K Number

Device Name

WITHINGS BLOOD PRESURE MONITOR

Manufacturer

WITHINGS

Date Cleared

2014-03-24

(175 days)

Product Code

DXN

Regulation Number

870.1130

Intended Use

The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.

Device Description

The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110872, K120672

Reference Devices

K051539

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The connection to an iPhone is for display and data transfer, not for advanced analysis using AI/ML.

Therapeutic

No
Explanation: This device is for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.

Diagnostic

An explanation will follow.

SaMD (Software as a Medical Device)

The device description explicitly states it is a blood pressure monitor that uses an inflatable cuff and oscillometric technology with a silicon integrated pressure sensor. While it connects to an iPhone for display and support software, the core blood pressure measurement is performed by hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The Withings BP-801 is a non-invasive device that measures blood pressure and pulse rate directly from the human body (the upper arm) using physical principles (oscillometric). It does not analyze any biological specimens.

The intended use and device description clearly state its function is to measure blood pressure and pulse rate non-invasively on an adult's upper arm. This falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXN

Device Description

Device composition:

A cuff
An alloy cylinder
A USB adapter to connect to an iPhone 4S.

Material description:
Alloy cylinder: Anodized 6061 aluminum
Cuff tissues: Lycra, Velcro loop, Velcro hook, PU leather, bias
The patient contacting materials of the cuffs has been tested in accordance with ISO10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

Collateral devices: An iPhone 4S shall be connected to the NIBP. The user interface which is shown to the patient is available on this collateral device (CD).

Operational process:

a) The patient first connects the NIBP to the CD.
b) The patient hits the START button on the CD.
c) The NIBP performs the measurement.
d) If no error condition is met, the NIBP sends the heart rate, systolic and diastolic pressure results to the CD for display.
e) If an error condition is met, the NIBP sends an error report for the CD, which displays an error message to the user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm

Indicated Patient Age Range

over age 18 / Adult individual / Adults

Intended User / Care Setting

Home settings

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)

Performance and Clinical Test conducted according to ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.

Criterion 1: For systolic and diastolic blood pressures, the mean error of determination, of the 108 individual paired determinations of BP-801 and the reference sphygmomanometer paired for all subjects shall not be greater than 5.0 mmHg, with a standard deviation no greater than 8.0 mmHg.
Sample size: 108 people, each with 3 determinations (Total N=324)
Key results:
Systolic Mean Difference: -0.242 mmHg (Standard Deviation: 3.70 mmHg)
Diastolic Mean Difference: -0.02 mmHg (Standard Deviation: 3.89 mmHg)

Criterion 2: For the systolic and diastolic blood pressures for each of the 108 subjects, the standard deviation of the averaged paired determinations per subject of BP-801 and of the reference sphygmomanometer shall meet the criteria listed in Table 1.
Sample size: 108 subjects
Key results:
Mean difference of Sys = -0.2 at the Standard Deviation of 1.86, which is within the criterion 6.95mmHg
Mean difference of Dia = -0.02 at the Standard Deviation of 2.13, which is within the criterion 6.95mm

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

Not Found

Predicate Device(s)

K110872, K120672

Reference Device(s)

K051539

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

Société par actions simplifiées au capital de 2 551 824 euros Siège social : 20, rue Rouget de Lisle – 92130 ISSY LES MOULINEAUX - FRANCE Nº de SIRET : 504 787 565 RCS NANTERRE Tél : +33 1 41 46 04 60 Fax : +33 9 56 83 90 32

K133125

" 510(k) Summary " K133125

Withings Submitter's Name: Address: 20 me Rouget de Lisle, 92130, Issy Les Moulineaux, 92130, FRANCE 33-1 41 46 04 60 Telephone: FAX: 33-9 56 83 90 32 Manufacturer's Name: YA HORNG Electronic Co., Ltd. No. 35, Zsha Lun, Jon Zsha Village, Antin Shiang, Address: Tainan, 74555, Taiwan, ROC Contact Person: Dr. Jen, Ke-Min Date Summary Prepared: September 18, 2013 Withings Blood Pressure Monitor, Upper Arm Type: Proprietary Name: BP-801 Common Name: BLOOD PRESSURE MONITOR NON-INVASIVE BLOOD-PRESSURE Classification Name: MEASUREMENT SYSTEM ( per 21CFR section 870.1130) Class II (performance standards) Device Class: Specialty: CARDIOVASCULAR Product code: DXN Withings Blood Pressure Monitor Upper Arm Legally Marketed Type: BP-800 (K110872) ( Predicate ) Device : KD-936 Fully Automatic Electronic Blood Pressure Monitor (K120672)

K133125

Withings

Société par actions simplifiées au capital de 2 551 824 euros Siège social : 20, rue Rouget de Lisle - 92130 ISSY LES MOULINEAUX - FRANCE Nº de SIRET : 504 787 565 RCS NANTERRE Tél : +33 1 41 46 04 60 Fax : +33 9 56 83 90 32

Description of significant physical and performance characteristics:

It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator.

The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

Indication for Use:

The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm.

The cuff circumference is limited to be 9 to 17 inches (22cm~42cm) for Upper Arm type.

Patient Population: Adults

Environment of Use: Home settings

Device composition:

· A cuff
· An alloy cylinder
· A USB adapter to connect to an iPhone 4S.

Image /page/1/Picture/17 description: The image shows a blood pressure cuff connected to a smartphone. The smartphone displays a reading of 120 for systolic blood pressure, 80 for diastolic blood pressure, and a heart rate of 72. The image also labels the cuff, connector, battery cover, and start/stop button.

Material description :

Alloy cylinder :

Cuff tissues

Anodized 6061 aluminum

Lycra, Velcro loop, Velcro hook, PU leather, bias :

The patient contacting materials of the cuffs has been tested in accordance with ISO10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

Collateral devices

An iPhone 4S shall be connected to the NIBP. The user interface which is shown to the patient is available on this collateral device (CD).

Operational process :

a) The patient first connects the NIBP to the CD.
b) The patient hits the START button on the CD.
c) The NIBP performs the measurement.
d) If no error condition is met, the NIBP sends the heart rate, systolic and diastolic pressure results to the CD for display.
e) If an error condition is met, the NIBP sends an error report for the CD, which displays an error message to the user.

Description of the new device: (Same as the predicate devices)

Withings Blood Pressure Monitor, Upper Arm Type: BP-801 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

Test Summary:

ELECTRIC SAFETY, EMC and FCC test reports, 1.

General safety	IEC 60601-1:2005	PASS
	EN 1060-1:2002, EN 1060-3:2005	PASS
EMC conformity	IEC 60601-1-2: 2007	PASS
FCC conformity	ANSI C63.4 & 47	PASS

2. WOVEN COTTON SHEETING:

(Same as the predicate devices: Withings Blood Pressure Monitor Upper Arm Type: BP-800, K110872)

Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

3. PERFORMANCE & CLINICAL TEST

The Withings BP-801 is a blood pressure monitor conforms to the following standards:

ANSI/AAMI/ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validationof automated measurement type.
. 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.

Société par actions simplifiées au capital de 2 551 824 euros Siège social : 20, rue Rouget de Lisle - 92130 ISSY LES MOULINEAUX -FRANCE Nº de SIRET : 504 787 565 RCS NANTERRE Tél : +33 1 41 46 04 60 Fax : +33 9 56 83 90 32

According to ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols:

I. The blood pressure values of a test person included in the analysis may not differ from each other by more than 12 mmHg for the systolic and 8 mmHg for test diastolic value (haemodynamic stability)
1. Out of 4 pairs of measured values, the first 2 consecutive pairs of measured values that were conforming with the criteria of the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 &ANSI/AAMI/IEC 80601-2-30:2009 protocol was included in the analysis.

[ Criterion 1 ]

For systolic and diastolic blood pressures, the mean error of determination, of the 108 individual paired determinations of BP-801 and the reference sphygmomanometer paired for all subjects shall not be greater than 5.0 mmHg, with a standard deviation no greater than 8.0 mmHg.

The total numbers of patients are 108 people and each patient carried with 3 determinations.

The total number of determinations ( N= 108*3=324 )

STANDARD DEVIATION		Mean Difference of systolic
mmHg		mmHg
Systolic	Diastolic	Systolic	Diastolic
3.70	3.89	-0.242	-0.02

[ Criterion 2 ]

For the systolic and diastolic blood pressures for each of the 108 subjects, the standard deviation of the averaged paired determinations per subject of BP-801 and of the reference sphygmomanometer shall meet the criteria listed in Table 1. The result is:

- The Mean difference of Sys =- 0.2 at the Standard Deviation of 1.86, which is within the criterion 6.95mmHg
- The Mean difference of Dia =- 0.02 at the Standard Deviation of 2.13, which is within the criterion 6.95mm

[Criterion 2] M=108 subjects
STANDARD DEVIATION		Mean Difference of systolic
mmHg		mmHg
Systolic	Diastolic	Systolic	Diastolic
1.86	2.13	-0.2	-0.02

K133125

Société par actions simplifiées au capital de 2 551 824 euros Siège social : 20, rue Rouget de Lisle - 92130 ISSY LES MOULINEAUX -FRĂNCE Nº de SIRET : 504 787 565 RCS NANTERRE Té! : +33 1 41 46 04 60 Fax : +33 9 56 83 90 32

Technological Characteristics of our new device compared to the predicate device:

Similarities:

Comparison item	Proposed device	Predicate device
Applicant
(Manufacturer)	Withings
(YA HORNG
Electronic Co., Ltd.)	Withings
(YA HORNG
Electronic Co., Ltd.)	Andon Health Co., Ltd.
Model name	BP-801	BP-800	KD-936
510K number	K133125	K110872	K120672
Intended use	SAME
except cuff
circumference is
limited to
22cm ~ 42cm
for Upper Arm type	SAME
except cuff
circumference is
limited to
22cm ~ 42cm
for Upper Arm type	The BLOOD
PRESSURE MONITOR
is a noninvasive blood
pressure measurement
system intended to
measure the systolic and
diastolic blood pressures
and pulse
rate of an adult individual
over age 18, at home by
using a non-invasive
technique in which an
inflatable cuff is
wrapped around the
Upper Arm. The cuff
circumference is
limited to be 22cm ~
48cm.
Technological
characteristics	SAME	SAME	Oscillometric method --
Sounds are heard over the
artery when blood
pressure is determined by
the indirect

(continue)

Société par actions simplifiées au capital de 2 551 824 euros Siège social : 20, rue Rouget de Lisle - 92130 ISSY LES MOULINEAUX -FRĂNCE Nº de SIRET : 504 787 565 RCS NANTERRE
TéI : +33 1 41 46 04 60 Fax : +33 9 56 83 90 32

Similarities:

Comparison item	Proposed device	Predicate device
Applicant
(Manufacturer)	Withings
(YA HORNG
Electronic Co., Ltd.)	Withings
(YA HORNG
Electronic Co., Ltd.)	Andon Health Co., Ltd.
Model name	BP-801	BP-800	KD-
036
510K number	K133125	K110872	K120672
Measuring
method	SAME	SAME	Oscillometric method
Accuracy	SAME
(as BP-800)	Pressure:
Trade/Device Names: Withings Blood Pressure Monitor BP-801 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 29, 2014 Received: February 5, 2014

Dear Dr. Jen:

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

Page 2 - Dr. Jen, Ke-Min

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 (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerelv vours

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

Enclosure

Indications for Use

K133125 510(k) Number:

Device Name: Withings Blood Pressure Monitor, Upper Arm Type: BP-801

· Indications for use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concur
Date	2024.03.24
	13:53:55 -04'00'
for Bram Zuckerman

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