(121 days)
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½"). It is intended for adult indoor use only.
Blood Pressure Monitor TMB-2296-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HI-121H material. The two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
The provided text describes the 510(k) submission for a Blood Pressure Monitor (Model TMB-2296-BT) and its substantial equivalence to a predicate device. The information focuses on regulatory compliance, non-clinical, and clinical performance data, primarily related to the accuracy of blood pressure and pulse rate measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The main acceptance criteria for blood pressure monitors is typically defined by standards like ISO 81060-2. The document specifically states that the device was tested according to ISO 81060-2:2018/Amd.1:2020 and "fulfilled both validation criteria 1 and 2".
The ISO 81060-2 standard defines the following criteria:
- Criterion 1: The mean difference between the device readings and reference blood pressure (BP) measurements should be within ±5 mmHg, with a standard deviation of 8 mmHg or less.
- Criterion 2: For each subject, the difference between the device reading and the reference BP should be within 5 mmHg for at least 65% of the subjects, within 10 mmHg for at least 85% of the subjects, and within 15 mmHg for at least 95% of the subjects.
Here's a table summarizing the reported device performance against these generally accepted criteria (as defined by ISO 81060-2):
| Acceptance Criteria (ISO 81060-2) | Reported Device Performance (Study 1) | Reported Device Performance (Study 2) |
|---|---|---|
| Criterion 1 (Mean Difference & SD) | ||
| Mean difference ≤ ±5 mmHg | SBP: 0.21 mmHg, DBP: 0.66 mmHg | SBP: -1.62 mmHg, DBP: 0.12 mmHg |
| Standard deviation ≤ 8 mmHg | SBP: 2.59 mmHg, DBP: 2.12 mmHg | SBP: 2.80 mmHg, DBP: 3.01 mmHg |
| Criterion 2 (Within specified range) | ||
| Mean difference ≤ ±5 mmHg | SBP: 2.07 mmHg, DBP: 1.76 mmHg (presumably mean difference for criterion 2 check) | SBP: 2.35 mmHg, DBP: 2.60 mmHg (presumably mean difference for criterion 2 check) |
| Specific percentages (e.g., 65% within 5mmHg) | Explicit percentages not provided, but stated "fulfilled both validation criteria." | Explicit percentages not provided, but stated "fulfilled both validation criteria." |
Note: The document states "fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020," indicating that the device met the required statistical thresholds for accuracy. The provided mean differences and standard deviations are the direct results from the studies, demonstrating compliance with Criterion 1. While specific percentages for Criterion 2 are not listed, the statement of fulfillment confirms compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Study 1: 88 qualified subjects. From these, 262 datasets were collected.
- Study 2: 87 qualified subjects. From these, 259 datasets were collected.
- Data Provenance: Not explicitly stated regarding the country of origin. The studies are described as "clinical studies," implying a prospective design where the data was collected specifically for the validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts for establishing ground truth. For blood pressure monitor validation according to ISO 81060-2, ground truth is established by multiple independent reference measurements, typically performed by trained observers using a mercury sphygmomanometer or a validated auscultatory device. The standard requires specific training and quality control for these observers, but their specific "qualifications" (e.g., as radiologists) are not applicable or mentioned. The primary focus is on the accuracy of the reference measurements, not expert interpretation.
4. Adjudication Method for the Test Set
The document does not explicitly describe an "adjudication method" in the context of expert review, as ISO 81060-2 validation primarily relies on direct comparison of the device's readings against a set of rigorously collected reference measurements. Multiple readings are taken per subject, and statistical analyses (mean difference, standard deviation) are applied directly to these comparative measurements, rather than requiring expert adjudication of "results" in the typical sense of image interpretation. The standard outlines specific procedures for simultaneous measurements by multiple observers to minimize bias in reference readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in interpreting medical images (e.g., detecting lesions). For a blood pressure monitor, the study evaluates the device's direct measurement accuracy against a gold standard, not its comparative effectiveness with or without human assistance in interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical validation described in the document is a standalone performance study. The device, a blood pressure monitor, measures blood pressure and pulse rate directly and automatically. The reported performance metrics (mean difference, standard deviation) are of the device itself, without human intervention in the measurement process (beyond proper cuff placement and initiation of the measurement).
7. The Type of Ground Truth Used
The ground truth used was reference blood pressure measurements obtained through a validated clinical method (implied to be auscultatory or an equivalent gold standard method, as per ISO 81060-2) against which the automated device's readings were compared. This is a form of "outcomes data" in the sense of comparing the device's output to a clinically accepted reference measurement for the physiological parameter it is designed to measure.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For a blood pressure monitor that uses an oscillometric method, the device's algorithm for determining BP values from oscillation waveforms is pre-programmed/calibrated. It's not typically a machine learning model that undergoes a 'training phase' on a distinct dataset in the way an AI image analysis algorithm would. The clinical studies described are for validation (test set performance) of the final device, not for training internal algorithms.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a traditional "training set" in the context of an AI/ML algorithm that would require a separate ground truth establishment for training. The ground truth for the device's internal calibration/oscillometric algorithm (if applicable) would have been established during its development and calibration phases, likely using established physiological models and comparisons to known accurate pressure measurements, but these details are not part of this 510(k) submission. The clinical studies establish the accuracy of the final, already "trained" or calibrated, device.
{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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 31, 2024
Guangdong Transtek Medical Electronics Co., Ltd. Jerry Fan RA Manager Zone A, No. 105, Dongli Road, Torch Development District Zhongshan, Guangdong 528437 China
Re: K240254
Trade/Device Name: Blood Pressure Monitor (TMB-2296-BT) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Mav 9, 2024 Received: May 9, 2024
Dear Jerry Fan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
Blood Pressure Monitor (TMB-2296-BT)
Indications for Use (Describe)
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8% - 12½") or 22cm to 42cm (about 83/4"-161/2").
It is intended for adult indoor use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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."
{4}------------------------------------------------
510(k) Summary
Prepared in accordance with the requirement of 21 CFR Part 807.92
Prepared Date: 03/30/2024
| 1. Submitter | |
|---|---|
| Name: | Guangdong Transtek Medical Electronics Co., Ltd. |
| Address: | Zone A, No. 105, Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong, China |
| Contact: | Jerry Fan |
| Title: | RA Manager |
| E-mail: | gt-rateam@transtekcorp.com |
| TEL: | +86 15728668528 |
2. Subject Device
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | TMB-2296-BT |
| Common Name | Blood Pressure Monitor |
| Classification | Class II |
| Product Code | DXN |
| Submission Type | Traditional 510(k) |
3. Predicate Device
| Manufacturer: | Guangdong Transtek Medical Electronics Co., Ltd. |
|---|---|
| Device Name / Model: | Blood Pressure Monitor / TMB-2266 |
| 510(k) Number: | K232713 |
| Classification | Class II |
| Product Code | DXN |
Device Description 4.
Blood Pressure Monitor TMB-2296-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors,
also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HI-121H material. The two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor.
{5}------------------------------------------------
K240254
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.
5. Indications for use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm (about 8¾"-12½″) or 22cm to 42cm (about 8¾"-16½") .
It is intended for adult indoor use only.
| Item | Subject Device | Predicate Device | Note |
|---|---|---|---|
| 510(k) | Applying | K232713 | / |
| Model | TMB-2296-BT | TMB-2266 | / |
| Device Name | Blood Pressure Monitor | Blood Pressure Monitor | Same |
| Product Code | DXN | DXN | Same |
| Classification | Class II | Class II | Same |
| Regulation # | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Type of Use | OTC | OTC | Same |
| Intended Use /Indication for Use | This Blood Pressure Monitor is adigital monitor intended for use inmeasuring blood pressure and pulserate with arm circumference rangingfrom 22cm to 32cm (about$8\frac{3}{4}"-12\frac{1}{2}"$ ) or 22cm to 42cm (about$8\frac{3}{4}"-16\frac{1}{2}"$ ).It is intended for adult indoor use | This Blood Pressure Monitor is adigital monitor intended for use inmeasuring blood pressure andpulse rate with arm circumferenceranging from 16cm to 36cm (about$6\frac{1}{3}"-14\frac{1}{5}"$ ), 22cm to 32cm (about$8\frac{3}{4}"-12\frac{1}{2}"$ ), 22cm to 42cm (about$8\frac{3}{4}"-16\frac{1}{2}"$ ) or 22cm to 45cm | Similar,refer toNote 1. |
| only. | (about 8¾"-17¾").The cuff with arm circumferencerange of 16 | ||
| Similar, | |||
| Patient Population | Adult | Population at or over 6 years old | refer toNote 2. |
| Principle | Oscillometric method | Oscillometric method | Same |
| Anatomical Site | Upper Arm | Upper Arm | Same |
| Where used(hospital, home,ambulance, etc.) | Home | Home | Same |
| Power Supply | 3.6V 1000mAH Built-in rechargeableli-polymer battery | 4*1.5V AAA batteries;Or by DC 5V adapter | Similar,refer toNote 3. |
| Human Factors | Blood pressure | Blood pressure | Same |
| Measurement Items | Measuring systolic and diastolicblood pressure and pulse rate ofintended population, includingirregular pulse rhythm detection. | Measuring systolic and diastolicblood pressure and pulse rate ofadult individual, includingirregular pulse rhythm detection. | Same |
| Cuff Deflation | Automatic deflation | Automatic deflation | Same |
| Blood PressureMeasurement | 0mmHg ~ 299mmHg,5°C - 40°C within ±3mmHg (0.4kPa) | 0mmHg ~ 299mmHg,5°C - 40°C within ±3mmHg(0.4kPa) | Same |
| Pulse RateMeasurement | 40-199 beat/minute, ±5% | 40-199 beat/minute, ±5% | Same |
| Display | LCD | LCD | Same |
| Memory | 2×199 | 2×199 | Same |
| OperationEnvironment | Temperature: 5°C~40°C;Relative Humidity: 15% | Temperature: 5°C~40°C;Relative Humidity: 15% | Same |
| Storage andtransportationEnvironment | Temperature: -20℃ | Temperature: -20℃ | Same |
| Performance | Compliance with IEC 80601-2-30 | Compliance with IEC 80601-2-30 | Same |
| Clinical | Compliance with ISO 81060-2 | Compliance with ISO 81060-2 | Same |
| Biocompatibility | All patient contact parts meet therequirements of ISO 10993-1/5/10/23 | All patient contact parts meet therequirements of ISO10993-1/5/10/23 | Same |
| Electrical Safety | Compliance with IEC 60601-1 andIEC 60601-1-11 | Compliance with IEC 60601-1 andIEC 60601-1-11 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Wireless | Bluetooth | Bluetooth | Same |
Comparison to Predicate Device 6.
{6}------------------------------------------------
{7}------------------------------------------------
Justification for difference:
Note 1:
The subject device shares a similar intended use with the predicate device, and the substantial difference between the subject device and the predicate device regarding the intended use lies in the arm circumference range and patient population. However, the range of the intended patient population of the subject device is within that of the predicate device, and used on its intended patient population with the intended arm circumference, the subject device with matched cuffs has also been validated according to IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Note 2:
Although there are some differences between the intended patient population of the subject device and the predicate device, the range of the intended patient population of the subject device is within that of the predicate device, and used on its intended patient population with the intended arm circumference, the subject device with matched cuffs has also been validated according to IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Note 3:
Although the power supply of subject device is different with predicate device,the subject device with its matched battery has been validated according to IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 and IEC 60601-1-2. Thus, the differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.
Conclusion:
{8}------------------------------------------------
Based on the comparison and analysis in this submission, it can be concluded that: the subject device is substantially equivalent to the predicate device and reference device regarding safety and effectiveness.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility testing:
The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing includes the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject device is considered as surface contacting for a duration of exceed 24 hours but not exceed 30 days.
Non-clinical data
The device has been tested according to following standards:
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirement for basic safety ● and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 80601-2-30: Medical electrical equipment – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
- IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- FDA Guidance for Non-Automated Sphygmomanometer
Wireless testing:
- . 47 CFR Part 15, Subpart C
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food . and Drug Administration Staff (August 14, 2013)
Clinical data
The device was tested according to ISO 81060-2:2018/Amd.1:2020. Non-invasive sphygmomanometers - Part 2: Clinical validation of intermittent automated measurement type. Two clinical studies were performed on the device matching with different models of cuff. The study population consisted of 88 and 87 qualified subjects respectively. 262 datasets were collected from 88 subjects with aged 51.9±16.3. The mean differences between reference BPs and
{9}------------------------------------------------
device readings were 0.21 ± 2.59/0.66 ± 2.12mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and 0.21 ± 2.07/0.66 ± 1.76mmHg for SBP/DBP of criterion 2. 259 datasets were collected from 87 subjects with aged 59.3±11.7. The mean differences between reference BPs and device readings were -1.62±2.80/0.12±3.01mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and -1.62 ± 2.35/0.12 ± 2.60mmHg for SBP/DBP of criterion 2. TMB-2296-BT fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
8. Conclusion
Based on the information presented in this 510(k) premarket notification submission, a conclusion can be drawn that the proposed subject device is considered substantially equivalent to the predicate device. The differences between the subject device and the predicate devices were successfully tested with relevant standards and FDA guidance, and do not affect equivalent safety and effectiveness or raise new issues concerning safety and effectiveness.
§ 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).