(261 days)
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.
The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor that uses the cuff oscillometric method to measure diastolic and systolic blood pressure and pulse rate. It has an LCD digital display, is powered by two "AAA" batteries, and uses automatic inflation with an electric pump and automatic rapid deflation valve.
The provided text describes the 510(k) submission for a Wrist Digital Blood Pressure Monitor. I will extract the information requested regarding acceptance criteria and the study that proves the device meets them.
Acceptance Criteria and Device Performance
A digital blood pressure monitor's primary acceptance criteria are its accuracy in measuring blood pressure and pulse rate. The relevant standard cited is ISO 81060-2: 2018 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type) for clinical performance, and specific accuracy values are mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Blood Pressure | Within ±3mmHg | "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." - This implies meeting the ±3mmHg criterion, as that is the standard for blood pressure accuracy in ISO 81060-2:2018. |
| Pulse Rate | Within ±5 % of reading | Not explicitly stated as a separate result, but implied to be met through ISO 81060-2:2018 compliance, which validates both BP and PR. |
| Cuff Pressure Range | 0 to 295mmHg (Proposed Device) | Passed the test of ISO 80601-2-30. |
| Operating Temp. | 5 to 40 °C (41 to 104 °F) (Proposed Device) | Passed IEC 60601-1-11 & IEC 80601-2-30 standards. |
| Storage Temp. | -20 to 55 °C (-4 to 131 °F) (Proposed Device) | Passed IEC 60601-1-11 & IEC 80601-2-30 standards. |
| Electrical Safety | According to IEC 60601-1-11 and IEC 80601-2-30 standards | Passed. |
| EMC | According to IEC 60601-1-2 standard | Passed. |
| Biocompatibility | According to ISO 10993-5 and ISO 10993-10 standards | Passed. |
| Software Validation | According to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Passed. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Enrolled: 130 subjects
- Selected (met inclusion requirements): 85 subjects (44 males and 41 females)
- Data Provenance: The document does not explicitly state the country of origin. It describes a "validation study" which implies a prospective clinical study rather than retrospective. The study was conducted as part of the regulatory submission process for a device from Shenzhen, China, suggesting the study might have been conducted there or in a region that supports compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for this device, nor does it mention experts in the context of ground truth for a blood pressure monitor. For blood pressure devices, ground truth is typically established by simultaneous readings from a reference manometer (mercury sphygmomanometer) as per ISO standards, not expert readers.
4. Adjudication method for the test set
The document does not describe any adjudication method. For blood pressure monitor validation studies by ISO 81060-2, adjudication by multiple readers is not typically part of the ground truth establishment process in the same way it would be for image interpretation tasks. The standard relies on simultaneous measurements by trained personnel using reference devices.
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
No MRMC comparative effectiveness study was done or is applicable here. This document pertains to a digital blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was performed. The device itself, which performs blood pressure and pulse rate measurements using an algorithm, was clinically validated against a ground truth (established by trained observers using a reference method as per ISO 81060-2) without human intervention in the device's measurement process.
7. The type of ground truth used
The ground truth used was based on clinical validation as per ISO 81060-2: 2018. This standard specifies that simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent reference standard) serve as the ground truth. The document states: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." This directly refers to the comparison of the device's readings against this established ground truth.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI training process. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-based device that would require a separate training set.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable.
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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, WulianCommunity, 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 PressureMonitor | Wrist Blood Pressure Monitor | / |
| Manufacturer | Shenzhen BSX TechnologyElectronics Co., Ltd. | Omron Healthcare, Inc. | / |
| Model | BSX312, BSX313, BSX315,BSX322, BSX323, BSX353,BSX355 | BP6100 (K182127) | / |
| Classification | 21 CFR§870.1130,Noninvasive blood pressuremeasurement system | 21 CFR§870.1130,Noninvasive blood pressuremeasurement system | SE |
| Product Code | DXN - Noninvasive bloodpressuremeasurement | DXN - Noninvasive bloodpressuremeasurement | SE |
| Indications for Use | The Wrist Digital BloodPressure Monitor (Model:BSX312, BSX313, BSX315,BSX322, BSX323, BSX353,BSX355) is a digital and non-invasive monitor intended tomeasure the diastolic, systolicblood pressure and pulse ratein adult with an inflatablewrist cuff circumferenceranging from 13.5 to 19.5cm.It is intended for clinical andhome use. | The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient populationwith wrist circumferenceranging from 5.3 inches to 8.5inches(13.5 cm to 21.5 cm). | DifferentNote1 |
| Environment ofUse | Clinical/Home Use | Home Use | DifferentNote1 |
| Patient Population | Adults | Adults | Same |
| Over-The-Counter(OTC) | Yes | Yes | SE |
| Measurementmethod | Cuff oscillometric method | Cuff oscillometric method | SE |
| MeasurementRange | Cuff pressure range 0 to295mmHgPulse Rate: 40 to 180beats/min. | Cuff pressure range 0 to 299mmHgPulse Rate: 40 to 180beats/min. | DifferentNote2 |
| Accuracy | Blood Pressure: Within±3mmHgPulse Rate: Within ±5 % ofreading | Blood Pressure: Within±3mmHgPulse Rate: Within ±5 % ofreading | SE |
| Pressure Sensor | Piezo resistance sensor | Piezo resistance sensor | SE |
| Inflation Method | Automatic inflation withelectric pump | Automatic inflation withelectric pump | SE |
| Deflation Method | Automatic rapid deflationvalve | Automatic rapid deflationvalve | SE |
| Display Type | LCD digital display | LCD digital display | SE |
| Power Source | Two "AAA" batteries | Two "AAA" batteries | SE |
| OperatingConditions | 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) | DifferentNote3 |
| Storage/TransportConditions | -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) | DifferentNote3 |
| Dimensions(WDH) | BSX312: 78.5 × 30.2 × 68mmBSX313: 78.5 x 30.2 x 68mmBSX315: 85.5 x 28.5 x 78mmBSX322: 86 x 28.3 x 66mmBSX323: 94 x 29.2 x 74.9mmBSX353: 78.5 x30.2 x 68mmBSX355: 85.5 x 28.5 x 78mm | 93× 20× 62mm | DifferentNote3 |
| Weight | Approx. 150g (containingWRIST CUFF) | Approx. 86g (3.0 oz) (notincluding battery) | DifferentNote3 |
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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 circumferencerangeEnvironment of Use | Proposed device: wrist circumference ranging from 13.5cm to 19.5 cm.Predicated device: wrist circumference ranging from 5.3 inches to 8.5inches (13.5 cm to 21.5 cm).Both devices achieved ISO 80601-2-30 Particular requirements forbasic safety and essential performance of automated non-invasivesphygmomanometers and have the same measurement accuracythough they have slightly wrist circumference and the subjected devicewould be used in clinic which would not change the intended use ofthe device. |
| Note2 | Cuff pressure range | Proposed device: Cuff pressure range 0 to 295mmHgPredicated device: Cuff pressure range 0 to 299 mmHgThere is slightly range difference and the device passed the test of ISO80601-2-30 Particular requirements for basic safety and essentialperformance of automated non-invasive sphygmomanometers, thisdifference would not affect the performance and safety of the proposedevice. |
| Note3 | Operating Conditions,Storage/TransportConditions,Dimensions,Weight | Minor differences in the dimensions, weight features relate mostly toconvenience considerations do not impact the safety or performanceof blood pressure or pulse rate measurements. These differences in thetechnological characteristics between the devices do not raise anydifferent 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).
§ 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).