ARTERIAL VENOUS BLOOD TUBING SET

K953823 · Medisystems Corp. · FJK · Sep 23, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K953823
• Device Name: ARTERIAL VENOUS BLOOD TUBING SET
• Applicant: Medisystems Corp.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Sep 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The blood tubing sets are intended for use with a blood access device and a medically approved flow-through treatment device.

Device Story

Arterial-Venous Blood Tubing Set; provides connection between blood access devices and flow-through treatment devices (e.g., hemodialyzers) during extracorporeal procedures. Device facilitates blood flow in clinical dialysis settings. Operation involves physical connection of tubing to access and treatment equipment. Output is the established fluid path for extracorporeal circulation. Benefits include standardized, safe blood transport during hemodialysis. Submission concerns labeling updates to include expanded directions for use and additional warnings/precautions per ANSI/AAMI RD-17 standards; no changes to device design, composition, or performance.

Clinical Evidence

No clinical data. Bench testing only; labeling changes do not affect product design or performance.

Technological Characteristics

Tubing set for extracorporeal blood flow. Design and materials unchanged from predicate. Labeling updated to comply with ANSI/AAMI RD-17, Hemodialyzer Blood Tubing.

Indications for Use

Indicated for patients undergoing extracorporeal procedures, such as hemodialysis, requiring connection between blood access devices and flow-through treatment devices.

Regulatory Classification

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.

Predicate Devices

• Medisystems blood tubing sets (cleared September 8, 1981)

Submission Summary (Full Text)

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SEP 23 1996

# Section B

## 510(k) Summary
Required by 21 CFR §807.92

### I. Submitter:

A. Name: McKenna & Cuneo, L.L.P.
on behalf of Medisystems Corporation

B. Address: 1575 Eye St. NW
Washington, DC 20005

C. Phone and Fax Numbers: Phone: [phone]
Fax [phone]

D. Contact Person: Ms. Suzan Onel

### II. Date of preparation of this Summary: July 25, 1995

### III. Trade Name: Arterial - Venous Blood Tubing Set

### IV. Common Name: Tubing set

### V. Classification Name: Set, Tubing, Blood, with and without Antiregurgation Valve

### VI. The Marketed Device(s) to which Equivalence is Claimed: The blood tubing sets which are the subject of this submission are substantially equivalent to Medisystems blood tubing sets in commercial distribution pursuant to a prior premarket notification that was cleared on September 8, 1981.

### VII. Product Description: Medisystems blood tubing sets are used during extracorporeal procedures by providing a means to connect blood access devices to flow-through treatment device(s) (e.g. a hemodialyzer).

### VIII. Statement of Intended Use Compared to Legally Marketed Device: The intended use of the Medisystems blood tubing set is identical to that of the legally marketed predicate device: The blood tubing sets are intended for use with a blood access device and a medically approved flow-through treatment device.

### IX. Discussion of Technological Characteristics: Because the intent of this 510(k) is to seek FDA acknowledgment for a change in the labeling of currently marketed devices, the technological

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characteristics of the device are unchanged. The specific proposed labeling changes consist of the following:

A. The directions for use have been expanded to provide the user with an increased amount of information concerning the use of the device.

B. Additional warnings and precautions are proposed to better inform the user of current information regarding hemodialysis procedures and to comply with the labeling requirements of ANSI/AAMI RD-17, Hemodialyzer Blood Tubing.

X. Safety and Effectiveness: The proposed changes to the blood tubing sets consist of modifications to the case insert label. The proposed labeling changes do not affect the product's design, composition, manufacturing, or performance characteristics. The labeling revisions are proposed to provide the user with an increased amount of information concerning the use of the device. Although none of the label changes raise new issues regarding safety and effectiveness, additional warnings and precautions are proposed to better inform the user of recent trends in dialysis procedures involving high efficiency or high flux dialysis and to be consistent with recognized standards.