(68 days)
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.
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.
This submission pertains to the KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors. The primary study used to demonstrate effectiveness is the conformance to the AAMI SP10:2002 standard for sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI SP10:2002) | Reported Device Performance (Summary) |
|---|---|
| Accuracy (Mean Difference) | |
| Mean difference between device and reference for SBP: ≤ ±5 mmHg | Conforms to AAMI SP10:2002 |
| Mean difference between device and reference for DBP: ≤ ±5 mmHg | Conforms to AAMI SP10:2002 |
| Standard Deviation (of Differences) | |
| Standard deviation of differences for SBP: ≤ 8 mmHg | Conforms to AAMI SP10:2002 |
| Standard deviation of differences for DBP: ≤ 8 mmHg | Conforms to AAMI SP10:2002 |
| Pulse Rate Accuracy | Conforms to AAMI SP10:2002 |
| Environmental Parameters | |
| Operational range for humidity: <90% | Device meets this new operational range (predicate was <80%) |
| Pulse rate range: 40-180 times/min | Device meets this new pulse rate range (predicate was 30-180 times/min) |
| Cuff pressure range | Differences from predicate acknowledged, but "small differences do not raise any new questions of safety and effectiveness." (Specific ranges not detailed in the summary). |
| Overpressure limit | Differences from predicate acknowledged, but "small differences do not raise any new questions of safety and effectiveness." (Specific limits not detailed in the summary). |
Note: The 510(k) summary explicitly states that the devices conform to AAMI SP10:2002 in section 8.0 "Performance summary." This standard outlines the specific acceptance criteria for accuracy (mean difference and standard deviation of differences).
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for the test set used to demonstrate conformance to AAMI SP10:2002. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). Conforming to AAMI SP10 typically involves a prospective clinical study with a specified number of subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The 510(k) summary does not provide details on the number of experts used or their qualifications for establishing ground truth. For AAMI SP10, ground truth measurements are typically taken simultaneously by trained observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer with stethoscope).
4. Adjudication Method for the Test Set
The 510(k) summary does not describe an adjudication method. In the context of AAMI SP10, ground truth is typically established by multiple trained observers, and differences between their readings are addressed through a standardized protocol, often involving reconciliation or averaging. However, the exact method for this specific submission is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. Blood pressure monitors are standalone measurement devices.
6. Standalone Performance
Yes, a standalone performance assessment was done. The conformance to the AAMI SP10:2002 standard is a standalone assessment of the device's accuracy and performance against an established reference without human-in-the-loop interaction for the measurement itself. The device is a "Fully Automatic Electronic Blood Pressure Monitor," implying its operation without continuous human interpretation during the measurement process.
7. Type of Ground Truth Used
The ground truth used for the AAMI SP10 standard typically involves simultaneous measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This is a form of expert reference measurement, but not necessarily "expert consensus" in the sense of multiple experts independently reviewing and agreeing on a singular pathology.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on a training set. For a blood pressure monitor, the algorithm for oscillometric measurement is typically developed and refined using a large dataset of pressure waveforms and corresponding auscultatory readings. This development process isn't usually described as a "training set" in the same way as for AI/ML algorithms. The 510(k) focuses on the validation of the final device.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is described for this device, information on how its ground truth was established is not provided in the summary. However, in general, for oscillometric blood pressure monitors, the algorithms are developed using data where ground truth is established through simultaneous auscultatory measurements by trained personnel.
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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.
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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 |
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K091737
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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 (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.
KD-5915 and KD-5902 is 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 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 (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.
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KD-5031 and KD-5902 is very similar in the intended use, the design principle, م 4/4 the material, the energy source and the applicable standards. Only their appearance and some functions such as 3×30 times memory and averaging the last three measurements are different. KD-5031 does not have a 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 (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min. The MCU is also changed.
KO91737
KD-5917, KD-5915 and KD-5031 all add a new cuff compared with the predicted device.
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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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 1 8 2009
Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300190
Re: K091737
Trade/Device Name: KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors 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 (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/ReportalProblem/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. 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
Kog1737 510(k) Number :
KD-5917, KD-5915 and KD-5031 Fully Automatic Device name: Electronic Blood Pressure Monitor
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.
AND/OR Over-The-Counter Use YES Prescription use (21 CFR 807 Subpart C) Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H.H. Stier for B. Zuckerman
vision Sign-Off) /
Division of Cardiovascular Devices
510(k) Number K091737
Page 1 of 1
§ 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).