(261 days)
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No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The performance testing is based on ISO standards for blood pressure measurement, not AI/ML validation.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is a monitor used for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess health status and can indicate underlying medical conditions, classifying it as a diagnostic device.
No
The device description explicitly mentions hardware components such as an inflatable wrist cuff, LCD digital display, batteries, electric pump, and rapid deflation valve.
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.
- Device Function: The Wrist Digital Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by applying a cuff to the wrist. It does not analyze any samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate, not for analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wrist Digital Blood Pressure Monitor (Model: BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.
Product codes
DXN
Device Description
The Wrist Digital Blood Pressure Monitor is a digital and non-invasive monitor that utilizes the cuff oscillometric method to measure diastolic, systolic blood pressure, and pulse rate. It features an LCD digital display and is powered by two "AAA" batteries. The device includes a piezo resistance sensor for pressure measurement and uses an electric pump for automatic inflation and an automatic rapid deflation valve for deflation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinical and home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The proposed device (BSX335) was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study enrolled 130 subjects, and 85 subjects (44 males and 41 females) met the inclusion requirements were selected with an age range of 12 to 81 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in the validation study.
Key Metrics
Blood Pressure: Within +/-3mmHg
Pulse Rate: Within +/-5 % of reading
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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February 19, 2025
Shenzhen BSX Technology Electronics Co., Ltd. Xivu Lu RA Manager Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang Distric Shenzhen. GuangDong 518116 China
Re: K241578
Trade/Device Name: Wrist Digital Blood Pressure Monitor (BSX312, BSX315, BSX322, BSX323, BSX353, BSX355) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 13, 2025 Received: January 13, 2025
Dear Xiyu Lu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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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).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Wrist Digital Blood Pressure Monitor (BSX312, BSX315, BSX315, BSX322, BSX323, BSX353, BSX355)
Indications for Use (Describe)
The Wrist Digital Blood Pressure Monitor (Model: BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.
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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Wrist Digital Blood Pressure Monitor
510(K) Summary
1. Prepared Date: 2024/05/15
2. Submitter Information
| Name | Shenzhen BSX Technology Electronics Co., Ltd. |
|---|---|
| Address | Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian |
| Community, Longgang Distric, ShenZhen, GuangDong, 518116, | |
| CHINA | |
| Contact person | Kai Fang |
| Tel | 86 - 755 - 28719103 |
| kaifang186@126.com |
3. Submission Correspondent
| Contact person | Xiyu Lu |
|---|---|
| Xiyu.Luke@outlook.com | |
| Tel | +86-13713938991 |
4. Subject Device Information
| Proprietary Name | Wrist Digital Blood Pressure Monitor |
|---|---|
| Common Name | Noninvasive blood pressure measurement system |
| Model | BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355 |
| Classification | System, Measurement, Blood-Pressure, Non-Invasive |
| Review Panel | Cardiovascular |
| Product Code | DXN |
| Regulation Number | 870.1130 |
| Regulatory Class | II |
5. Predicate Device
| K182127, Omron Healthcare, Inc. | |||
|---|---|---|---|
| Trade/Device Name | Wrist Blood Pressure Monitor | ||
| Model | BP6100 | ||
| Regulation Name | Noninvasive Blood Pressure Measurement System | ||
| Regulatory Class | Class II | ||
| Product Code | DXN |
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6. Indications for Use
The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.
7 . Summary of technological characteristics of device compared to the predicate devices, see the table
A comparison of similarities and differences between the proposed devices (Wrist Digital Blood Pressure Monitor, BSX312, BSX315, BSX322, BSX322, BSX353, BSX355) and the predicate device (K182127) is provided below:
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K241578
Wrist Digital Blood Pressure Monitor
| Propose Device | Predicated Device | Comparison | |
|---|---|---|---|
| Product Name | Wrist Digital Blood Pressure | ||
| Monitor | Wrist Blood Pressure Monitor | / | |
| Manufacturer | Shenzhen BSX Technology | ||
| Electronics Co., Ltd. | Omron Healthcare, Inc. | / | |
| Model | BSX312, BSX313, BSX315, | ||
| BSX322, BSX323, BSX353, | |||
| BSX355 | BP6100 (K182127) | / | |
| Classification | 21 CFR§870.1130, | ||
| Noninvasive blood pressure | |||
| measurement system | 21 CFR§870.1130, | ||
| Noninvasive blood pressure | |||
| measurement system | SE | ||
| Product Code | DXN - Noninvasive blood | ||
| pressure | |||
| measurement | DXN - Noninvasive blood | ||
| pressure | |||
| measurement | SE | ||
| Indications for Use | The Wrist Digital Blood | ||
| Pressure Monitor (Model: | |||
| BSX312, BSX313, BSX315, | |||
| BSX322, BSX323, BSX353, | |||
| BSX355) is a digital and non- | |||
| invasive monitor intended to | |||
| measure the diastolic, systolic | |||
| blood pressure and pulse rate | |||
| in adult with an inflatable | |||
| wrist cuff circumference | |||
| ranging from 13.5 to 19.5cm. | |||
| It is intended for clinical and | |||
| home use. | The device is a digital monitor | ||
| intended for use in measuring | |||
| blood pressure and pulse rate | |||
| in adult patient population | |||
| with wrist circumference | |||
| ranging from 5.3 inches to 8.5 | |||
| inches | |||
| (13.5 cm to 21.5 cm). | Different | ||
| Note1 | |||
| Environment of | |||
| Use | Clinical/Home Use | Home Use | Different |
| Note1 | |||
| Patient Population | Adults | Adults | Same |
| Over-The-Counter | |||
| (OTC) | Yes | Yes | SE |
| Measurement | |||
| method | Cuff oscillometric method | Cuff oscillometric method | SE |
| Measurement | |||
| Range | Cuff pressure range 0 to | ||
| 295mmHg | |||
| Pulse Rate: 40 to 180 | |||
| beats/min. | Cuff pressure range 0 to 299 | ||
| mmHg | |||
| Pulse Rate: 40 to 180 | |||
| beats/min. | Different | ||
| Note2 | |||
| Accuracy | Blood Pressure: Within | ||
| ±3mmHg | |||
| Pulse Rate: Within ±5 % of | |||
| reading | Blood Pressure: Within | ||
| ±3mmHg | |||
| Pulse Rate: Within ±5 % of | |||
| reading | SE | ||
| Pressure Sensor | Piezo resistance sensor | Piezo resistance sensor | SE |
| Inflation Method | Automatic inflation with | ||
| electric pump | Automatic inflation with | ||
| electric pump | SE | ||
| Deflation Method | Automatic rapid deflation | ||
| valve | Automatic rapid deflation | ||
| valve | SE | ||
| Display Type | LCD digital display | LCD digital display | SE |
| Power Source | Two "AAA" batteries | Two "AAA" batteries | SE |
| Operating | |||
| Conditions | 5 to 40 °C (41 to 104 °F) | ||
| 15 to 85 %RH (non- | |||
| condensing) | 10 to 40 °C ( 50 to 104 °F) | ||
| 15 to 90 %RH (non- | |||
| condensing) | Different | ||
| Note3 | |||
| Storage/Transport | |||
| Conditions | -20 to 55 °C (-4 to 131 °F) | ||
| 10 to 93 %RH (non- | |||
| condensing) | -20 to 60 °C (-4 to 140 °F) | ||
| 10 to 90 %RH (non- | |||
| condensing) | Different | ||
| Note3 | |||
| Dimensions | |||
| (WDH) | BSX312: 78.5 × 30.2 × 68mm | ||
| BSX313: 78.5 x 30.2 x 68mm | |||
| BSX315: 85.5 x 28.5 x 78mm | |||
| BSX322: 86 x 28.3 x 66mm | |||
| BSX323: 94 x 29.2 x 74.9mm | |||
| BSX353: 78.5 x30.2 x 68mm | |||
| BSX355: 85.5 x 28.5 x 78mm | 93× 20× 62mm | Different | |
| Note3 | |||
| Weight | Approx. 150g (containing | ||
| WRIST CUFF) | Approx. 86g (3.0 oz) (not | ||
| including battery) | Different | ||
| Note3 |
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K241578
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Analysis
From the comparison table, the propose device and predicate device have the same measurement method, measurement accuracy, patient population, pressure sensor and display type etc. There are slightly differences between the devices as follow:
| Difference clause | Discussion | |
|---|---|---|
| Note1 | Wrist circumference | |
| range | ||
| Environment of Use | Proposed device: wrist circumference ranging from 13.5cm to 19.5 cm. | |
| Predicated device: wrist circumference ranging from 5.3 inches to 8.5 | ||
| inches (13.5 cm to 21.5 cm). | ||
| Both devices achieved ISO 80601-2-30 Particular requirements for | ||
| basic safety and essential performance of automated non-invasive | ||
| sphygmomanometers and have the same measurement accuracy | ||
| though they have slightly wrist circumference and the subjected device | ||
| would be used in clinic which would not change the intended use of | ||
| the device. | ||
| Note2 | Cuff pressure range | Proposed device: Cuff pressure range 0 to 295mmHg |
| Predicated device: Cuff pressure range 0 to 299 mmHg | ||
| There is slightly range difference and the device passed the test of ISO | ||
| 80601-2-30 Particular requirements for basic safety and essential | ||
| performance of automated non-invasive sphygmomanometers, this | ||
| difference would not affect the performance and safety of the propose | ||
| device. | ||
| Note3 | Operating Conditions, | |
| Storage/Transport | ||
| Conditions, | ||
| Dimensions, | ||
| Weight | Minor differences in the dimensions, weight features relate mostly to | |
| convenience considerations do not impact the safety or performance | ||
| of blood pressure or pulse rate measurements. These differences in the | ||
| technological characteristics between the devices do not raise any | ||
| different questions of safety or effectiveness. |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The proposed devices and the predicate device have similar technological characteristics. Both devices are battery-operated wrist blood pressure monitors intended for home use and employ the oscillometric method for measuring blood pressure and pulse rate. Both devices have the same pulse rate range of 40 to 180 beats/min though slightly difference of cuff pressure range (Note2). The devices share the same accuracy range of pressure reading of ±3 mmHg and the same accuracy range for pulse rate reading of ± 5%.
SUBSTANTIAL EQUIVALENCE
The proposed Indications for Use for the Wrist Digital Blood Pressure Monitor is similar to the Indications for Use for the predicate device.
They both intended for use in homecare for blood pressure and pulse rate measurement of adults. The different cuff circumference would not change the intended use. (Note1), and
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different use environment has been tested by IEC 60601-1 & ISO 80601-2-30 and showed positive result.
Comparison testing demonstrated that the proposed device is equivalent to the predicate device with regard to measurement of blood pressure in a pulse wave generator test.
Minor differences in the technological features relate mostly to convenience considerations or routine performance updates and do not impact the safety or performance of blood pressure or pulse rate measurements (Note3). Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the proposed device is substantially equivalent to the predicate device.
Wrist Digital Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing as following:
- V Electrical safety test according to IEC 60601-1-11 and IEC 80601-2-30 standards
- V Electromagnetic compatibility test according to IEC 60601-1-2 standard
- v Performance according to AAMI / ANSI / ISO 81060-2 standard
- V Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- V Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Clinical data
The proposed device (BSX335) was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study enrolled 130 subjects, and 85 subjects (44 males and 41 females) met the inclusion requirements were selected with an age range of 12 to 81 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in the validation study.
CONCLUSIONS [807.92(b)(3)]
The conclusions drawn from the nonclinical and clinical tests performed in support of that the proposed device is safe and effective and performs at least as safely and effectively as the legally marketed K182127 predicate device.
SUMMARY
The Wrist Blood Pressure Monitor (Model BSX312, BSX315, BSX315, BSX322, BSX323, BSX353, BSX355) is substantially equivalent to the Omron Model BP6100 predicate device(K182127).