KD-936 Fully Automatic Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Device Description

KD-936 Fully Automatic Wireless Blood Pressure Monitor is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results.

KD-936 Fully Automatic Wireless Blood Pressure Monitor achieves its function by integrate the device with an iPhone, ipod or ipad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth,

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the KD-936 Fully Automatic Wireless Blood Pressure Monitor, based on the provided FDA 510(k) files:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for blood pressure monitors generally stem from the ANSI/AAMI SP10 standard. While the document doesn't explicitly list numerical thresholds in a table, it states that the device "met all applicable requirements of the standard." For context, ANSI/AAMI SP10 typically requires:

Acceptance Criterion (Based on ANSI/AAMI SP10 General Requirements)	Reported Device Performance
Accuracy (Mean Difference)	Met all applicable requirements of the standard.
Accuracy (Standard Deviation)	Met all applicable requirements of the standard.
Pulsation Rate Accuracy	Met all applicable requirements of the standard.
Safety (Electrical, Mechanical, Biocompatibility, EMC)	Met all applicable requirements of relevant standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, FCC Part 15). No new questions of safety and effectiveness were raised.
Performance (General Functionality)	Met all applicable requirements of the standard.

Explanation of "Met all applicable requirements of the standard" for accuracy:

While not explicitly stated in the document, ANSI/AAMI SP10 (and its derivatives, such as ISO 81060-2) typically requires the following for blood pressure measurement accuracy:

Mean Difference: The average difference between the device's readings and a reference standard (e.g., auscultatory measurement) should be ±5 mmHg or less.
Standard Deviation: The standard deviation of the differences should be 8 mmHg or less.

The statement "the device met all applicable requirements of the standard" implies that these numerical thresholds were achieved in the clinical test.

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

Sample Size: The document does not explicitly state the sample size used for the clinical test. It only mentions, "a new clinical test is done in accordance with ANSI/AAMI SP10." ANSI/AAMI SP10 typically requires a minimum of 85 participants for clinical validation. This would likely be the sample size used, though it's not confirmed.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but clinical validation studies for device approval are almost always prospective.

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

Number of Experts: The document does not explicitly state the number of experts used. However, for blood pressure monitor validation according to ANSI/AAMI SP10, it typically requires at least two independent trained observers to perform reference measurements (e.g., auscultatory method).
Qualifications of Experts: The document does not specify the qualifications of the experts, but in clinical validation studies for blood pressure monitors, these would typically be clinicians or trained personnel (e.g., nurses, physicians) proficient in manual auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not explicitly detail an adjudication method. In the context of ANSI/AAMI SP10 for blood pressure monitors, the "ground truth" (reference measurement) is typically established by simultaneous measurements by two independent observers, and their readings are averaged or compared for agreement. If disagreements exceed a certain threshold (e.g., 4 mmHg for systolic/diastolic readings), a third observer might be involved, or the readings might be discarded. This implies an implicit "2 (+1 if needed)" type of approach for establishing reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was done. This type of study is not typically applicable or required for the approval of a non-invasive blood pressure measurement system like the KD-936. MRMC studies are usually relevant for image-based diagnostic aids where human readers interpret medical images with and without AI assistance.

6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done. The clinical test performed "in accordance with ANSI/AAMI SP10" evaluates the device's performance directly against a reference standard, without human intervention in the measurement process (other than proper cuff placement and activation). The device itself (the algorithm for blood pressure determination) is being tested for its accuracy.

7. The Type of Ground Truth Used

Expert Consensus/Reference Standard Measurement: The ground truth for the clinical test would have been established using a reference standard method, which for blood pressure monitors is typically auscultatory measurement performed by trained observers, potentially with a mercury sphygmomanometer or a validated electronic device used as the reference. This aligns with the requirements of ANSI/AAMI SP10.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" sample size. For traditional medical devices like blood pressure monitors, the concept of a distinct 'training set' and 'test set' in the machine learning sense is not always explicitly delineated. The development and internal validation (or "training and tuning") of the oscillometric algorithm would happen during the device's engineering phase, likely using proprietary data, before the formal clinical validation study (test set). The 510(k) summary focuses on the final validation.

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

Since a specific "training set" is not detailed, the method for establishing its ground truth is also not provided. However, any internal development or optimization of the device's algorithm would have used reference blood pressure measurements, likely obtained through similar standard auscultatory methods, to "train" or refine its oscillometric algorithm.

Summary

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KD- 936 Fully Automatic Wireless Blood Pressure Dock FDA 510(k) Files

510(k) Summary

2012

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

1.0 submitter's information

Name: Andon Health Co., Ltd. Address: No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China Phone number: 86-22-6052 6161 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 02/27/2012

2.0 Device information

iHealth BP5 Fully Automatic Arm Cuff Wireless Blood Trade name: Pressure Dock Device name: KD-936 Fully Automatic Wireless Blood Pressure Monitor Classification name: Noninvasive blood pressure measurement system

3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. Device: iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock 510(k) number: K102939

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5.0 Device description

KD-936 Fully Automatic Wireless Blood Pressure Monitor is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

6.0 Intended use

The intended use and the indication for use of the KD-936 Fully Automatic Wireless Blood Pressure Monitor, as described in its labeling are the same as the predicate device iHealth BP3.

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7.0 Summary comparing technological characteristics with predicate device

Technological Characteristics	Comparison result
Design principle.	Identical
Appearance	Similar
Patients contact Materials	Identical
Performance	Similar
Biocompatibility	Identical
Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility test according to IEC 60601-1-2;
b. Electrical safety according test to IEC 60601-1 and IEC 60601-1-1
c. FCC test according to FCC part 15 (2009)
d. Safety and performance characteristics of the test according to SP10

None of the test demonstrates that KD-936 Fully Automatic Wireless Blood Pressure Monitor brings new questions of safety and effectiveness.

Clinical Test Concerning the Compliance of ANSI/AAMI SP10

Compared to inflation detection of its predicate device iHealth BP3, KD-936 Fully Automatic Wireless Blood Pressure Monitor is an deflation detection device, so the arithmetic is changed. As a result, a new clinical test is done in accordance with ANSI/AAMI SP10, and the device met all applicable requirements of the standard.

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9.0 Performance summary

KD-936 Fully Automatic Wireless Blood Pressure Monitor conforms to the following standards:

· IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
60601-1, Medical Electrical Equipment · UL Part 1: General Requirements for Safety, 2003.
IEC 60601-1-1, Medical Electrical Equipment Part 1: General ● Requirements for Safety – 1. Collateral standard: Safety Requirements for Medical Electrical Systems, 2000.
EN 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

10.0 Comparison to the predicate device and the conclusion

Our device KD-936 Fully Automatic Wireless Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor iHealth BP3 whose 510(k) number is K102939.

The two devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, and the user interface are different. The measure process is also changed, that is the new device will get the measurement results when the device is deflating, while iHealth BP3 gets the result during the inflating period. Both KD-936 Fully Automatic Wireless Blood Pressure Monitor and its predicate device can achieve their function with an iphone, ipod or ipad, the difference is that KD-936 transfer the data through blue tooth while iHealth BP3 transfer the data through a data line.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Public Health Service

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

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3 Jin Ping Street. Ya An Road, Nankai District Tianjin, 300190 CHINA

JUN - 1 2012

Re: K120672

Trade Name: KD-936 Fully Automatic Wireless Blood Pressure Monitor, or iHealth BP5 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: May 2, 2012

Dear Mr. Liu:

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.

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 Mr. Liu Yi

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Statement of Indications for Use

K120672 510(k) Number :

Device name: KD-936 Fully Automatic Wireless Blood Pressure Monitor

Indications for use:

Prescription use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1

Page I of

ision of Cardiovascular Devices

510(k) Number K120672

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).