(123 days)
Not Found
No
The description focuses on standard oscillometric technology and pressure sensors, with no mention of AI or ML terms or methodologies.
No
The device is a blood pressure monitor intended for measurement and monitoring, not for treating a condition.
Yes
The device is described as an "Electronic Blood Pressure Monitor" intended to "measure the diastolic and systolic blood pressures and pulse rate," and it can detect "irregular heartbeat." These are all measurements taken to diagnose a patient's health status.
No
The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes its operational principle based on "oscillometric and silicon integrates pressure sensor technology," indicating the presence of hardware components (cuff, sensor).
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 living 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 directly from the body using a cuff and oscillometric technology. It does not analyze samples taken from the body.
Therefore, based on the provided information, this Fully Automatic Electronic Blood Pressure Monitor is a non-invasive medical device used for physiological measurement, 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 17cm-48cm (approx, 6 11/16"- 18 29/32").
Product codes
DXN
Device Description
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, the measurements results can also be classified. 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
Clinical test has been performed in accordance with ISO 81060-2. For the cuff size with 15-24 cm, 20-34 cm, 30-44 cm, 15-24 cm, 22-42 cm, and 42-48 cm, 231 patients ( 107 males and 124 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
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
April 22, 2024
Andon Health Co Ltd Yi Liu President No. 3 Jin Ping Street, Ya An Road Nankai District Tianjin, Tianjin 300190 China
Re: K234041
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA): Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 1, 2024 Received: April 1, 2024
Dear Yi Liu:
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Stephen C. Browning -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K234041
Device Name Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT): Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
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 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 17cm-48cm (approx, 6 11/16"- 18 29/32").
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: | January 29, 2024 |
2.0 Device Information
| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
|---|---|
| Common Name: | Non-Invasive Blood Pressure Measurement System |
| 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 noninvasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff
5
circumference is limited to 17cm-48cm (approx. 6 11/16"- 18 29/32").
6.0 Device Description
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, the measurements results can also be classified. 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
(KD-5811VA, KD-5811BT,
KD-5810VA, KD-5810BT,
KD-5920VA, KD-5920BT,
KD-5923TS) | Predicate Device
(KD-5811 K210770) | Comparison
Result |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Name and
mode | Fully Automatic Electronic
Blood Pressure Monitor | Fully Automatic Electronic
Blood Pressure Monitor | Same |
| Model | KD-5811VA, KD-5811BT, KD-
5810VA, KD-5810BT, KD-
5920VA, KD-5920BT,
KD-5923TS | KD-5811 | -- |
| 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
17cm-48cm (approx. 6 11/16"
- 18 29/32" ). | 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. | Different 1
(Note 1) |
| 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-5811VA, KD-5811BT:
Approx. 239g (8 7/16 oz.)
KD-5810VA, KD-5810BT:
Approx. 191g (6 3/4oz.) | About 239g | Different 2
(Note 2) |
| Item | Subject Device | Predicate Device
(KD-5811 K210770) | Comparison
Result |
| | (KD-5811VA, KD-5811BT,
KD-5810VA, KD-5810BT,
KD-5920VA, KD-5920BT,
KD-5923TS) | | |
| | KD-5920VA, KD-5920BT:
Approx. 235g (8 9/32oz.) | | |
| | KD-5923TS:
Approx. 166g (5 27/32 oz.) | | |
| Dimensions | KD-5811VA, KD-5811BT:
Approx.139.4mm×93.8mm×43.4mm (5 1/2" × 3 11/16″ × 1 23/32")
KD-5810VA, KD-5810BT:
Approx.139.4mm×93.8mm×41.8mm (5 1/2" × 3 11/16" x 1 21/32")
KD-5920VA, KD-5920BT:
Approx.150mm×95mm×41mm (5 29/32" × 3 3/4″ × 1 5/8")
KD-5923TS:
Approx.107mm×80mm×52mm (4 7/32" × 3 5/32" × 2 1/16") | 139.4mm×93.8mm×43.4mm | Different 3
(Note 3) |
| Memory | KD-5811VA, KD-5811BT, KD-
5810VA, KD-5810BT, KD-
5920VA, KD-5920BT:
2x120 times
KD-5923TS: 4×30 times | 2×120 times
2×60 times
2×30 times | Different 4
(Note 4) |
| Displayed
Calculated
Parameters | SYS
DIA
Pulse
IHB | SYS
DIA
Pulse
IHB | Same |
| Wireless
Function | KD-5811BT, KD-5810BT, KD-
5920BT:
Bluetooth wireless transmission
function
KD-5811VA, KD-5810VA,
KD-5920VA, KD-5923TS:
None | None | Different 5
(Note 5) |
| Voice Function | KD-5811VA, KD-5810VA,
KD-5920VA:
Voice guidance test procedure
function
KD-5811BT, KD-5810BT, KD-
5920BT, KD-5923TS:
None | None | Different 6
(Note 6) |
| Body
Movement
Reminder | KD-5811VA, KD-5811BT, KD-
5810VA, KD-5810BT, KD-
5920VA, KD-5920BT and KD-
5923TS: | None | Different 7
(Note 7) |
| Item | Subject Device | Predicate Device | Comparison Result |
| | (KD-5811VA, KD-5811BT,
KD-5810VA, KD-5810BT,
KD-5920VA, KD-5920BT,
KD-5923TS)
Body movement reminder
function | (KD-5811 K210770) | |
| Cuff Wrap
Reminder | KD-5811VA, KD-5811BT, KD-
5810VA, KD-5810BT, KD-
5920VA, KD-5920BT and KD-
5923TS:
Cuff wrap reminder function | None | Different 8
(Note 8) |
| Electrical Power | | | |
| Battery | KD-5811VA, KD-5811BT, KD-
5810VA, KD-5810BT:
4 ×1.5V SIZE AA
KD-5920VA, KD-5920BT,
KD-5923TS:
4 ×1.5V SIZE AAA | 4 ×1.5V SIZE AA | Different 9
(Note 9) |
| Environmental Operation | | | |
| Temperature | 5°C40°C(41°F104°F) | 1040°C | Different 1055°C(-4°F
(Note 10) |
| Humidity | ≤85%RH | ≤85% | Same |
| Environmental Storage | | | |
| Temperature | -20°C131°F) | -2050°C | Different 11
(Note 11) |
| Humidity | ≤90%RH | ≤85% | Different 12
(Note 12) |
| Performance NIBP | | | |
| Pulse Rate
Range | 40-180 beats/minute | 40 -180times/min | Same |
| Pulse Rate
Accuracy | Less than 60: ±3bpm
More than 60 (incl.): ±5% | Less than 60: ±3bpm
More than 60 (incl.): ±5% | Same |
| Technique/
Method | Oscillometric | Oscillometric | Same |
| Pressure
Accuracy | Within±3mmHg | Within ±3mmHg | Same |
| Cuff Pressure
Range | 0-300mmHg | 0-300mmHg | Same |
| Over pressure
Limit | 300mmHg | 300mmHg | Same |
6
7
Note 1: The cuff range has changed, but the clinical report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 2: Some of the device weight has changed, but the electrical safety report and the EMC report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 3: Some of the device dimensions have changed, but the electrical safety report and the EMC report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 4: Some of the device memory times have changed, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 5: Bluetooth wireless transmission function has been added to some models, but the software validation
8
K234041
we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 6: Voice function has been added to some models, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 7: The body movement reminder function has been added to all subject models, but the software
validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 8: The cuff wrap reminder function has been added to all subject models, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 9: The battery volume of some new models has changed, but the electrical safety report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 10: The temperature range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 11: The temperature range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 12: The humidity range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.
8.0 Discussion of Non-Clinical Testing
Non-clinical tests 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+AMD1: 2012+AMD2:2020 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2:2014+A1:2020Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-11:2015 +A1:2020 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: 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 test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness.
9.0 Clinical Test
9
Clinical test has been performed in accordance with ISO 81060-2. For the cuff size with 15-24 cm, 20-34 cm, 30-44 cm, 15-24 cm, 22-42 cm, and 42-48 cm, 231 patients ( 107 males and 124 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.
10.0 Conclusion
The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT and KD-5923TS) is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5811 (K210770).