Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Device Description

Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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 Truly Automatic Wrist Blood Pressure Monitor DW series are 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 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device also compares 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 pulse rhythm when the difference of the time intervals is over 25%.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The Truly Automatic Wrist Blood Pressure Monitor (Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903) conducted a clinical study to demonstrate its accuracy in measuring systolic and diastolic blood pressure.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria (ANSI/AAMI SP10 Standard)	Systolic Pressure Performance	Diastolic Pressure Performance
Mean difference ≤ ±5mmHg	-3.5 mmHg (meets criteria)	-3.2 mmHg (meets criteria)
SD differences ≤ 8 mmHg	3.5 mmHg (meets criteria)	3.5 mmHg (meets criteria)
Between-observer agreement: 95% or more readings agree to within ±10mmHg	100% (meets criteria)	100% (meets criteria)
Between-observer agreement: 85% or more readings agree to within ±5 mmHg	99% (meets criteria)	99% (meets criteria)

2. Sample Size and Data Provenance

Sample Size (Test Set): 90 subjects, including 15 hypertensive patients.
Data Provenance: The document does not explicitly state the country of origin, but the submitter's address is in Guangdong Province, China, suggesting the study was likely conducted there. The study appears to be prospective, as it involved actively recruiting subjects and performing blood pressure determinations.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Two doctors.
Qualifications of Experts: The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"). It only mentions they are "two doctors" who performed simultaneous and blinded blood pressure determinations.

4. Adjudication Method

The adjudication method used was paired, simultaneous, and blinded reference measurements by two observers against the test device. This implies a 2-reader, 1-device comparison method:
* The two observers ("doctors") simultaneously and independently measured blood pressure using a standard mercury sphygmomanometer (the reference standard).
* The agreement between these two observers also had its own acceptance criteria (95% within ±10mmHg, 85% within ±5mmHg).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described for AI-assisted human readers. The study focused on the standalone accuracy of the device itself compared to a reference standard with human observers. There is no mention of a scenario where human readers' performance was compared with and without AI assistance from this device.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The entire clinical study described is a demonstration of the device's accuracy in measuring blood pressure and pulse rate (algorithm only/standalone without human-in-the-loop performance, beyond interacting with the device itself) compared to a reference standard.

7. Type of Ground Truth Used

The ground truth used was expert consensus / reference standard comparison using a standard mercury sphygmomanometer. The "between-observer agreement" criteria also implies the ground truth for the reference measurements themselves was established by agreement between the two doctors.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This is typical for a traditional medical device (like a blood pressure monitor) which relies on established physical principles (oscillometric method) and calibration rather than machine learning models that require distinct training data.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" for an AI/machine learning model is mentioned, this information is not applicable to this device's development as described. The device's measurement algorithm ("oscillometric method") is a well-established technique that would have been developed and validated through general engineering and physiological principles rather than a distinct machine learning training phase.

Summary

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Truly Instrument Limited

K113085

510(k) Summary

JAN 1 2 2012

Date of Summary Preparation: August.16.2011

1. Submitter's Identifications

Submitter's Name:	Truly Instrument Limited
Address:	Site 2, Truly Industrial Area, Shanwei City,Guangdong Province, China
Contact Person:	Manager Yang Jian-Hao
Telephone:	86-0660-3380070
Fax:	86-0660-3380377

2. Name of the Device

Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Truly Automatic Wrist Blood Pressure Monitor Trade Nam: DW801, DW802, DW803, DW805, DW806, DW807, DW808, Models: DW901, DW902, DW903 cardio-vascular Classification Panel: Automatic Wrist Blood Pressure Monitor Common/Usual Name: DXN Product Code: Device Classification: Class II N/A Contraindications :

3. The Predicate Devices

Truly Automatic Wrist Blood Pressure Monitor, Model DW700, K091415

4. Device Description

The device also compares the longest and the shortest time intervals of detected pulse waves Page 1 of 6

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Truly Instrument Limited

(113,085

to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

5. Intended use of device

The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

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Truly Instrument Limited TRULY®

KII3085

6. Summary of Substantial Equivalence

Parameter	Predicate Device DW700	DW801	DW808
Intended use	Measuring systolic and diastolic blood pressureand pulse rate of adult individual	Measuring systolic and diastolic blood pressure and pulse rate of adult individual	Same
Indications for use	Measuring systolic and diastolic blood pressureand pulse rate of adult individual, Includingirregular pulse rhythm detection.Over-The-Counter Use	Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection.Over-The-Counter Use	Same
Target Population	Adult	Adult	Same
Anatomical sites	Wrist	Wrist	Same
Where used (hospital, home, ambulance. etc)	Home	Home	Same
Energy used and / or delivered	2x 1.5V AAA Battery	2x 1.5V AAA Battery	Same
Human factors	Blood pressure	Blood pressure	Same
Design	Refer to Table-2	Refer to Table-2	Same
Performance	Measuring systolic and diastolic blood pressureand pulse rate of adult individual, Includingirregular pulse rhythm detection	Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection	Same
Materials	Refer to Table-2	Refer to Table-2	Same
Biocompatibility	CuffAccording to ISO-10993	CuffAccording to ISO-10993	Same
Compatibility with the environment and other devices	Operation Environment:10°C ~ 40°C, 15% ~ 90%RHStorage Environment:	Operation Environment:10°C ~ 40°C, 15% ~ 90%RHStorage Environment:	Same

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											Result
		DW801	DW802	DW803	DW805	DW806	DW807	DW808	DW901	DW902	DW903
Truly Instrument LimitedK113085
	Parameter	Predicate Device DW700
	sterility	N/A	-20°C ~ 60°C, 10%~95%RH								Same
	Electrical safety			According to IEC60601-1-2							Same
	Mechanical safety			According to IEC60601-1							Same
	Chemical safety			Same							Same
	Thermal safety			N/A							Same

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Parameter	Predicate Device DW700	DW801	DW802	DW803	DW805	DW806	DW807	DW808	DW901	DW902	DW903
Measurement algorithmMethod	Oscillometric method		No change, all same
Measurement site of body	Wrist		No change, all same
Pressure Sensor	MSP-2107		No change, all same
Cuff			No change, all same
Software			No change, all same
Irregulardetection	heartbeat		More than ±25% to the mean interval of pulse intervals.About the more detailed description of the IH detection algorithm, please refer to"Software validation report 1-5. Algorithm description 4. Determination method of irregular heartbeat".
Memory Size
MeasurementRange	Pressure20 ~ 280 mmHg		No change, all same
MeasurementRange	Pulse40 ~ 195 beats/min		No change, all same
Parameter	Truly Instrument LimitedPredicate Device DW700	K113085	DW801	DW802	DW803	DW805	DW806	DW807	DW808	DW901	DW902	DW903
Measuring resolution	1 mmHg	No change, all same
Accuracy Pressure	$\pm$ 3mmHg	No change, all same
Accuracy Pulse	$\pm$ 5%	No change,all same
Pressurization Source	Automatic internal pump	No change, all same
Cuff Deflation	Automatic deflation	No change,all same
Operating Environment	10~40℃	No change,all same
Power Voltage	15~90%RH	No change,all same
Hardware circuit	2 x 1.5V	No change,all same
Electronic element		No change,all same
PCB		No change,all same
Display Type	Liquid crystal display	Liquid crystal display ,Only difference size
Cover		Difference

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7. Summary of Clinical study

I). Subjects:
Ninety subjects including 15 hypertensive patients in the hospital were participated in clinical study.
2). Method:
A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.
3). Criteria:
The ANSI/AAMI SP10 Standard recommended :
a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg A. between test device and reference method,
1. Between-observer agreement should be:95% or more of readings made simultaneously by observers agree to within x10mmHg and 85% or more agree to within x5 mmHg.
4). Result

Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.

Criteria	Test Result
	Systolic Pressure	Diastolic Pressure
Mean differences	x 5 mmHg	-3.5 mmHg	-3.2 mmHg
SD differences	x 8 mmHg	3.5 mmHg	3.5 mmHg

Table-1 Between test device and reference method

	Table-2 Betwee-observer agreement
--	-----------------------------------	--

Criteria	Test Result
	Systolic Pressure	Diastolic Pressure
At least 95% of readings agree towithin x 10mmHg	100%	100%
At least 85% of readings agree towithin x 5mmHg	99%	99%

6. Conclusions

The new subject series devices of Truly Automatic Wrist Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DW700(K091415), and the feature, safety, effectiveness are also as same as Dw700., just only in case and LCD''s size changes. Thus, the subject devices are substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird-like shape.

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

JAN 1 2 2012

Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Site 2. Truly Industry Area Shan Wei, Guang Dong 516600 China

Re: K113085

Trade/Device Name: Truly Automatic Wrist Blood Pressure Monitor Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 16, 2011 Received: October 18, 2011

Dear Mr. Yang:

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.

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Page 2 - Mr. Yang Jian-Hao

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

Sincerely yours,

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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Truly Instrument Limited

Indications for Use

K113085 510(K) Number (if Known)

Device Name: Truly Automatic Wrist Blood Pressure Monitor DB Series:

Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903

Indication For Use:

Truly Automatic Wrist Blood Pressure Monitor, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are a series device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1510{k} Number

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).