Blood pressure monitor

K232621 · Guangdong Transtek Medical Electronics Co., Ltd. · DXN · Nov 22, 2023 · Cardiovascular

Device Facts

• Record ID: K232621
• Device Name: Blood pressure monitor
• Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

Device measures systolic/diastolic blood pressure and pulse rate via non-invasive oscillometric method; electronic pressure sensor detects cuff pressure oscillations; microprocessor calculates results. Intended for home use by patients. Main unit (ABS housing) connects to inflatable cuff (polyester shell); includes LCD, operation keys, and electromagnetic deflation valve. Device features cellular wireless (GSM/LTE) for data transmission of measurements (BP, pulse, date, time) to receiving end. Healthcare providers/patients view results on LCD; data supports monitoring of BP trends. Benefits include convenient, automated home BP tracking for diverse populations, including those with specific clinical conditions like diabetes or pregnancy.

Clinical Evidence

Four clinical studies conducted per ISO 81060-2:2018/Amd.1:2020. Study 1 (n=88, children/adults): SBP/DBP mean diff 0.25±3.02/0.96±2.54 mmHg. Study 2 (n=86, adults): SBP/DBP mean diff -1.1±3.51/-0.2±3.70 mmHg. Study 3 (n=90, diabetics): SBP/DBP mean diff -1.11±3.50/-1.24±3.21 mmHg. Study 4 (n=91, pregnant): SBP/DBP mean diff -2.74±5.61/0.13±4.48 mmHg. All studies met ISO validation criteria.

Technological Characteristics

Oscillometric non-invasive sphygmomanometer. Materials: ABS (housing), polyester (cuff shell). Power: 6VDC (4x1.5V batteries) or AC adapter. Connectivity: Cellular (GSM/LTE). Standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 60601-1-6, ISO 10993-1. Biocompatibility: Surface contacting <24h.

Indications for Use

Indicated for measuring blood pressure and pulse rate in patients aged 3+ years with arm circumferences 16-45cm. Cuff AC1636-01 for children >3 years or adults without diabetes, pregnancy, or pre-eclampsia. Cuff AC2245-021 for adults, including those with diabetes, pregnancy, or pre-eclampsia.

Regulatory Classification

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.

Predicate Devices

• Blood Pressure monitor (K202891)
• Welch Allyn 901123 Digital Blood Pressure Device (K181832)
• Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K222979)

Submission Summary (Full Text)

{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 [phone] 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [phone]

### 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: [phone]

| 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<br>(Primary) | Predicate Device 2 | Predicate Device 3 |
|------------------|--------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------|
| Sponsor | Guangdong Transtek<br>Medical Electronics<br>Co., Ltd. | Guangdong Transtek<br>Medical Electronics Co.,<br>Ltd. | MICROLIFE<br>INTELLECTUAL<br>PROPERTY GMBH |
| Device Name | Blood Pressure monitor | Welch Allyn 901123<br>Digital Blood Pressure<br>Device | Microlife Upper Arm<br>Automatic Digital Blood<br>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<br>Electronics Co., Ltd. | Guangdong Transtek Medical<br>Electronics Co., Ltd. | Guangdong Transtek Medical<br>Electronics Co., Ltd. | MICROLIFE<br>INTELLECTUAL<br>PROPERTY GMBH | / |
| Trade name | Blood pressure monitor | Blood pressure monitor | Welch Allyn 901123 Digital<br>Blood Pressure Device | Microlife Upper Arm<br>Automatic Digital Blood<br>Pressure Monitor | / |
| Model | TMB-2092-G | LS802-GS | ProBPTM 2000 | BP3KV1-5W | / |
| 510(k) Number | Applying | K202891 | K181832 | K222979 | / |
| Classification<br>Regulation | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | / |
| Classification and<br>Code | Class II,<br>DXN | Class II,<br>DXN | Class II,<br>DXN | Class II,<br>DXN | Same |
| Intended use | This Blood Pressure Monitor is<br>intended for use in measuring<br>blood pressure and pulse rate in<br>patients with arm<br>circumferences from 16 to 36<br>cm (6.3 to 14.1 inch) or 22 to<br>45cm (8.6 to 17.7 inch).<br>Cuff model AC1636-01, arm<br>circumference range is<br>16~36cm (6.3 to 14.1 inch),<br>which is intended for children<br>older than 3 years old or adults | The Transtek Blood Pressure<br>Monitor is digital monitors<br>intended for use in measuring<br>blood pressure and heartbeat rate<br>with arm circumference ranging<br>from 22cm to 45cm (about 83/4"-<br>17½")<br>It is intended for adult indoor use<br>only. | The Welch Allyn ProBP 2000<br>Digital blood pressure device is<br>intended for use in measuring<br>blood pressure and heart rate in<br>patients at least 3 years of age or<br>older with arm circumferences<br>between 15 cm to 55 cm<br>(approximately 5.9 to 21.7<br>inches).<br>The Welch Allyn ProBP 2000<br>automatically measures systolic<br>and diastolic pressure and pulse | The Upper Arm Blood<br>Pressure Monitor, Model<br>BP3KV1-5W is a device<br>intended to measure the<br>systolic and diastolic<br>blood pressure and pulse rate<br>of an adult individual by<br>using a non-invasive<br>oscillometric technique in<br>which an inflatable<br>cuff is wrapped around the<br>upper arm for a circumference | Similar<br>Note 1 |
| Features | Subject Device | Predicate Device 1<br>(Primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | without conditions of diabetes,<br>pregnancy, or pre-eclampsia.<br>Cuff model AC2245-021, arm<br>circumference range is<br>22~45cm (8.6 to 17.7 inch),<br>which is intended for adult<br>population or those who with<br>conditions of diabetes,<br>pregnancy, or pre-eclampsia.<br>It is intended indoor use only. | | rate. The device is intended to be<br>used by clinicians and medically<br>qualified personnel. | range from 22 to 52cm.<br>The device is suitable for use<br>by adults, including adults<br>with conditions of diabetes,<br>pregnancy, or pre-eclampsia.<br>The device detects the<br>appearance of irregular<br>heartbeat during measurement<br>and gives a warning signal<br>with the reading<br>once the irregular heartbeat is<br>detected.<br>The device can be used in<br>connection with a smart<br>phone via Bluetooth or with a<br>personal computer (PC) via<br>USB. The<br>measurement data can be<br>transferred to a smart phone<br>running the Microlife<br>Connected Health+ mobile<br>software (App) or<br>a PC running the Microlife<br>BP Analyzer+ (BPA+)<br>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<br>(Primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| Populations | | | | diabetes, pregnancy, or pre-<br>eclampsia | Note 1 |
| Principle | This product uses the<br>Oscillometric Measuring<br>method to detect blood<br>pressure.<br>Before every measurement, the<br>unit establishes a "zero<br>pressure" equivalent to the<br>atmospheric pressure. Then it<br>starts inflating the arm cuff,<br>meanwhile, the unit detects<br>pressure oscillations generated<br>by beat-to-beat pulsatile, which<br>is used to determine the systolic<br>and diastolic pressure, and also<br>pulse rate. | This product uses the<br>Oscillometric Measuring method<br>to detect blood pressure.<br>Before every measurement, the<br>unit establishes a "zero pressure"<br>equivalent to the atmospheric<br>pressure. Then it starts inflating<br>the arm cuff, meanwhile, the unit<br>detects pressure oscillations<br>generated by beat-to-beat<br>pulsatile, which is used to<br>determine the systolic and<br>diastolic pressure, and also pulse<br>rate. | The subject device uses the<br>Oscillometric Measuring method<br>to detect blood pressure. The<br>device detects blood pressure<br>measurement on the inflation.<br>Before every measurement, the<br>unit establishes a "zero pressure"<br>equivalent to the air pressure.<br>Then it starts inflating the cuff<br>with the inflation rate 7mmHg/s,<br>meanwhile, the device detects<br>pressure oscillations generated by<br>beat-to-beat pulsatile. Then the<br>measurement finishes, and the<br>device starts deflating. Deflation<br>occurs in step intervals based on<br>the cuff pressure. The deflation<br>step range is about 6-12 mmHg.<br>Higher cuff pressure corresponds<br>to the larger pressure deflation<br>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<br>(Primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| ambulance, etc.) | | | | | |
| Energy used and /<br>or delivered | Battery mode: 6VDC (4 * 1.5V<br>batteries)<br>AC adapter mode: Input 100–<br>240V, 50-60Hz, 0.2A max;<br>Output 6VDC, 1A | Battery mode: 6VDC (4 * 1.5V<br>batteries)<br>AC adapter mode: Input 100–<br>240V, 50-60Hz, 0.2A max;<br>Output 6VDC, 1A | Battery mode: 6VDC (4 AA<br>batteries)<br>AC adapter mode: Input 100–<br>240V, 50-60Hz, 400mA; Output<br>6VDC, 1A | 4 AA batteries,<br>Or AC adapter 6 V DC 600<br>mA | Same |
| Human factors | Blood pressure | Blood pressure | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic<br>blood pressure and pulse rate of<br>patients at least 3 years of age<br>or older, including irregular<br>pulse rhythm detection | Measuring systolic and diastolic<br>blood pressure and pulse rate of<br>adult individual, including<br>irregular pulse rhythm detection | Measuring systolic and diastolic<br>blood pressure and pulse rate and<br>adult patients at least 3 years of<br>age or older. | The device intended to<br>measure the systolic and<br>diastolic blood pressure and<br>pulse rate of an adult, who<br>with conditions of diabetes,<br>pregnancy, or preeclampsia.<br>The device detects the<br>appearance of irregular<br>heartbeat during measurement<br>and gives a warning signal<br>with the reading once the<br>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<br>Environment | Temperature: 5°C~ 40°C<br>Relative Humidity:<br>15%~90%RH,<br>Atmospheric Pressure:<br>70KPa~106KPa. | Temperature:5°C~ 40°C<br>Relative Humidity:<br>15%~90%RH,<br>Atmospheric: 70KPa~106KPa. | Temperature: 5°C to 40°C;<br>Relative Humidity: ≤85% RH<br>Atmospheric Pressure: 86kPa to<br>106kPa | +10°Cto +40°C<br>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<br>(Primary) | Predicate Device 2 | Predicate Device 3…