Guidance for Industry
Non-Automated Sphygmomanometer
(Blood Pressure Cuff) Guidance
Version 1
Document issued on: November 19, 1998
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Circulatory Support and Prosthetic Devices Branch
Division Cardiovascular and Respiratory Devices
Office of Device Evaluation
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1 Page 1 Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to,
Sandy F. Stewart, Ph.D., Center for Devices and Radiological Health, 9200 Corporate
Boulevard, HFZ-132, Rockville, MD 20850.  Comments may not be acted upon by the
Agency until the document is next revised or updated.  For questions regarding the use or
interpretation of this guidance contact Sandy F. C. Stewart, Ph.D., at 301-827-5610 or by
electronic mail at sxs@cdrh.fda.gov.
Additional Copies
World Wide Web CDRH  page:  http://www.fda.gov/cdrh/ode/blprcuff.pdf, or CDRH
Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 2239 when
prompted for the document shelf number.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1  Page 2 Table of Contents
1.  Scope..............................................................................................................................................................................4
2.  Regulatory Requirements...............................................................................................................................................4
3.  Recommended Information and Testing........................................................................................................................5
a.  Device Description....................................................................................................................................................5
b.  In vitro Performance Testing.....................................................................................................................................6
i.  Comparison Testing..............................................................................................................................................6
ii.  SP9 Standard Testing............................................................................................................................................6
iii.    Foreign Standards.................................................................................................................................................7
c.  Additional Testing.....................................................................................................................................................7
d.  Suggested Format for Test Reports...........................................................................................................................7
i.  Test Protocol..........................................................................................................................................................7
ii.  Test Data and Results............................................................................................................................................7
iii.    Analysis................................................................................................................................................................8
4.  In Vitro Safety Testing...................................................................................................................................................8
a.  Biocompatibility........................................................................................................................................................8
b.  Sterilization................................................................................................................................................................8
c.  Shelf Life....................................................................................................................................................................8
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1  Page 3 Non-automated Sphygmomanometer
1
(Blood Pressure Cuff) Guidance
1.  Scope
This guidance in intended to aid in the preparation or review of premarket notification
(510(k)) applications for some of the devices regulated under:
CFR Section:  21 CFR 870.1120, Blood Pressure Cuff
Class:  II
Panel:  Circulatory System Devices Panel (74)
Product Code:  DXQ
This guidance applies to blood pressure cuffs covered by the ANSI/AAMI SP9-1994
standard for non-automated sphygmomanometers (SP9 standard).  Included in the SP9
standard are non-automated sphygmomanometers that use (1) an occluding cuff, (2) either
an aneroid or mercury gravity sphygmomanometer to measure pressure, and (3) a
stethescope or other manual system for detecting Korotkoff sounds.
This guidance does not apply to any automated non-invasive blood pressure monitors, whether 
using the oscillometric method or any other method, nor does it apply to direct or invasive blood
pressure monitoring systems.  These devices are classified elsewhere.
This guidance is complementary to the requirements of 21 CFR  807.87.  Other
information not identified in this guidance may be required in a 510(k) application.  This
guidance is subordinate to all other applicable statutes, regulations, and policies.
2.  Regulatory Requirements
a.  A "Statement of Intended Use," an explicit description of all clinical functions
performed by the device, e.g., measures systolic and diastolic blood pressures, etc.;
b.  An "Indications for Use Statement," according to Office of Device Evaluation
policy.  Indications for use should include the intended patient population and
contraindications (when the device is or is not to be clinically used);
c.  Either a "Summary of Safety and Effectiveness" as described in  21 CFR  807.92,
or a "510(k) Statement" as described in 21 CFR  807.93;
d.  A "Truthful and Accuracy Statement" according to 21 CFR 807.87 (j);
                                                            
1 This document is intended to provide guidance.  It represents the Agencys current thinking on the above.  It does not
create or confer any rights for or on any person and does not operate to bind FDA or the public.  An alternative approach
may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1  Page 4 e. Identification of the predicate device, including:
i. The predicate device name;
ii. The predicate device's manufacturer;
iii. The predicate device's 510(k) number;
f. If application is for a modification to an existing device then provide:
i. Specifications for original device;
ii. Complete description of the similarities and differences between the two
versions of the device;
iii. A table comparing the two versions of the device for the items listed above;
g. Labeling
i. Conformance to the labeling regulations and policies is necessary. 
Appropriate labeling guidances are available through the Division of Small
Manufacturers Assistance (DSMA) at its toll-free number (800) 638-2041
or at its Internet address:
http://www.fda.gov/cdrh/dsmamain.html
ii. If the SP9 standard is used, then the labeling requirements of the standard
(Section 4.1) should be included or justification provided for any
modifications.
3. Recommended Information and Testing
a. Device Description
The description should include sufficient information to define the design,
capabilities, and function of the device, and the scope of the 510(k) submission. 
Minimal information includes:
i. The overall design;
ii. Photographs of the device with all accessories;
iii. Identification of all components and accessories covered by the 510(k);
iv. Material descriptions for all patient or operator contacting materials;
v. Product specifications with ranges and/or accuracies, including
measurement limits, operating limitations, and any other functional or
physical limitation of the device;
vi. Packaging, including a description of the design, materials, and the sealing
method.  For package integrity, any appropriate standard may be used.  If
the SP9 standard is used, the manufacturer should conform to the
standards requirements (section 4.1) or justify any modification;
vii. If the 510(k) application is for a modification to an existing device, then
provide:
(1) specifications for the original device;
(2) a complete, detailed description of the similarities and differences
between the two versions of the device;
(3) a table comparing the items listed above for the two versions.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1 Page 5 b. In vitro Performance Testing
Substantial equivalence can be demonstrated by showing either (1) sufficient
comparison testing with a legally-marketed predicate device, (2) conformance to
the SP9 standard, or (3) conformance to any foreign or domestic standard which
meets or exceeds the requirements of the SP9 standard.
i. Comparison Testing
It is strongly recommended that substantial equivalence be demonstrated by
showing conformance to the SP9 standard.  However, if the manufacturer
chooses to provide comparative testing, the provided data should meet the
Suggested Format for Test Reports (listed below) and account for the
following:
 (1) The manufacturer should identify all of the safety and effectiveness
issues for their device.  These issues can be identified independently
or in parallel with the SP9 standard, i.e., a testing issue identified in
the SP9 standard is usually (but not always) relevant to the safety
and effectiveness of a device.  The SP9 standard may not be
sufficient, however, for every device;
(2) There should be sufficient comparison testing provided to
encompass every safety and effectiveness issue related to the
device.  Usually, a test will be necessary if it is capable of evaluating
a failure mode, functional limitation, or a labeling claim for the
device;
(3) All testing should evaluate the device in worst case and normal
operating conditions.  The worst case scenario should be justified
and based on the clinical or actual use of the device;
(4) The comparison testing should be scientifically sound and have a
statistically valid sample size.  Since this usually results in a large
sample size, most manufacturers rely on the smaller sample size
required by the SP9 standard;
(5) The pass/fail criteria of the SP9 and other standards cannot be used.
 Rather, the new device should show better or equal performance as
compared to the predicate device.
ii. SP9 Standard Testing
To show conformance to the SP9 standard, the manufacturer should list each
of the requirements of the standard and describe how the device conforms to
each requirement.2  For in vitro testing, the test protocol, test data and
results, and analysis should be provided and clearly identified.  The
appropriate detail for each element of a test report is described below in
Suggested Format for Test Reports.  For devices with unique features or
intended uses, additional testing beyond the SP9 standard may be necessary.
                                                            
2  If SP9 becomes a Recognized Standard, it will not be necessary to submit the test report.  Instead, a Declaration of
Conformity should be submitted (see the Guidance on the Recognition and Use of Consensus Standards).  Refer to
the CDRH Web page for the most recent list of Recognized Standards.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1 Page 6 If the SP9 standard is chosen by the manufacturer, conformance to the
entire standard should be demonstrated.  Conformance to portions of
the standard is usually insufficient to permit the standards use or to allow a
labeling claim to that effect.  Therefore, if only part of the standard is met,
the manufacturer should refer to the Comparison Testing section of this
guidance.
iii. Foreign Standards
If the manufacturer chooses to conform to a standard other than the SP9,
list each requirement of the SP9 standard, compare the foreign standard to
the SP9 requirements, and clearly identify where the foreign standard does
not meet the requirements of the SP9 standard (if at all).  Justification for
any differences should be based on valid scientific or statistical analyses and
supported by testing if necessary.
c. Additional Testing
In addition to the testing described above, the manufacturer should evaluate the
intra-device variability among a minimum of three devices.
d. Suggested Format for Test Reports
In general, any in vitro test report should include the following:
i. Test Protocol
The test protocol should include:
(1) the purpose of the test;
(2) a clear description (with schematics) of the test set-up and any
device modifications;
(3) identification and precision of equipment used;
(4) step-by-step descriptions of the data collection methods used;
(5) derivation of any formulae used;
(6) justification for the testing parameters (e.g., testing temperature,
length of test, the selection of device modes, etc.) and the pass/fail
criteria.  The testing parameters and pass/fail criteria should be
conservative and based on the extreme clinical use of the device,
according to the intended use or applicable standard.  Depending on
the test, it may be appropriate to base the testing parameters on the
normal use of the device.  However, if an extreme exists, it should
be explored.
ii. Test Data and Results
The test data and results should include:
(1) clearly labeled data with appropriate units;
(2) data that is easily associated with the methods described in the
protocol;
(3) if graphs are present, a table listing each data point shown on the
graph;
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1 Page 7 (4) if calculated values are present, a section showing how the values
were calculated according to formulae presented in the protocol;
iii. Analysis
An analysis should include:
(1) an evaluation of the test data according to the pass/fail criteria and
purpose defined in the test protocol;
(2) identification of the inadequacies and accuracy of the test;
(3) evaluation of any need for additional testing;
(4) a clear conclusion within the scope of the particular test.
4. In Vitro Safety Testing
a. Biocompatibility
The manufacturer should identify all patient and operator contacting materials and
conform to the International Standard ISO-10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing.  For materials that are widely
used in the same or similar applications, supportive information demonstrating the
materials use in other medical devices or products may be acceptable in
establishing biocompatibility.  However, any references should be to the same
vendor and material, and account for any changes to the material due to
subsequent processes or manufacturing (e.g., sterilization, forming, melting).
b. Sterilization
Blood pressure cuffs usually have no sterile components; however, if sterile
components are identified, refer to the 510(k) Sterility Review Guidance #K90-1
(February 1990) or the most recent sterilization policy or guidance.
c. Shelf Life
Usually a shelf life is not applicable to blood pressure cuffs.  However, if the
device contains any sterile or degradable components, shelf life data may be
necessary.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance, Version 1 Page 8