(85 days)
Not Found
No
The description details the use of the oscillometric method and a microprocessor to analyze pressure signals, which are standard techniques for blood pressure monitors and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is a blood pressure monitor intended for measuring blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic. It measures, but does not treat, a condition.
Yes
This device is a blood pressure monitor intended for measuring blood pressure and pulse rate, which are physiological parameters used to diagnose and monitor various medical conditions. The clinical studies conducted with this device further support its diagnostic nature.
No
The device description explicitly lists hardware components such as a main unit, cuff unit (inflatable bladder and polyester shell), microprocessor, pressure sensor, operation keys, electromagnetic deflation control valve, and LCD. It also describes a physical method of measurement using an inflatable cuff.
Based on the provided information, 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 for diagnosis, monitoring, or screening.
- Device Function: This device is a Blood Pressure Monitor. It measures blood pressure and pulse rate non-invasively by applying a cuff to the upper arm. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in patients, not to analyze biological samples.
- Device Description: The description details the mechanical and electronic components used for non-invasive measurement, not for analyzing biological samples.
Therefore, this Blood Pressure Monitor falls under the category of 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 intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 450 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
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
children older than 3 years old or adults
Intended User / Care Setting
Home / Over-The-Counter Use
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
Clinical data was collected through four clinical studies according to ISO 81060-2:2018/Amd.1:2020.
- First clinical study (AC1636-01): 261 datasets were collected from 88 subjects (36 child subjects aged 9.8±5.1, 52 adult subjects aged 52.6±28.2).
- Second clinical study (AC2245-021): 258 datasets were collected from 86 subjects aged 49.1±18.5.
- Third clinical study (diabetes): 268 valid BP dataset pairs were collected from 90 diabetics.
- Fourth clinical study (pregnant): 270 valid datasets were collected from 91 subjects with 12-40 weeks pregnant (38.5% normotensive pregnant patients, 30.8% hypertensive pregnant and 30.8% preeclampsia).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Investigations and Non-clinical data (biocompatibility, electrical safety, electromagnetic compatibility, usability, wireless testing).
Sample Size: A total of 138 general adult subjects, 90 diabetic patients, and 91 pregnant women were included across four clinical studies. Specifically:
- First clinical study (AC1636-01): 88 subjects (36 children, 52 adults); 261 datasets.
- Second clinical study (AC2245-021): 86 subjects; 258 datasets.
- Third clinical study (diabetes): 90 diabetics; 268 valid BP dataset pairs.
- Fourth clinical study (pregnant): 91 pregnant subjects; 270 valid datasets.
Key Results: - First Clinical Study (AC1636-01): Mean differences between reference BPs and device readings were 0.25±3.02/0.96±2.54mmHg for SBP/DBP of criterion 1, and 0.25± 2.55/0.96±2.32mmHg for SBP/DBP of criterion 2. The device fulfilled both validation criteria 1 and 2 of ISO 81060-2:2018/Amd.1:2020.
- Second Clinical Study (AC2245-021): Mean differences between reference BPs and device readings were -1.1±3.51/-0.2±3.70mmHg for SBP/DBP of criterion 1, and -1.1± 2.22/-0.2±2.82mmHg for SBP/DBP of criterion 2. The device fulfilled both validation criteria 1 and 2 of ISO 81060-2:2018/Amd.1:2020.
- Third Clinical Study (diabetes): Mean differences between reference BPs and TMB-2092-G readings were -1.11 ± 3.50/-1.24± 3.21mmHg for SBP/DBP of criterion 1, and -1.11 ±3.19/-1.24±3.01 mm Hg for SBP/DBP of criterion 2. The device fulfilled both criteria 1 and 2 of ISO 81060-2:2018/Amd.1:2020 for diabetics.
- Fourth Clinical Study (pregnant): Mean differences between reference BPs and TMB-2092-G readings were -2.74 ±5.61/0.13 ±4.48 mmHg for SBP/DBP for criterion 1 and -2.74 ±5.11/0.13 ±4.02 mmHz for SBP/DBP for criterion 2. The device fulfilled validation criteria 2 of ISO 81060-2:2018/Amd.1:2020 for pregnant subjects.
- Biocompatibility: Tests included Cytotoxicity, Sensitization, and Irritation, in accordance with ISO 10993-1.
- Non-clinical data: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 60601-1-6, IEC 62366-1, and FDA Guidance for Non-Automated Sphygmomanometer. Wireless testing according to FCC 47 CFR Part22 subpart H, FCC 47 CFR Part24 subpart E, FCC 47 CFR Part27 subpart C, and the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 22, 2023
Guangdong Transtek Medical Electronics Co., Ltd. Jerry Fan, RA Manager Zone A, No. 105, Dongli Road, Torch Development District Zhongshan, Guangdong, China 528437
Re: K232621
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 28, 2023 Received: August 29, 2023
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/cdrb/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.
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).
1
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 820.70) 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations. please see Device (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).
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K232621
Device Name Blood Pressure Monitor
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
Type of Use (Select one or both, as applicable)
| 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
Prepared Date: 2023/10/19
1. Submission sponsor
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan Title: RA Manager E-mail: gt-rateam(@transtekcorp.com Tel: +86-157 2866 8528
2. Submission correspondent
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan E-mail: gt-rateam(@transtekcorp.com
Tel: +86-157 2866 8528
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | TMB-2092-G |
| Common Name | Blood Pressure Monitor |
| Regulatory Class | Class II |
| Product Code | DXN |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device Information 4.
| | Predicate Device 1
(Primary) | Predicate Device 2 | Predicate Device 3 |
|------------------|--------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------|
| Sponsor | Guangdong Transtek
Medical Electronics
Co., Ltd. | Guangdong Transtek
Medical Electronics Co.,
Ltd. | MICROLIFE
INTELLECTUAL
PROPERTY GMBH |
| Device Name | Blood Pressure monitor | Welch Allyn 901123
Digital Blood Pressure
Device | Microlife Upper Arm
Automatic Digital Blood
Pressure Monitor |
| Model | LS802-GS | ProBP™ 2000 | BP3KV1-5W |
| 510(k) Number | K202891 | K181832 | K222979 |
| Product Code | DXN | DXN | DXN |
| Regulation Class | Class II | Class II | Class II |
4
The Predicate Devices have not been subject to a design-related recall.
The Predicate Device 2 is to reference the safety and effectiveness of population at least 3 years of age or older, and the Predicate Device 3 is to reference the safety and effectiveness of adults with conditions of diabetes, pregnancy, or pre-eclampsia.
5. Device Description
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 450 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
Intended use & Indication for use 6.
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. It is intended indoor use only.
5
7. Comparison to the Predicate Device & Reference Device
| Features | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark |
|---|---|---|---|---|---|
| (Primary) | |||||
| Applicant | Guangdong Transtek Medical | ||||
| Electronics Co., Ltd. | Guangdong Transtek Medical | ||||
| Electronics Co., Ltd. | Guangdong Transtek Medical | ||||
| Electronics Co., Ltd. | MICROLIFE | ||||
| INTELLECTUAL | |||||
| PROPERTY GMBH | / | ||||
| Trade name | Blood pressure monitor | Blood pressure monitor | Welch Allyn 901123 Digital | ||
| Blood Pressure Device | Microlife Upper Arm | ||||
| Automatic Digital Blood | |||||
| Pressure Monitor | / | ||||
| Model | TMB-2092-G | LS802-GS | ProBPTM 2000 | BP3KV1-5W | / |
| 510(k) Number | Applying | K202891 | K181832 | K222979 | / |
| Classification | |||||
| Regulation | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | / |
| Classification and | |||||
| Code | Class II, | ||||
| DXN | Class II, | ||||
| DXN | Class II, | ||||
| DXN | Class II, | ||||
| DXN | Same | ||||
| Intended use | This Blood Pressure Monitor is | ||||
| intended for use in measuring | |||||
| blood pressure and pulse rate in | |||||
| patients with arm | |||||
| circumferences from 16 to 36 | |||||
| cm (6.3 to 14.1 inch) or 22 to | |||||
| 45cm (8.6 to 17.7 inch). | |||||
| Cuff model AC1636-01, arm | |||||
| circumference range is | |||||
| 16~36cm (6.3 to 14.1 inch), | |||||
| which is intended for children | |||||
| older than 3 years old or adults | The Transtek Blood Pressure | ||||
| Monitor is digital monitors | |||||
| intended for use in measuring | |||||
| blood pressure and heartbeat rate | |||||
| with arm circumference ranging | |||||
| from 22cm to 45cm (about 83/4"- | |||||
| 17½") | |||||
| It is intended for adult indoor use | |||||
| only. | The Welch Allyn ProBP 2000 | ||||
| Digital blood pressure device is | |||||
| intended for use in measuring | |||||
| blood pressure and heart rate in | |||||
| patients at least 3 years of age or | |||||
| older with arm circumferences | |||||
| between 15 cm to 55 cm | |||||
| (approximately 5.9 to 21.7 | |||||
| inches). | |||||
| The Welch Allyn ProBP 2000 | |||||
| automatically measures systolic | |||||
| and diastolic pressure and pulse | The Upper Arm Blood | ||||
| Pressure Monitor, Model | |||||
| BP3KV1-5W is a device | |||||
| intended to measure the | |||||
| systolic and diastolic | |||||
| blood pressure and pulse rate | |||||
| of an adult individual by | |||||
| using a non-invasive | |||||
| oscillometric technique in | |||||
| which an inflatable | |||||
| cuff is wrapped around the | |||||
| upper arm for a circumference | Similar | ||||
| Note 1 | |||||
| Features | Subject Device | Predicate Device 1 | |||
| (Primary) | Predicate Device 2 | Predicate Device 3 | Remark | ||
| without conditions of diabetes, | |||||
| pregnancy, or pre-eclampsia. | |||||
| Cuff model AC2245-021, arm | |||||
| circumference range is | |||||
| 22~45cm (8.6 to 17.7 inch), | |||||
| which is intended for adult | |||||
| population or those who with | |||||
| conditions of diabetes, | |||||
| pregnancy, or pre-eclampsia. | |||||
| It is intended indoor use only. | rate. The device is intended to be | ||||
| used by clinicians and medically | |||||
| qualified personnel. | range from 22 to 52cm. | ||||
| The device is suitable for use | |||||
| by adults, including adults | |||||
| with conditions of diabetes, | |||||
| pregnancy, or pre-eclampsia. | |||||
| The device detects the | |||||
| appearance of irregular | |||||
| heartbeat during measurement | |||||
| and gives a warning signal | |||||
| with the reading | |||||
| once the irregular heartbeat is | |||||
| detected. | |||||
| The device can be used in | |||||
| connection with a smart | |||||
| phone via Bluetooth or with a | |||||
| personal computer (PC) via | |||||
| USB. The | |||||
| measurement data can be | |||||
| transferred to a smart phone | |||||
| running the Microlife | |||||
| Connected Health+ mobile | |||||
| software (App) or | |||||
| a PC running the Microlife | |||||
| BP Analyzer+ (BPA+) | |||||
| software. | |||||
| Patient | Adults | adults with conditions of | Similar | ||
| at least 3 years of age or older | at least 3 years of age or older | ||||
| Features | Subject Device | Predicate Device 1 | |||
| (Primary) | Predicate Device 2 | Predicate Device 3 | Remark | ||
| Populations | diabetes, pregnancy, or pre- | ||||
| eclampsia | Note 1 | ||||
| Principle | This product uses the | ||||
| Oscillometric Measuring | |||||
| method to detect blood | |||||
| pressure. | |||||
| Before every measurement, the | |||||
| unit establishes a "zero | |||||
| pressure" equivalent to the | |||||
| atmospheric pressure. Then it | |||||
| starts inflating the arm cuff, | |||||
| meanwhile, the unit detects | |||||
| pressure oscillations generated | |||||
| by beat-to-beat pulsatile, which | |||||
| is used to determine the systolic | |||||
| and diastolic pressure, and also | |||||
| pulse rate. | This product uses the | ||||
| Oscillometric Measuring method | |||||
| to detect blood pressure. | |||||
| Before every measurement, the | |||||
| unit establishes a "zero pressure" | |||||
| equivalent to the atmospheric | |||||
| pressure. Then it starts inflating | |||||
| the arm cuff, meanwhile, the unit | |||||
| detects pressure oscillations | |||||
| generated by beat-to-beat | |||||
| pulsatile, which is used to | |||||
| determine the systolic and | |||||
| diastolic pressure, and also pulse | |||||
| rate. | The subject device uses the | ||||
| Oscillometric Measuring method | |||||
| to detect blood pressure. The | |||||
| device detects blood pressure | |||||
| measurement on the inflation. | |||||
| Before every measurement, the | |||||
| unit establishes a "zero pressure" | |||||
| equivalent to the air pressure. | |||||
| Then it starts inflating the cuff | |||||
| with the inflation rate 7mmHg/s, | |||||
| meanwhile, the device detects | |||||
| pressure oscillations generated by | |||||
| beat-to-beat pulsatile. Then the | |||||
| measurement finishes, and the | |||||
| device starts deflating. Deflation | |||||
| occurs in step intervals based on | |||||
| the cuff pressure. The deflation | |||||
| step range is about 6-12 mmHg. | |||||
| Higher cuff pressure corresponds | |||||
| to the larger pressure deflation | |||||
| step. | Oscillometric method | Same | |||
| Anatomical sites | Upper Arm | Upper Arm | Upper Arm | Upper Arm | Same |
| Where used | Home | Home | Medical Institutions | Home | Same |
| (hospital, home, | |||||
| Features | Subject Device | Predicate Device 1 | |||
| (Primary) | Predicate Device 2 | Predicate Device 3 | Remark | ||
| ambulance, etc.) | |||||
| Energy used and / | |||||
| or delivered | Battery mode: 6VDC (4 * 1.5V | ||||
| batteries) | |||||
| AC adapter mode: Input 100– | |||||
| 240V, 50-60Hz, 0.2A max; | |||||
| Output 6VDC, 1A | Battery mode: 6VDC (4 * 1.5V | ||||
| batteries) | |||||
| AC adapter mode: Input 100– | |||||
| 240V, 50-60Hz, 0.2A max; | |||||
| Output 6VDC, 1A | Battery mode: 6VDC (4 AA | ||||
| batteries) | |||||
| AC adapter mode: Input 100– | |||||
| 240V, 50-60Hz, 400mA; Output | |||||
| 6VDC, 1A | 4 AA batteries, | ||||
| Or AC adapter 6 V DC 600 | |||||
| mA | Same | ||||
| Human factors | Blood pressure | Blood pressure | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic | ||||
| blood pressure and pulse rate of | |||||
| patients at least 3 years of age | |||||
| or older, including irregular | |||||
| pulse rhythm detection | Measuring systolic and diastolic | ||||
| blood pressure and pulse rate of | |||||
| adult individual, including | |||||
| irregular pulse rhythm detection | Measuring systolic and diastolic | ||||
| blood pressure and pulse rate and | |||||
| adult patients at least 3 years of | |||||
| age or older. | The device intended to | ||||
| measure the systolic and | |||||
| diastolic blood pressure and | |||||
| pulse rate of an adult, who | |||||
| with conditions of diabetes, | |||||
| pregnancy, or preeclampsia. | |||||
| The device detects the | |||||
| appearance of irregular | |||||
| heartbeat during measurement | |||||
| and gives a warning signal | |||||
| with the reading once the | |||||
| irregular heartbeat is detected. | Same | ||||
| Biocompatibility | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Same |
| Operation | |||||
| Environment | Temperature: 5°C~ 40°C | ||||
| Relative Humidity: | |||||
| 15%~90%RH, | |||||
| Atmospheric Pressure: | |||||
| 70KPa~106KPa. | Temperature:5°C~ 40°C | ||||
| Relative Humidity: | |||||
| 15%~90%RH, | |||||
| Atmospheric: 70KPa~106KPa. | Temperature: 5°C to 40°C; | ||||
| Relative Humidity: ≤85% RH | |||||
| Atmospheric Pressure: 86kPa to | |||||
| 106kPa | +10°Cto +40°C | ||||
| at RH 15% to 90% | Same | ||||
| Storage and | Temperature: -4°F to +140°F (- | Temperature: -20°C to +60°C | Temperature: -20°C to 60°C | - 20°C to +55°C | Same |
| Features | Subject Device | Predicate Device 1 | |||
| (Primary) | Predicate Device 2 | Predicate Device 3 | Remark | ||
| transportation | |||||
| environment | 20°C to +60°C) | ||||
| Relative humidity: ≤93%, non- | |||||
| condensing, at a water vapour | |||||
| pressure up to 50hPa | |||||
| Atmospheric pressure: 500hPa t | |||||
| o 1060hPa | A relative humidity range of ≤ 93 | ||||
| %, non-condensing, at a water | |||||
| vapour pressure up to 50hPa | |||||
| An atmospheric pressure range of | |||||
| 500 hPa to 1060 hPa | Relative Humidity: 10% RH - | ||||
| 93% RH | |||||
| Atmospheric Pressure: 50kPa - | |||||
| 106kPa | at RH 15% to 90% | ||||
| Electrical safety | According to IEC60601-1-2 | ||||
| According to IEC60601-1 | According to IEC60601-1-2 | ||||
| According to IEC60601-1 | According to IEC60601-1-2 | ||||
| According to IEC60601-1 | According to IEC60601-1-2 | ||||
| According to IEC60601-1 | Same | ||||
| Blood Pressure | |||||
| Measurement | 0mmHg ~ 299mmHg, | ||||
| 5°C - 40°C within ±3mmHg | |||||
| (0.4kPa) | 0mmHg ~ 299mmHg, | ||||
| 5°C - 40°C within ±3mmHg | |||||
| (0.4kPa) | 0mmHg ~ 300mmHg, | ||||
| 5°C - 40°C within ±3mmHg | |||||
| (0.4kPa) | 0 to 299mmHg | ||||
| 10°C - 40°C within ± 3 | |||||
| mmHg or 2% of | |||||
| reading >200mmHg | Same | ||||
| Pulse rate | |||||
| measurement | 40-199 beat/minute, ±5% | 40 ~ 199 beat/minute, ±5% | 40 ~ 199 beat/minute, ±4% | 40 to 199 beats/minute | |
| ± 5 % of the reading | Same | ||||
| Cuff Deflation | Automatic deflation | Automatic deflation | Automatic deflation | Automatic deflation | Same |
| Memory Size | 500 | 60 | 99 | 99*2 | Different(1) |
| ) | |||||
| Wireless | GSM, LTE | LTE | No wireless function | Bluetooth | Similar |
| Note 2 |
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Justification of difference:
Note 1: The substantial differences of the patient populations and arm circumference ranging. Both subject device and predicate device 1 (K202891) are suitable for home use environment, and predicate device 2 (K181832) are suitable for children over three years old, and the arm circumference of predicate device 2 (K181832) is 15-55cm, which can circumference of the subject device from 16-45cm, and both subject device and predicate device 3 (K222979) are suitable with larger than 22cm arm circumference, adults with conditions of tiabetes, pregnancy, or pre-eclampsia. Meanwhile, all four of then are intended to be operated by adults. Both the predicate device are intended to be operated by adults. In addition, the subject device has been verified according to EC 60601-1-11 and IEC 60601-1-6, and it also has
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been validated according to ISO 80601-2-30 and ISO 81060-2. Thus, the subject device and the predicate devices do not raise different questions of safety and effectiveness.
Note 2: Both the predicate device 1(K202891) and subject device use they can transmit the measurement results through wireless. The subject device has more GSM functions than the which can be used as network compensation. The subject device has been verified according to IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-30 and ISO 81060-2. Thus, this difference does not raise different questions of safety and effectiveness.
Different (1): Although the memory sizes are different between subject device 1(K20289), the function is similar and they all meet the requirements of standard IEC 60601-1-2 and ISO 80601-2-30. This difference does not affect the normal measuring function of the blood pressure monitor. Thus, this difference does not raise different questions of safety and effectiveness.
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8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the subject 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 battery of testing included the following tests:
- . Cytotoxicity
- Sensitization .
- . Irritation
The subject device is considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data
The subject device has been tested according to the 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 requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 80601-2-30: Medical electrical equipment - Particular requirements for the 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
- . IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General requirements for safety – Collateral Standard: Usability.
- . IEC 62366-1: Medical devices – Application of usability engineering to medical devices.
- . FDA Guidance for Non-Automated Sphygmomanometer.
Wireless testing:
- GSM and LTE test according to FCC 47 CFR Part22 subpart H, FCC 47 CFR Part24 subpart E, FCC 47 CFR Part27 subpart C.
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)
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Clinical data
This device was tested to ISO 81060-2:2018/Amd.1:2020 Non- invasive sphygmomanometers -Part 2: Clinical investigation of intermittent automated measurement type AMENDMENT 1. Four clinical studies of this device consisted of 138 general adult subjects aged between three years and twelve years, 90 diabetic patients and 91 pregnant women.
The first clinical study (AC1636-01)
The clinical study aimed to validate the accuracy of TMB-2092-G blood pressure monitor with cuff AC1636-01. 261 datasets were collected from 88 subjects. There are 36 child subjects with aged 9.8±5.1, 52 adult subjects with aged 52.6±28.2. The mean differences between reference BPs and device readings were 0.25±3.02/0.96±2.54mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and 0.25± 2.55/0.96±2.32mmHg for SBP/DBP of criterion 2. TMB-2092-G with armbands of 16.0-36.0 cm fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
The second clinical study (AC2245-021)
The clinical study aimed to validate the accuracy of TMB-2092-G blood pressure monitor with cuff AC2245-021. 258 datasets were collected from 86 subjects with aged 49.1±18.5. The mean differences between reference BPs and device readings were -1.1±3.51/-0.2±3.70mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and -1.1± 2.22/-0.2±2.82mmHg for SBP/DBP of criterion 2. TMB-2092-G with armbands of 22.0-45.0 cm fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
The third clinical study (diabetes)
The purpose of the clinical study is to validate the accuracy of SUT (TMB-2092-G with cuff AC2245-021) in subjects with diabetes. 268 valid BP dataset pairs were collected from 90 diabetics. The mean differences between reference BPs and TMB-2092-G readings were -1.11 ± 3.50/-1.24± 3.21mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and -1.11 ±3.19/-1.24±3.01 mm Hg for SBP/DBP of criterion 2. TMB-2092-G BP monitor with cuff of 22-45cm for diabetics fulfilled both criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
The fourth clinical study (pregnant)
The purpose of the clinical study is to validate the accuracy of SUT (TMB-2092-G with cuff AC2245-021) in subjects with pregnant. 270 valid datasets were collected from 91 subjects with 12-40 weeks pregnant (38.5% normotensive pregnant patients, 30.8% hypertensive pregnant and 30.8% preeclampsia). The mean differences between reference BPs and TMB-2092-G readings were -2.74 ±5.61/0.13 ±4.48 mmHg for systolic BP (SBP)/diastolic BP (DBP) for criterion 1 and -2.74 ±5.11/0.13 ±4.02 mmHz for systolic BP (SBP)/diastolic BP (DBP) for criterion 2. The TMB-2092-G with cuff of 22-45cm intended use for pregnant fulfilled validation criteria 2 of the ISO 81060-2:2018/Amd.1:2020.
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Summary
Based on the clinical performance in the clinical studies, the blood pressure monitor model TMB-2092-G was found to have a safety and effectiveness profile that is similar to the predicate devices.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subjected device is substantially equivalent to the predicate device.