(243 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement techniques and hardware features, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a non-invasive blood pressure measurement system intended to measure vital signs (blood pressure and pulse rate), which is a diagnostic function, not a therapeutic one. It provides information for monitoring conditions but does not treat them.
Yes
Explanation: The device measures diastolic and systolic blood pressures and pulse rate, which are used to assess the health status of an individual, thereby aiding in diagnosis.
No
The device description explicitly states it is a "battery powered automatic non-invasive blood pressure monitor" and details hardware components like batteries, an inflatable cuff, and mentions different models based on battery type and backlight indicators. This indicates it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a blood pressure monitor that measures blood pressure and pulse rate non-invasively by wrapping a cuff around the arm. It does not involve the analysis of any specimens taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to analyze biological samples for diagnostic purposes.
Therefore, based on the provided information, this blood pressure monitor falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523 is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.
The difference between the six models include the battery type and the backlight indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion Battery. Moreover, the subject device is equipped with backlight indicator except models BSX516 and BSX525.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed Arm-type Electronic Blood Pressure Monitor share the similar software, measurement principle and NIBP algorithm.
The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
hospital environment or at home.
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)
Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:
Biocompatibility testing: The biocompatibility evaluation for the Arm-type Electronic Blood Pressure Monitor and the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests: Cytotoxicity, Skin Sensitization, Skin Irritation.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 and the IEC 60601-1-2: 2014.
Bench Testing: Bench testing was conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010, ISO 80601-2-30: 2009 for performance effectiveness.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance. The software for this device was considered as a "major" level of concern.
Clinical data: Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
Summary: Based on the non-clinical and clinical performance as documented, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Static Pressure: +/- 3 mmHg
Pulse: +/- 5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure Monitor / K170151
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 3, 2019
Shenzhen BSX Technology Electronics Co., Ltd. Zhijian Zhao Sales Director Rm301.3F&4F, 8th Building, LiHao Industrial Area No.78 AiNan Road, Longgang Shenzhen. 518116 CHINA
Re: K183058
Trade/Device Name: Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 13, 2019 Received: May 29, 2019
Dear Zhijian Zhao:
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. 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 located 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.
1
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) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 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,
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
2
Indications for Use
510(k) Number (if known) K183058
Device Name
Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX525, BSX583, BSX593 and BSX595
Indications for Use (Describe)
The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
Type of Use (Select one or both, as applicable)
| ❏ Research Use ( As 1 CFR 201 Subpart D ) |
|---|
| ☑ Some Other Use ( As 1 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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3
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Applicant | Shenzhen BSX Technology Electronics Co., Ltd. |
|---|---|
| Rm301.3F&4F, 8th Building, LiHao Industrial Area, No.78 AiNan Road, | |
| Longgang, Shenzhen 518116, Shenzhen, P.R. China | |
| Tel.: +86 -755- 2870 2440 | |
| Fax: +86 -755- 2888 2567 | |
| Contact Person | Zhijian Zhao |
| Prepare date | 2019-05-10 |
| 2. Device name | |
| and classification | Device Name: Arm-type Electronic Blood Pressure Monitor |
| Models: BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595 | |
| Classification Name: | |
| 21 CFR 870.1130 | |
| Noninvasive Blood Pressure Measurement System | |
| Product code: DXN | |
| Regulatory Class: Class II | |
| 3. Predicate | |
| Device(s) | Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure |
| Monitor / K170151 | |
| 4. Device | |
| Description | The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic |
| non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583, | |
| BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523 | |
| is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the | |
| inflation, deflation and measurement, which can measure systolic and diastolic | |
| blood pressure and pulse rate of the adult person at upper arm within its claimed | |
| range and accuracy via the oscillometric technique. User can select the unit of the | |
| measurement: mmHg or kPa. | |
| The difference between the six models include the battery type and the backlight | |
| indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by | |
| 4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion | |
| Battery. Moreover, the subject device is equipped with backlight indicator except | |
| models BSX516 and BSX525. | |
| The device has the data storage function in order for data reviewing, including the | |
| systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed | |
| Arm-type Electronic Blood Pressure Monitor share the similar software, | |
| measurement principle and NIBP algorithm. | |
| The proposed device is intended to be used in medical facilities or at home. And the | |
| effectiveness of this sphygmomanometer has not been established in pregnant | |
| (including pre-eclamptic) patients. | |
| The product is provided non-sterile, and not to be sterilized by the user prior to use. |
4
The blood pressure monitor is a non-invasive blood pressure measurement system 5. Indications for intended to measure the diastolic and systolic blood pressures and pulse rate of an Use adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.
6. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Proposed Device
BSX516, BSX523, BSX525,
BSX583, BSX593 and BSX595 | Predicate Device
PG-800B36/ K170151 | Comparison
Result |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen BSX Technology
Electronics Co., Ltd. | Shenzhen Pango Electronic Co., Ltd. | --- |
| Indications for
Use | The blood pressure monitor is a
non-invasive blood pressure
measurement system intended to
measure the diastolic and systolic
blood pressures and pulse rate of an
adult individual by using a
non-invasive oscillometric technique
in which an inflatable CUFF is
wrapped around the arm of which the
circumference includes 22 cm3232 cm
cm. It is intended to be used in
hospital environment or at home. | The Electronic Blood Pressure
Monitor is intended to measure the
systolic and diastolic blood pressure
as well as the pulse rate of adult
person via non-invasive oscillometric
technique in which an inflatable cuff
is wrapped around the upper arm. It
can be used at medical facilities or at
home. The intended arm
circumference includes 22 cm
and 32 cm~42 cm. | Different |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| Patient Population | Adult | Adult | Same |
| Measurement
Type | Upper arm | Upper arm | Same |
| Measurement
Principle | Oscillometric | Oscillometric | Same |
| Components | LCD / Key / Cuff / MCU / Pump /
Batteries | LCD / Key / Cuff / MCU / Pump /
Batteries | Same |
| Power Source | 4x1.5V AAA Alkaline Battery
(BSX516, BSX525, BSX583,
BSX593 and BSX595) | 4x1.5V AAA Alkaline Battery | Same |
| | 3.7V 400mAh Li-ion
Battery(BSX523) | | Different |
| Physical
Dimensions(mm)(
LengthWidthHe
ight) | Approx:
516: 110 x130 x 58
523: 106 x 145 x 68.5
525: 110 x130 x 58
583: 112 x 132 x 70.5
593: 112 x 132 x 70.5
595: 112 x 132 x 70.5 | Approx: 140 x100 x50 | Different |
| Weight | Approx: 370g, containing dry battery,
CUFF | Approx: 420 g, excluding battery | Different |
Table 1 Comparison between the predicate PG-800B36 and the subject device
5
| Measurement | |||||
|---|---|---|---|---|---|
| Range | Blood | ||||
| Pressure | 0 ~ 299 mmHg | Blood | |||
| Pressure | 30 ~ 280 mmHg | Different | |||
| Pulse Rate | 40 -180 bpm | Pulse Rate | 40-199 bpm | ||
| Accuracy | Static | ||||
| Pressure | $\pm3$ mmHg | Static | |||
| Pressure | $\pm3$ mmHg | Same | |||
| Pulse | $\pm5%$ | Pulse | $\pm5%$ | ||
| Arm | |||||
| Circumference | 22 cm~32 cm | 22 cm~42 cm | Different | ||
| Patient Contact | |||||
| Material | Cuff - Polyester | Cuff -Nylon | Different | ||
| Applied Standards | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| 80601-2-30:2009 | |||||
| 81060-2:2013 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| 80601-2-30:2009 | |||||
| 81060-2:2013 | Same | ||||
| Operation | |||||
| Environments | + 5℃~ + 40℃, 15%RH~85%RH | ||||
| Atmospheric Pressure: 80 kPa~106 | |||||
| kPa | + 5℃~ + 40℃, 15%RH~93%RH | ||||
| Atmospheric Pressure: 50 kPa~106 | |||||
| kPa | Different | ||||
| Storage | |||||
| Environments | - 20℃~ + 55℃, 10%RH~93%RH | ||||
| Atmospheric Pressure: 70 kPa~106 | |||||
| kPa | - 20℃~ + 55℃, 0%RH~93%RH | ||||
| Atmospheric Pressure: 50 kPa~106 | |||||
| kPa |
As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the system.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Arm-type Electronic Blood Pressure Monitor and the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
6
Bench testing was conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance =Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. ISO 80601-2-30: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement tvpe.
Summary
Based on the non-clinical and clinical performance as documented in the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the BSX Arm-type Electronic Blood Pressure Monitor is substantially equivalent to the predicate devices.