(148 days)
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No
The description focuses on standard oscillometric blood pressure measurement and basic signal processing (irregular heartbeat detection, classification indicator). There is no mention of AI, ML, or related concepts, nor any description of training or test sets for such algorithms.
No
The device is a blood pressure monitor, which is a diagnostic tool used to measure blood pressure and pulse rate. It does not actively treat or alleviate a medical condition.
Yes
Explanation: The device measures blood pressure and pulse rate, providing information about the user's physiological state, and can detect irregular heartbeats, which are all diagnostic functions. It classifies blood pressure and alerts the user to irregular heartbeats, indicating a potential health issue.
No
The device description explicitly mentions hardware components like an inflatable cuff, pressure sensor technology, and an LCD display, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "non-invasive blood pressure measurement system" that measures blood pressure and pulse rate by using 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 is to measure blood pressure and pulse rate, which are physiological parameters, not to diagnose a disease or condition based on a sample.
Therefore, this device falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-553, KD-557BR, KD-558BR, KD-5031M 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
DXN
Device Description
KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
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)
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;
c. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 16, 2019
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CHINA
Re: K183534
Trade/Device Name: KD-553, KD-557BR, KD-558BR, KD-5031M 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: April 18, 2019 Received: April 22, 2019
Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183534
Device Name
KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-553, KD-557BR, KD-558BR, KD-5031M 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Preparation: | 11/28/2018 |
2.0 Device information
Trade name: KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor
Noninvasive blood pressure measurement system Common name:
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-5920 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K162230
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5.0 Intended use
KD-553, KD-557BR, KD-558BR, KD-5031M 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-553 as described in its labeling are the same as the predicate device KD-5920 (K162230).
6.0 Device description
KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. 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.
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 | Identical |
| Mechanical safety | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
8.0 Discussion of non-clinical and clinical test performed
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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;
c. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness.
9.0 Performance summary
KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 -● IEC And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- 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 Noninvasive Sphygmomanometers
10.0 Comparison to the predicate device and the conclusion
Our devices KD-553, KD-557BR, KD-558BR, KD-5031M are substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5920 whose 510(k) number is K162230.
KD-553, KD-557BR, KD-558BR, KD-5031M are very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Their appearance, the memory capacity, the average function is different, more over, the MCU used is also different.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.