(266 days)
Not Found
No
The device uses "software algorithms within the microprocessor" to analyze waveform data and determine blood pressure and pulse rate. While this involves algorithms, the description does not mention or imply the use of AI or ML techniques. The irregular heartbeat detection is based on a simple comparison of time intervals against a threshold, not an AI/ML model.
No
The device is a diagnostic tool used to measure blood pressure and heart rate; it does not provide treatment or therapy.
No
While the device measures blood pressure and pulse rate, and even indicates irregular heartbeat, the "Intended Use" states it is "intended to measure" and the "Device Description" explicitly states that the accompanying app "does not provide any diagnostic or measurement functions" and "does not interpret or analyze the data for medical decision making." This indicates it provides data, but not a diagnosis.
No
The device description clearly outlines hardware components like a cuff, piezoelectric pump, electric automatic rapid deflation valve, and a microprocessor. While it includes software algorithms and an app, it is fundamentally a hardware device with integrated 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 Arm-type Fully Automatic Digital Blood Pressure Monitor measures blood pressure and pulse rate by applying pressure to the arm and analyzing the resulting oscillations. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters, not to analyze a biological sample for diagnostic purposes.
Therefore, this device falls under the category of a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arm-type Fully Automatic Digital Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series, noninvasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, the electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement compares the longest and the shortest time intervals of detected pulse waves to the mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
Meanwhile, this blood pressure monitor device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display measurement results from the blood pressure monitor device, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by 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
adults and adolescents over 12 years of age
Intended User / Care Setting
Home and clinical environment
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
A total of 90 patients participated in the clinical study (2 were excluded because they were part of other clinical trials). Same arm sequential method was adopted during the clinical testing. A manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteers to take part in the clinical study. All the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation:
- ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type.
The key factors that affect clinical trials, such as the sensors, and the core algorithms are the same between BM92 and DBP-6279B. Therefore, the clinical investigation report for the model for DBP-6279B is applicable for BM92.
A total of 90 patients participated in the clinical study (2 were excluded because they were part of other clinical trials). Same arm sequential method was adopted during the clinical testing. A manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteers to take part in the clinical study. All the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.
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.
Not Found
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).
0
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.
January 26, 2024
Joytech Healthcare Co., Ltd Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou, Zhejiang 311100 China
Re: K231303
Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor, Model: BM 92 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 26, 2023 Received: December 26, 2023
Dear Ren Yunhua:
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.
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"
1
(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 OS 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
510(k) Number (if known) K231303
Device Name
Arm-type Fully Automatic Digital Blood Pressure Monitor
Model: BM 92
Indications for Use (Describe)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for TECH-I, with the letters in blue and red. The first part of the logo is a blue arrow pointing to the right. The letters 'TEC' are in blue, and the letter 'H' is in red. To the right of 'TECH-I' are some Chinese characters in blue.
510(k) Summary
The assigned 510(k) number is:
2.1 Subjectter's Identification:
Name: JOYTECH Healthcare Co., Ltd.
Add.: No. 365. Wuzhou Road. Yuhang Economic Development Zone. Hangzhou City.
311100 Zhejiang, China.
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: renyh@sejoy.com
2.2 Name of the Device:
Trade Name: Arm-type Fully Automatic Digital Blood Pressure Monitor
Model: BM 92
Common Name: Blood Pressure Monitor
Classification name: Non-invasive blood pressure measurement System
21 CFR 870-1130, Class II, 74-DXN.
2.3 Classification Information:
Regulation Number: 870.1130
Product Code: DXN
Device Class: II
Panel: 74 Cardiovascular
2.4 Predicate Device Information:
The Arm-Type Fully Automatic Digital Blood Pressure Monitor is substantially equivalent to the following predicate device:
| 510(k)
number | Predicate
device model | Product
code | Manufacturer |
| ------------------ | --------------------------- | ----------------- | -------------- |
|---|
5
Image /page/5/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.
| K192609 | GUS622 | DXN | Globalcare Medical Technology Co., Ltd |
|---|
2.5 Device Description:
The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series, noninvasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, the electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement compares the longest and the shortest time intervals of detected pulse waves to the mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
Meanwhile, this blood pressure monitor device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display measurement results from the blood pressure monitor device, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.
6
Image /page/6/Picture/2 description: The image shows the logo for JOYTECH. The logo is in blue and red. The text "JOYTECH" is in blue, except for the "T", which is in red. To the right of "JOYTECH" is some text in another language, also in blue.
The detail functions for BM 92 are listed in table below:
| Models
| Features | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BM 92 | Y | N | 2*120 | |||||||||||
| memories | Y | Y | Y | Y | 1259544 | 22- | ||||||||
| 42cm | 71*76 | Y | Y | Y | Y |
A = Powered by alkaline battery
B= Powered by AC adaptor
C = Memory Size
D = Time & Date
E = WHO (World Health Organization) Classification Indicator
F = Average of all memories, AM/PM Average for the last 7 days
G = Irreqular Heartbeat Detection
H = Outside Demission (L x W x H in unit mm)
I = Cuff Size
- J = LCD Size (Viewing Area in unit mm)
K = LCD Backlight
L = Voice
- M= Bluetooth Function
N= Cuff Loose Detection
Note:
Y= Yes N = No
The device is designed and manufactured according to IEC80601-2-30:2018, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
2.6 Intended Use:
The Arm-type Fully Automatic Digital Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.
2.7 Comparison of Technological Characteristics with predicate device:
The arm-type blood pressure monitor BM 92 manufactured by JOYTECH have the same arm cuff type, features and specifications with the Globalcare blood pressure monitor GUS622 which 510k number is K192609, therefore we choose the device act as
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Image /page/7/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text "JOYTECH-I" is in English, and there is also Chinese text to the right of the English text.
the predicate device. The detail comparison of technical characteristic as below:
| Comparison
item | Subject devices for BM 92 | Predicate device GUS622
(K192609) | Comparison
result
Explanation |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| The trade name | Arm-type Fully Automatic
Digital Blood Pressure
Monitor | Globalcare GUS622 Blood
Pressure Monitor | / |
| Manufacturer | JOYTECH Healthcare Co.,
Ltd. | Globalcare Medical Technology
Co., Ltd | / |
| Recommended
classification
regulation | 21CFR 870.1130,
Noninvasive Blood
Pressure Measurement
System | 21CFR 870.1130,
Noninvasive Blood
Pressure Measurement
System | Identical |
| Regulatory
class | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | Identical |
| for
Indication
use | The Arm-type Fully
Automatic Blood Pressure
Monitors are intended to
measure blood pressure
(systolic and diastolic) and
pulse rate of adults and
adolescents over 12 years
of age with circumference
ranging from 22cm to 42cm. | The Globalcare GUS622
automatic Blood Pressure
Monitor is indicated for home use
for the non-invasive
measurement of diastolic and
systolic blood pressures and
pulse rate of adults by means of
an inflatable cuff which is
wrapped around the upper arm.
The cuff circumference is limited
to 22 to 42 cm. | Similar
Note 1 |
| Measuring
principle | Oscillometric method | Oscillometric method | Identical |
| Measurement
type | Determined during inflation | Determined during inflation | Identical |
| Cuff location | Upper arm | Upper arm | Identical |
| Specification | | | |
| Measuring
range | Systolic Pressure:
60mmHg ~ 260 mmHg;
Diastolic Pressure:
40mmHg ~ 200 mmHg;
Pulse:
30180 Beats/Minute | Systolic Pressure:199 Beats/Minute | Similar.
50mmHg ~ 280 mmHg;
Diastolic Pressure:
30mmHg ~ 220 mmHg;
Pulse:
40
Note 2 |
| Max
cuff
pressure | 299 mmHg | 300mmHg | Similar |
| Accuracy | Static Pressure:± 3mmHg
Pulse: ± 5% | Pressure:±0.4kPa ( 3mmHg)
Pulse value: ± 5% | Identical |
| Inflation | By air pump | By air pump | Identical |
| Pressure
release | By solenoid valve | By solenoid valve | Identical |
| Operating
Temp. & | Temp.: 10°C40°C93%RH | Temp.: 10°C~40°C
Humidity: 15
Humidity: