(73 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using electronic pressure sensors and signal analysis based on established methods. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or training/test set descriptions. The irregular pulse detection is based on simple interval comparisons, not complex learning algorithms.
No
The device is a Blood Pressure Monitor, which measures blood pressure and pulse rate, but it is not intended for therapeutic purposes. It provides diagnostic information but does not actively treat a condition.
Yes
The device measures blood pressure and pulse rate, and it also has a function to detect and display "irregular pulse rate," which provides information beyond a simple measurement to indicate a potential health issue.
No
The device description explicitly lists hardware components such as a main unit, cuff, PCB, thermistor, pressure pump, motor, release valve, and pressure sensor. It also describes a physical mechanism for measuring blood pressure using an inflatable cuff and electronic pressure sensor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: This Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using an oscillometric method. This is a non-invasive measurement performed on the body (in vivo).
- Intended Use: The intended use clearly states it's for "measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾ -12½´) or 22cm to 42cm (about 834"-161/2´)." This is a physiological measurement, not an analysis of a biological specimen.
- Device Description: The description details the components and method of operation, all of which relate to measuring pressure changes in a cuff on the arm, not analyzing a sample.
The device is a medical device, but specifically a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½").
It is intended for adult indoor use only.
Product codes
DXN
Device Description
Blood Pressure Monitor BBZ32-AA01 is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals.
Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor.
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is intended to transmit clinical data from Point B only, and not involved in active patient monitoring. Therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.
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
Adult
Intended User / Care Setting
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
The clinical study was performed on the device matching with cuffs ranging from 22-32cm and 22-42cm. The study population consisted of 86 qualified subjects. 258 datasets were collected from 86 subjects with aged 52±13.5.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing includes the following tests: Cytotoxicity, Sensitization, Irritation. The subject device is considered as surface contacting for a duration not exceed 24hours.
Non-clinical data: The device has been tested according to following standards:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety ● and essential performance
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 80601-2-30: Medical electrical equipment – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
- IEC 60601-1-11: 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
- FDA Guidance for Non-Automated Sphygmomanometer
Wireless testing:
- 47 CFR Part 15, Subpart B, Subpart C
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)
Clinical data: device was tested according to ISO 81060-2:2018/Amd.1:2020 Non-invasive The sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type AMENDMENT 1. The clinical study was performed on the device matching with cuffs ranging from 22-32cm and 22-42cm. The study population consisted of 86 qualified subjects. 258 datasets were collected from 86 subjects with aged 52±13.5. The mean differences between reference BPs and device readings were 0.17±2.57/0.79±2.09mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and 0.17 ± 1.99/0.79 ± 1.68mmHg for SBP/DBP of criterion 2. BBZ32-AA01 fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The mean differences between reference BPs and device readings were 0.17±2.57/0.79±2.09mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and 0.17 ± 1.99/0.79 ± 1.68mmHg for SBP/DBP of criterion 2.
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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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2024
Guangdong Transtek Medical Electronics Co., Ltd. Jerry Fan RA Manager Zone A. No. 105. Dongli Road. Torch Development District Zhongshan, Guangdong 528437 China
Re: K240832
Trade/Device Name: Blood Pressure Monitor (BBZ32-AA01) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 26, 2024 Received: March 26, 2024
Dear Jerry Fan:
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.
1
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 (QS) 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.
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.
2
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 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 C. Browning -S
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
Blood Pressure Monitor (BBZ32-AA01)
Indications for Use (Describe)
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8%"-12½") or 22cm to 42cm (about 83/4"-161/2").
It is intended for adult indoor use only.
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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510(k) Summary
Prepared in accordance with the requirement of 21 CFR Part 807.92
Prepared Date: 03/26/2024
- Submitter Guangdong Transtek Medical Electronics Co., Ltd. Name: Zone A, No. 105, Dongli Road, Torch Development District, 528437 Zhongshan, Address: Guangdong, China Contact: Jerry Fan Title: RA Manager E-mail: gt-rateam@transtekcorp.com TEL: +86 15728668528
2. Subject Device
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | BBZ32-AA01 |
| Common Name | Blood Pressure Monitor |
| Classification | Class II |
| Product Code | DXN |
| Submission Type | Traditional 510(k) |
3. Predicate Device
| Manufacturer: | Omron Healthcare, Inc. |
|---|---|
| Device Name / Model: | Noninvasive blood pressure measurement system / |
| HEM-7311 | |
| 510(k) Number: | K133379 |
| Classification | Class II |
| Product Code | DXN |
4. Device Description
Blood Pressure Monitor BBZ32-AA01 is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals.
Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve
5
and pressure sensor.
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is intended to transmit clinical data from Point B only, and not involved in active patient monitoring. Therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.
5. Indications for use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾ -12½´) or 22cm to 42cm (about 834"-161/2").
It is intended for adult indoor use only.
| Item | Subject Device | Predicate Device | Note |
|---|---|---|---|
| 510(k) | Applying | K133379 | / |
| Model | BBZ32-AA01 | HEM-7311 | / |
| Applicant | Guangdong Transtek Medical | ||
| Electronics Co., Ltd. | OMRON HEALTHCARE, INC. | Same | |
| Device Name | Blood Pressure Monitor | Blood Pressure Monitor | Same |
| Product Code | DXN | DXN | Same |
| Classification | Class II | Class II | Same |
| Regulation # | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Type of Use | OTC | OTC | Same |
| Intended Use / | |||
| Indication for | |||
| Use | This Blood Pressure Monitor is a | ||
| digital monitor intended for use in | |||
| measuring blood pressure and pulse | |||
| rate with arm circumference ranging | |||
| from 22cm to 32cm (about 8¾"-12½") | The device is a digital monitor | ||
| intended for use in measuring blood | |||
| pressure and pulse rate in adult patient | |||
| population. | |||
| The device detects the appearance of | Similar, refer | ||
| to Note 1. | |||
| or 22cm to 42cm (about 8¾"-16½") | |||
| It is intended for adult indoor use only. | irregular heartbeats during | ||
| measurement and gives a warning | |||
| signal with readings. | |||
| Arm | |||
| circumference | 22cm to 32cm (about 8¾"-12½") or | ||
| 22cm to 42cm (about 8¾"-16½") | Small 17-22cm, Standard 22-32cm, | ||
| Large 22-42cm | Similar, refer | ||
| to Note 2. | |||
| Patient | |||
| Population | Adult | Adult | Same |
| Principle | Oscillometric method | Oscillometric method | Same |
| Anatomical Site | Upper Arm | Upper Arm | Same |
| Where used | |||
| (hospital, home, | |||
| ambulance, etc.) | Home | Home | Same |
| Power Supply | 4*1.5V AAA batteries | 4*AA batteries or AC adapter | Similar, refer |
| to Note 3. | |||
| Human Factors | Blood pressure | Blood pressure | Same |
| Measurement | |||
| Items | Measuring systolic and diastolic blood | ||
| pressure and pulse rate of intended | |||
| population, including irregular pulse | |||
| rhythm detection. | Measuring systolic and diastolic blood | ||
| pressure and pulse rate of intended | |||
| population, including irregular pulse | |||
| rhythm detection. | Same | ||
| Cuff Deflation | Automatic deflation | Automatic pressure release valve | Same |
| Blood Pressure | |||
| Measurement | 0mmHg ~ 299mmHg, | ||
| 5°C - 40°C within ±3mmHg (0.4kPa) | 0mmHg ~ 299mmHg, within | ||
| ±3mmHg or 2% of reading | Same | ||
| Pulse Rate | |||
| Measurement | 40-199 beat/minute, ±5% | 40-180 beat/minute, within ±5% of | |
| reading | Similar, refer | ||
| to Note 2. | |||
| Display | LCD | LCD | Same |
| Memory | 2×99 | 2×100 | Similar, refer |
| to Note 3. | |||
| Operation | |||
| Environment | Temperature: 5°C~40°C; | ||
| Relative Humidity: 15%~90% RH; | |||
| Atmospheric: 700hPa~1060hPa | Temperature: 10°C~40°C; | ||
| Relative Humidity: 15%~90% RH; | Similar, refer | ||
| to Note 3. | |||
| Storage and | |||
| transportation | |||
| Environment | Temperature: -20°C~60°C; | ||
| Relative humidity≤93%RH, | |||
| non-condensing; | |||
| Atmospheric: 500hPa~1060hPa | Temperature: -20°C~60°C; | ||
| Relative humidity 10 to 95%RH, | |||
| non-condensing; | Similar, refer | ||
| to Note 3. | |||
| Performance | Compliance with IEC 80601-2-30 | Compliance with IEC 80601-2-30 | Same |
| Clinical | Compliance with ISO 81060-2 | Compliance with ANSI/AAMI/ISO | |
| 81060-2 | Same | ||
| Biocompatibility | All patient contact parts meet the | Compliance with ISO 10993-1 | Same |
| requirements of ISO 10993-1/5/10/23 | |||
| Electrical Safety | Compliance with AAMI ANSI ES | ||
| 60601-1 and IEC 60601-1-11 | Compliance with AAMI ANSI ES | ||
| 60601-1 and IEC 60601-1-11 | Same | ||
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Wireless | Bluetooth | Not publicly available | Similar, refer |
| to Note 3. |
6. Comparison to Predicate Device
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Justification for difference:
Note 1:
Although there are some differences between the "Intended Use / Indication for Use" of the subject device and predicate device, it is only expressed differently, and the general meaning is the same, and they both use in measuring blood pressure and pulse rate. Thus, the difference here does not raise any issues concerning safety and effectiveness.
Note 2:
Although there are some differences between the "Arm circumference" and "Pulse Rate Measurement" of the subject device and the predicate device, both the subject device and predicate device can be applied to 22-32cm and 22-42cm arm circumference, the pulse rate range of the subject device is similar to that of the predicate device, and the subject device has also been validated according to IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Note 3:
Although there are some differences between the "Power Supply", "Memory", "Operation Environment", "Storage and transportation Environment" and "Wireless" of the subject device and the predicate device, both the subject device and predicate device comply with the requirement of standard AAMI ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2 and IEC 80601-2-30, and the subject device also complies with the guidance "Content of Premarket Submissions for Device Software Functions". As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Conclusion:
Based on the comparison and analysis in this submission, it can be concluded that: the subject device is substantially equivalent to the predicate device and reference device regarding safety and effectiveness.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
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Biocompatibility testing:
The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing includes the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject device is considered as surface contacting for a duration not exceed 24hours.
Non-clinical data
The device has been tested according to following standards:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety ● and essential performance
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 80601-2-30: Medical electrical equipment – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
- IEC 60601-1-11: 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
- FDA Guidance for Non-Automated Sphygmomanometer
Wireless testing:
- 47 CFR Part 15, Subpart B, Subpart C
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)
Clinical data
device was tested according to ISO 81060-2:2018/Amd.1:2020 Non-invasive The sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type AMENDMENT 1. The clinical study was performed on the device matching with cuffs ranging from 22-32cm and 22-42cm. The study population consisted of 86 qualified subjects. 258 datasets were collected from 86 subjects with aged 52±13.5. The mean differences between reference BPs and device readings were 0.17±2.57/0.79±2.09mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and 0.17 ± 1.99/0.79 ± 1.68mmHg for SBP/DBP of criterion 2. BBZ32-AA01 fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
8. Conclusion
Based on the information presented in this 510(k) premarket notification submission, a conclusion can be drawn that the proposed subject device is considered substantially equivalent to the predicate device. The differences between the subject device and the predicate devices were
9
successfully tested with relevant standards and FDA guidance, and do not affect equivalent safety and effectiveness or raise new issues concerning safety and effectiveness.