Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches).

These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

Contraindications:

This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.

These device are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Description

Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Transtek Device RPM-BP100SBP and H-BP100SBP are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The three devices are the same except brand name, model number and the layout of labeling.

Measurement method to define systolic and diastolic pressure is similar to the ausculatory 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

These devices also compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.

These devices include the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. ABS is used to outer housing of the main unit. The three preformed cuff units, which are applicable to arm circumference between 15-24cm, 22-42cm and 40-54cm to meet different population's need. The subject device is powered by four AA alkaline batteries or by a DC 6V 1AA adapter.

These devices embed a Bluetooth module that allows it to connect with nearby BT receiving terminal (such as iphone, ipad). Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the pair-up BT terminal automatically. Thus users can display, manage and storage measurement data more easily.

AI/ML Overview

The requested information is related to an automated non-invasive sphygmomanometer (blood pressure monitor), not an AI device. Therefore, some of the questions, particularly those related to experts, ground truth methods for AI, MRMC studies, and separate training/test sets for AI, are not directly applicable.

However, I can extract the information relevant to the clinical validation of this medical device, which is typically a performance study comparing the device's measurements against a reference standard.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The clinical validation was performed against the standard AAMI/ANSI/ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. While the document states that the device "meet the requirements of AAMI/ANSVISO 81060-2:2013," it does not explicitly list the numerical acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure measurements).

Table of Acceptance Criteria and Reported Device Performance:

Criterion	Acceptance Criteria (Specified by AAMI/ANSI/ISO 81060-2:2013)	Reported Device Performance (TMB-1591-A, RPM-BP100SBP, H-BP100SBP)
Mean Difference between Device and Reference (Systolic BP)	(Not explicitly stated in document, but standard specifies limits, typically within ±5 mmHg)	Device meets requirements of AAMI/ANSI/ISO 81060-2:2013
Standard Deviation of Differences (Systolic BP)	(Not explicitly stated in document, but standard specifies limits, typically ≤ 8 mmHg)	Device meets requirements of AAMI/ANSI/ISO 81060-2:2013
Mean Difference between Device and Reference (Diastolic BP)	(Not explicitly stated in document, but standard specifies limits, typically within ±5 mmHg)	Device meets requirements of AAMI/ANSI/ISO 81060-2:2013
Standard Deviation of Differences (Diastolic BP)	(Not explicitly stated in document, but standard specifies limits, typically ≤ 8 mmHg)	Device meets requirements of AAMI/ANSI/ISO 81060-2:2013

Note: The document confirms compliance with the standard but omits the specific numerical results. To get the exact acceptance criteria and the device's measured performance (mean differences, standard deviations), one would need to consult the AAMI/ANSI/ISO 81060-2:2013 standard itself and the detailed clinical validation report, which is not provided here.

Study Information (Clinical Validation)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The AAMI/ANSI/ISO 81060-2:2013 standard typically requires a minimum of 85 subjects for clinical validation.
- Data Provenance: Not explicitly stated. Clinical studies are generally prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure monitors, the "ground truth" is typically established by trained human observers using a reference sphygmomanometer (e.g., mercurial or auscultatory method) alongside the device under test. This usually involves multiple observers.
- Number of Experts: Not explicitly stated, but the AAMI/ANSI/ISO 81060-2:2013 standard usually mandates at least two trained observers.
- Qualifications: Not explicitly stated. The standard requires observers to be clinically trained and experienced in auscultatory blood pressure measurement. (e.g., physicians, nurses, or trained technicians).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For blood pressure validation, adjudication typically involves averaging readings between multiple observers or using a third observer in cases of significant discrepancy, as per the AAMI/ANSI/ISO 81060-2:2013 protocol.
- Adjudication Method: Not explicitly stated in the document, but the AAMI/ANSI/ISO 81060-2:2013 standard outlines a specific protocol for how observer readings are to be collected and compared to obtain the reference blood pressure.
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:
- Not Applicable. This is a blood pressure monitor, not an AI device. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "standalone" performance in this context refers to the device's ability to accurately measure blood pressure on its own, which is what the clinical validation (AAMI/ANSI/ISO 81060-2:2013) assesses against a human-obtained reference. This study evaluates the device's performance without a human interpreting its output in the same way an AI output would be interpreted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Reference Measurement: The ground truth for a non-invasive sphygmomanometer is established by simultaneous or carefully timed measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or validated aneroid device).
The sample size for the training set:
- Not Applicable. As this is not an AI device, there isn't a "training set" in the machine learning sense. The device's calibration and internal algorithms are developed during its engineering phase, which is distinct from a clinical validation study used for regulatory approval.
How the ground truth for the training set was established:
- Not Applicable. See point 7. The device's internal algorithms are based on established oscillometric principles and refined through engineering and calibration processes, not a "training set" with ground truth in the AI context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Guangdong Transtek Medical Electronics Co., Ltd Ada Zhang Product Certification Supervisor Zone B, No.105, Dongli Road, Torch Development District Zhongshan, Guandong, China 528437

Re: K161886

Trade/Device Name: TRANSTEK Blood Pressure Monitor amd Welch Allyn Blood Pressure Device, Models: TMB-1591-A, RPM-BP100SBP and H-BP100SBP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 5, 2016 Received: August 5, 2016

Dear Ada Zhang:

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 (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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Yellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161886

Device Name

Transtek Blood Pressure Monitor, Welch Allyn Blood Pressure Device Models: TMB-1591-A, RPM-BP100SBP and H-BP100SBP

Indications for Use (Describe)

Indications of USe (Deschbe)
Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP I rallstek blood fressure Momor se in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches).

These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

Contraindications:

This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.

These device are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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 I he burden time for this Galloorch existing data sources, gather and maintain the data needed and complete time to review the collection. 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."

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510(k) Summary

Date of Summary Preparation: 10/13/2016

1. Submitter's Identifications

Submitter's Name: Guangdong Transtek Medical Electronics Co., Ltd Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China 528437 Contact Person: Ada Zhang Contact Email Address: zhangjiapei@lifesense.com Telephone: 086-760-85166358 Fax: 086-760-85166358

2. Name of the Device

Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: TRANSTEK Blood Pressure Monitor, Welch Allyn Blood Pressure Device Trade Name: TRANSTEK, Welch Allyn Models: TMB-1591-A, RPM-BP100SBP, H-BP100SBP Classification Panel: Cardiovascular Common/Usual Name: Arm Blood Pressure Monitor Product Code: DXN Device Classification: Class II

3. The Predicate Devices

TRANSTEK, Blood Pressure Monitor, Model TMB-1018-BT, K131395

4. Device Description

Measurement method to define systolic and diastolic pressure is similar to the ausculatory method but

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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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

5. Intended Use of Device

These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

Contraindications:

This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.

These device are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

6. Discussion of performance tests in design verification and design validation

We conducted design verification and design validation activities to demonstrate that these proposed device met all design specifications as are Substantially Equivalent to the predicate device. The result

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show that TMB-1591-A, RPM-BP100SBP and H- BP100SBP conform to the following standards: a. Safetv Test:

AAMI/ANSI ES60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance - Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment

b. EMC Test:

IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests

c. Performance and Reliability test:

IEC 80601-2-30 Edition1.1 2013-07 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

d. FCC Test:

FCC 47 CFR Part 15, Subpart B

e. Biocompatibility Test:

ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for

irritation and skin sensitization

f. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices - Application of risk management to medical devices

g. Software Verification and Validation:

-IEC 62304 Ed.1.0 (2006), Medical device software - Software life cycle processes,

h. Usability Validation:

-IEC 62366-1:2007+A1:2014 Medical devices - Application of usability engineering to medical devices

-IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

i. Wireless coexistence

Radio-Frequency Wireless Technology in Medical Devices

j. Clinical Validation

AAMI/ANSI/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

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7. Summary of Substantial Equivalence

Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP have identical technology, energy type, cuff surface material and similar intended use, performance specifications, software/firmware and functions to the predicate device.

The only significant difference between these proposed devices and the predicate device is that these proposed devices add two other intended cuffs which are applicable for population with arm circumference 15-24cm and 40-54cm. The additional cuffs size are appropriate to the claimed intended arm circumference per IEC 80601-2-30. The material of two additional cuffs is the same with original cuff. Thus there is no biocompatibility problem. The clinical performance and accuracy of these proposed devices have been demonstrated that meet the requirements of AAMI/ANSVISO 81060-2:2013. Thus the difference does not raise any new questions of safety and effectiveness.

8. Conclusions

Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are substantially equivalent to the predicate device TMB-1018-BT by having the identical technologies and similar intended use. Two added cuffs does not impact the safety and effectiveness of these proposed devices.

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Regulation Number and Section

§ 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).