Arm automatic blood pressure monitor

• K Number: K161712
• Device Name: Arm automatic blood pressure monitor
• Manufacturer: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
• Date Cleared: 2017-04-05 ( 288 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm~44cm (8.7in~17.3in)) is wrapped around the single upper arm.

Device Description

Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.

Predicate Devices

K151258

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard oscillometric blood pressure monitor using a pressure sensor and CPU for calculation, with no mention of AI or ML terms or concepts.

Therapeutic

No
The device is intended to measure blood pressure and pulse rate, not to treat a medical condition.

Diagnostic

No

The device is an automatic blood pressure monitor that measures blood pressure and pulse rate. It does not provide a diagnosis of a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like an inflatable cuff, air pump, and pressure sensor, which are integral to its function. The software component is described as calculating values based on data from these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
• Device Function: This device measures blood pressure and pulse rate using a non-invasive oscillometric technique on the upper arm. It does not involve the collection or analysis of any specimens taken from the body.
• Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the body, not to analyze samples taken from the body.

Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate. The arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

single upper arm

Indicated Patient Age Range

Adult

Intended User / Care Setting

Over-The-Counter Use / Home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non Clinical tests:

• IEC 60601-1 Test
• IEC 60601-1-2 Test
• IEC 60601-1-11 Test
• IEC 80601-2-30 Test
  Key results: None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B B; tested met all relevant requirements of the aforementioned tests.

Clinical Tests: The subject device is identical to the predicate device from a technical perspective, and the differences do not affect blood pressure measurement technology. Therefore, repeated clinical testing in accordance with IEC 80601-2-30:2009 & A1:2013 is unnecessary.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151258

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 19, 2017

Shenzhen Pump Medical System Co., Ltd. Ms. Migo Yang Clinical Registration Specialist 2/f West, M-7 Sinosteel Building, Maqueling Estate Hi-tech Industrial Park Nanshan District, Shenzhen, 518057 CN

Re: K161712

Trade/Device Name: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 23, 2016 Received: June 21, 2016

Dear Ms. Migo Yang.

This letter corrects our substantially equivalent letter of April 5, 2017.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

1

Page 2 - Ms. Migo Yang

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mada Yellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K161712

Device Name

Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6055B;

Indications for Use (Describe)

It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K161712

Submitter's Identification: 1.

SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, PEOPLE'S REPUBLIC OF CHINA

Contact: Xie Qiongyu Tel:[phone] Fax:[phone] E-mail: [e-mail]

2. Name of the Device:

Trade Name: Arm automatic blood pressure monitor Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; Regulation Description: Non-invasive blood pressure measurement system. Regulation Number: 21 CFR 870.1130 Regulation Class: II Product Code: DXN Review Panel: Cardiovascular

3. Information for the 510(k) Cleared Device(Predicate device):

Arm automatic blood pressure monitor, Model: BE6034, BE6134, K151258, SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

4. Description of the device

Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.

4

The arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.

5. Intended Use:

Arm automatic blood pressure monitor, model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter.

6. Indications for Use:

Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; is intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.

7. Comparison to the 510(k) Cleared Device (Predicate device):

The subject device, Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B;and the predicate device: Arm automatic blood pressure monitor. Model: BE6034, BE6134 uses the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically by air pump and the pressures are transferred via tubing to a sensor in the unit.

They differ by the appearance , the Bluetooth function and the way of energy supply. The appearance of subject device is a little different from predicate device; The appearance of subject device has Bluetooth function while the subject device has not the Bluetooth function. The only way of energy supply of predicate device is battery while the way of energy supply of subject device can be both battery and adapter. But those differences do not affect the accuracy or normal use of this device because they use the same fundamental scientific technology based on clinical declaration of identity and the declaration of clinical identity.

The subject device: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; uses the same oscillometric method as the predicate device: Arm automatic blood pressure monitor, Model: BE 6034, BE6134 to determinate the systolic and diastolic blood pressure and pulse rate. They have the same intended use. Based upon the aforementioned information, these devices are substantially equivalent.

Please refer to table below for comparison.

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No	Items	Model
		BE6034, BE6134	BF3213(0B)	BF1214(0B)	BF6123A	BF6148A	BF6055B
1	Manufacturer	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.	SHENZHEN
PUMP
MEDICAL
SYSTEM
CO.,LTD.
2	Intended Use	It is a device
intended to
measure the
systolic, diastolic
blood pressure
and pulse rate of
an adult
individual by
using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available sizes:
22cm to 44cm
(8.7in to 17.3in))
is wrapped around
the single upper
arm.	It is a device
intended to
measure the
systolic,
diastolic blood
pressure and
pulse rate of
an adult
individual by
using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available
sizes: 22cm to
44cm (8.7in to
17.3in)) is
wrapped
around the
single upper
arm.	It is a device
intended to
measure the
systolic,
diastolic blood
pressure and
pulse rate of an
adult individual
by using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available sizes:
22cm to 44cm
(8.7in to
17.3in)) is
wrapped around
the single upper
arm.	It is a device
intended to
measure the
systolic,
diastolic blood
pressure and
pulse rate of an
adult individual
by using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available sizes:
22cm to 44cm
(8.7in to
17.3in)) is
wrapped around
the single upper
arm.	It is a device
intended to
measure the
systolic,
diastolic blood
pressure and
pulse rate of an
adult individual
by using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available sizes:
22cm to 44cm
(8.7in to 17.3in))
is wrapped
around the single
upper arm.	It is a device
intended to
measure the
systolic,
diastolic blood
pressure and
pulse rate of
an adult
individual by
using a non-
invasive
oscillometric
technique in
which an
inflatable cuff
(available
sizes: 22cm to
44cm (8.7in to
17.3in)) is
wrapped
around the
single upper
arm.
3	Indications for
Use	It is intended for
measuring
systolic, diastolic
blood pressure
and pulse rate of	It is intended
for measuring
systolic,
diastolic blood
pressure and	It is intended for
measuring
systolic,
diastolic blood
pressure and	It is intended for
measuring
systolic,
diastolic blood
pressure and	It is intended for
measuring
systolic,
diastolic blood
pressure and	It is intended
for measuring
systolic,
diastolic blood
pressure and
	Items	Model
No		BE6034, BE6134	BF3213(0B)	BF1214(0B)	BF6123A	BF6148A	BF6055B
		an adult over the
counter.	pulse rate of
an adult over
the counter.	pulse rate of an
adult over the
counter.	pulse rate of an
adult over the
counter.	pulse rate of an
adult over the
counter.	pulse rate of
an adult over
the counter.
4	Patient
population	Adult	Adult	Adult	Adult	Adult	Adult
5	Environment
of use	Home	Home	Home	Home	Home	Home
6	Measuring
Principle	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method
7	Measurement
Range	Pressure:
0mmHg~280mm
Hg
(0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280m
mHg
(0kPa~37.3kPa)
a)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280mm
Hg
(0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280mm
Hg
(0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280mm
Hg
(0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280mm
Hg
(0kPa~37.3kPa)
a)
Pulse: 40 bpm
~180 bpm
8	Accuracy	Pressure:
±3mmHg(±0.4kPa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4
kPa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4 Pa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4 Pa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4 Pa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4kPa)
Pulse: ±5%
9	Display	TN-LCD Digital
Display	TN-LCD
Digital
Display	TN-LCD Digital
Display	TN-LCD Digital
Display	TN-LCD Digital
Display	TN-LCD
Digital
Display
10	Memory	2 Memory sets, 60
readings each set.	2 Memory
sets, 60
readings each
set.	2 Memory sets, 60 readings
each set.	2 Memory sets, 60 readings each
set.	2 Memory sets, 60 readings each
set.	2 Memory
sets, 60
readings each
set.
11	Power Source	4 AA Alkaline
battery	4 AA Alkaline
battery or
AC Adapter
(Input: AC
100-240 V,
50/60Hz,400mA
Output:	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA
: Output : D.C.	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA
: Output : D.C.	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA
: Output : D.C.	4 AA Alkaline
battery or
AC Adapter
(Input: AC
100-240 V,
50/60Hz,400
mA: Output :
No	Items	Model
		BE6034, BE6134	BF3213(0B)	BF1214(0B)	BF6123A	BF6148A	BF6055B
		D.C. 6.0V,
0.5A;)	6.0V, 0.5A;)	6.0V, 0.5A;)	6.0V, 0.5A;)	D.C. 6.0V,
0.5A;)
12	Broadcast
Function	BE6034: YES;
BE6134: No	No	No	No	No
13	Operating
Environment	Temperature:
+5°C~+40°C;
Humidity: 15%-
93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3 000
m	Temperature:
+5°C~
+40°C;
Humidity:
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3
000 m	Temperature:
+5°C~+40°C;
Humidity:
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3
000 m	Temperature:
+5°C~+40°C;
Humidity:
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3
000 m	Temperature:
+5°C~+40°C;
Humidity:
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3 000
m	Temperature:
+5°C~
+40°C;
Humidity:
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: ≤ 3
000 m
14	Storage and
Transport
Environment	Temperature:
-25°C~+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa	Temperature:
-25°C~
+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa	Temperature:
-25°C~+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa	Temperature:
-25°C~+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa	Temperature:
-25°C~+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa	Temperature:
-25°C~
+70°C;
Humidity:
10%~95%
Pressure: 50.0kPa
~106.0kPa
15	Weight	360g (Without
batteries)	278g(without
batteries)	355g(without
batteries)	341g(without
batteries)	342g(without
batteries)	381g(without
batteries)
16	Size	140
mm×116mm×81
mm	138mm×110m
m×68mm	140mm×116mm
×81mm	154mm×124mm
×65mm	141mm×114mm
×67mm	157mm×113m
m×60mm
17	Bluetooth
function	No	Yes	Yes	Yes	Yes	Yes
18	Algorithm	Identical	Identical	Identical	Identical	Identical	Identical

6

7

8

K161712

The product specification of subject device is identical in Intended Use, Indication for Use, Patient population, Environment of use, Measuring Principle, Measurement Range, Operating Environment, Storage and Transport Environment;

The subject device and predicate device are similar in Display, Broadcast Function: BF3213(0B) has 85×57(mm) standard screen; BE6034, BE6134 BF1214(0B), BF6123A, BF6055B has 94×80(mm) supersize screen; Model BE6034 has Broadcast Function; BE6134, BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B does not have Broadcast Function: But the minor discrepancies mentioned above do not affect the safety or effectiveness of the device.

The subject device and predicate device are differing in Power Source, Weight, Size; Comparing to the subject device has additional power Adapter; Besides, the subject device also has different appearance, which result in different weight and size; But the differences mentioned above do not affect the safety or effectiveness of the device.

The subject device are Substantially Equivalent (SE) to the predicate device which are US legally market devices.

9

8. Discussion of Non Clinical tests Performed for Determination of Substantial Equivalence: are as follows:

Testing information demonstrating substantial equivalence to the predicate device and safety and effectiveness of the Arm automatic blood pressure monitor, model: BF3213(0B), BF1214(0B), BF6123B, BF6148B, BF6155B; in the intended environment of use is supported by testing that was conducted in accordance with the FDA guidance "Reviewer Guidance for Premarket Notification Submissions", which outlines Electrical, Mechanical and Environmental Performance requirements.

The following testing was conducted:

• a. IEC 60601-1 Test
• b. IEC 60601-1-2 Test
• c. IEC 60601-1-11 Test
• d. IEC 80601-2-30 Test

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B B; tested met all relevant requirements of the aforementioned tests.

9. Discussion of Clinical Tests Performed

The subject device: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; are identical to the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 from the technical point of view. The differences between them do not relate to blood pressure measurement technology, so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical test in accordance with the standard IEC 80601-2-30:2009 & A1:2013 is unnecessary.

10. Software Information

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

11. Conclusion

We have demonstrated that there are no significant differences between the subject device: Arm automatic blood pressure monitor (Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B;), and the predicate device: Arm automatic blood pressure monitor (Model: BE6034, BE6134), in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA guidance "Non-Invasive Blood Pressure (NIBP) Monitor Guidance", and the IEC 80601-2-30:2009 + A1:2013.