(146 days)
No
The description focuses on standard oscillometric and pressure sensor technology, and there is no mention of AI, ML, or related concepts in the provided text. The performance studies reference a predicate device with the same algorithm, further suggesting a traditional approach.
No.
The device is for measuring blood pressure, which is a diagnostic or monitoring function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
The device is described as a blood pressure monitor intended to measure blood pressure and pulse rate. While these measurements can be used by medical professionals as part of a diagnostic process, the device itself performs a measurement and classification of that measurement (e.g., blood pressure classification indicator, irregular heartbeat detection), rather than diagnosing a disease or condition. It provides data points that might inform a diagnosis, but it does not make a diagnosis itself.
No
The device description explicitly mentions hardware components like an inflatable cuff, pressure sensor technology, and an LCD display, indicating it is a physical device with integrated software, not a software-only medical device.
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 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 upper arm."
- Method of Measurement: The device measures blood pressure and pulse rate directly from the body using a cuff and oscillometric principles. It does not analyze samples taken from the body.
Therefore, based on its intended use and method of operation, this Fully Automatic Electronic Blood Pressure Monitor is a non-invasive medical device and not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
DXN
Device Description
Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 IEC 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . IEC 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, and IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. None of the tests demonstrate that the new Blood Pressure Monitors raises new questions of safety and effectiveness as compared to the predicate.
Clinical tests were conducted by comparison and evaluation between the subject device and cleared devices. The proposed devices KD-5811A, KD-5811V and KD-5815 has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961 can be used as a reference when considering the clinical effect of KD-5811A, KD-5811V and KD-5815. 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 (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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
February 15, 2023
Andon Health Co., Ltd. Liu Yi. President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China
Re: K222869
Trade/Device Name: 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: December 26, 2022 Received: January 4, 2023
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,
Robert T. Kazmierski -S
for
LCDR Stephen Browning 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) K222869
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) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | September 15, 2022 |
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. |
|---|---|
| Device: | Fully Automatic Electronic Blood Pressure Monitor |
| 510(k) Number: | K210770 |
| Classification | II |
| Product Code | DXN |
5.0 Intended 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.
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6.0 Device Description
Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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-5811
K210770) | Comparison
Result |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and
mode | Fully Automatic Electronic
Blood Pressure Monitor | Fully Automatic Electronic
Blood Pressure Monitor | -- |
| Model | KD-5811A, KD-5811V,
KD-5815 | KD-5811 | -- |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff
Location | Upper arm | Upper arm | Same |
| Physical Attributes | | | |
| Weight
(exclude
batteries and
cuff) | KD-5811A: About 223g
KD-5811V:About 239g
KD-5815:About 189g | About 239g | KD-5811V is
same with
predicate.
KD-5811A and
KD-5815 are
changed. |
| Dimensions | KD-5811A:
139.4mm×93.8mm×42mm
KD-5811V:
139.4mm×93.8mm×43.4mm
KD-5815:
138mm×98mm×48.9mm | 139.4mm×93.8mm×43.4mm | KD-5811V is
same with
predicate.
KD-5811A and
KD-5815 are
changed. |
| Memory | KD-5811A, KD-5811V:
2×120 times
2×60 times
2×30 times | 2×120 times
2×60 times
2×30 times | KD-5811A and
KD-5811V are
same with
predicate. |
| Item | Subject Device | Predicate Device
(KD-5811
K210770) | Comparison
Result |
| | KD-5815:
1×60 times | | KD-5815 is less
memory times
than predicate.. |
| Displayed
Calculated
Parameters | SYS | SYS | Same |
| | DIA | DIA | |
| | Pulse | Pulse | |
| | IHB | IHB | |
| Display
component | KD-5811A, KD-5811V:
LCD with backlight
KD-5815: LCD | LCD with backlight | KD-5811A and
KD-5811V are
same with
predicate.
KD-5815 is
without
backlight. |
| Average
function | 1.Average value of all results in
the current user memory zone.
2.Average the value of the latest
3 times. | 1.Average value of all results
in the current user memory
zone.
2.Average the value of the
latest 3 times | Same |
| Other
Displayed
Information | KD-5811A:
Date
Time
Memory
Battery usage
Blood pressure classification
Bodymove
KD-5811V:
Date
Time
Memory
Battery usage
Blood pressure classification
KD-5815
Memory
Battery usage
Blood pressure classification | Date
Time
Memory
Battery usage
Blood pressure classification | KD-5811A is
more function
than predicate.
KD-5811V is
same with
predicate.
KD-5815 is less
function than
predicate. |
| Electrical Power | | | |
| DC Mains | 5V | 6V | Changed |
| Battery | 4 ×1.5V SIZE AA | 4 ×1.5V SIZE AA | Same |
| Item | Subject Device | Predicate Device
(KD-5811
K210770) | Comparison
Result |
| Environmental Operation | | | |
| Temperature | 1040°C | 1040°C | Same |
| Humidity |