Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-81: AAMI / ANSI / ISO 81060-2:2009, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. (Cardiovascular)
Date of Standard: 2009. |
| 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) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Non-invasive Blood Pressure Monitors |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
The complete standard is recognized except for the following bulleted items:
*Any reference to IEC 60601-1-:2005 (i.e the 3rd edition of IEC 60601-1). CDRH recognizes the ANSI/AAMI ES 60601--1:2005 standand instead.
*This sentence in Clause 5.1.6 Special patient populations: "If the sphygmomanometer has been evaluated according to the requirements of 5.1.1, it shall then be validated in at least an additional 35 special population subjects."
*Examples 3 and 6 in Clause 5.2.4.2.2 Data analysis
* Clause 5.2.4.2.2 Data analysis, on its disallowing use of averaging the reference blood pressure determinations taken before and after each test monitor determination.
*Clause 5.2.5 Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments
*Clause 5.2.6. Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring
*These sentences in Clause 6.1.3.1 Age distribution: "For a sphygmomanometer additionally intended for use in children, an additional 5 children aged between 3 y and 12 y shall be included in the validation study.
NOTE 2 Minimum total of 20 subjects."
*This sentence in Clause 6.1.6 Special patient populations: "If the sphygmomanometer has been evaluated according to the requirements of 6.1.1, then only seven additional special population patients shall be included in the validation study."
FDA Notes:
This standard is recognized when used together with ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
Because Clause 5.2.4.1.1 Procedure removes from the clinical study any patient whose reference systolic blood pressure determinations differ by more than 12 mmHg or whose reference diastolic blood pressure determinations differ by more than 8 mmHg, device labeling should indicate that the device is not intended to record blood pressure from subjects whose blood pressure values change significantly during the data recording session.
For Clause 6.2.4 Determining the reference blood pressure, Please calculate the variation of the reference systolic blood pressure and that of the reference diastolic blood pressure separately. If the number of reference blood pressure determinations is very small, the mathematically calculated standard deviation can be artificially large, resulting in a variation (i.e., the limits of mean +/- one standard deviation) that is larger than the range of the reference blood pressure. In that case, please simply average all reference systolic (or separately for diastolic) blood pressures to use as the comparator for the test monitor systolic (or diastolic) determination. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1130 |
System, Measurement, Blood-Pressure, Non-Invasive |
Class 2 |
DXN |
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| Relevant Guidance: |
| Non-invasive Blood Pressure (NIBP) Monitor Guidance (version 1.0 issued March 10,1997) |
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| FDA Technical Contacts: |
| Charles Ho, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1318 |
| Silver Spring MD 20993 |
| 301/796-6320 |
| Email: charles.ho@fda.hhs.gov |
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| Sandy Weininger |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 4212 |
| Silver Spring MD 20993 |
| 301/796-2582 |
| Email: sandy.weininger@fda.hhs.gov |
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