(237 days)
Not Found
No
The description mentions "software algorithms within the microprocessor to determine systolic pressure, and diastolic pressure" and "analyzed by software algorithms," but there is no mention of AI, ML, deep learning, or any related terms. The method described is the standard oscillometric method with algorithmic analysis, not indicative of AI/ML.
No.
This device is for measuring blood pressure, which is a diagnostic or monitoring function, not a therapeutic one intended to treat or cure a condition.
No
The device is intended to measure blood pressure, which is a physiological parameter, not to diagnose a specific condition. The 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."
No
The device description clearly outlines a physical blood pressure monitor with hardware components like a cuff, pump, valve, and microprocessor. While there is an accompanying app, it is explicitly stated that the app only displays results and does not perform any diagnostic or measurement functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Arm-type Fully Automatic Digital Blood Pressure Monitor measures blood pressure directly from the patient's arm using a cuff and oscillometric method. It does not analyze any biological specimens.
- Intended Use: The intended use is to measure blood pressure, which is a physiological parameter, not to analyze a sample taken from the body.
The device is a non-invasive medical device used for measuring a vital sign.
N/A
Intended Use / Indications for Use
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood Pressure (systolic and diastolic) of adults and adolescents over 12 years of age with circumference ranging from 22cm to 24cm.
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 is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at 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 inflation measurements, an 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 systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg.
Meanwhile, some models whith bluetooth function 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.
There are total 7 arm-type blood pressure monitor models we submitted: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6193 and they are both bodyworn medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Clinical Validation:
- ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers —Part 2: Clinical investigation of intermittent automated measurement type.
Model DBP-6279B was selected as representative for testing. It was conducted according to ISO 81060-2 Non-Invasive Sphygmomanometers - Part2: Clinical Investigation Of Automated Measurement Type. The subject demographics include total of 90 subjects meeting the inclusion criteria, all 90 include subjects are all older than 12 years.
Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer 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.
Meanwhile, through the verification of internal simulation tests, it prove that even if the appearance is different, but in the case of the same algorithm, the performance of the DBP-6279B and the current submitted models are the same. There is no need to carry out clinical research on the new design, and the clinical results of DBP-6279B can cover the current submitted models.
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.
Model DBP-6279B was selected as representative for testing. It was conducted according to ISO 81060-2 Non-Invasive Sphygmomanometers - Part2: Clinical Investigation Of Automated Measurement Type. The subject demographics include total of 90 subjects meeting the inclusion criteria, all 90 include subjects are all older than 12 years.
Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer 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.)
Accuracy: Pressure deviation:±3 mmHg;
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 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.
January 13, 2025
JOYTECH Healthcare Co., Ltd. Cong Jing Official Correspondent No. 365. Wuzhou Road, Yuhang Economic Development Zone Hangzhou, 310000 China
Re: K241431
Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, Dated: April 22, 2024 Received: May 21, 2024
Dear Cong Jing:
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.
1
Page 2
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
2
assistance/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
3
Indications for Use
510(k) Number (if known) K241431
Device Name
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
Indications for Use (Describe)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood Pressure (systolic and diastolic) of adults and adolescents over 12 years of age with circumference ranging from 22cm to 24cm.
| 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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Image /page/4/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 "JOYTECH" are two Chinese characters in blue.
510(k) Summary
The assigned 510(k) number is: K241431
2.1 Subiectter's Identification:
Name: JOYTECH Healthcare Co., Ltd.
Add .: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100
Zhejiang, China.
Contact Person: Cong Jing
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: Jingc(@sejoy.com
2.2 Name of the Device:
Trade Name: Fully Automatic Digital Blood Pressure Monitor
| Arm-type | DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193 |
|---|---|
| ---------- | --------------------------------------------------------------------------- |
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 Monitors are substantially equivalent to the following predicate devices:
5
| 510(k) number | Predicate device model | Product code | Manufacturer |
|---|---|---|---|
| K162092 | Evolv Model Bp7000 | DXN | Omron Healthcare, Inc. |
2.5 Device Description:
The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at 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 inflation measurements, an 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 systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg.
Meanwhile, some models whith bluetooth function 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.
There are total 7 arm-type blood pressure monitor models we submitted: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6193 and they are both bodyworn medical devices.
2.5.1 The detail functions for DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193 are listed in table below:
| Model | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-6193 | Y | Y | Y | Y | Y | 2*150 memories | Y | Y | N | N | Y | Y | Y | Y |
| DBP-6293B | Y | Y | Y | Y | Y | 2*150 memories | Y | Y | N | Y | Y | Y | Y | Y |
| DBP-6293L | Y | Y | Y | Y | Y | 2*150 memories | Y | Y | Y | Y | Y | Y | Y | Y |
6
| JOYTECH | ll建拓 |
|---|---|
| --------- | ------ |
| DBP-62D0L | Y | Y | Y | Y | Y | 2*150 memories | Y | N | Y | Y | Y | Y | Y | Y |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-62D0B | Y | Y | Y | Y | Y | 2*150 memories | Y | N | N | Y | Y | Y | Y | Y |
| DBP-61D0 | Y | Y | Y | Y | Y | 2*150 memories | Y | N | N | N | Y | Y | Y | Y |
| DBP-61D0L | Y | Y | Y | Y | Y | 2*150 memories | Y | N | Y | N | Y | Y | Y | Y |
A = Systolic pressure, Diastolic pressure measuring function
B = Automatic Power-Off
C =-WHO (World Health Organization) Classification Indicator
D = Last 3 Tests Average
E = Low Battery Detection
F = Memory
G = Voice
H = Backlight
I = lithium battery
J = Bluetooth Function
K = Arm Shake Detection
L = Cuff Loose Detection
M = Triple measurement function
N =Cuff size(22cm-42cm)
Note:
Y= Yes
N= No
2.6 Indication for use/Intended Use:
DBP-62D0L,DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193: The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) 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:
2.7.1 Arm-type
The arm-type blood pressure monitor for model DBP-62D0L,DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193 manufactured by JOYTECH have the same arm cuff type, features and specifications with the Omron Evolv model Bp 7000 Upper Arm Blood
7
JOYTECH-健拓
Pressure Monitor which 510k number is K162092, therefore we choose the device act as the
predicate device. The detail comparison of technical characteristic as below:
| Comparison item | Subject device for Model DBP-
6193,DBP-6293B,DBP-6293L,DBP-
62D0L,DBP-62D0B, DBP-61D0, DBP-
61D0L, DBP-6293L, DBP-6293B, DBP-
6193 | Predicate device for Bp7000
(K162092) | Comparison
result
Explanation |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| The trade name | Arm-type Fully Automatic Digital Blood
Pressure Monitor | EVOLV Upper Arm Blood Pressure
Monitor Model Bp7000 | / |
| Manufacturer | JOYTECH Healthcare Co., Ltd. | Omron Healthcare,Inc. | / |
| 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 |
| Indication for
use/Intended use | The Arm-type Fully Automatic Blood
Pressure Monitors are intended to measure
blood pressure (systolic and diastolic) of
adults and adolescents over 12 years of
age with circumference ranging from
22cm to 42cm. | The device is a digital monitor intended
for use in measuring blood pressure and
pulse rate in adult patient population
with arm circumference ranging from 9
inches to 17 inches (22cm to 42cm).
The device detects the appearance of
irregular heartbeats during measurement
and gives a warning signal with
readings. | Similar |
| Measuring
principle | Oscillometric method | Oscillometric method | Identical |
| Measurement
type | Determined during inflation | Determined during inflation | Identical |
| Classification of
installation and
use | body-worn | body-worn | Identical |
| Cuff location | Upper arm | Upper arm | Identical |
| Specification | | | |
| Measuring range | Systolic Pressure:
60mmHg260 mmHg;200 mmHg;
Diastolic Pressure:
40mmHg
Cuff pressure:
0mmHg299 mmHg; | Pressure:0mmHg299 mmHg;
Pressure: 40 to 260 mmHg
Pulse rate:40180 Beats/Minute; | Similar40°C
Note 1 |
| Accuracy | Pressure deviation:±3 mmHg; | Pressure deviation:±3 mmHg;
Pulse deviation: ±5% | Identical |
| Pressure release | By solenoid valve | By solenoid valve | Identical |
| Operating
Temp. &
humidity | Temp.: 10°C
Humidity: 1593%RH106kPa | Temp.:10°C
Atmospheric
pressure: 80kPa40°C90%RH
Relative humidity :15
Atmospheric
pressure: 80kPa106kPa | Similar55°C
Note 2 |
| Storage Temp.
& humidity | Temp.: -25°C
Humidity: