(30 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
The Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic and diastolic blood pressure and pulse rate.
The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. 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 end of 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. For BP-1305, BP-1307,BP-1211, BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-1305,BP-1307,BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13will display an irregular heartbeat symbol " " if an irregular heartbeat was detected during the measurement process. BP-1305,BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 can display average results in three ways: BP-1307 can display the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements.
The Sejoy Electronics & Instruments Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (multiple models listed) underwent a clinical study to demonstrate its accuracy and substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
The device aimed to meet the accuracy requirements of ISO 81060-2:2013, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
| Acceptance Criteria (from ISO 81060-2:2013) | Reported Device Performance (Implied by meeting the standard) |
|---|---|
| Criterion 1: Mean difference (device - reference) ≤ 5 mmHg | Met (Implied by clinical test results adhering to the standard) |
| Criterion 2: Standard deviation of the differences ≤ 8 mmHg | Met (Implied by clinical test results adhering to the standard) |
| Criterion 3: Percentage of differences within 5, 10, and 15 mmHg of the reference measurement (accuracy zone) | Met (Implied by clinical test results adhering to the standard) |
Note: The detailed numerical results for each criterion were not explicitly provided in the document, but the statement "Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" implies that all these criteria were successfully met.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the clinical test set. However, a clinical validation study following ISO 81060-2:2013 typically requires a minimum of 85 participants for accuracy assessment. Given the nature of a 510(k) submission, it is highly probable that the study was prospective and conducted with participants whose blood pressure measurements were taken specifically for the validation of this device. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. According to ISO 81060-2:2013, oscillometric blood pressure monitor validation requires measurements by trained observers (typically two or more) using a mercury sphygmomanometer or an equivalent reference device. These observers usually have specific training and certification in blood pressure measurement to ensure accuracy and inter-observer reliability.
4. Adjudication Method for the Test Set:
The document does not explicitly state the adjudication method. In clinical validation studies for blood pressure monitors following ISO 81060-2:2013, the ground truth is typically established by simultaneous or sequential measurements by two or more trained observers. Discrepancies between observers are often resolved by a third trained observer, or through averaging if within an acceptable range, or by re-measurement. This often aligns with a "2+1" or similar consensus-based method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The purpose of this submission was to demonstrate substantial equivalence and meet specific accuracy standards for a medical device, not to compare human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
Yes, a standalone performance evaluation was done. The clinical validation study described, which complied with ISO 81060-2:2013, assesses the device's ability to accurately measure blood pressure independently, without human intervention in the measurement process itself. The device is an "Arm-type Fully Automatic Digital Blood Pressure Monitor," implying it operates without a human 'in the loop' for the actual pressure measurement and reading.
7. Type of Ground Truth Used:
The ground truth used was expert consensus (or highly accurate reference measurements). Specifically, for blood pressure monitor validation according to ISO 81060-2:2013, the reference standard for comparison is typically simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference blood pressure device.
8. Sample Size for the Training Set:
The document does not specify a separate training set or its sample size. For medical devices like blood pressure monitors, the "training" (i.e., algorithm development and internal testing) is typically conducted by the manufacturer using internal data or publicly available physiological datasets. The clinical validation study, as described, serves as the independent test set for regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set and its ground truth establishment are detailed in the document, this information is not available from the provided text. However, for internal development, manufacturers would likely use similar methods as the test set: expert auscultatory measurements against which the device's algorithms are refined.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other. Below the faces are three wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Sejoy Electronics & Instruments Co., Ltd. Ren Yunhua General Manager Bldg 2, No. 202, Zhenzhong Rd West Lake Economy & Technology Zone Hangzhou, Zhejiang 310030 CN
Re: K150545
Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 15, 2014 Received: March 3, 2015
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 (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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
incerely yours,
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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世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.
Indications for Use
510(k) Number (if known):
Blood Pressure Monitors for BP-1211, BP-1312, BP-1305, Device Name: BP-1307, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use √ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Sejoy Electronics & Instruments Co., Ltd.
世佳电子有限公司
510(k) Summary
The assigned 510(k) number is:_
1. Date Prepared:
2014.12.15
2. Submitter's Identification:
Name: Sejoy Electronics & Instruments Co., Ltd.
Add .: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: renyh@sejoy.com
3. Name of the Device:
Trade Name: Fully Automatic Digital Blood Pressure Monitor Including the following models: - BP-1211, BP-1312, BP-1305, BP-1307, BP-1318, BP-1326, BSP-11, BSP-12, BSP-13 for Arm-type Fully Automatic Digital Blood Pressure Monitor Common Name: Blood Pressure Monitor Classification name: Non-invasive blood pressure measurement System 21 CFR 870-1130, Class II, 74-DXN.
4. Classification Information:
Regulation Number: 870.1130 Product Code: DXN Device Class: II Panel: 74 Cardiovascular
5. Predicate Device Information:
The Arm-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following device: Blood Pressure Monitor (Model BP-1307); FDA 510(k) number: K120554 ; manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
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6. Device Description:
The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. 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 end of 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. For BP-1305, BP-1307,BP-1211, BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-1305, BP-1307,BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13will display an irregular heartbeat symbol " " if an irregular heartbeat was detected during the measurement process. BP-1305,BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 can display average results in three ways: BP-1307 can display the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements.
| Features | A | B | C | D | E | F | G | H | I (mm) | J | K(mm) | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Models | ||||||||||||||
| BP-1307(The PredicateDevices) | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ● | ● | 166×114×72 | 22-36cm | 84.1×55.1 | ● | ○ | ○ |
| BP-1211 | ● | ● | 120 Memoriesin one groups | ● | ○ | ● | ○ | ○ | 131×102×65 | 22-36cm | 45×30 | ○ | ○ | ○ |
| BP-1312 | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ● | ● | 131 ×102 ×65 | 22-36cm | 62.4×46.1 | ○ | ○ | ○ |
| BP-1318 | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ○ | ● | 139× 88× 43 | 22-36cm | 66 ×43 | ○ | ○ | ○ |
| BP-1326 | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ○ | ● | 139 ×88 ×44 | 22-36cm | 65.9×42.8 | ○ | ○ | ○ |
| BP-1305 | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ● | ● | 166 ×114× 72 | 22-36cm | 84.1×55.1 | ○ | ○ | ○ |
| BP-1307 | ● | ● | 120 Memoriesin two groups | ● | ● | ● | ○ | ● | 166 ×114× 72 | 22-36cm | 102.1×68.9 | ○ | ○ | ○ |
| BP-1319 | ● | ● | 120 Memoriesin two groups | ● | ○ | ● | ● | ● | 166 ×114× 72 | 22-36cm | 101.6×67.6 | ○ | ○ | ○ |
| BSP-11 | ● | ● | 120 Memoriesin one groups | ● | ○ | ● | ○ | ● | 140 ×98× 48 | 22-36cm | 62.3× 46 | ○ | ○ | ○ |
| BSP-12 | ● | ● | 120 Memoriesin one groups | ○ | ○ | ● | ● | ● | 148× 100× 56 | 22-36cm | 84.1×55.1 | ○ | ○ | ○ |
The detail comparisons among devices are listed below:
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世佳电子有限公司
| Standard County and Children College of Children | Sejoy Electronics & Instruments Co., Ltd. | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| in two groups | |||||||||||||
| BSP-13 | . . | 120 Memories | ● ○ ● ● ● 164× 111× 60 | 22-36cm | 102.1×68.9 | 0 0 0 | |||||||
| in two groups |
A = Powered by 4 AA size batteries
B= Powered by AC adaptor
C = Memory Size
D = Time & Date
E = Results Average in Three way
F = WHO (World Health Organization) Classification Indicator
G = Last 3 Results Average
H = Irregular Heartbeat Detection
I = Outside Demission (L x W x H in mm)
J = Cuff Size
K = LCD Size (Viewing Area in mm)
L = LCD Backlight
M= Voice
N= PC connecter
• = Yes
o = No
O= Optional function depending on clients' needs
The devices are all designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
7. Intended Use:
The Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic and diastolic blood pressure and pulse rate.
The intended user and the indication for use of the Fully Automatic Blood Pressure Monitors
BP series and BSP series as described in the labeling are nearly the same as their Predicate devices, Blood Pressure Monitor (Model: BP-1307).
Summary comparing technological characteristics with predicate device: 8.
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Identical |
| Biocompatibility | Identical |
| Mechanical Safety | Identical |
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世侯甲子有限公
| Sejoy Electronics & Instruments Co., Ltd | |
|---|---|
| Energy Source | Identical |
| Standards Met | Identical |
| Electrical Safety | Identical |
| EMC | Identical |
| Function | Similar |
The difference of technological characteristic between the predicate device and the submit arm-type fully automatic blood pressure monitors is the appearance and the function.
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards including IEC 80601-2-30:2009, medical electrical equipment - part 2-30 as well as AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(t)2012 , IEC/EN 60601-1-2:2007, 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 Bluebook Memorandum G95-1Use of International Standard ISO 10993."
Non-clinical Tests:
Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007
General Safety Provisions Test according to AAMI / ANSI ES60601-1:2005(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012
Performance Test according to IEC 80601-2-30:2009, 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 Bluebook Memorandum G95-1Use of International Standard ISO 10993, 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.
10. Discussion 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.
11. Conclusions:
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Sejoy Electronics & Instruments Co., Ltd.
Our Arm-type Fully Automatic Blood Pressure Monitors BP-1211, BP-1312, BP-1305, BP-1307,BP-1318,BP-1319,BP-1326,BSP-11,BSP-12,BSP-13 have the same intended use and similar technological characteristics as the Blood Pressure Monitor (Model BP-1307); FDA 510(k) number: K120554;manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices.
In the other words, those engineering difference do 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).