BRAUN HEMODIALYSIS BLOOD CIRCUITS

K952631 · B.Braun Medical, Inc. · FJK · Apr 30, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K952631
• Device Name: BRAUN HEMODIALYSIS BLOOD CIRCUITS
• Applicant: B.Braun Medical, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Apr 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system.

Device Story

Braun Hemodialysis Blood Circuits consist of tubing segments; function as conduit for extracorporeal blood flow between patient vascular access and hemodialyzer. Used in clinical hemodialysis settings; operated by trained healthcare professionals. Device facilitates blood transport during dialysis therapy; ensures closed-loop connection between patient and dialysis machine. Design accounts for various hemodialysis systems and user preferences.

Clinical Evidence

No clinical data. Bench testing only; includes sterility, pyrogenicity (LAL method), physical testing, and visual examination. Performance conforms to AAMI RD17R-6/94 draft standards.

Technological Characteristics

Tubing segments for extracorporeal blood transport. Biocompatibility testing per Tripartite Guidance. Performance standards: AAMI RD17R-6/94. Quality control per Device Master Records and GMPs.

Indications for Use

Indicated for patients requiring hemodialysis treatment; used to transport blood between the patient's vascular access device and hemodialyzer systems.

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

• Blood Tubing Set (K884243)

Submission Summary (Full Text)

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APR 30 1996
K952631

II 510(k) Summary

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

April 19, 1996

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Hemodialysis Blood Circuits

TRADE NAME: Braun Hemodialysis Blood Circuits

CLASSIFICATION NAME:

Gastroenterology and Urology
Class II, 78 KOC, Hemodialysis Blood Circuits
21 CFR 876.5820

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K884243 | Blood Tubing Set | Mediflex International Inc. |

DEVICE DESCRIPTION:

B. Braun Medical Inc. intends to introduce into interstate commerce the Braun Hemodialysis Blood Circuits in various configurations. The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system. The various configurations account for user preferences and various hemodialysis systems currently marketed. These all have the similar design and performance characteristics.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.

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## MATERIAL:

B. Braun Medical certifies that the biocompatibility tests recommended in the Tripartite Guidance for this category of contact duration will be completed for the materials use in the manufacture of the device.

## SUBSTANTIAL EQUIVALENCE:

The Braun Hemodialysis Blood Circuits are equivalent in materials, form, and intended use to the Blood Tubing Set currently marketed by Mediflex International Inc. There are no new issues of safety or effectiveness raised by the Braun Hemodialysis Blood Circuits.

## SAFETY AND EFFECTIVENESS:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The physical testing for the Braun Hemodialysis Blood Circuits are defined in detail in the "Device Master Records".

The Braun Hemodialysis Blood Circuits follow the recommended performance standards outlined by The Association for the Advancement of Medical Instrumentation in the draft standard AAMI RD17R-6/94.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.