(282 days)
K/DEN: Not Found
No
The description focuses on standard oscillometric blood pressure measurement and basic data processing (averaging, classification, irregular heartbeat detection). There is no mention of AI, ML, or any advanced algorithms that would suggest their use.
No.
The device is a blood pressure monitor intended for measurement and classification of blood pressure and pulse rate, not for providing therapy.
Yes
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate," and it "can calculate the systolic and diastolic blood pressure" and alert the user if "any irregular heartbeat is detected." These functions involve assessing physiological parameters to provide information about a patient's health status, which is a diagnostic purpose.
No
The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes hardware components like an inflatable cuff, pressure sensor technology, and an LCD or cell phone for display, indicating it is a hardware device with integrated software.
No, 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. These tests are performed outside of the body (in vitro).
- Device Function: The KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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
DXN
Device Description
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are designed and manufactured according to IEC80601-2-30--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. Achieves its function by an LCD or cell phone.
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
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. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting hair or clothing. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Andon Health Co., Ltd Mr. Liu Yi President No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China
Re: K141984
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitors Models KD-927 and KD-928 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: March 13, 2015 Received: March 16, 2015
Dear Mr. 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.
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
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Page 2 - Mr. Liu Yi
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 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/Resourcesfor You/Industry/default.htm. 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 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.
Sincerelv vours.
Withell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indications for Use
K141984 510(k) Number :
Device name: - KD-927,KD-928 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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.
Prescription use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use YES (Part 21 CFR 801 Subpart D) (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 of
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510(k) Summary
510 (k) number: K141984
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: | 7/7/2014 |
2.0 Device information
Trade name: KD-927,KD-928 Fully Automatic Electronic Blood Pressure Monitor Device name: KD-927,KD-928 Fully Automatic Electronic 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: KD-936 Fully Automatic Wireless Blood Pressure Monitor 510(k) number: K120672
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5.0 Intended use
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor, as described in its labeling are the same as the predicate device KD-936(K120672) .
6.0 Device description
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are designed and manufactured according to IEC80601-2-30--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. Achieves its function by an LCD or cell phone.
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Similar |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
7.0 Summary comparing technological characteristics with predicate device
5
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. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance)
- IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests)
- IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)
10.0 Comparison to the predicate device and the conclusion
Our device KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the Fully Automatic Wireless Electronic Blood Pressure Monitor KD-936 whose 510(k) number is K120672.
The KD-927 and KD-928 are very similar with the predicate device KD-936(K120672) in the intended use, the design principle, the material, the performance and the applicable standards, only their appearance, the memory time, the display components, electrical power, measure process, average measure function and Blood pressure non - rest condition index (BPNRI) function are different from the KD-936.
The conclusions drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.