(72 days)
The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
This submission describes a medical device, the "Blood Tubing Accessory with CLAVE Connector," not an AI/ML powered device. As such, the information provided does not align with the requested categories for AI/ML device studies. I will provide the acceptance criteria and study information that is available in the provided text.
Acceptance Criteria and Device Performance (based on non-AI/ML device information):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hemolysis (no significant hemolysis) | A hemolysis study conducted by an independent laboratory found no significant hemolysis occurs with the use of the CLAVE Connector. |
| Sterile barrier maintenance (for 6 days/144 hours with 24 activations/day) | A microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day with a standard disinfection protocol. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst-case clinical simulation. |
Study Details (based on non-AI/ML device information):
- Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are non-clinical laboratory studies, not based on patient data in the context of an "AI/ML test set."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical studies like hemolysis and microbial challenge is typically established by laboratory testing methodologies and standards, not expert consensus in the diagnostic sense.
- Adjudication method: Not applicable. This applies to diagnostic assessments, not non-clinical device performance studies.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device; an MRMC study is not relevant.
- If a standalone study was done: Yes, the described studies (hemolysis and microbial challenge) are standalone performance tests for the device's physical and biological properties.
- The type of ground truth used:
- Hemolysis: The ground truth would be based on established laboratory methods and standards for quantifying hemolysis in blood samples.
- Microbial challenge: The ground truth would be based on microbiological techniques to assess sterility and barrier integrity, likely quantifying microbial growth or penetration under controlled conditions.
- The sample size for the training set: Not applicable. This device does not involve AI/ML.
- How the ground truth for the training set was established: Not applicable. This device does not involve AI/ML.
§ 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.