The Withings Blood Pressure Monitor, Upper Arm Type: HP-800 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'~~' 7' (22cm~~42cm) for Upper Arm type.

Device Description

Withings Blood Pressure Monitor, Upper Arm Type:BP-800 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.

AI/ML Overview

The provided document is a 510(k) summary for the Withings Blood Pressure Monitor, Upper Arm Type: BP-800. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and outcome measurements as might be found in a clinical trial publication.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The document references "AAMI / ANSI SP10" as the performance standard. While it states "Withings believes this information and referred document to be sufficient...", it does not explicitly list the specific acceptance criteria defined by AAMI/ANSI SP10 or the device's reported performance against those criteria in a table format within this document.

AAMI/ANSI SP10 is a standard for automated sphygmomanometers, and it sets limits for accuracy (e.g., mean difference and standard deviation between the device and a reference method). However, these specific numerical criteria and the device's measured performance are not provided in this 510(k) summary. The summary only states "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" implying that the device was tested per this standard, but the results are not detailed.

Key Missing Information: Specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation as per AAMI/ANSI SP10) and the actual performance results of the BP-800 device against these criteria.

Acceptance Criteria (AAMI/ANSI SP10 - Not explicitly stated in document)	Reported Device Performance (BP-800 - Not explicitly stated in document)
(e.g., Mean difference between device and reference ≤ ±5 mmHg)	(e.g., Mean difference = X mmHg)
(e.g., Standard deviation between device and reference ≤ 8 mmHg)	(e.g., Standard deviation = Y mmHg)

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

The document references "AAMI / ANSI SP10" for performance and clinical tests. This standard typically requires a specific number of subjects for clinical validation. However, the sample size used for the test set is not explicitly stated within this 510(k) summary.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details on the number of experts used to establish the ground truth for the test set or their qualifications. For an AAMI/ANSI SP10 validation, typically multiple independent observers (often with specific training in auscultatory blood pressure measurement) are used to establish reference measurements.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set. In AAMI/ANSI SP10 validation, often a consensus of multiple observers or a specific protocol for resolving discrepancies between observers' measurements is employed.

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

A MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not applicable to this device. This is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done, implicitly, as the device is an automated blood pressure monitor. The "AAMI / ANSI SP10" standard is specifically for validating the accuracy of such automated devices against Riva-Rocci/Korotkoff auscultation (the traditional "human-in-the-loop" method with a stethoscope). The document states the device "uses the Oscillometric method... 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." This describes its standalone algorithmic operation. The lack of specific results, however, prevents a quantitative answer here.

7. Type of Ground Truth Used

Based on the reference to "AAMI / ANSI SP10," the standard ground truth for automated blood pressure monitors is typically auscultatory blood pressure measurement performed by trained human observers using a stethoscope and sphygmomanometer, often referred to as the "reference method" or "gold standard" for non-invasive blood pressure.

8. Sample Size for the Training Set

The document describes the device as being "substantially equivalent" to predicate devices and mentions the use of the oscillometric method and microcomputer calculations. It does not mention or provide details about a "training set" in the context of machine learning or AI models. This device is a traditional electronic medical device, not one that relies on a machine learning model trained on a dataset.

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

Since there is no mention of a "training set" for a machine learning model, this question is not applicable in the context of this device's description. The device's operation is based on an established oscillometric algorithm rather than a data-trained AI model.

Summary

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Withings

Willings. 37 bis, rue ou General Lectore 92130 ISSY LES MOULINEAUX. FRANCE

いい。このいいいから、このか Tel: +33 i 41 46 04 60

Fa. • 33 9 56 83 90 32

" 510(k) Summary for_ יי MAY 2 0 2011

Submitter's Name: Withings Address: 37 bis, rue du General Leclerc, Issy Les Moulineaux Cedex, 92442, FRANCE Telephone: 33-1 41 46 04 60 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: March 20, 2011 Withings Blood Pressure Monitor, Upper Arm Type: Proprietary Name: BP-800 Common Name: BLOOD PRESSURE MONITOR Classification Name: NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM ( per 21CFR section 870.1130) Device Class: Class II (performance standards) Specialty: CARDIOVASCULAR Product code: DXN YA HORNG Digital Upper Arm Blood Pressure . Legally Marketed Monitor BP-700, BP-700T, BP-700U, BP-700B, ( Predicate ) Device : BP-700TB, BP-700UB, and BP-700TUB (K090058) ● KD-931D Fully Automatic Electronic Blood Pressure Monitor (K 102631)

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

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

The technological characteristics of Withings Blood Pressure Monitor. Upper Arm Type:BP-800 is substantially equivalent to YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB (K090058); and KD-931D Fully Automatic Electronic Blood Pressure Monitor (K102631). There is the same manufacturer, YA HORNG Electronic Co., Ltd., which FDA owner number is 9040892 for the new device BP-800 and predicate BP-700 series. 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 mainly different are:

1. The new devices are different vision appearance and specifications for the predicate devices.
1. There are different storage temperature, operating temperature, and humidity for the new device and predicate devices.
1. The new device and the predicate devices have the different sizes of the cuff for upper arm.

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1. The new device BP-800 and the predicate device KD-931D can connect to iPhone; and the predicate devices BP-700 series are the identical device with the optional functions for the BP-700U, BP-700UB, and BP-700TUB which can connect to the PC, backlight, and the voice function for the general upper arm use.
  Thus there are substantially equivalent.

Test Summary:

1. ELECTRIC SAFETY, EMC and FCC test reports,

General safety	IEC/EN 60601-1:2007	PASS
	EN 1060-1:2009, EN 1060-3:2009	PASS
EMC conformity	EN 60601-1-2: 2007	PASS
FCC conformity	ANSI C63.4: 2008	PASS

2. WOVEN COTTON SHEETING:

( Same as the predicate devices: K090058, BP-700 series ) Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10

Withings believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.

Ko Zinzton

Dr. Jen, Ke-Min official correspondent

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures, possibly representing health, family, and community.

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

JUL 1 8 2011

Withings c/o Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industry Research Society No. 58 Fu Chiun Street Hsin Chu City CHINA (TAIWAN) 30067

Re: K110872

Trade/Device Name: Withings Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated (Date on orig SE ltr): March 20, 2011 Received (Date on orig SE ltr): March 29, 2011

Dear Dr. Ke-Min:

This letter corrects our substantially equivalent letter of May 20, 2011.

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 (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.

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.

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Page 2 – Dr. Jen Ke-Min

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 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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.

Sincerely yours,

G. Bram D. Zuckerman, M.D.

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

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Indications for Use

K 510(k) Number:

Device Name: Withings Blood Pressure Monitor, Upper Arm Type: BP-800

· Indications for use:

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 80 | 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)
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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K110872

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).