Recognized Consensus Standards

Recognition List Number: 026 Publication Date: 03/18/2011

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-66: AAMI / ANSI / ISO 8638:2010, Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. (ObGyn/Gastroenterology)

Date of Standard: 2010.

Addresses of Standards Organizations:

Association for the Advancement of Medical Instrumentation (AAMI)

4301 North Fairfax Drive

Suite 301

Arlington, VA 22203

American National Standards Institute (ANSI)

25 West 43rd Street

4th Floor

New York, NY 10036

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Hemodialyzer blood tubing, hemodialysis systems

Processes Affected:

510(k), PMA, PDP, IDE, HDE, Quality System Regulations

Type of Standard:

Vertical, International

Extent of Recognition:

ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs-Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and Hemofilters; With the following qualifications:

Additional testing not included in this standard may be required for marketing clearance or approval.

For 510(k) devices, testing and design requirements specified in Sections 4 and 5 should be applied in terms of comparing predicate and proposed devices and determining substantial equivalence.

For Section 4.2 Sterility, all fluid-contacting surfaces of the device, and the mating surfaces of all connectors integral to the device, should be sterile.

For Section 4.4.1 Structural integrity, additionally, device should be capable of enduring its maximum blood flow rate for a period of time representative of expected clinical use without tubing collapse or other signs of lack of performance.

For Section 4.4.9.1 Integral transducer protectors, the transducer protector should be capable of maintaining secure and leak-free connection to the hemodialysis machine when subjected to pressures of 2 times the manufacturer's recommended pressure for the device.

For Section 4.4.9.2 Non-integral transducer protectors, the transducer protector should be capable of maintaining secure and leak-free connection to the hemodialysis machine when subjected to pressures of 2 times the manufacturer's recommended pressure for the device.

For Section 4.4.11 Pump segment performance, performance characteristics of the pump segment should be evaluated at maximum specified flow rate. Also, endurance testing should be performed, looking for tubing collapse or other signs of lack of performance, for a period of time representative of expected clinical use.

For Section 5.2 Biological safety, testing shall be carried out in accordance with FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

For Section 5.5.1.1 Positive-pressure test, additionally, endurance testing at maximum blood flow rates should be performed, looking for tubing collapse or other signs of lack of performance, for a period of time representative of expected clinical use.

For Section 5.5.6.1 Needle access ports, testing should be performed with the largest recommended gauge needle and for a period of time representative of expected clinical use. Testing pressure should be 1.5 times the maximum specified pressure, even if it exceeds 700 mm Hg.

For Section 5.5.6.2 Needleless access ports, testing should be performed for a period of time representative of expected clinical use. Testing pressure should be 1.5 times the maximum specified pressure, even if it exceeds 700 mm Hg.

For Section 5.5.9 Transducer protectors, compliance with 4.4.9 and 4.4.9.1 should be verified by testing to withstand pressures of 2 times the manufacturer's recommended pressure for the device.

For Section 5.5.10 Blood pathway flow dynamics, compliance with 4.4.10 should be verified by mechanical hemolysis testing for new or significantly altered hemodialysis tubing designs that affect the pattern of blood flow.

For Section 5.5.11 Pump segment performance, testing should be performed for a period of time representative of expected clinical use and using the maximum recommended blood flow rate.

For Section 6 Labeling, the notes stating "in all cases above, symbols from ISO 15223 may be used where appropriate," does not apply. Symbols alone should not be used in lieu of their meaning.

For Section 6.2 Labeling on the unit containers, e) should provide a statement of sterility and nonpyrogenicity, and whether the entire contents of the container or only the fluid pathways and mating surfaces of connectors integral to the device are sterile. Additionally, the unit container labeling should identify the specific dialysis delivery system(s) with which it has been successfully tested and validated.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§876.5820	Accessories, Blood Circuit, Hemodialysis	Class 2	KOC
§876.5820	Adaptor, Fistula	Class 2	FKM
§876.5820	Adaptor, Y	Class 2	FJP
§876.5820	Connector, Blood Tubing, Infusion T	Class 2	FKB
§876.5820	Connector, Tubing, Dialysate	Class 2	FKY
§876.5820	Declotting Tray, Kit (Including Contents)	Class 2	FJZ
§876.5820	Filter, Blood, Dialysis	Class 2	FKJ
§876.5820	Protector, Transducer, Dialysis	Class 2	FIB
§876.5820	Set, Dialysis, Single Needle With Uni-Directional Pump	Class 2	FIF
§876.5820	Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed	Class 2	NNG
§876.5820	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class 2	FJK
§876.5820	System Accessories, Extracorporeal	Class 2	KXM
§876.5820	System, Blood, Extracorporeal And Accessories	Class 2	LLB
§876.5820	Tray, Start/Stop (Including Contents), Dialysis	Class 1	FKG
§876.5820	Tubing, Dialysate	Class 2	FID
§876.5820	Tubing, Dialysate (And Connector)	Class 2	KQQ