Arm automatic blood pressure monitor

• K Number: K161708
• Device Name: Arm automatic blood pressure monitor
• Manufacturer: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD
• Date Cleared: 2016-11-22 ( 154 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 measurement process using a pressure sensor and CPU for calculation, with no mention of AI or ML terms, training/test sets, or performance metrics typically associated with AI/ML models.

Therapeutic

No
This device is intended to measure blood pressure and pulse rate, not to treat a condition or disease.

Diagnostic

Yes

The device measures physiological parameters (blood pressure and pulse rate) which can be used by healthcare professionals to monitor and assess a patient's health status, providing information that aids in diagnosing conditions like hypertension.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like an inflatable cuff, air pump, and pressure sensor, indicating it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
• This Device's Function: This device measures blood pressure and pulse rate by applying a cuff to the upper arm and using an oscillometric technique. This is a non-invasive measurement taken on the body (in vivo). It does not involve analyzing any bodily fluids or tissues.

The description clearly indicates it's a device for measuring physiological parameters directly from the body, not for testing samples in a lab setting.

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 sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.

Product codes

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.

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

Home / Over-The-Counter Use

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

The following testing was conducted:
IEC 60601-1 Test
IEC 60601-1-2 Test
IEC 60601-1-11 Test
IEC 60601-2-30 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: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215,BF1213,BF6051,BF6151,BF6043,BF6143,BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; tested met all relevant requirements of the aforementioned tests.

The subject device: Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214.BF6023L.BF6123L. BF6048L.BF6148L. BF6053.BF6153. BF6055; 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 ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type is unnecessary.

Key Metrics

Pressure: ±3mmHg(±0.4kPa)
Pulse: ±5%

Predicate Device(s)

K151258

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, with a ribbon-like element flowing beneath them.

Public Health Service

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

November 22, 2016

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

Re: K161708

Trade/Device Name: Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF6002, BF6102, BF1205, BF1215, BF1213, BF6051, BF6151, BF6043, BF6143, BF1204,BF1214, BF6023L, BF6123L, BF6048L, BF6148L, BF6053, BF6153, BF6055 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,

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

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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 Yellen
for

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

Enclosure

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Indications for Use

510(k) Number (if known) K161708

Device Name

Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6148L, BF6053,BF6153, BF6055;

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: _K161708

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: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153,BF6055; 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

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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: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; 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: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; 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: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; 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: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; 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 way of energy supply as well as PCB. The appearance of subject device is different from predicate device; 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. The PCB of subject device has been updated. 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: BF3202,BF3212, BF6002,BF6102,BF1205,BF1215,BF1213,BF6051,BF6151,BF6043,BF6143, BF1204,BF1214,BF6023L,BF6123L,BF6048L,BF6148L,BF6053,BF6153,BF6055;

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uses the same oscillometric method as the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 to determinate the systolic and diastolic blood pressure and pulse rate. They have the same function and intended use. Based upon the aforementioned information, these devices are substantially equivalent. Please refer to table below for comparison.

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(Subject Devices:BE6034,BE6134,BF3202,BF3212,BF6002,BF6102,BF1213)
		Model						Comparison
No	Items	BE6034, BE6134	BF3202	BF3212	BF6002	BF6102	BF1213	Result	Note
1	Manufa
cturer	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.	Identical	NA
2	Intende
d 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.	Identical	NA
3	Indicati
ons for
Use	It is intended for
measuring
systolic, diastolic
blood pressure
and pulse rate of
an adult over the
counter.	It is intended
for measuring
systolic,
diastolic blood
pressure and
pulse rate of an
adult over the
counter.	It is intended for
measuring
systolic, diastolic
blood pressure
and pulse rate of
an adult over the
counter.	It is intended for
measuring
systolic, diastolic
blood pressure
and pulse rate of
an adult over the
counter.	It is intended for
measuring
systolic, diastolic
blood pressure and
pulse rate of an
adult over the
counter.	It is intended
for measuring
systolic,
diastolic blood
pressure and
pulse rate of an
adult over the
counter.	Identical	NA
					Model			Comparison
No	Items	BE6034, BE6134	BF3202	BF3212	BF6002	BF6102	BF1213	Result	Note
4	Patient
populati
on	Adult	Adult	Adult	Adult	Adult	Adult	Identical	NA
5	Environ
ment of
use	Home	Home	Home	Home	Home	Home	Identical	NA
6	Measuri
ng
Principl
e	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Identical	NA
7	Measur
ement
Range	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)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280mmH
g (0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Pressure:
0mmHg~280m
mHg
(0kPa~37.3kPa)
Pulse: 40 bpm
~180 bpm	Identical	NA
8	Accurac
y	Pressure:
±3mmHg(±0.4kPa
)
Pulse: ±5%	Pressure:
±3mmHg(±0.4
kPa)
Pulse: ±5%	Pressure:
±3mmHg(±0.4kPa
)
Pulse: ±5%	Pressure:
±3mmHg(±0.4kPa
)
Pulse: ±5%	Pressure:
±3mmHg(±0.4kPa
)
Pulse: ±5%	Pressure:
±3mmHg(±0.4k
Pa)
Pulse: ±5%	Identical	NA
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	Identical	NA
10	Memor
y	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.	Identical	NA
11	Power
Source	4 AA Alkaline
battery	4 AA Alkaline
battery or
AC Adapter
(Input: AC
100-240 V,
50/60Hz,400m
A; Output :
D.C. 6.0V,
0.5A;)	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA;
Output : D.C.
6.0V, 0.5A;)	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA;
Output : D.C.
6.0V, 0.5A;)	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400mA;
Output : D.C.
6.0V, 0.5A;)	4 AA Alkaline
battery or
AC Adapter
(Input: AC 100-
240 V,
50/60Hz,400m
A; Output :
D.C. 6.0V,
0.5A;)	Different	NA
	Items	Model							Comparison
No		BE6034, BE6134	BF3202	BF3212	BF6002	BF6102	BF1213	Result	Note
12	Broadca
st
Functio
n	BE6034: YES;
BE6134: No	No	No	No	No	No	Different	NA
13	Operati
ng
Environ
ment	Temperature:
+5℃~+40℃;
Humidity: 15%-
93%
Pressure: 70.0kPa
~106.0kPa
Altitude: ≤ 3 000
m	Temperature:
+5℃~+40℃
Humidity :
15%-93%
Pressure:
70.0kPa~
106.0kPa
Altitude: