KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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 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. Achieves its function by an LCD.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Fully Automatic Electronic Blood Pressure Monitor. It does not describe an AI medical device or provide the level of detail necessary to answer all parts of your request regarding AI acceptance criteria and study proving performance. The document focuses on showing substantial equivalence to a predicate blood pressure monitor.

However, I can extract information related to the device's performance validation as a non-AI medical device, based on the provided text.

Here's how I can address your request based on the available information, highlighting what is not applicable (N/A) for this type of device or not provided in the document:

1. A table of acceptance criteria and the reported device performance

The document states the device conforms to several standards, one of which is highly relevant for performance:

ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type

This standard defines the acceptance criteria for clinical validation of automated non-invasive sphygmomanometers. While the document states the device will conform, it does not provide the specific reported performance data against these criteria in a table. It simply asserts compliance.

Therefore, for this device (a blood pressure monitor), the acceptance criteria would be those laid out in the ANSI/AAMI/ISO 81060-2:2009 standard. The document states compliance, but the specific performance results (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method) are not explicitly listed in the provided text.

2. Sample size used for the test set and the data provenance

The document mentions clinical validation according to ANSI/AAMI/ISO 81060-2:2009. This standard typically requires a specific number of subjects (e.g., often a minimum of 85 subjects for the main validation) evenly distributed across different blood pressure ranges.

Sample Size: Not explicitly stated in the provided text, but implied to be sufficient to meet the ANSI/AAMI/ISO 81060-2:2009 standard.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies for medical devices are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For a blood pressure monitor, the "ground truth" is typically established by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer).

Number of Experts: Not explicitly stated, but typically involves two or more trained observers to establish reference measurements according to the validation standard.
Qualifications of Experts: Not explicitly stated, but they would be clinicians/technicians trained in standardized blood pressure measurement techniques.

4. Adjudication method for the test set

For blood pressure validation studies, adjudication often involves averaging readings from multiple trained observers after ensuring inter-observer agreement.

Adjudication method: Not explicitly stated, but implied to follow the methodology of ANSI/AAMI/ISO 81060-2:2009, which involves obtaining simultaneous or very close reference measurements from trained observers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, this is not applicable for a standalone blood pressure monitor. MRMC studies are typically for image-based diagnostic devices where human readers interpret images with and without AI assistance. This device is an automated measurement system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the fundamental performance evaluation of an automated blood pressure monitor is inherently "standalone" in that it measures blood pressure without direct human interpretation of a reading (other than taking the measurement itself). The validation according to ISO 81060-2 is a direct assessment of its accuracy against a gold standard.

7. The type of ground truth used

Ground Truth Type: Clinical reference measurements from trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or another validated oscillometric device, as per the AAMI/ISO standard).

8. The sample size for the training set

The concept of "training set" is typically associated with machine learning/AI models. For a traditional medical device like this, there isn't a "training set" in the AI sense. The device's algorithms for blood pressure measurement are developed and refined during R&D, not typically "trained" on a data set in the same way an AI model is.

Training Set Sample Size: N/A (not an AI device).

9. How the ground truth for the training set was established

Since there is no "training set" in the AI context applicable to this device, this question is N/A.

In summary, the provided document is for a traditional, non-AI medical device. While it states compliance with relevant performance standards (like ANSI/AAMI/ISO 81060-2:2009), it does not provide the detailed study results or address AI-specific questions like training sets, MRMC studies, or multi-expert ground truth establishment for AI.

Summary

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Public Health Service

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

August 10, 2016

Andon Health Co., Ltd Ms. Liu Yi President No.3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN

Re: K160565

Trade/Device Name: KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD- 595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 26, 2016 Received: March 4, 2016

Dear Ms. Liu Yi,

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.

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Page 2 - Ms. 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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

M.A. Hillebrenner

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

510(k) Number (if known) K160565

Device Name

KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account.Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account.		Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account.		Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account.
	Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account.
	Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account.

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K160565

Page 1 of 4

510(k) Summary

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:	02/26/2016

2.0 Device information

Trade name: KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor
Common name: Noninvasive blood pressure measurement system 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: KD-513LU Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K121372

5.0 Device description

KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and

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K160565 Page 2 of 4

KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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.

6.0 Intended use

KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 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 these monitors, as described in their labelings are the same as the predicate device KD-513LU.

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Theweight(excluding batteries) anddimensions are changed.
Patients contact Materials	Identical
Function	The memory time, function of display IHB,voice and touch function, averagingfunction, time format displayedarechanged.
Biocompatibility	Identical

7.0 Summary comparing technological characteristics with predicate device

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KD-388N, 5031L, 5031N, 5031N, 525EN, 575N, 5917N, 595B, 5961B, 5963NG, 559 and 516 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Performance	The cuff pressure range andmicroprocessor are changed.
Environmental	The temperature and humidity foroperation, storage and transport arechanged.

8.0 Performance summary

IEC60601-1:2005+CORR.1(2006)+CORR.2(2007)/EN60601-1:2006/A11: 2011, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
· IEC 60601-1-2:2007/EN 60601-1-2:2007+AC:2010, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Performance - Collateral Standard: Electromagnetic Essential Compatibility - Requirements And Tests
IEC 80601-2-30: 2009+A1: 2013, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
· ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type

9.0 Comparison to the predicate device and the conclusion

Our device KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-513LU whose 510(k) number is K121372.

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K160565 Page 4 of 4

These 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.

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

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).