FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031

• K Number: K091737
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
• Manufacturer: ANDON HEALTH CO.,LTD
• Date Cleared: 2009-08-18 ( 68 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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. It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

Predicate Devices

K083317

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard oscillometric blood pressure measurement technology and basic electronic functions like memory and averaging, with no mention of AI or ML.

Therapeutic

No
Explanation: The device is a blood pressure monitor intended to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic. It does not actively treat or mitigate a condition.

Diagnostic

Yes
Explanation: The device is intended to "measure the diastolic and systolic blood pressures and pulse rate," which are measurements used in the process of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as an inflatable cuff, LCD, electronic interface module, and silicon integrate pressure sensor technology. It is a physical blood pressure monitor with integrated electronics and software, not a standalone software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors measure blood pressure and pulse rate by using a non-invasive technique involving a cuff wrapped around the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
• Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate of an adult individual using a non-invasive technique.

Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a non-invasive physiological monitoring device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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.

It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

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

adult individual

Intended User / Care Setting

medical professionals or at home

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)

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor conform to the following standards:

• · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
• · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
• · 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.

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

The pulse rate range is changed from 30-180 times/min to 40-180 times/min.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083317

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

KD-5917. KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor FDA 310(k) Files

510(k) Summary

K091737
P 1/4

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

Andon Health Co., Ltd. Name: No 31, Changjiang Road, Nankai District, Tianjin, Address: P.R. China 86-22-6052 6161 Phone number: 86-22-6052 6162 Fax number: Liu Yi Contact: 05/27/2009 Date of Application:

2.0 Device information

Fully Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:

3.0 Classification

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

4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-5902 Fully Automatic Electronic Blood Pressure Monitor Device: Device: K083317 510(k) number:

5.0 Device description

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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.

1

It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

6.0 Intended use

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic 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.

The intended use and the indication for use of KD-5917, KD-5915 and KD-5031, as described in its labeling are the same as the predict device KD-5902.

7.0 Summary comparing technological characteristics with predicate device

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

2

K091737
p 3/4

8.0 Performance summary

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor conform to the following standards:

• · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
• · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
• · 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.

9.0 Comparison to the predict device and the conclusion

Our device KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5902 whose 510(k) number is K083317.

KD-5917 and KD-5902 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, KD-5917 does not have the voice function. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. The Environmental parameters is changed, the operational range for humidity (