(90 days)
Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows:
a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines.
b. The Recirculation Connector is indicated for use as a male to male Luer adaptor.
c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system.
d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.
A series of blood tubing set accessories to be used as part of the extracorporeal circuit.
A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices. The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems.
B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines.
C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit.
D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.
The provided text describes a 510(k) submission for "Blood Tubing Set Accessories" by Medisystems Corporation. The document outlines the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically found in AI/ML device submissions.
Instead, the submission focuses on establishing substantial equivalence to a legally marketed predicate device (Medisystems' Blood Tubing Sets described in K953823) and details the safety and effectiveness measures in terms of manufacturing processes and quality control.
Here's a breakdown of the requested information based on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study for K994306 (Medisystems Blood Tubing Set Accessories)
Given the nature of the device (blood tubing set accessories for hemodialysis) and the regulatory context (510(k) submission from 2000), the testing described is primarily for manufacturing quality assurance and functional integrity rather than AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Manufacturing/Quality Control | Sterility | "all finished products are tested and must meet all required release specifications before distribution" |
| Pyrogenicity | "all finished products are tested and must meet all required release specifications before distribution" | |
| Physical Testing | "all finished products are tested and must meet all required release specifications before distribution" | |
| Visual Examination (in-process and finished product) | "all finished products are tested and must meet all required release specifications before distribution" | |
| Functional Integrity | Gasket to prevent leakage (for Reverso™ valve) | The device description states it has a "gasket to prevent leakage," implying this is a design feature meant to be met. The general statement about meeting release specifications would cover this. |
| Ability to interconnect between blood tubing set and access devices (for Reverso™) | The device description states it is "equipped with tubing and Luer connectors to allow it to interconnect..." Implied to be met through design and quality checks. | |
| Ability to reverse arterial and venous access without disconnection (for Reverso™) | This is the intended function. No specific performance metric is given beyond the description of functionality. | |
| Proper interconnection as male-to-male Luer adaptor (Recirculation Connector) | Implied through design and quality checks. Functionality as described is the performance. | |
| Ability to connect two dialyzers in parallel (Parallel Dialyzer Interconnector) | Implied through design and quality checks. Functionality as described is the performance. | |
| Ability to connect two dialyzers in series (Series Dialyzer Interconnector) | Implied through design and quality checks. Functionality as described is the performance. |
Missing Information: The document does not specify quantitative acceptance criteria for device performance (e.g., "leakage rate must be
§ 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.