(136 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components, algorithms, or training/test data.
No
This device is intended for measurement and monitoring of blood pressure and pulse rate, not for providing therapy.
Yes
Explanation: The device measures and displays systolic and diastolic blood pressures and pulse rate, and can identify irregular heartbeats. This information is used to assess an individual's health status related to blood pressure, which is a diagnostic function.
No
The device description explicitly mentions an "inflatable cuff" and "silicon integrates pressure sensor technology," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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." This describes a device that measures physiological parameters directly from the body, not from a sample taken from the body.
- Device Description: The description explains the operational principle is based on "oscillometric and silicon integrates pressure sensor technology." This further confirms it's a physical measurement device, not one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that definition.
N/A
Intended Use / Indications for Use
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
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) 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
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with 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 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- 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
The proposed devices KD-5810, KD-5810B, KD-5811 and KD-5920TL has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961can be used as a reference when considering the clinical effect of KD-5810, KD-5810B, KD-5811 and KD-5920TL.
The proposed devices KD-552 has the same algorithm and design principle with cleared device BP3 (K102939) and BP5 (K120672), so the clinical test report of BP3 (K102939) and BP5 (K120672) can be used as a reference when considering the clinical effect of KD-552.
Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
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 & 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.
July 29, 2021
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China
Re: K210770
Trade/Device Name: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2021 Received: July 1, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Jennifer Shih Kozen Assistant Director 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) K210770
Device Name
Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
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 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
(In accordance with 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, |
| 300190, P.R. China | |
| Phone Number: | 86-22-87611660 |
| Fax Number: | 86-22-87612379 |
| Contact: | Mr. Liu Yi |
| Date of Preparation: | March 1, 2021 |
2.0 Device Information
| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
|---|---|
| Common Name: | Arm Blood Pressure Monitor |
| Classification Name: | Non-Invasive Blood Pressure Measurement System |
3.0 Classification
| Product Code: | DXN |
|---|---|
| Regulation Number: | 21 CFR 870.1130 |
| Classification: | II |
| Review Panel: | 870 Cardiovascular |
4.0 Predicate Device Information
| Manufacturer: | Andon Health Co., Ltd. | Andon Health Co., Ltd. |
|---|---|---|
| Device: | Fully Automatic Electronic | |
| Blood Pressure Monitor | Wireless Electronic Blood | |
| Pressure Monitor | ||
| 510(k) Number: | K183534 | K162668 |
| Classification | II | II |
| Product Code | DXN | DXN |
5.0 Indications for Use
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.
4
6.0 Device Description
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) 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 Comparison of Technological Characteristics with Predicate Device
The following table is the summary of the technological characteristics of the proposed subject device and predicate device.
| Item | Subject Device | Predicate
Device
(KD-5031M
K183534) | Predicate
Device
(KD-926)
(K162668) | Comparison
Result |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Name and
mode | Fully Automatic Electronic
Blood Pressure Monitor | Fully Automatic
Electronic
Blood Pressure
Monitor | Wireless
Electronic
Blood
Pressure
Monitor | -- |
| Model | KD-5810, KD5810B,
KD-5811,KD-5920TL
KD-552 | KD-5031M | KD-926 | -- |
| Rx or OTC | OTC | OTC | OTC | Same |
| Population | Adult | Adult | Adult | Same |
| Cuff
Location | Upper arm | Upper arm | Upper arm | Same |
| Physical Attributes | | | | |
| Weight
(exclude
batteries and
cuff) | KD-5810: About 191g
KD-5810B: About 180g
KD-5811: About 239g
KD-5920TL:About 235g
KD-552: About 270g | About 300g | About 234g | Changed |
| Dimensions | KD-5810:
139.4mm×93.8mm×41.8mm
KD-5810B:
139.4mm×93.8mm×41.8mm | 165mmx96mm
x65mm | 145mm×90mm
×51mm | Changed |
| Item | Subject Device | Predicate Device
(KD-5031M
K183534) | Predicate Device
(KD-926)
(K162668) | Comparison Result |
| | KD-5811:
139.4mm×93.8mm×43.4mm
KD-5920TL:
150mm×95mm×
41mm
KD-552:
158.5mm×92.3mm×76.7mm | | | |
| Memory | KD-5810, KD-5810B,
KD-5920TL& KD-552:
2×120 times
4×60 times
2×60 times
4×30 times
KD-5811:
2×120 times
2×60 times
2×30 times | 1×120 times
1×60 times
2×60 times
4×30 times | 2×60 times | More memory
function on
meter |
| Displayed
Calculated
Parameters | SYS
DIA
Pulse
IHB | SYS
DIA
Pulse
IHB | SYS
DIA
Pulse
IHB | Same |
| Display
component | KD-5810, KD-5811,
KD-5920TL &KD-552:
LCD with backlight
KD-5810B: LCD | LCD | 1. LCD
2. Display on
Smart Phone | Similar |
| Average
function | KD-5810, KD-5810B,
KD-5920TL& KD-552:
1.Average value of all
results in the current user
memory zone.
2. Average the value of the
latest 3 times
3. Average value of all the
results in last 7 days AM
4. Average value of all the
results in last 7 days PM
KD-5811: | Average the
value of the
latest 3 times | Averaging of
the last three
times
measurement | More functions
are added |
| Item | Subject Device | Predicate
Device
(KD-5031M
K183534) | Predicate
Device
(KD-926)
(K162668) | Comparison
Result |
| | 1. Average value of all
results in the current user
memory zone.
2. Average the value of the
latest 3 times | | | |
| Other
Displayed
Information | Date
Time
Memory
Battery usage
Blood pressure classification | Date
Time
Memory
Battery usage
Blood pressure
classification | Date
Time
Memory
Battery usage
Blood pressure
classification
(Displayed on
device) | Similar |
| Electrical Power | | | | |
| DC Mains | 6V | 6V | 6V | Same |
| Battery | KD-5810, KD-5810B,
KD-5811, & KD-552:
4 ×1.5V SIZE AA
KD-5920TL:
4 ×1.5V SIZE AAA | 4 ×1.5V SIZE
AAA | 4 ×1.5V SIZE
AAA | Same |
| Environmental Operation | | | | |
| Temperature | 1040℃ | 1040℃ | 10~40°C | Same |
| Humidity |