety, material compatibility, and sterilization (e.g., ISO 10993 series for biological evaluation, ISO 11607-1 for packaging, ISO 11135 for sterilization, USP Pyrogenic standards).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.