(177 days)
The Arm-type Fully Automatic Digital 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 36cm or 22cm to 42cm or 32cm to 48cm.
The Wrist-type Fully Automatic Digital 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 13.5cm to 21.5cm.
The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, 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, an electric pump within the main unit slowly inflates the arm/wrist 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 cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to 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, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the 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 trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.
The provided document outlines the substantial equivalence of the "Arm-type Fully Automatic Digital Blood Pressure Monitor" and "Wrist-type Fully Automatic Digital Blood Pressure Monitor" to previously cleared predicate devices. The primary focus for proving substantial equivalence concerning performance criteria relies on adherence to the ISO 81060-2:2018+AMD2020 standard for non-invasive sphygmomanometers.
Here's an breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard, which is a recognized standard for clinical validation of non-invasive sphygmomanometers. The reported performance is the conclusion that the devices meet these requirements.
| Acceptance Criteria (from ISO 81060-2:2018+AMD2020) | Reported Device Performance |
|---|---|
| Accuracy Standard Deviations (SD): | |
| Systolic Blood Pressure: SD ≤ 8 mmHg | Met the criteria |
| Diastolic Blood Pressure: SD ≤ 8 mmHg | Met the criteria |
| Mean Difference (MD): | |
| All measurements: MD ≤ 5 mmHg | Met the criteria |
| Individual measurements: Differences ≤ 5 mmHg for Majority of Measurements | Met the criteria |
| Pulse Rate Accuracy: | Pulse: ± 5% |
| Pulse Rate: Within specified limits |
Note: The document broadly states that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." Specific numerical mean differences and standard deviations for systolic and diastolic pressures are not explicitly provided, but the statement confirms compliance with the standard's thresholds.
2. Sample Sizes Used for the Test Set and Data Provenance
- Arm-type (Cuff 22cm~42cm): 88 patients (47 females and 41 males). This data was from a clinical investigation report from another submission. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
- Arm-type (Cuff 32cm-48cm): 85 patients (36 females and 49 males). This data was collected using Model DBP-6279B as a representative for testing. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
- Arm-type (Cuff 22cm~36cm) and all Wrist-type models: For these, the applicant states they "cite the clinical investigation report of K212115," implying the sample sizes and provenance from that prior submission. The specific sample sizes for K212115 are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for blood pressure measurements in the clinical validation studies was established through the "same arm sequential method" using a manual Mercury Sphygmomanometer as a reference device. This method implies that trained healthcare professionals, likely physicians or nurses, would have been responsible for obtaining the reference measurements. However, the exact number of experts/operators and their specific qualifications are not explicitly stated in this document. The ISO 81060-2 standard would require trained observers, but the document does not elaborate on this.
4. Adjudication Method for the Test Set
The "same arm sequential method" involves taking measurements simultaneously or in quick succession using both the device under test and the reference device on the same arm. This method inherently minimizes the need for an adjudication method in the traditional sense, as the comparison is direct. The standard outlines specific procedures for discrepancies and ensuring observer blinding where appropriate, but no explicit "adjudication" of disagreements between device and reference (beyond the statistical analysis) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a fully automatic digital blood pressure monitor, not an AI-assisted diagnostic device involving human readers or interpretation of medical images. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The clinical validation studies described (using the "same arm sequential method" against a reference sphygmomanometer) directly assess the accuracy of the device's algorithm in measuring blood pressure and pulse rate without human-in-the-loop diagnostic interpretation. The device's primary function is automatic measurement, and the clinical studies validate this automatic function.
7. The Type of Ground Truth Used
The ground truth used was expert reference measurements obtained using a manual Mercury Sphygmomanometer. This is considered a gold standard (or a widely accepted clinical standard) for blood pressure measurement in clinical validation studies as per ISO 81060-2.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate training set or its sample size. Medical devices like blood pressure monitors are typically developed using internal data and engineering principles, with clinical validation as the final step to demonstrate accuracy against a recognized standard. It's common for the development and optimization of the oscillometric algorithm to occur internally without public disclosure of a specific "training set" size in regulatory submissions for these types of devices. The filing focuses on the validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned, the method for establishing its ground truth is also not provided. The focus of the submission is on the clinical validation of the finished device.
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August 25, 2023
Joytech Healthcare Co.,Ltd Yunhua Ren, General Manager No.365. Wuzhou Road Yuhang Economic Development Zone, Hangzhou City Hangzhou, Zhejiang 311100 China
Re: K230566
Trade/Device Name: Arm-tvpe Fully Automatic Digital Blood Pressure Monitor. Wrist-type Fully Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 27, 2023 Received: July 27, 2023
Dear Yunhua Ren:
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.
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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 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 (QS) 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 medical devices and radiation-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).
Sincerelv.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230566
Device Name Fully Automatic Digital Blood Pressure Monitor Including Arm-type: DBP-61A0, DBP-62A1B, DBP-62A2B, DBP-61A3, DBP-61A3B, DBP-61A4, DBP-62A4B, DBP-6194, DBP-6294B, DBP-6195, DBP-6295B, DBP-6196, DBP-6296B; Wrist-type: DBP-81A5, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8198, DBP-8298B, DBP-8199, DBP-8299B: Indications for Use (Describe)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 vears of age with circumference ranging from 22cm to 22cm to 42cm or 32cm to 48cm.
The Wrist-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 13.5cm.
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/3/Picture/0 description: The image shows the logo for JOYTEC-I. The logo is in blue and red. The text "JOYTEC-I" is in blue, except for the "I", which is in red. To the right of the text is a Chinese word in blue.
510(k) Summary
The assigned 510(k) number is:
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: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: renyh@sejoy.com
2.2 Name of the Device:
Trade Name: Fully Automatic Digital Blood Pressure Monitor
| Arm-type | DBP-61A0, DBP-62A1B, DBP-61A2, DBP-62A2B, DBP-61A3,DBP-62A3B, DBP-61A4, DBP-62A4B, DBP-6194, DBP-6294B, DBP-6195, DBP-6295B, DBP-6196,DBP-6296B, SBM53, DBP-6279B,DBP-6179, DBP-6273B, DBP-6173 |
|---|---|
| Wrist-type | DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8198, DBP-8298B, DBP-8199, DBP-8299B |
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:
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Image /page/4/Picture/2 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH are some Chinese characters.
The Arm-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following predicate device:
| 510(k) number | Predicatedevice model | Product code | Manufacturer |
|---|---|---|---|
| K212115 | DBP-6279B | DXN | JOYTECH Healthcare Co., Ltd. |
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following prdicate devices:
| 510(k) number | Predicate device model | Product code | Manufacturer |
|---|---|---|---|
| K212115 | DBP-8278B | DXN | JOYTECH Healthcare Co., Ltd. |
2.5 Device Description:
The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, 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, an electric pump within the main unit slowly inflates the arm/wrist 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 cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to 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, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the 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 trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.
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Unlimited readings can be stored in the app for archiving and review by the user.
The all models of this application are DBP-61A0, DBP-62A1B, DBP-61A2, DBP-62A2B, DBP-61A3,DBP-62A3B,DBP-61A4,DBP-62A4B,DBP-6194,DBP-6294B,DBP-6195,DBP-6295B,DBP-6196, DBP-6296B, SBM53, DBP-6279B,DBP-6179, DBP-6273B, DBP-6173,DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8298B, DBP-8199, DBP-8299B.
And DBP-6279B,DBP-6179, DBP-6273B, DBP-6173 already have 510k number of K212115. But now these models have changed specifications on cuff size and measuring range of diastolic Pressure.So we are applying for new 510K.
| ModelsFeatures | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-61A0 | 3*1.5V AAA orAdaptor | 1*30 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 98×90×61.8mm | Y |
| DBP-62A1B | 3*1.5V AAA orAdaptor | 1*30 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 98×90×61.8mm | Y |
| DBP-61A2 | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y |
| DBP-62A2B | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y |
| DBP-61A3 | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y |
| DBP-62A3B | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y |
| DBP-61A4 | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y |
| DBP-62A4B | 4*1.5V AAA orAdaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y |
| DBP-6194 | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 110.2101.957.3mm | Y |
| DBP-6294B | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 110.2101.957.3mm | Y |
| DBP-6195 | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 140.2103.351.1mm | Y |
| DBP-6295B | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 140.2103.351.1mm | Y |
| DBP-6196 | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 1039351mm | Y |
The detail comparisons among the Arm-Type series are listed in table below:
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Image /page/6/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text is in English and Chinese.
| Adaptor | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-6296B | 3*1.5V AAA orAdaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 1039351mm | Y |
| SBM53 | 4*1.5V AAA | 2*120 | Y | N | Y | N | Y | N | N | Y | Y | Y | 125 X 95 X 44mm | Y |
| DBP-6279B | 3*1.5V AAA oradaptor; | 2*60 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 142.5 x 107.2 x44mm | Y |
| DBP-6179 | 3*1.5V AAA oradaptor; | 2*60 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 142.5 x 107.2 x44mm | Y |
| DBP-6273B | 3*1.5V AAA oradaptor; | 2*60 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 142.5 x 107.2 x44mm | Y |
| DBP-6173 | 3*1.5V AAA oradaptor; | 2*60 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 142.5 x 107.2 x44mm | Y |
A = Powered Source
B= Memory Size with Time & Date
C = WHO (World Health Organization) Classification Indicator
D = Last 3 Results Average
- E = Irregular Heartbeat Detection
- F = Arm Shake Detection
G = Cuff Loose Detection
- H = Bluetooth Function
- I = MAM fucntion
J = Voice
K = Backlight
L = LCD display
M= Size (Viewing Area in unit mm)
N= Cuff Size (22-36cm,22-42cm,32-48cm)
- Note:
- Y= Yes N = No
| Models | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Features | ||||||||||||||
| DBP-81A5 | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-82A5B | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-81A6 | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-82A6B | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-8197 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8297B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8198 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 82.3 $\times$ 63.8 $\times$ 27.5mm | Y |
| DBP-8298B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 82.3 $\times$ 63.8 $\times$ 27.5mm | Y |
| DBP-8199 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8299B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
The detail comparisons among the Wrist-Type series are listed in table below:
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Image /page/7/Picture/0 description: The image shows the text 'K230566' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The black text stands out against the white background.
Image /page/7/Picture/1 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. There are some Chinese characters to the right of the text.
A = Powered Source B= Memory Size with Time & Date C = WHO (World Health Organization) Classification Indicator D = Last 3 Results Average E = Irregular Heartbeat Detection F = Arm Shake Detection G = Cuff Loose Detection H = Bluetooth Function I = MAM function J = Voice K = Backlight L = LCD display M= Size (Viewing Area in unit mm) N= Cuff Size (13.5-21.5cm) Note: Y= Yes N = No
The devices are all designed and manufactured according to AAMI/ANSV/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 Indication for use/Intended Use:
The Arm-type Fully Automatic Digital 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 36cm or 22cm to 42cm or 32cm to 48cm.
The Wrist-type Fully Automatic Digital 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 13.5cm to 21.5cm.
2.7 Comparison of Technological Characteristics with predicate device:
2.7.1 Arm-type
The arm-type blood pressure monitor manufactured by JOYTECH Healthcare Co., Ltd. have the same features and specifications with the JOYTECH blood pressure monitor DBP-6279B which 510k number is K212115, therefore we choose the device act as the predicate device. The detail comparison of technical characteristic as below:
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Image /page/8/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters.
| Comparison item | Subject device in present application | Predicate device K212115 (model: DBP-6279B) | Comparison result / Explanation | |
|---|---|---|---|---|
| The trade name | Arm-type Fully Automatic Digital Blood Pressure Monitor | Arm-type Fully Automatic Digital Blood Pressure Monitor | Identical | |
| Manufacturer | JOYTECH Healthcare Co., Ltd. | JOYTECH Healthcare Co., Ltd. | / | |
| Recommended classification regulation | 21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem | 21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem | Identical | |
| Regulatory class | II | II | Identical | |
| Panel | 74 Cardiovascular | 74 Cardiovascular | Identical | |
| Product code | DXN | DXN | Identical | |
| Indication for 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. | 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. | Identical | |
| Measuring principle | Oscillometric method | Oscillometric measurement | Identical | |
| Measurement type | Determined during inflation | Determined during inflation | Identical | |
| Cuff location | Upper arm | Upper arm | Identical | |
| Specification | ||||
| Measuring range | Systolic Pressure: 60mmHg ~ 260 mmHgDiastolic Pressure:40mmHg ~ 200 mmHgPressure: 0mmHg | Systolic Pressure: 60mmHg ~ 260 mmHgDiastolic Pressure:30mmHg ~ 200 mmHgPressure: 0mmHg | Similar,The difference has tested with qualified results. | |
| Inflation | By air pump | By air pump | Identical | |
| Pressure release | By solenoid valve | By solenoid valve | Identical | |
| Operating Temp. & humidity | Temp.: 10°C | Temp.: 10°C | Identical | |
| Storage Temp. & humidity | Temp.: -25°C~55°CHumidity:<93% RH | Temp.: -25°C~55°CHumidity:<93% RH | Identical | |
| Cuff circumference | Fits arm circumference 22-36 cm or 22-42cm or 32-48cm; | Fits arm circumference 22-36 cm | Similar, only the cuff size is different | |
| Supply power source | DBP-61A0,DBP-62A1B,DBP-6194,DBP-6294B,DBP-6195,DBP-6295B,DBP-6196,DBP-6296B,DBP-6279B,DBP-6179, DBP-6273B,DBP-6173:3*1.5V AAA battery or Medical AC adaptor | 3*1.5V AAA battery or Medical AC adaptor; | Similar,The different power has tested with qualified results. | |
| DBP-61A2,DBP-62A2B,DBP-61A3,DBP-62A3B,DBP-61A4,DBP-62A4B:4*1.5V AAA battery or MedicalAC adaptor | ||||
| SBM53: 4*1.5V AAA battery | ||||
| PCB or Electricalscheme | BP94PCBBP97PCBBP98PCBBPA0PCBBPA4PCBBPA5PCBBPA6PCBBP73PCBSBM53PCB | BP73PCB | Similar,The different in thePCB isdocumentedand tested | |
| Displaycomponent | 1.Device LCD;2.iOS device or Android device | 1.Device LCD;2.iOS device or Android device | Identical | |
| BluetoothModule version | V5.0 | V5.0 | Identical | |
| Systemrequirement | Bluetooth 4.0 or later/Android 5.0 or later/IOS 9.0 or later | Bluetooth 4.0 or later/Android 5.0 or later/IOS 9.0 or later | Identical | |
| Bluetoothfeatures | Transmit data tosmart phone viaBluetooth | Transmit data tosmart phone viaBluetooth | Identical | |
| Function on APP | Storage test result/Announce test result/ Readmemories in App/ Emptymemories in App/ Draw curve/Set the personalinformation in app | Storage test result/Announce test result/ Readmemories in App/ Emptymemories in App/ Draw curve/ Setthe personalinformation in app | Identical | |
| Wirelesscommunication | Frequency range: 2.4 GHz (2400- 2483.5 MHz)Modulation type: GFSKAntenna gain: 0.5dBi | Frequency range: 2.4 GHz (2400 -2483.5 MHz)Modulation type: GFSKAntenna gain: 0dBi | Equivalent,The differencehave verified byFCC test | |
| Sterilization | Not applicable | Not applicable | Identical | |
| Features | ||||
| Irregular heartbeat | Yes | Yes | Identical | |
| Blood Pressurecategories | WHO classification | WHO classification | Identical | |
| Arm shakeindicator | DBP-6194,DBP-6294B,DBP-6195,DBP-6295B,DBP-6196,DBP-6296B,DBP-61A0,DBP-62A1B,DBP-61A2,DBP-62A2B,DBP-61A3,DBP-62A3B,DBP-61A4,DBP-62A4B,DBP-6279B,DBP-6179, DBP-6273B,DBP-6173 | Yes Yes | Identical | |
| SBM53 | No | |||
| Cuffindicator | loose | Yes | Yes | Identical |
| Memory | DBP-6194,DBP-6294B,DBP-6195,DBP-6295B,DBP-6196,DBP-6296B: 2*150 Memories | Similar,Note 1 | ||
| DBP-61A0,DBP-62A1B:1*30 Memories | ||||
| DBP-61A2,DBP-62A2B,DBP-61A3,DBP-62A3B,DBP-61A4,DBP-62A4B,SBM53: 2*120 Memories | 2*60 Memories | |||
| DBP-6279B,DBP-6179,DBP-6273B,DBP-6173: 2*60 Memories | ||||
| Material | ABS for the case and plastic foil for thelabels of the device. Bio-compatibilitymaterials are used for the applied parts(Cuff containing a interal bladder) | ABS for the case andplastic foil for the labelsof the device. Bio-compatibility materialsare used for the appliedparts (Cuff containing ainteral bladder) | Identical |
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Image /page/9/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH are two Chinese characters.
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Note 1: The quantity of storage readings is different between the subject device and predicate device. The change in the specification is documented, and The change does not affect the intended use or the fundamental scientific technology.
2.7.2 Wrist-type
The wrist-type blood pressure monitor manufactured by Joytech Healthcare Co.,Ltd have the same wrist cuff type, features and specifications with the Joytech blood pressure monitor DBP-8278B which 510k number is K212115, therefore we choose the device act as the predicate device. The detail comparison of technical characteristic as below:
| Comparisonitem | Subject device in present application | Predicate device K212115(Model: DBP-8278B) | Comparisonresult /Explanation |
|---|---|---|---|
| The trade name | Wrist-type Fully Automatic Digital BloodPressure Monitor | Wrist-type Fully Automatic Digital BloodPressure Monitor | / |
| Manufacturer | JOYTECH Healthcare Co., Ltd. | JOYTECH Healthcare Co., Ltd. | / |
| Recommendedclassificationregulation | 21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem | 21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem | Identical |
| Regulatoryclass | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | Identical |
| Indication foruse | The Fully Automatic Blood Pressure Monitorsare intended to measure blood pressure | The Fully AutomaticBlood Pressure Monitors | Identical |
| (systolic and diastolic) and pulse rate of adultsand adolescents over 12 year of age. | are intended to measureblood pressure (systolicand diastolic) and pulserate of adults andadolescents over 12 yearof age. | ||
| Measuringprinciple | Oscillometric method | Oscillometric method | Identical |
| Measurementtype | Determined during inflation | Determined duringinflation | Identical |
| Cuff location | Wrist | Wrist | Identical |
| Specification | |||
| Measuringrange | Systolic Pressure: 60mmHg | Systolic Pressure:60mmHg | Identical |
| Cuffcircumference | Fits wrist circumference 13.5-21.5cm | Fits wrist circumference13.5-21.5cm | Identical |
| Accuracy | Static Pressure:± 3mmHgPulse: ± 5% | Static Pressure:± 3mmHgPulse: ± 5% of displayreading | Identical |
| Inflation | By air pump | By air pump | Identical |
| Pressurerelease | By solenoid valve | By solenoid valve | Identical |
| OperatingTemp. &humidity | Temp.: 10°C | Temp.: 10°C | Identical |
| Storage Temp.& humidity | Temp.: -25°C~55°CHumidity:<93% RH | Temp.: -25°C~55°CHumidity:<93% RH | Identical |
| Supply powersource | DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8198,DBP-8298B, DBP-8199, DBP-8299B: 2*1.5VAAA battery | 2*1.5V AAA battery | Identical |
| Displaycomponent | 1.Device LCD;2.iOS device or Android device | 1.Device LCD;2.iOS device or Androiddevice | Identical |
| BluetoothModule version | V5.0 | V5.0 | Identical |
| Wirelesscommunication | Frequency range: 2.4 GHz (2400 - 2483.5MHz)Modulation type: GFSKAntenna gain: 0.5dBi | Frequency range: 2.4 GHz(2400 - 2483.5 MHz)Modulation type: GFSKAntenna gain: 0 dBi | Equivalent,Thedifferencehave verifiedby FCC test. |
| Bluetoothfeatures | Transmit data tosmart phone viaBluetooth | Transmit data tosmart phone viaBluetooth | Identical |
| Function onAPP | Storage test result/Announce test result/ Read memories in App/ | Storage test result/Announce test result/ | Identical |
| Empty memories in App/ Draw curve/ Set the personal information in app | Read memories in App/Empty memories in App/Draw curve/ Set the personal information in app | ||
| SterilizationFeatures | Not applicable | Not applicable | Identical |
| Irregular heartbeat | Yes | Yes | Identical |
| Bodymovementdetection | Yes | Yes | Identical |
| WHOclassificationindicator | Yes | Yes | Identical |
| Memory | DBP-8197, DBP-8297B, DBP-8198, DBP-8298B, DBP-8199, DBP-8299B: 2150Memories;DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B: 2100 Memories; | 2*60 memories | SimilarNote 1 |
| Dimension ofLCD display | DBP-8197, DBP-8297B:46mm×31.2mmDBP-8199, DBP-8299B: 45mm×30.5mmDBP-8198, DBP-8298B: 36.5mm×36.5mmDBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B:47mm×38mm | 44mm×42mm | DifferentNote 2 |
| Dimension ofdeviceapperance | DBP-8197, DBP-8297B, DBP-8199, DBP-8299B: 83mm×64mm×30.7mmDBP-8198, DBP-8298B:82.3mm×63.8mm×27.5mmDBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B: 86mm×64mm×30mm | 73mm×66mm×27.5mm | DifferentNote 3 |
| Number ofbuttons | DBP-8197, DBP-8297B, DBP-8199, DBP-8299B, DBP-81A6, DBP-82A6B: 3DBP-8198, DBP-8298B: 2DBP-81A5, DBP-82A5B: 4 | 2 | SimilarNote 4 |
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Image /page/11/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 two Chinese characters in blue.
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Image /page/12/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The text "JOYTECH" is in blue, and the "T" is stylized with a red horizontal line. There are three Chinese characters to the right of the logo.
Note 1: The quantity of storage readings is different between the subject device and predicate device. The change in the specification is documented, and The change does not affect the intended use or the fundamental scientific technology.
Note 2: The dimension of LCD display is different between subject devices and predicate device, the difference does not affect the intended use or the fundamental scientific technology. And all subject devices models passed relevant IEC series standard. These differences will not bring any new risks.
Note 3: The dimension of device apperance is different between subject devices and predicate device. Differen apperance design to meet market's requirement. the difference does not affect the intended use or the fundamental scientific technology. And all subject devices models passed relevant IEC series standard. These differences will not bring any new risks.
Note 4: The number of buttons is different between subject devices and predicate device. the difference does not affect the intended use or the fundamental scientific technology. And all subject devices models passed relevant IEC series standard. These differences will not bring any new risks.
2.8. Performance Data:
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Testing information demonstrating safety and effectiveness of the device in the intended environment of use is supported by testing that was conducted.
The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.
The following National and International Standards were utilized for testing the subject device. Electrical Safety and performance requirements:
- . IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance.
- AAMI ES60601-1:2005+AMD1:2012+AMD2:2021,Medical Electrical Equipment.
- IEC 80601-2-30:2018, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
Home-used medical equipment requirements and environmental test:
-
. IEC 60601-1-11:2015+AMD1:2020 , 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
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014+AMD1:2020 , Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Bio-compatibility Evaluation for patient contacting components: -
ISO 10993-5:2009 , Biological evaluation of medical devices -- Part 5: Tests for in vitro cvtotoxicitv
-
ISO10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
FCC Test
- FCC Part15 Subpart C ●
- RF Exposure Evaluation
Guidance Document:
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
The test result all meet or exceed the requirement of these standards.
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2.9. Discussion of Clinical Tests Performed:
Clinical Validation:
- ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers --Part 2: Clinical investigation of intermittent automated measurement type.
Arm-type:
We are applying for 3 different size Arm cuff under 22cm42cm42cm and 32cm~48cm of this submission.
For 22cm~36cm, we cite the clinical investigation report of K212115 which already registered since the cuff is totally same.
For 22cm42cm, we use a clinical investigation report from another submission. Because the cuff is totally same. In this report, there are 88 patients (47females and 41 males) with cuff 22cm42cm participated in the clinical study.
For 32cm-48cm, Model DBP-6279B was selected as representative for testing. 85 patients (36 females and 49 males) participated in the clinical study.
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.
Wrist-type:
For Wrist-type blood pressure monitor of 10 Models only with one cuff size of 13.5cm~21.5cm. we cite the clinical investigation report of K212115 which already registered since the cuff is totally same.
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2.10. Conclusions:
This submitted arm-type series manufactured by JOYTECH Healthcare Co., Ltd. have been found to be respectively substantially equivalent to the predicate device (DBP-6279B) manufactured by JOYTECH Healthcare Co., Ltd. (K212115). Based on the information provided in this submission, differences between the subject device and predicate device have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.
This submitted wrist-type series manufactured by JOYTECH Healthcare Co., Ltd. have been found to be respectively substantially equivalent to the predicate device (DBP-8278B) manufactured by JOYTECH Healthcare Co., Ltd. (K212115). Based on the information provided in this submission, differences between the subject device and predicate devices have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.
In the other words, the difference between the subject and the predicate devices does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices。
--- End of this section---
§ 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).