(85 days)
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.
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.
The provided text describes the acceptance criteria and study proving the device meets those criteria for a Blood Pressure Monitor.
Here's the breakdown of the information requested:
Acceptance Criteria and Reported Device Performance
The clinical performance acceptance criteria for this blood pressure monitor are based on the ISO 81060-2:2018/Amd.1:2020 standard, specifically Criterion 1 and Criterion 2. These criteria define the acceptable mean difference and standard deviation between the device readings and reference blood pressure measurements.
Table of Acceptance Criteria and Reported Device Performance
| Criterion | Measurement | Acceptance Criteria (Mean Difference ± Standard Deviation) | Reported Performance (Mean Difference ± Standard Deviation) | Study(s) this applies to |
|---|---|---|---|---|
| Criterion 1 | SBP | ≤ ±5 mmHg | ||
| DBP | ≤ ±5 mmHg | |||
| Criterion 2 | SBP & DBP | Standard deviation of differences ≤ 8 mmHg | ||
| The percentage of differences within 5 mmHg: at least 65% | ||||
| The percentage of differences within 10 mmHg: at least 85% | ||||
| The percentage of differences within 15 mmHg: at least 95% |
Detailed Reported Performance from Clinical Studies:
| Clinical Study | Cuff Model | Subjects | SBP Mean Difference ± SD (Criterion 1) | DBP Mean Difference ± SD (Criterion 1) | SBP Mean Difference ± SD (Criterion 2) | DBP Mean Difference ± SD (Criterion 2) | Fulfilled Criteria (ISO 81060-2:2018/Amd.1:2020) |
|---|---|---|---|---|---|---|---|
| First Clinical Study (AC1636-01) | AC1636-01 | 36 children (aged 9.8±5.1) and 52 adults (aged 52.6±28.2) | 0.25 ± 3.02 mmHg | 0.96 ± 2.54 mmHg | 0.25 ± 2.55 mmHg | 0.96 ± 2.32 mmHg | Both Criterion 1 and 2 and |
| Second Clinical Study (AC2245-021) | AC2245-021 | 86 subjects (aged 49.1±18.5) | -1.1 ± 3.51 mmHg | -0.2 ± 3.70 mmHg | -1.1 ± 2.22 mmHg | -0.2 ± 2.82 mmHg | Both Criterion 1 and 2 |
| Third Clinical Study (diabetes) | AC2245-021 | 90 diabetic patients | -1.11 ± 3.50 mmHg | -1.24 ± 3.21 mmHg | -1.11 ± 3.19 mmHg | -1.24 ± 3.01 mmHg | Both Criterion 1 and 2 |
| Fourth Clinical Study (pregnant) | AC2245-021 | 91 pregnant women (12-40 weeks pregnant: 38.5% normotensive, 30.8% hypertensive, 30.8% preeclampsia) | -2.74 ± 5.61 mmHg | 0.13 ± 4.48 mmHg | -2.74 ± 5.11 mmHg | 0.13 ± 4.02 mmHg | Criterion 2 (Only Criterion 2 for pregnant as per standard) |
| The text indicates that the device fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020 for the first three studies and fulfilled validation criteria 2 for the pregnant patient study. This implies the reported mean differences and standard deviations were within the limits specified by the standard. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Total Clinical Study Subjects: 138 general adult subjects (aged 3-12 years for children and general adults), 90 diabetic patients, and 91 pregnant women.
- First Clinical Study (AC1636-01): 261 datasets collected from 88 subjects (36 children and 52 adults)
- Second Clinical Study (AC2245-021): 258 datasets collected from 86 subjects (general adults)
- Third Clinical Study (diabetes): 268 valid BP dataset pairs collected from 90 diabetic patients
- Fourth Clinical Study (pregnant): 270 valid datasets collected from 91 pregnant subjects
- Data Provenance: Not explicitly stated, but typically clinical studies for regulatory submissions are prospective. The location (country of origin) is not mentioned in the provided text, but the manufacturer is based in China.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth (reference blood pressure measurements) was established by standard clinical methods using a reference device or trained observers as required by ISO 81060-2:2018/Amd.1:2020. However, the exact number and qualifications of experts (e.g., radiologists, cardiologists) that would typically establish such ground truth in the context of blood pressure measurement (e.g., supervising the auscultatory method or reading a reference device) are not specified in the provided text. The standard usually requires trained observers for the reference measurements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not explicitly state an adjudication method. For blood pressure measurement validation studies, this typically involves simultaneously taking measurements with the device under test and a calibrated reference device (or multiple trained observers using the auscultatory method). The ISO 81060-2 standard outlines the methodology for obtaining reference measurements, often involving multiple mercury sphygmomanometers and trained observers. No further details on adjudication are provided.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a study to validate a blood pressure monitor, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes. The tests described are for the standalone performance of the blood pressure monitor, which uses an oscillometric algorithm to measure blood pressure without active human interpretation during the measurement process itself, beyond initiation and cuff placement. The performance data presented are for the device (algorithm) measuring blood pressure against a reference.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by reference blood pressure measurements obtained from clinical studies, presumably following the methodology detailed in ISO 81060-2:2018/Amd.1:2020. This standard typically relies on simultaneously recording blood pressure using a validated reference method (e.g., auscultatory method by trained observers using mercury sphygmomanometers, or other validated reference devices) and comparing it to the device under test.
-
The sample size for the training set:
- The document describes clinical validation studies (test sets) for the device. It does not provide information on the sample size used for the training set for the device's underlying algorithm development. Blood pressure monitors often use long-established algorithms, but if machine learning was used, the training set details are not provided.
-
How the ground truth for the training set was established:
- Since details of a specific training set are not provided, information on how its ground truth was established is also not available in the provided text.
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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 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).
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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
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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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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 TranstekMedical ElectronicsCo., Ltd. | Guangdong TranstekMedical Electronics Co.,Ltd. | MICROLIFEINTELLECTUALPROPERTY GMBH |
| Device Name | Blood Pressure monitor | Welch Allyn 901123Digital Blood PressureDevice | Microlife Upper ArmAutomatic Digital BloodPressure 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 |
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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.
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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 MedicalElectronics Co., Ltd. | Guangdong Transtek MedicalElectronics Co., Ltd. | Guangdong Transtek MedicalElectronics Co., Ltd. | MICROLIFEINTELLECTUALPROPERTY GMBH | / |
| Trade name | Blood pressure monitor | Blood pressure monitor | Welch Allyn 901123 DigitalBlood Pressure Device | Microlife Upper ArmAutomatic Digital BloodPressure Monitor | / |
| Model | TMB-2092-G | LS802-GS | ProBPTM 2000 | BP3KV1-5W | / |
| 510(k) Number | Applying | K202891 | K181832 | K222979 | / |
| ClassificationRegulation | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | 21CRF 870.1130 | / |
| Classification andCode | Class II,DXN | Class II,DXN | Class II,DXN | Class II,DXN | Same |
| Intended use | This Blood Pressure Monitor isintended for use in measuringblood pressure and pulse rate inpatients with armcircumferences from 16 to 36cm (6.3 to 14.1 inch) or 22 to45cm (8.6 to 17.7 inch).Cuff model AC1636-01, armcircumference range is16~36cm (6.3 to 14.1 inch),which is intended for childrenolder than 3 years old or adults | The Transtek Blood PressureMonitor is digital monitorsintended for use in measuringblood pressure and heartbeat ratewith arm circumference rangingfrom 22cm to 45cm (about 83/4"-17½")It is intended for adult indoor useonly. | The Welch Allyn ProBP 2000Digital blood pressure device isintended for use in measuringblood pressure and heart rate inpatients at least 3 years of age orolder with arm circumferencesbetween 15 cm to 55 cm(approximately 5.9 to 21.7inches).The Welch Allyn ProBP 2000automatically measures systolicand diastolic pressure and pulse | The Upper Arm BloodPressure Monitor, ModelBP3KV1-5W is a deviceintended to measure thesystolic and diastolicblood pressure and pulse rateof an adult individual byusing a non-invasiveoscillometric technique inwhich an inflatablecuff is wrapped around theupper arm for a circumference | SimilarNote 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, armcircumference range is22~45cm (8.6 to 17.7 inch),which is intended for adultpopulation or those who withconditions of diabetes,pregnancy, or pre-eclampsia.It is intended indoor use only. | rate. The device is intended to beused by clinicians and medicallyqualified personnel. | range from 22 to 52cm.The device is suitable for useby adults, including adultswith conditions of diabetes,pregnancy, or pre-eclampsia.The device detects theappearance of irregularheartbeat during measurementand gives a warning signalwith the readingonce the irregular heartbeat isdetected.The device can be used inconnection with a smartphone via Bluetooth or with apersonal computer (PC) viaUSB. Themeasurement data can betransferred to a smart phonerunning the MicrolifeConnected Health+ mobilesoftware (App) ora PC running the MicrolifeBP 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 theOscillometric Measuringmethod to detect bloodpressure.Before every measurement, theunit establishes a "zeropressure" equivalent to theatmospheric pressure. Then itstarts inflating the arm cuff,meanwhile, the unit detectspressure oscillations generatedby beat-to-beat pulsatile, whichis used to determine the systolicand diastolic pressure, and alsopulse rate. | This product uses theOscillometric Measuring methodto detect blood pressure.Before every measurement, theunit establishes a "zero pressure"equivalent to the atmosphericpressure. Then it starts inflatingthe arm cuff, meanwhile, the unitdetects pressure oscillationsgenerated by beat-to-beatpulsatile, which is used todetermine the systolic anddiastolic pressure, and also pulserate. | The subject device uses theOscillometric Measuring methodto detect blood pressure. Thedevice detects blood pressuremeasurement on the inflation.Before every measurement, theunit establishes a "zero pressure"equivalent to the air pressure.Then it starts inflating the cuffwith the inflation rate 7mmHg/s,meanwhile, the device detectspressure oscillations generated bybeat-to-beat pulsatile. Then themeasurement finishes, and thedevice starts deflating. Deflationoccurs in step intervals based onthe cuff pressure. The deflationstep range is about 6-12 mmHg.Higher cuff pressure correspondsto the larger pressure deflationstep. | 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 * 1.5Vbatteries)AC adapter mode: Input 100–240V, 50-60Hz, 0.2A max;Output 6VDC, 1A | Battery mode: 6VDC (4 * 1.5Vbatteries)AC adapter mode: Input 100–240V, 50-60Hz, 0.2A max;Output 6VDC, 1A | Battery mode: 6VDC (4 AAbatteries)AC adapter mode: Input 100–240V, 50-60Hz, 400mA; Output6VDC, 1A | 4 AA batteries,Or AC adapter 6 V DC 600mA | Same |
| Human factors | Blood pressure | Blood pressure | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolicblood pressure and pulse rate ofpatients at least 3 years of ageor older, including irregularpulse rhythm detection | Measuring systolic and diastolicblood pressure and pulse rate ofadult individual, includingirregular pulse rhythm detection | Measuring systolic and diastolicblood pressure and pulse rate andadult patients at least 3 years ofage or older. | The device intended tomeasure the systolic anddiastolic blood pressure andpulse rate of an adult, whowith conditions of diabetes,pregnancy, or preeclampsia.The device detects theappearance of irregularheartbeat during measurementand gives a warning signalwith the reading once theirregular 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 |
| OperationEnvironment | Temperature: 5°C~ 40°CRelative Humidity:15% | Temperature:5°C~ 40°CRelative Humidity:15% | Temperature: 5°C to 40°C;Relative Humidity: ≤85% RHAtmospheric Pressure: 86kPa to106kPa | +10°Cto +40°Cat 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 |
| transportationenvironment | 20°C to +60°C)Relative humidity: ≤93%, non-condensing, at a water vapourpressure up to 50hPaAtmospheric pressure: 500hPa to 1060hPa | A relative humidity range of ≤ 93%, non-condensing, at a watervapour pressure up to 50hPaAn atmospheric pressure range of500 hPa to 1060 hPa | Relative Humidity: 10% RH -93% RHAtmospheric Pressure: 50kPa -106kPa | at RH 15% to 90% | |
| Electrical safety | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | Same |
| Blood PressureMeasurement | 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 299mmHg10°C - 40°C within ± 3mmHg or 2% ofreading >200mmHg | Same |
| Pulse ratemeasurement | 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 | SimilarNote 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.
§ 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).