(261 days)
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.
The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
Here's an analysis of the acceptance criteria and study details for the JOYTECH Healthcare Co., Ltd. Wrist-type Fully Automatic Digital Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ISO 81060-2:2013) | Reported Device Performance (Systolic Blood Pressure) | Reported Device Performance (Diastolic Blood Pressure) |
|---|---|---|
| Criterion A: Mean difference ≤ ±5 mmHg, with standard deviation of differences ≤ 8 mmHg (between test device and reference method) | Method 1: Average = 0.84 mmHg (< ±5 mmHg), SD = 5.25 mmHg (<8 mmHg) | Method 1: Average = 0.21 mmHg (< ±5 mmHg), SD = 4.92 mmHg (<8 mmHg) |
| Criterion B: Standard deviation ($s_m$) of averaged paired determinations for each subject must meet criteria in ISO 81060-2 Table 1 (max permissible $s_m$ as a function of mean difference, $\bar{x}_n$) | Method 2: Average = 0.84 mmHg (< ±5 mmHg), SD = 4.52 mmHg (<6.95 mmHg for $\bar{x}_n$ of 0.84 - interpolated from table) | Method 2: Average = 0.21 mmHg (< ±5 mmHg), SD = 4.36 mmHg (<6.95 mmHg for $\bar{x}_n$ of 0.21 - interpolated from table) |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: 85 subjects
- Data Provenance: The study was conducted in a hospital, indicating prospective data collection. The country of origin is not explicitly stated, but the company (Joytech Healthcare Co., Ltd.) is based in Hangzhou, China, suggesting the study likely took place in China.
3. Number of Experts to Establish Ground Truth and Qualifications:
- Number of Experts: Two doctors ("two doctors")
- Qualifications: Not explicitly stated beyond "doctors." They performed "simultaneous and blinded blood pressure determinations," implying their expertise in taking manual blood pressure measurements.
4. Adjudication Method for the Test Set:
- The text states: "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies that the measurements from the two doctors served as the ground truth, but it doesn't describe a specific adjudication method (e.g., 2+1, 3+1). It is most likely a consensus or average, given the use of "averaged paired determinations" mentioned in Criterion B.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on the accuracy of the device against a reference standard, not its impact on human reader performance.
6. Standalone Performance Study:
- Yes, a standalone (algorithm only) performance study was conducted. The clinical validation directly assesses the device's accuracy in measuring blood pressure compared to a reference standard (mercury sphygmomanometer).
7. Type of Ground Truth Used:
- The ground truth used was expert consensus/reference standard measurement. Specifically, a "standard mercury sphygmomanometer was used as a reference standard," with readings taken by two doctors.
8. Sample Size for the Training Set:
- The document describes a clinical validation study for accuracy, not a training set for an AI/machine learning model. Therefore, a "training set" in the context of machine learning is not applicable to this device's validation. The device uses an "oscillometric method and silicon integrate pressure sensor technology," which is a traditional algorithm, not typically a deep learning AI requiring large training sets in the same way.
9. How Ground Truth for the Training Set Was Established:
- As mentioned above, a training set for an AI/machine learning model is not applicable here. The device functions based on an oscillometric algorithm, which relies on physical principles and pre-programmed logic, not a data-driven training process in the AI sense. Its accuracy is evaluated against established clinical validation standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 22, 2017
Joytech Healthcare Co., Ltd. Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, 311100 CN
Re: K170666
Trade/Device Name: Wrist-type Fully Automatic Digital Blood Pressure Monitor, Models DBP-2101, DBP-2202, DBP-2229, DBP-2228, DBP-2127, DBP-2206, DBP-2208, DBP-2116, DBP-2220, DBP-2141, DBP-2242, DBP-2156, DBP-2152, DBP-2253 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 23, 2017 Received: October 23, 2017
Dear Ren Yunhua:
We have reviewed vour 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemsen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170666
Device Name
The Wrist-type Fully Automatic Digital Blood Pressure Monitors, Models DBP-2101, DBP-2228, DBP-2127, DBP-2206, DBP-2208, DBP-2116, DBP-2220, DBP-2141, DBP-2242, DBP-2156, DBP-2152, DBP-2253
Indications for Use (Describe)
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The assigned 510(k) number is: K170666
2.1. Date Prepared:
2017.02.10
2.2. Subjectter's Identification:
Name: JOYTECH Healthcare Co., Ltd.. Add .: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou, China. Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: renyh@sejoy.com
2.3. Name of the Device:
Trade Name: The Wrist-type Fully Automatic Digital Blood Pressure Monitor Including all models DBP-2101,DBP-2202,DBP-2229,DBP-2228,DBP-2127,DBP-2206,DBP-2208, DBP-2116,DBP-2220,DBP-2141,DBP-2242,DBP-2156,DBP-2152,DBP-2253. Common Name: Blood Pressure Monitor Classification name: Non-invasive blood pressure measurement System 21 CFR 870-1130, Class II, DXN.
2.4. Classification Information:
Regulation Number: 870.1130 Product Code: DXN Device Class: II Panel: 74 Cardiovascular
2.5. Predicate Device Information:
The Wrist-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the Predicate device of Sejoy, BP-2208 (K Number: K121355).
2.6. Device Description:
The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
| FeaturesModels | A | B | C | D | E | F | G | H (mm) | I (cm) | J(mm) | K | L |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-2101 | Y | 120 Memories×1 | N | N | N | N | N | 76×67.5×29 | 13.5-21.5 | 30×36 | N | N |
| DBP-2202 | Y | 30 Memories×4 | Y | N | N | N | N | 79×64×29 | 13.5-21.5 | 42×34 | N | N |
| DBP-2229 | Y | 30 Memories×4 | Y | Y | N | Y | Y | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N |
| DBP-2228 | Y | 30 Memories×4 | Y | N | N | N | N | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N |
| DBP-2127 | Y | 120 Memories×1 | N | N | N | N | N | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N |
The detail comparisons between Wrist-type series are listed in table below:
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JOYTECH Healthcare Co., Ltd..
| FeaturesModels | A | B | C | D | E | F | G | H (mm) | I (cm) | J(mm) | K | L |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-2206 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32.5 | 13.5-21.5 | 45×30 | N | O |
| DBP-2208 | Y | 60 Memories×2 | Y | Y | Y | Y | N | 77×64×32.5 | 13.5-21.5 | 49×38 | O | O |
| DBP-2116 | Y | 120 Memories×1 | Y | Y | N | N | N | 79×66×28 | 13.5-21.5 | 45×30 | N | N |
| DBP-2220 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32 | 13.5-21.5 | 49×38 | O | O |
| DBP-2141 | Y | 120 Memories×1 | Y | Y | N | Y | Y | 84×64×29 | 13.5-21.5 | 45×30 | N | O |
| DBP-2242 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 84×64×29 | 13.5-21.5 | 49×38 | O | O |
| DBP-2152 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32 | 13.5-21.5 | 45×30 | N | O |
| DBP-2253 | Y | 60 Memories×2 | Y | Y | Y | Y | N | 77×64×32.5 | 13.5-21.5 | 49×38 | O | O |
| DBP-2156 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32 | 13.5-21.5 | 45×30 | N | O |
Table2.3- Characteristics of Wrist-type Blood Pressure Monitor
A = Powered by AAA Batteries
B= Memory Size
C= Time & Date
D = WHO (World Health Organization) Classification Indicator
E = Results Average in Three way
F = Irregular Heartbeat Detection
G = Last 3 Results Average
H= Outside Dimension (L x W x H in unit mm)
I = Cuff Size
J = LCD Size (Viewing Area in unit mm)
K= LCD Backlight
L= Voice
Y= Yes N = No
O= Optional function depending on clients' needs
The devices are all designed and manufactured according to AAMI/ANSI/IEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
2.7. Intended Use:
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.
2.8.Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards including AAMI/ANSVIEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30 as well as AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012, AAMI/ANSVIEC 60601-1-2:2014, ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5:Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
Guidance documents include the "FDA Non-invasive Blood Pressure (NIBP) Monitor Guidance" and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "FDA guidance Use of International Standard ISO 10993."
Non-clinical Tests:
Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2014
General Safety Provisions Test according to AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012
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Performance Test according to AAMI/ANSI/IEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers The test result all meet or exceed the requirement of the standards.
Biocompatibility Test according to FDA Use of International Standard ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
2.9. Summary of Clinical Tests Performed:
Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.
- Subjects:
Eighty-five subjects in the hospital were participated in clinical study.
| Table 2.2.1.1 The distribution of test objects(13.5~21.5cm) | |||
|---|---|---|---|
| Project | Frequency | Percentage | EffectivePercentage |
| Gender | Female 41Male 44 | 48.2%51.8% | 30%30% |
| Age | >12(the elderly) 85 | 100% | 100% |
| Systolicblood | ≤100 24≥140 100 | 9.4%39.2% | 5%20% |
| pressure | ≥160 23 | 9.0% | 5% |
| Diastolicblood | ≤60 23≥85 154 | 9.0%60.4% | 5%20% |
| pressure | ≥100 50 | 19.6% | 5% |
2) Method:
A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.
3) Criteria:
The ISO81060-2 Standard recommended :
A. a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg between test device and reference method.
B.For the systolic and diastolic blood pressures for each of the m subjects, the standard deviation, of the averaged paired determinations per subject of the sphygmomanometer-under-test and of the reference sphygmomanometer shall meet the criteria listed in Tab 1 when calculated according to Equation(3).
Table 1 - Averaged subject data acceptance (criterion 2) in mmHg
| Maximum permissible standard deviation, $s_m$ , as function of, $\bar{x}_n$ ,mmHg | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| $\bar{x}_n$ | 0,0 | 0,1 | 0,2 | 0,3 | 0,4 | 0,5 | 0,6 | 0,7 | 0,8 | 0,9 |
| ± 0, | 6,95 | 6,95 | 6,95 | 6,95 | 6,93 | 6,92 | 6,91 | 6,90 | 6,89 | 6,88 |
| ± 1, | 6,87 | 6,86 | 6,84 | 6,82 | 6,80 | 6,78 | 6,76 | 6,73 | 6,71 | 6,68 |
| ± 2, | 6,65 | 6,62 | 6,58 | 6,55 | 6,51 | 6,47 | 6,43 | 6,39 | 6,34 | 6,30 |
| ± 3, | 6,25 | 6,20 | 6,14 | 6,09 | 6,03 | 5,97 | 5,89 | 5,83 | 5,77 | 5,70 |
| ± 4, | 5,64 | 5,56 | 5,49 | 5,41 | 5,33 | 5,25 | 5,16 | 5,08 | 5,01 | 4,90 |
| ± 5, | 4,79 | - | - | - | - | - | - | - | - | - |
| EXAMPLE For mean of ± 4,2 mmHg, the maximum permissible standard deviation is 5,49 mmHg. |
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Image /page/6/Picture/1 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH are three Chinese characters.
4) Result
JOYTECH Healthcare Co., Ltd..
Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.
| Average(mmHg) | Standard deviation(mmHg) | |
|---|---|---|
| Method 1 | ||
| Systolic blood pressure | 0.84 | 5.25 |
| Diastolic blood pressure | 0.21 | 4.92 |
| Method 2 | ||
| Systolic blood pressure | 0.84 | 4.52 |
| Diastolic blood pressure | 0.21 | 4.36 |
According to Table, the statistical results are as follows:
Method 1:
Average of systolic blood pressure is 0.84 mmHg (< ± 5 mmHg), standard deviation of systolic blood pressure is 5.25 mmHg (<8 mmHg)
Average of diastolic blood pressure is 0.21 mmHg (< ± 5 mmHg), standard deviation of diastolic blood pressure is 4.92 mmHg (<8 mmHg)
Method 2:
Average of systolic blood pressure is 0.84mmHg (< ± 5 mmHg), standard deviation of systolic blood pressure is 4.52 mmHg (<6.95mmHg)
Average of diastolic blood pressure is 0.21 mmHg (< ± 5 mmHg), standard deviation of diastolic blood pressure is 4.36 mmHg (<6.879 mmHg)
After comparing, the conclusion is that the averages difference in systolic and diastolic pressure and the corresponding standard deviation fall are within the range of the standard.It meets the requirements of clinical program.
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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 English, and there are Chinese characters to the right of the English text.
JOYTECH Healthcare Co., Ltd..
2.10. Summary comparing technological characteristics with predicate devices: 2.10.1. Summary of subject models on comparison with BP-2208 (K121355)
| Item | Model | BP-2208(K121355) | DBP-2101 | DBP-2229 | DBP-2202 | DBP-2228 | DBP-2127 | DBP-2206 | DBP-2208 | DBP-2116 | DBP-2220 | DBP-2141 | DBP-2242 | DBP-2152 | DBP-2253 | DBP-2156 | result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indication for Use | The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adultsand adolescents age 12 through 21 years of age. | Identical | |||||||||||||||
| Measurement Method | Oscillometric Method | Identical | |||||||||||||||
| Materials | ABS housing and Nylon Fleece cuff | Identical | |||||||||||||||
| Power Source | Battery: 1.5V (AAA) ×2 | Identical | |||||||||||||||
| Cuff | No change, all same According to ISO-10993 | Identical | |||||||||||||||
| РСВ | BP08PCB | BP01PCB | BP20PCB | BP02PCB | BP20PCB | BP20PCB | BP08PCB | BP08PCB | BP16PCB | BP08PCB | BSP22PCB | BSP22PCB | BSP22PCB | BSP22PCB | BP08PCB | Similar | |
| USB port | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | NO | different | |
| Ingress ProtectionRating | IP22 | Identical | |||||||||||||||
| display size(mm) | 49×38 | 30×36 | 45×30 | 42×34 | 45×30 | 45×30 | 45×30 | 49×38 | 45×30 | 49×38 | 45×30 | 49×38 | 45×30 | 49×38 | 45×30 | Similar | |
| Accuracy Pressure | $\pm 3mmHg$ | Identical | |||||||||||||||
| Accuracy Pulse | $\pm 5%$ | Identical | |||||||||||||||
| MeasurementPressure Range | Systolic pressure: 60mmHg | Identical | |||||||||||||||
| MeasurementPulse Range | 30~180 Beats/minute | Identical | |||||||||||||||
| Electrical Safety | According to IEC60601-1-2 According to IEC60601-1 | Identical |
There are no difference of technological characteristics between the subject devices fully automatic blood pressure monitors.
Version:Z
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Image /page/8/Picture/1 description: The image shows the Joytech logo in blue and red. Below the logo is the text "2.11. Conclusions:". The text is in bold font and is underlined.
Our Fully Automatic Blood Pressure Monitors wrist-type series as the Predicate Device: BP-2208 (K Number: K121355), which is manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
Moreover, verification and validation tests contained in this submission demonstrate that the difference in the subject models could maintain the same safety and effectiveness as that of cleared devices.
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.
§ 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).