Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-65: AAMI / ANSI / ISO 8637:2010, Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators. (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 |
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| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Hemodialyzers, Hemoconcentrators, Hemofilters, Hemodiafilters |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulations |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and artificial organs-Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators;
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, the dialysate pathway should also be sterile.
For Section 4.5.1 Clearance of hemodialyzers and hemodiafilters, clearances should be measured at blood flow rates of 200 ml/min, 300 ml/min, 400 ml/min, 500 ml/min, and maximum flow rate, when different from these rates.
For Section 4.5.2 Sieving coefficient of hemodiafilters, hemofilters and hemoconcentrators, sieving coefficients for urea and Vitamin B12 should also be measured.
For Section 4.5.3 Filtration rate, ultrafiltration coefficients (Kuf) should be computed by measuring the slope of the ultrafiltration rate (UFR) vs. transmembrane pressure (TMP) curve at UFR of 600 and 1800 ml/hr (or the maximum capability of the dialyzers that are not able to achieve 1800 ml/hr), using a minimum of four data points.
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 5.6.5.1.3 Test procedure, pressure drop in the blood compartment should be measured for blood flow rates of 200 ml/min, 300 ml/min, 400 ml/min, 500 ml/min, and maximum flow rate, when different from these rates.
For Section 5.6.5.2.2 Test procedure, pressure drop in the dialysate compartment should be measured for dialysate flow rates of 500 ml/min, 600 ml/min, 700 ml/min, 800 ml/min, and maximum flow rate, when different from these rates.
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, part e) 3) does not apply; the dialysate pathway should be sterile. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5820 |
Dialyzer, Capillary, Hollow Fiber |
Class 2 |
FJI |
| §876.5820 |
Dialyzer, Parallel Flow |
Class 2 |
FJG |
| §876.5820 |
Dialyzer, Single Coil |
Class 2 |
FHS |
| §876.5820 |
Dialyzer, Twin Coil |
Class 2 |
FJJ |
| §876.5820 |
Filter, Blood, Dialysis |
Class 2 |
FKJ |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5860 |
Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Class 2 |
KDI |
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| Relevant Guidance: |
| Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers. Issued on August 7, 1998. |
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| FDA Technical Contacts: |
| Carolyn Neuland |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G226 |
| Silver Spring MD 20993 |
| 301/796-6523 |
| Email: carolyn.neuland@fda.hhs.gov |
|
| Gema Gonzalez |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G220 |
| Silver Spring MD 20993 |
| 301/796-6519 |
| Email: gema.gonzalez@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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