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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Withings Blood Pressure Monitor BP-801, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.

Acceptance Criteria	Device Performance - Systolic	Device Performance - Diastolic
Criterion 1: The mean error of determination for 108 individual paired determinations shall not be greater than 5.0 mmHg, with a standard deviation no greater than 8.0 mmHg.	Mean Difference: -0.242 mmHg < 5.0 mmHg	Mean Difference: -0.02 mmHg < 5.0 mmHg
Standard Deviation: 3.70 mmHg < 8.0 mmHg	Standard Deviation: 3.89 mmHg < 8.0 mmHg
Criterion 2: For each of the 108 subjects, the standard deviation of the averaged paired determinations per subject shall meet the criteria listed in Table 1 (implied to be <= 6.95 mmHg based on the result provided).	Mean Difference: -0.2 < 6.95 mmHg	Mean Difference: -0.02 < 6.95 mmHg
Standard Deviation: 1.86 < 6.95 mmHg	Standard Deviation: 2.13 < 6.95 mmHg

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Patients: 108 people.
- Determinations: 3 determinations per patient, totaling 324 determinations (N = 108 * 3).
Data Provenance: Not explicitly stated, but the study was conducted to conform to international standards (ANSI/AAMI/ISO) which are globally recognized. It is a prospective clinical test as described in the "PERFORMANCE & CLINICAL TEST" section.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established using "the reference sphygmomanometer" in accordance with the specified protocols (ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009). These protocols typically involve trained operators for manual (auscultatory) measurements for comparison.

4. Adjudication Method for the Test Set

The adjudication method is implicitly defined by the protocols:

"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)"
"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."

This suggests a selection criterion based on consistency for including data, rather than a formal adjudication process by multiple experts reviewing discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This study focuses on the accuracy of the automated device against a reference sphygmomanometer, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "PERFORMANCE & CLINICAL TEST" section describes the evaluation of the Withings BP-801 (the device/algorithm) against a reference sphygmomanometer, without human interaction in the measurement by the device itself. The device automatically measures and calculates blood pressure.

7. Type of Ground Truth Used

The ground truth used was comparative measurements from a reference sphygmomanometer (referred to as "the reference sphygmomanometer") performed according to established clinical validation protocols (ANSI/AAMI/ISO 81060-1, 81060-2, and IEC 80601-2-30). This is a well-accepted method for validating automated blood pressure monitors.

8. Sample Size for the Training Set

The document does not provide information on a "training set." This type of premarket submission (510(k)) typically focuses on the clinical validation of the final device, not on the development or training of algorithms that might be part of the device (unless the algorithm itself is novel and requires specific validation). The device uses the oscillometric method, which is a well-established principle for blood pressure measurement, not necessarily a machine learning algorithm that requires a separate training set.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set or a machine learning algorithm that would require one, information on how its ground truth was established is not provided.

Summary

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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)

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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.

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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.

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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.

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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

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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 HORNGElectronic Co., Ltd.)	Withings(YA HORNGElectronic Co., Ltd.)	Andon Health Co., Ltd.
Model name	BP-801	BP-800	KD-936
510K number	K133125	K110872	K120672
Intended use	SAMEexcept cuffcircumference islimited to22cm ~ 42cmfor Upper Arm type	SAMEexcept cuffcircumference islimited to22cm ~ 42cmfor Upper Arm type	The BLOODPRESSURE MONITORis a noninvasive bloodpressure measurementsystem intended tomeasure the systolic anddiastolic blood pressuresand pulserate of an adult individualover age 18, at home byusing a non-invasivetechnique in which aninflatable cuff iswrapped around theUpper Arm. The cuffcircumference islimited to be 22cm ~48cm.
Technologicalcharacteristics	SAME	SAME	Oscillometric method --Sounds are heard over theartery when bloodpressure is determined bythe indirect

(continue)

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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 HORNGElectronic Co., Ltd.)	Withings(YA HORNGElectronic Co., Ltd.)	Andon Health Co., Ltd.
Model name	BP-801	BP-800	KD-036
510K number	K133125	K110872	K120672
Measuringmethod	SAME	SAME	Oscillometric method
Accuracy	SAME(as BP-800)	Pressure:<200 mmHg ± 3mmHg or ≥200mmHg ± 2%Pulse: ±5% ofreading value	Pressure: ±3mmHgPulse: ±5% of readingvalue
Pressuredeflation	SAME	SAME	Automatic linearpressure deflationvalve
Pressurerelease device	SAME	SAME	Automatic solenoidventing valve
Sensor	SAME	SAME	Semiconductorpressure sensor
Accessories	SAME	SAME	Storage case,instruction manual and
Life cycle	SAME	SAME	3 years
Comparison item	Proposed device	Predicate device
Applicant(Manufacturer)	Withings(YA HORNGElectronic Co., Ltd.)	Withings(YA HORNGElectronic Co., Ltd.)Andon Health Co., Ltd.
Model name	BP-801	BP-800KD-936
510K number	K133125	K110872 K120672
Electric power	SAME(as BP-800)	AAA Alkalinebattery x 4 pcs(no adapter)Rechargeablebatteries(Li-Ion 400 mAh)
Wirelesscommunication:	Bluetooth V4.0dual mode(V2.1 + EDR)Frequency Band:2.402-2.480 GHz	NABluetooth V3.0 +EDR Class 2SPP FrequencyBand:2.402-2.480 GHz
Display	can display themeasurement resulton theiPhone 4S	SAME(as KD-936)can display themeasurement result onthe iPhone
Sleeve	SAME(as BP-800)	Arm type:22cm ~ 42cmArm type:22cm ~ 48cm
Operatingtemperature &humidity	10 to 40°C, 15 to 90%RH, atmospheric86Kpa~106kpa,altitude: 2000m	10~40 °C(50 ~ 104 °F)15 ~90 % RH5 ~ 40 °C< 90 %RH
Storagetemperature &humidity	25 to 70°C,10 to95%RH, atmospheric86Kpa~106kpa,altitude: 2000m	-5 ~ 50 °C(23 ~ 122 °F)15 ~90 % RH-20 to 55 °C< 90 %RH

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

Differences:

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K133125

Withings

Conclusion:

The technological characteristics of Withings Blood Pressure Monitor Upper Arm Type: BP-801 is substantially equivalent to Withings Blood Pressure Monitor Upper Arm Type: BP-800 (K110872); and KD-936 Fully Automatic Electronic Blood Pressure Monitor (K120672). There is the same manufacturer, YA HORNG Electronic Co., Ltd., which FDA owner number is 9040892 for the new device BP-801 and predicate BP-800. Especially, there are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.

The main differences are:

1. The new devices are different vision appearance and specifications for the predicate devices.
There are different storage temperature, operating temperature, and humidity for the 2. new device and predicate devices.
The new device and the predicate devices BP-800 have the same cuff size for upper 3. arm.
The new device BP-801 can connect to iPhone 4S with Bluetooth or USB cable; and 4. the predicate device KD-936 can connect to iPhone with Bluetooth; and the predicate devices BP-800 can connect to iPhone with 30 pin cable.

Thus there are substantially equivalent.

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Image /page/9/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wave-like shapes below it.

Public Health Service

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

March 24, 2014

Withings c/o Dr. Jen, Ke-Min 20 rue Rouget de Lisle, 92130 Issy Les Moulineaux, 92130 FRANCE

Re: K133125

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

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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

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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

Page_ 1_of _1

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).