The Welch Allyn ProBP 2000 Digital blood pressure device is intended for use in measuring blood pressure and heart rate in patients at least 3 years of age or older with arm circumferences between 15 cm to 55 cm (approximately 5.9 to 21.7 inches).

The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.

Contraindications:

This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients.

Device Description

The device is 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.

This device is designed for professional use, in other words, it is a professional BP device that only for trained users such as nurses, clinicians, and medically qualified personnel.

The measurement method for determining the systolic and diastolic pressure is similar with 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. This well-known technique for measuring blood pressure is called the "Oscillometric method".

The device includes the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation key, the pump, the electromagnetic deflation control valve and the LCD. ABS is the plastic used in the outer housing. The device comes with one standard Reusable-11 Welch Allyn FlexiPort cuff. Other size cuffs can be ordered as needed for arm circumferences ranging from 15cm to 55cm. This device is equipped with the same wireless radio (Bluetooth) as supplied with the predicate device cleared in K161886, TMB-1591-A.

The subject device does not incorporate any software to support the BT wirelessly transmit function. In other word, ProBP 2000 has BT module but disabled the Bluetooth functionality. And Welch Allyn does not provide an application to receive data utilizing BT

The subject device does not have any externally-facing electronic interfaces.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Welch Allyn ProBP 2000 Digital Blood Pressure Device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device's accuracy was validated according to ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. The core requirement is that "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013."

While the exact numerical limits of the ISO standard are not explicitly stated in the document, the report confirms that the device met these requirements.

Acceptance Criteria (Based on ISO 81060-2:2013)	Reported Device Performance
Mean error and standard deviation of differences for systolic blood pressure not exceeding specified limits.	Met: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013"
Mean error and standard deviation of differences for diastolic blood pressure not exceeding specified limits.	Met: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013"

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 88 qualified healthy subjects.
- Subject Demographics:
  - Age: 3-12 years (35 pediatric) & 12-75 years (53 adults / adolescents)
  - Gender: 39 males & 49 females
  - Racial/Ethnic Background: Any
- Data Provenance: The document does not explicitly state the country of origin where the clinical validation study was conducted, nor does it specify if the data was retrospective or prospective. Given it's a clinical validation study for a new device, it is highly likely to be a prospective study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications for establishing ground truth, as is typical for blood pressure device clinical validation studies. ISO 81060-2 usually involves simultaneous measurements by trained observers using a mercury sphygmomanometer as the reference standard, rather than a panel of "experts" in the sense of image review or diagnostic interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe a specific adjudication method. For blood pressure device validation, the standard approach involves two or more trained observers performing simultaneous auscultatory measurements alongside the automated device, with discrepancies resolved according to the standard's protocol (e.g., if a certain difference is exceeded, a third observer might be involved, or the measurement discarded).
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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure measurement device and does not involve AI assistance for human readers/clinicians in diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation described is a standalone performance study. The device's algorithm measures blood pressure and heart rate without human interpretation being part of the measurement process itself. The study compared the device's readings directly to a reference standard (auscultatory measurement) to assess its accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established through a reference standard method, which, for blood pressure devices, typically involves simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer), as per the requirements of ISO 81060-2.
The sample size for the training set:
The document does not explicitly state the sample size for the training set. It mentions the device uses an "oscillometric algorithm" and that the algorithm's accuracy "has been validated through bench testing including testing to the blood pressure standard, IEC 80601-2-30." It also states, "The oscillometric algorithm in the device measures pulse heights at various cuff pressures throughout the cycle. Those pulse heights are used to build a patient specific pulse envelope as taught by standard oscillometric technique." This suggests general physiological principles and established oscillometric techniques are used, rather than a specific algorithm trained on a large, labeled dataset in the way a modern AI algorithm might be.
How the ground truth for the training set was established:
As there is no explicit mention of a training set in the context of a machine learning model, the concept of "ground truth for the training set" as it applies to AI algorithms doesn't directly apply here. The algorithm is based on well-established oscillometric principles for blood pressure measurement rather than being "trained" on a specific dataset in the modern AI sense. The development of such algorithms typically involves engineering and physiological understanding, and refinement through extensive testing (including bench and clinical testing as mentioned) against reference methods.

Summary

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April 9, 2019

Guangdong Transtek Medical Electronics Co. Ltd Nicole Hu Certification Commissioner Zone A, No 105 Dongli Road, Torch Development District Zhongshan, 528437 Cn

Re: K181832

Trade/Device Name: Model: ProBP™ 2000, Welch Allyn 901123 Digital Blood Pressure Device Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 1, 2019 Received: March 7, 2019

Dear Nicole Hu:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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510(k) Summary

[per 21 CFR 807.92]

Submitter / Owner:	Guangdong Transtek Medical Electronics Co., LtdAddress: Zone A, No.105, Dongli Road, Torch Development District,Zhongshan, Guangdong, China 528437
Contact Person:	Nicole Hu, Certification CommissionerPhone: 086-760-85166220 Fax: 086-760-86742877E-mail: wan.hu@lifesense.com
Date Prepared:	Apr. 9, 2019
Trade Name:	Model: ProBP™ 2000,Welch Allyn 901123 Digital Blood Pressure Device
Common Name:	Blood pressure device
Classification Name:	System, Measurement, Blood pressure, Noninvasive(Class II, Cardiovascular, 21 CFR 870.1130, Product Code: DXN)
Predicate Device:	Transtek Blood Pressure Monitor, TMB-1591-A510(k) Number: K161886(Class II, Cardiovascular, 870.1130, DXN)

Description of the Subject Device:

This device is designed for professional use, in other words, it is a professional BP device that only for trained users such as nurses, clinicians, and medically qualified personnel.

The subject device does not have any externally-facing electronic interfaces.

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ProBP™ 2000

The device's block diagram

Image /page/3/Figure/4 description: The image is a block diagram of a blood pressure monitoring system. The system consists of a cuff, pressure sensor, amplifier, A/D converter, MCU, key, valve, motor pump, and display. The cuff is connected to the pressure sensor, motor pump, and valve. The pressure sensor is connected to the amplifier, which is connected to the A/D converter, which is connected to the MCU. The key, valve, motor pump, and display are also connected to the MCU.

Refer to above chart, the operational processes as following.

- The patient prepared according to the device's guidance. The user (trained operator, such as nurse) places the CUFF wrapped on the proper position of the patient's upper arm.
- The user presses the Key to power the device for measuring.
- The MCU sends a signal to activate Motor Pump to inflate the CUFF.
- During the inflation, the Pressure sensor measures the pulse waveform of the pressure change.
- The waveform is amplified by the Amplifier for subsequent processing.
- The analog signal of waveform is converted into a digital signal through the A/D (Analog/Digital) module.
- The MCU analyzes and calculates the digital signal by a specific algorithm and outputs the value of blood pressure and pulse rate.
- After the measurement is completed, the Motor Pump is controlled by MCU to stop inflating. And a signal from MCU is sent to the Valve to deflate the CUFF.
- The device stores the measurement data in the ROM, and directly shows the Systolic/Diastolic blood pressure (Arabic numerals + mmHg) & Pulse rate (Arabic numerals + Pul/min) on the LCD Display, available for user to read and record.
- The device is powered by either four AA alkaline batteries or an optional AC to DC power supply. These options are identical to the predicate device TMB-1591-A (K161886).

Principle and Measurement Algorithm of the Device:

The subject device uses the Oscillometric Measuring method to detect blood pressure. The device detects blood pressure measurement on the inflation. Before every measurement, the unit establishes a "zero pressure" equivalent to the air pressure. Then it starts inflating the cuff with the inflation rate 7mmHg/s, meanwhile, the device detects pressure oscillations generated by beat-to-beat pulsatile. Then the measurement finishes, and the device starts deflation occurs in step intervals based on the cuff pressure. The deflation step range is about 6-12 mmHg. Higher cuff pressure corresponds to the larger pressure deflation step.

The oscillometric algorithm in the device measures pulse heights at various cuff pressures throughout the cycle. Those pulse heights are used to build a patient specific pulse envelope as taught by standard oscillometric technique. That pulse envelope is used to calculate systolic and diastolic blood pressure.

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Image /page/4/Picture/0 description: The image shows the word "TRANSTEK" in a stylized, sans-serif font. The letters are all capitalized and appear to be a light gray color. The font has a futuristic or technological feel due to its sharp angles and geometric shapes.

The algorithm in the device detect erroneous readings by checking for inconsistencies in the data measured. This can be strange shapes to the pulse profile, large changes in rate of inflation, and wide variances in pulse heights and rates. If one of those conditions is detected, the device switches to the deflation algorithm. The deflation algorithm uses comparisons between multiple pulses to filter out erroneous pulses caused by motion. It also ensures that the pulse profile is of a reasonable shape.

The signal is picked up by the transducer then converted to a digital value via the Analog-to-Digital converter. The digital value is fed into the MCU will calculate the blood pressure and heart rate measurement values according to built-in algorithms.

The values calculated by the algorithm are displayed to the correct section of the screen for the values. Digits are displayed on individual 7 segment areas specifically designed to display digits. The areas where the readings are displayed are labeled as to which reading is being displayed in those segments.

The accuracy of the device's algorithm has been validated through bench testing including testing to the blood pressure standard, IEC 80601-2-30. The device was also clinically tested and met the accuracy requirements of ISO 81060-2.

Indications for Use:

The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.

Contraindications:

Technological Characteristics:

The subject device is modified based on the predicate device. Model 2000 essentially the same device and has the same technical characteristics as the marketed devices cleared in K161886. They use the same oscillometric blood pressure algorithm. The form factor and device material are the same.

The differences between the subject device and predicate device are as following.

1. The proposed device is for use by clinically trained professionals (Rx), rather than by patients for self-monitoring (OTC) as stated in the cleared device indications;
1. The subject device is intended for patients at least 3 years of age or older with arm circumferences between 15 cm to 55 cm (approximately 5.9 to 21.7 inches), while the predicate device is intended for use in adult patient populations with arm circumferences between 15 cm to 54 cm (approximately 6 to 21 inches);
1. The subject device BP hose is not detachable from the device. The cuff connection is Welch Allyn FlexiPort design which is inherently compliant to IEC 80369-5 because the inner-fluid pathway of the FlexiPort connector is greater than 8.5 mm. Model 2000 is exempt from the requirements of IEC 80369-1:2010 – small-bore connectors for liquids and gasses in healthcare applications because there are no connectors accessible to the user in normal use with a diameter less than 8.5mm.
1. The subject device modified the range of arm circumferences from 15~55cm;
1. The proposed device uses Welch Allyn FlexiPort Blood Pressure Cuffs (K070060);

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1. Differs from the predicate device, ProBP 2000 device does not have wirelessly transmission functionality.
1. The subject device is not contraindicated for "...any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator." We have no evidence to support this patient demographic should be contraindicated. We performed a literature review and found no evidence that any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator should be contraindicated. We did however add a note in the directions for use stating the device has not been evaluated for this demographic. "Note This device has not been evaluated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator."

Performance Tests

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

The results show that the subject devices conform to the following standards:

Biocompatibility Testing

The Welch Allyn FlexiPort Blood Pressure Cuffs used with these devices were tested for biocompatibility in compliance to ISO 10993-1 and cleared in 510(k) (K070060).

Software Verification and Validation Testing

The software of proposed devices was verified and validated in compliance to IEC 62304 Edition 1.1 2015-06. Medical Device Software - Software life cycle processes.

Clinical Validation

This device was tested to ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

The study population consisted of 88 qualified healthy subjects ranging in age of 3~~12 years (35 pediatric) & 12~~75 years (53 adults / adolescents), and gender of 39 males & 49 females, of any racial / ethnic background. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013, and the accuracy of subject device is better than predicate device. No adverse effect and/or complication is found in this study.

Non-Clinical Tests

These devices were tested / assessed to evaluate its safety and effectiveness based on below standards:

Standard	Version	Title
IEC 60601-1	3ED 2005,AMD 1 2012	Medical electrical equipment - Part 1: general requirements forbasic safety and essential performance
IEC 60601-1-2	4 ED 2014	Medical electrical equipment - Part 1-2: general requirements forbasic safety and essential performance - collateral standard:electromagnetic compatibility - requirements and tests
IEC 80601-2-30	1.1 ED 2013	Medical electrical equipment - Part 2-30: particular requirementsfor the basic safety and essential performance of automated non-invasive sphygmomanometers
EN/ISO 14971	2007	Medical devices - Application of risk management to medicaldevices

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IEC 60601-1-6	2013	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 62366	2014	Medical devices - Application of usability engineering to medicaldevices

Device Comparison:

The subject device is very similar to the predicate device (K161886). They have the identical technology principle, blood pressure algorithm, energy source; and have the same appearance and mechanical architecture. Also, they have very similar intended use, performance specifications, software and functions.

The subject device's clinical use is modified to professional use that different from the home use of the predicate device. The indications for use and contraindications for the subject devices have been modified to be suitable for a trained clinician, and to match the target patient populations, at least 3 years of age or older. This subject device is set-up to use Welch Allyn FlexiPort BP Cuffs (K070060) for arm circumferences from 15~~54 to 15~~55 cm. Correspondingly, the hose connection fitting (FlexiPort) was designed to be applied for these Cuffs.

The subject device ProBP 2000 does not provide wireless transmission functionality.

For above mentioned modifications / differences, we implemented as much as required performance tests, validations, evaluation, to ensure subject device is safe and effective. These bench tests' results proved that the subject device met all requirements of statutory standards. The clinical validation shows the subject device complied with the specific standard, and the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

In addition, the predicate device's contraindication of "This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument" was added when the parent predicate device embedded wireless module. At that time we did not find any evidence of risk to those persons who are connected to wearable or implantable electronic device or instrument. We added this contraindication only because of precautionary motive. From our experiences, industry practices, and those market wireless devices' 510(k) records, still no risk be found, and this (similar) contraindication is not required. Thus, we remove it in this submission and added a note in the DFU, Directions For Use, indicating that "This device has not been evaluated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator."

Conclusion:

Based on the information presented in this 510(k) premarket notification submission, the subject device is considered substantially equivalent. This subject device is as safe and effective as the currently marketed predicate device TMB-1591-A (K161886). The differences between the indications for use and contraindications, hardware, and mechanical aspects of the proposed device and the predicate device were successfully tested with the relevant standards and FDA guidance, and do not affect equivalent safety and effectiveness or raise new questions of safety or effectiveness.

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Indications for Use

510(k) Number (if known)

K181832

Device Name

Welch Allyn 901123 Digital Blood Pressure Device ProBP 2000

Indications for Use (Describe)

The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.

Contraindications:

Type of Use (Select one or both , as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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).