KD-3917 and KD-3909 Semi 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-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitors:

Based on the provided 510(k) summary, the device's performance is not reported against specific acceptance criteria in a detailed table as requested. However, it states that the device "conforms to the following standards," which define the performance expectations for such devices. The primary standard for blood pressure monitors is AAMI SP10.

Here's a breakdown of the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria in a quantitative table with corresponding reported performance for this specific device are not explicitly provided in the executive summary. Instead, the document states conformity to relevant standards.

Implicit Acceptance Criteria (based on AAMI SP10:2002)

Criteria Category	General Performance Acceptance (AAMI SP10)	Reported Device Performance (from K091739 summary)
Accuracy (Blood Pressure)	Mean difference between device and reference standard ± 5 mmHg, with standard deviation ≤ 8 mmHg (for both systolic and diastolic pressure). This is a common requirement in AAMI SP10. The sum of the absolute differences between the device and reference for any 5 mmHg interval should not exceed 25% for 30 or more subjects.	Not explicitly stated with specific numerical results (mean difference, standard deviation) for blood pressure accuracy. The document states that the device "conforms to the following standards," including AAMI SP10:2002, AAMI/ANSI SP10:2002/A1:2003, and AAMI/ANSI SP10:2002/A2:2006. This implies that the device met the accuracy requirements outlined in these standards.
Accuracy (Pulse Rate)	Typically, within ± 5% or ± 5 beats/min (whichever is greater) of a reference standard.	Not explicitly stated with specific numerical results. The document notes that the "pulse rate range is changed from 30-180 times/min to 40-180 times/min" for the new devices compared to the predicate, but this is a range change, not an accuracy claim. The conformity to AAMI SP10 would imply meeting its pulse rate accuracy requirements.
Cuff Pressure Range	Typically specified pressure range.	"The performance parameter of cuff pressure range... are different from the predicted device KD-391." Actual range for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for the stated use.
Overpressure Limit	Device should not exceed a safe overpressure limit (e.g., typically 300 mmHg for adult blood pressure monitors).	"The performance parameter of... overpressure limit are different from the predicted device KD-391." Actual limit for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for safety.
Environmental Parameters	Operational range for temperature and humidity.	The operational range for humidity is "<90%" for the new devices, changed from "<80%" for the predicate device. This implies the device was tested and found to perform effectively within this new range and still be compliant with the relevant safety and performance standards.
Safety Standards	Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and mechanical safety standards.	The devices conform to: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC). Mechanical safety is listed as "Identical" to the predicate device, which also conformed to these standards.
Biocompatibility	Materials in patient contact are biocompatible.	Listed as "Similar" to the predicate device, which would have met biocompatibility standards. "Patients contact Materials" is listed as "Identical" on a separate comparison table, suggesting the same materials are used and thus prior biocompatibility assessments for the predicate device apply.
Cuff Circumference	Specified range.	"The cuff circumference is limited to 22cm-48cm."
Irregular Heartbeat Detection	If a feature exists, it should be accurately indicated according to its intended functionality.	"If any irregular heartbeat is detected, it can be shown on the LCD." The accuracy of this detection is not numerically quantified but implied to meet performance expectations by adhering to relevant standards (if any apply to this specific feature within the general BP monitor standards).
Memory Function	Functionality validation.	KD-3909 has 2x60 times memory, KD-3917 has 60 times memory. KD-3909 also averages the last three measurements. The functionality of these features would have been tested implicitly under "Performance - Similar" and "Function - Similar" categories compared to the predicate, and against general device functional verification.

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

The 510(k) summary does not provide details on the specific clinical or performance test executed to demonstrate conformity to standards. It states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."

Typically, for a blood pressure monitor to comply with AAMI SP10, a clinical validation study involving a minimum of 85 subjects (some interpretations allow for 30 subjects for initial validation, but 85 is often preferred or required for full compliance) would be performed. However, this document does not explicitly state the sample size.

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical validation for such devices is almost always prospective to ensure standardized measurement protocols against a reference.

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

For blood pressure monitor validation studies (e.g., against AAMI SP10), the ground truth is typically established by two or three trained observers using a mercury sphygmomanometer or an equivalent reference standard, who are blinded to the device's readings. Their consistency is a crucial part of the validation process.

Number of Experts: Not explicitly stated, but typically 2 or 3 trained observers.
Qualifications of Experts: Not explicitly stated. For AAMI SP10, these are typically trained and certified human observers (e.g., clinical staff, nurses, physicians) proficient in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

For blood pressure validation studies using multiple observers, an adjudication method is used to establish the "reference" blood pressure. Common methods include:

Averaging: Averaging the readings of the two or three observers.
Deviation Check: If two observers' readings differ by more than a pre-defined threshold (e.g., 4 mmHg), a third observer's reading might be used, or the measurement might be discarded/repeated.

The specific adjudication method is not stated in the provided summary.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically relevant for medical imaging AI devices where multiple human readers interpret cases with and without AI assistance.

This is not applicable to a standalone semi-automatic electronic blood pressure monitor. The device is not designed to assist human readers in interpreting complex cases, but rather to directly provide a measurement. Therefore, no MRMC study would have been performed or reported.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The statement that the device "conforms to the following standards" (including AAMI SP10) means that the device's accuracy and performance were tested independently against a reference standard without human intervention in the measurement process (beyond applying the cuff and starting the device). The goal is to ensure the algorithm only (the device's measurement method) provides accurate readings.

7. Type of Ground Truth Used

For blood pressure monitors conforming to AAMI SP10, the ground truth is established by expert auscultatory measurements (typically using a mercury sphygmomanometer or an equivalent reference device) taken simultaneously or in close succession by trained human observers. This is effectively an expert consensus based on direct physiological measurement.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a traditional medical device (semi-automatic electronic blood pressure monitor) that operates based on established oscillometric principles and fixed algorithms, not machine learning or AI models that require training data. Therefore, there is no "training set" in the context of an AI/ML device. The device's algorithms are developed and refined through engineering and validation, not through learning from a dataset.

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

As stated above, there is no "training set" for this type of device. The ground truth for developing and verifying the underlying algorithms would come from extensive physiological research, engineering principles, and validation studies performed during the development phase of oscillometric technology itself, rather than a specific "training set" for this particular device model.

Summary

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510(k) Summary

K091739
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

AUG 1 8 2009

Name:	Andon Health Co., Ltd.
Address:	No 31, Changjiang 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:	05/27/2009

2.0 Device information

Semi 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 Panel: Cardiovascular

4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-391 Semi Automatic Electronic Blood Pressure Monitor Device: K080326 510(k) number:

5.0 Device description

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It is designed and manufactured according to ANSI/AAMI SP10--manual, P2/4 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-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.

6.0 Intended use

The intended use and the indication for use of KD-3917 and KD-3909, as described in their labelings are the same as the predict device KD-391.

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

7.0 Summary comparing technological characteristics with predicate device

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8.0 Performance summary

KD-3917 and KD-3909 Semi Automatic Electronic 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.
· 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-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Semi Automatic Electronic Blood Pressure Monitor KD-391 whose 510(k) number is K080326.

KD-3917 and KD-391 are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance is different. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-391. The pulse rate range is changed from 30-180 times/min to 40-180 times/min. KD-3917 also adds a new cuff.

KD-3909 and KD-391 are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance and some functions such as 2×60 times memory and averaging the last three measurements are different. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-391. The pulse rate range is changed from 30-180 times/min to 40-180 times/min, KD-3909 also adds a new cuff.

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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 shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianiin China 300190

'AUG 1 8 2009

Re: K091739

Trade/Device Name: KD-3917, KD-3909 Semi Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: July 21, 2009

Dear Mr. 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.

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 (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,

Bram D. Žuckerman, 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

510(k) Number :	K091739
Device name:	KD-3917 and KD-3909 Semi Automatic Electronic 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)

Hofstetter B Zuckerman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

Page 1 of

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).