Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-75: AAMI / ANSI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(, Manual, electronic or automated sphygmomanometers. (Cardiovascular)
Date of Standard: 2008. |
| 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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| 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, including blood pressure cuffs |
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
FDA recognition of ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002 /A1:2003/(R)2008 & ANSI/AAMI SP10:2002/ A2:2006/(R)2008 Manuel, electronic or automated sphygmomanometers is hereby superseded by recognition of the following three standards:
a. ANSI/AAMI/ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
b. ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
c. 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
FDA will accept declarations of conformity, in support of premarket submissions, to ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers until June 30, 2013. After this transitional period, declarations of conformity to ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI
SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers will not be accepted.
The standard is recognized in whole except for the following changes:
a. The second paragraph in Clause C.3 Data collection in Annex C of SP10:2002/(R) 2008, is not recognized. To determine 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.
b. A reporting requirement described in clause 4.4.5.1.2.B Method 2 and clause 4.4.5.2.B is not recognized. The reporting requirement is excerpted below:
"A report of study findings, which shall be made available by the manufacturer upon request, shall contain at least the following statistics and descriptors... Whether K4 or K5 is used for determination of diastolic pressure."
c. If a device is claimed to be able to function within specification in the presence of common arrhythmias, as indicated in clause 4.1.3 d, please provide clinical data to substantiate the claim. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1110 |
Computer, Blood-Pressure |
Class 2 |
DSK |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1120 |
Blood Pressure Cuff |
Class 2 |
DXQ |
| §870.1120 |
Reprocessed Blood Pressure Cuff |
Class 2 |
NPP |
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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: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| 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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