(246 days)
No
The description details a standard oscillometric blood pressure monitor using established methods and sensors, with no mention of AI/ML algorithms for data processing, classification, or feature detection. The classification against WHO standards and irregular heartbeat detection are based on predefined thresholds, not learned patterns.
No
The device is for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device measures blood pressure and pulse rate, and it compares blood pressure results with WHO classifications, indicating its use in diagnosing or monitoring health conditions. While it is an over-the-counter device, its function inherently involves providing information used for diagnostic purposes (e.g., identifying hypertension).
No
The device description explicitly details hardware components such as an inflatable cuff, internal pump, silicon integrate pressure sensor, mechanical valve, and LCD display, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The described device is a blood pressure monitor. It measures blood pressure and pulse rate by applying a cuff to the patient's upper arm and using oscillometric methods. This is a non-invasive measurement performed on the living body.
The description clearly indicates a device that interacts directly with the patient's body to obtain physiological measurements, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
Product codes
DXN
Device Description
The Arm-Type Fully Automatic Digital Blood Pressure Monitor 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-46 and BP-1304, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification. which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, and pulse rate information. They will display an irregular heartbeat symbol "《♥》" if an irregular heartbeat was detected during the measurement process. BP-46 can display average results in three ways.
The device is 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults and adolescents age 12 through 21 years of age.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007;
General Safety Provisions Test according to AAMI/ANSI ES 60601-1:2005/(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.
Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2017
Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua, General Manager Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hang Zhou, 310030 CHINA
Re: K161577
Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor models BP-46 and BP-1304 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 27, 2016 Received: January 10, 2017
Dear Mr. 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.
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 device
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related 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.
Minde Yellman
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) K161577
Device Name
The Arm-type Fully Automatic Digital Blood Pressure Monitors for BP-1304 and BP-46
Indications for Use (Describe)
Measure blood pressure (systolic and diastolic) 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 (Read 21 CFR 201 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 2
510 (k) Summary
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Image /page/4/Picture/0 description: The image shows the logo for SEJOY. The logo is in blue, with the letters "SEJOY" in a bold, sans-serif font. Above the "J" is a small orange triangle. To the right of the "Y" is the registered trademark symbol.
世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.
510(k) Summary
The assigned 510(k) number is:
2.1. Date Prepared:
2016.03.29
2.2. Subjectter'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
2.3. Name of the Device:
Trade Name: The Arm-type Fully Automatic Digital Blood Pressure Monitor
Including the following models: BP-46, BP-1304
Common Name: Blood Pressure Monitor
Classification name: Non-invasive blood pressure measurement System
21 CFR 870-1130, Class II, 74-DXN.
2.4. Classification Information:
Regulation Number: 870.1130 Product Code: DXN Device Class: II Panel: 74 Cardiovascular
2.5. Predicate Device Information:
The Arm-Type Fully Automatic Digital Blood Pressure Monitor BP-1304 is substantially equivalent to the following device: Blood Pressure Monitor BP-1304, and BP-46 substantially equivalent to BM-40, FDA 510(k) number: K120554, manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD..
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Image /page/5/Picture/1 description: The image shows the logo for SEJOY. The logo is in blue and has a small yellow triangle above the letter 'O'. The font is bold and sans-serif. The logo is simple and modern.
2.6. Device Description:
The Arm-Type Fully Automatic Digital Blood Pressure Monitor 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-46 and BP-1304, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification. which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, and pulse rate information. They will display an irregular heartbeat symbol "《♥》" if an irregular heartbeat was detected during the measurement process. BP-46 can display average results in three ways.
The device is 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.
2.7.Intended Use:
The Arm-Type Fully Automatic Digital Blood Pressure Monitors BP-1304 and BP-46 are intended to use for adults and adolescents age 12 through 21 years of age to measure the systolic and diastolic blood pressure and pulse rate.
2.8. Difference of comparison with predicate device:
The difference between the predicate device BP-1304 and the subject Arm-type fully automatic blood pressure monitor BP-1304 is one new arm-cuff (Size: 22.0cm-42cm) added as optional for users.The difference between BM-40 and BP-46 is technological characteristics as described below.
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Image /page/6/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the "J". The logo is simple and modern.
2.9. Non-clinical Tests:
Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007;
General Safety Provisions Test according to AAMI/ANSI ES 60601-1:2005/(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.
2.10. Discussion of Clinical Tests Performed:
Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.
2.11. Conclusions:
The subject Arm-type Fully Automatic Blood Pressure Monitor BP-1304 is itself of the predicate device BP-1304 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. (FDA 510(k) number: K120554). The addition of new armcuff (Size: 22cm-42cm) will not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
The subject Arm-type Fully Automatic Blood Pressure Monitor BP-46 is substantially equivalent to the predicate device BM-40 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. (FDA 510(k) number: K120554). The difference between them will not (1) affect the intended use or (2) alter the fundamental scientific technology of the device.