(167 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI/ML terms, image processing, or data training/testing sets indicative of AI/ML use.
No
The device is a blood pressure monitor used for measurement and monitoring, not for treating a condition.
Yes
The device measures physiological parameters (diastolic and systolic blood pressures and pulse rate) and includes a "blood pressure classification indicator" and detection of "irregular heartbeat," which are used to assess a health condition.
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 display. It also mentions being designed and manufactured according to IEC 80601-2-30, which is a standard for medical electrical equipment, not solely software.
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 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 wrist."
- No Sample Analysis: The device measures physiological parameters directly from the body (blood pressure and pulse) without requiring any samples to be taken and analyzed outside the body.
Therefore, since the device operates non-invasively and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
KD-753, KD-738BR, KD-733 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 wrist. The cuff circumference is limited to 14cm-25cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-753, KD-738BR, KD-733 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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
85 patients (40 males and 45 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests
Bench testing was conducted to demonstrate that the device meets its requirements and specification. The following performance tests were completed:
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
The proposed devices KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor meets all the applicable requirements.
Clinical Tests
Clinical test has been performed in accordance with ISO 81060-2. 85 patients (40 males and 45 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
June 4, 2019
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN
Re: K183535
Trade/Device Name: KD-733, KD-738BR, KD-733 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 19, 2019 Received: May 9, 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
2
Indications for Use
510(k) Number (if known) K183535
Device Name
KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure ment 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 wrist. The cuff circumference is limited to 14cm-25cm.
| 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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3
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-753, | KD-738BR, | KD-733 | 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
Primary Predicate:
Manufacturer: Andon Health Co., Ltd. KD-7920 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K162915
Reference Predicate:
Manufacturer: Andon Health Co., Ltd. Device: KD-7901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K092510
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5.0 Intended use
KD-753, KD-738BR, KD-733 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 wrist. The cuff circumference is limited to 14cm-25cm.
The intended use and the indication for use of KD-753, KD-738BR, KD-733 , as described in its labeling are the same as the predicate device KD-7920(K162915).
6.0 Device description
KD-753, KD-738BR, KD-733 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
| Item | Subject
Device | Predicate Device | Conclusion |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Name and
mode | Fully Automatic Electronic
Blood Pressure Monitor | Fully Automatic Electronic
Blood Pressure Monitor | Same |
| Model | KD-753
KD-738BR
KD-733 | KD-7920 | The model is
different |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff Location | Wrist | Wrist | Same |
| | | | |
| Physical Attributes | | | |
| Weight | KD-753: 71g
KD-738BR: 80g
KD-733: 78.7g | 69.5g | Changed |
| Dimensions
(mm) | KD-753:
83mm x 74mm x 26mm
KD-738BR:
83mm x 64mm x 28mm
KD-733:
87mm×66.3mm×31.5mm | 80mm x 60mm x 31mm | changed |
| Memory | 1×120 times
1×60 times
2×60 times
4×30 times | 4 x 30 times | Added memory
function on meter |
| Displayed
Calculated
Parameters | SYS
DIA
Pulse
IHB | SYS
DIA
Pulse
IHB | Same |
| Display
component | LCD | LCD | Same |
| Average
function | KD-753:
1.Average value of all
results in the current user
memory zone.
2. Average the value of
the latest 3 times.
KD-738BR: Average the
value of the latest 3 times.
KD-733: Average value of
all results in the current
user memory zone. | Average value of all the
results which is measured
from 5 o'clock to 9 o'clock
and 18 o'clock to 20
o'clock in last 7 days. | Average function
is different |
| Other
Displayed
Information | Date
Time
Memory
Battery usage
Blood pressure
classification | Date
Time
Memory
Battery usage
Blood pressure
classification | Same |
| Electrical | | | |
| Power | | | |
| DC Mains | 3 VDC | 3 VDC | Same |
| Battery | 2 x 1.5 VDC AAA size | 2 x 1.5 VDC AAA size | Same |
| Environmental | | | |
| Operation | | | |
| Temperature | 1040°C | 1040°C | Same |
| Humidity | ≤85% | ≤85% | Same |
| Environmental
Storage | | | |
| Temperature | -2050°C | -2050°C | Same |
| Humidity | ≤85% | ≤85% | Same |
| Performance
NIBP | | | |
| Pulse Rate
Range | 40 --- 180times/min | 40 --- 180times/min | Same |
| Pulse Rate
Accuracy | Within ±5% | Within ±5% | Same |
| Technique/Method | Oscillometric | Oscillometric | Same |
| Measure process | Measure during deflating | Measure during deflating | Same |
| Systolic Range | 60-260mmHg | 60-260mmHg | Same |
| Diastolic Range | 40-199mmHg | 40-199mmHg | Same |
| Pressure
Accuracy | Within ±3mmHg | Within ±3mmHg | Same |
| Cuff Pressure
Range | 0-300mmHg | 0-300mmHg | Same |
| Over pressure
Limit | 300mmHg | 300mmHg | Same |
| Algorithm | Amplitude | Amplitude | Same |
5
K183535
6
K183535
KD-753 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests
Bench testing was conducted to demonstrate that the device meets its requirements and specification. The following performance tests were completed:
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
The proposed devices KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor meets all the applicable requirements.
Clinical Tests
Clinical test has been performed in accordance with ISO 81060-2. 85 patients
7
(40 males and 45 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
9.0 Performance summary
KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 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
- ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type
10.0 Comparison to the predicate device and the conclusion
Our device KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the predicate device KD-7920 Fully Automatic Electronic Blood Pressure Monitor.
The intended use, the design principle, the material of the new devices is exactly the same as the predicate device, their appearance, memory capacity, average function and MCU used is different.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.