The Digital Blood Pressure Monitor is Arm-type fully automatic Digital Blood Pressure Monitor and used the oscillometric method for non-invasive measurement of blood-pressure at home.

The equipment is non-transit-operable, portable equipment, not used at the conditions of patient movement in normal use. The unit is powered by internal dry battery.

Digital Blood Pressure Monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.

Digital Blood Pressure Monitor, JDS-189, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20 in term of intended use measurement method, structure, and specifications are totally same, only the appearance, memory space has difference.

AI/ML Overview

The provided document is a 510(k) summary for a Digital Blood Pressure Monitor, aiming to demonstrate its substantial equivalence to a predicate device. It includes information on the device's intended use, technology, and applied standards, as well as testing data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance (Target Value)
Performance Requirement (IEC 80601-2-30)	Not explicitly stated in terms of specific performance metrics from this standard, but compliance is claimed.
Measurement Accuracy (Pressure)	± 3 mmHg
Measurement Accuracy (Pulse)	± 5% of the displayed value
Electrical Safety (AAMI / ANSI ES 60601-1:2005)	Complies with the standard.
Electromagnetic Compatibility (IEC 60601-1-2)	Complies with the standard.
Home-used Medical Equipment Requirements (IEC 60601-1-11)	Complies with the standard.
Biocompatibility (ISO 10993-5, ISO 10993-10)	Complies with the standards.
Clinical Evaluation (ANSI/AAMI/ISO 81060-2)	Evaluated according to this standard.

Note: The document states that "Laboratory testing was conducted to validate and verify that Digital Blood Pressure Monitor met all requirements of related international standards," and specifically lists the performance requirements for pressure and pulse accuracy. It also notes "clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2." This implies that the device achieved accuracy within the limits specified by the accuracy requirement, which are typical for blood pressure monitors.

2. Sample Size Used for the Test Set and the Data Provenance

The document states: "Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2."

Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical study that followed ANSI/AAMI/ISO 81060-2. This standard generally requires a minimum number of subjects (e.g., typically 85 subjects with specific age and blood pressure distribution) for accuracy validation.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the submitter's location (SUZHOU SUNSPIRIT CO., LTD., P. R. China), it is highly probable the study was conducted there. It is typically a prospective study to meet the requirements of ISO 81060-2.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document mentions "Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2," but it does not provide details on the number of experts, their qualifications, or how ground truth was established within the context of that clinical study. For blood pressure measurement, the ground truth (reference measurements) would typically be established by trained observers using a calibrated sphygmomanometer following a standardized protocol, rather than "experts" in the sense of physicians establishing a diagnosis.

4. Adjudication Method (for the test set)

The document does not specify an adjudication method. In the context of blood pressure device validation, and specifically for ISO 81060-2, adjudication would usually involve comparing the device's readings against simultaneously obtained reference readings. The standard outlines specific procedures for taking these reference readings (e.g., using two trained observers auscultating simultaneously).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

The document does not mention or imply that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not applicable to a digital blood pressure monitor that performs automatic measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation was done. The device itself is an "Arm-type fully automatic Digital Blood Pressure Monitor" that uses an "oscillometric method" to calculate systolic and diastolic blood pressure and pulse rate automatically. The clinical study according to ANSI/AAMI/ISO 81060-2 evaluates the accuracy of this automatic measurement against a reference standard, which is a standalone assessment of the device's algorithm.

7. The Type of Ground Truth Used

The ground truth used for the clinical evaluation, as per ANSI/AAMI/ISO 81060-2, would be simultaneously measured blood pressure readings obtained by trained observers using a reference sphygmomanometer (typically mercury or a validated equivalent) following a strict protocol. This method is often referred to as "reference measurement" or "expert auscultation" and is the gold standard for non-invasive blood pressure device validation.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since this typically refers to data used to train a machine learning model. While the device utilizes an oscillometric method with software, it's not explicitly stated if it employs machine learning that would require a separate training dataset. The "clinical study" mentioned refers to the validation study for regulatory approval, not a training phase.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established. The oscillometric method relies on established physiological principles and algorithms, rather than typically being "trained" in the modern machine learning sense with a distinct training dataset and corresponding ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 24, 2016

Suzhou Sunspiri Co., Ltd. % Long Yang Coo Shenzhen Hlongmed Biotech Company Limited R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, 518054 CN

Re: K153033

Trade/Device Name: Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 13, 2016 Received: May 19, 2016

Dear Long 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,

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)

Device Name

Digital Blood Pressure Monitor

Models: JWS Series, including: JDS-189, JDS-500A, IDS-500E, JDS-600, JDS-700, IDS-703, IDS-704, JDS-800, BM20

Indications for Use (Describe)

This device is intended to measure the blood pressure and pulse rate on upper arms of adults.

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.

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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:

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510(k) Summary

Date Prepared: June 22, 2016

1. Submitter

SUZHOU SUNSPIRIT CO., LTD.

No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 Establishment Registration Number: 3010271644 Tel: 0086-512-68238996 Fax: 0086-512-68234280

2. Submission Correspondent

Ms. Jing Zhang (QA manager) SUZHOU SUNSPIRIT CO., LTD. No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 2) Mr. Long Yang (COO) Shenzhen Hlongmed Biotech Company Limited R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China,518054

Tel: 0086-755-86664986

Fax: 0086-755-86664933

E-mail: yanglong@hlongmed.com

3. Proposed Device Information

Trade name: Digital Blood Pressure Monitor Model: JDS Series, including: JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM20 Common name: Digital Blood Pressure Monitor Classification name: Noninvasive Blood Pressure Measurement System Review Panel: Cardiovascular System Devices Panel (74) Product Code: DXN Regulation Class: II Regulation Number: 870.1130

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4. Predicate Device Information

Company Name: Shenzhen Pump Medical System Co., Ltd. Device Name: Arm Automatic Blood Pressure Monitor, model BF1115 510(k) number: K130325

5. Device Description

The Digital Blood Pressure Monitor is Arm-type fully automatic Digital Blood Pressure Monitor and used the oscillometric method for non-invasive measurement of blood-pressure at home.

The equipment is non-transit-operable, portable equipment, not used at the conditions of patient movement in normal use. The unit is powered by internal dry battery.

Digital Blood Pressure Monitor, JDS-189, JDS-500A, JDS-500E, JDS-600,

JDS-700, JDS-703, JDS-704, JDS-800, BM 20 in term of intended use measurement method, structure, and specifications are totally same, only the appearance, memory space has difference.

6. Intended use/Indications for use:

This device is intended to measure the blood pressure and pulse rate on upper arms of adults.

7. Testing data and clinical study

Laboratory testing was conducted to validate and verify that Digital Blood Pressure Monitor met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.

Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2.

Applied Standard:

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Electrical Safety requirement: AAMI / ANSI ES 60601-1:2005
Performance requirement: IEC80601-2-30 ●
Electromagnetic Compatibility Requirements: IEC 60601-1-2 ●
Home-used medical equipment requirements: IEC 60601 -1 -11
Biocompatibility Evaluation for NIBP Cuff: ISO 10993-5, ISO 10993-10 ●
Clinical Evaluation: ANSI/AAMI/ISO 81060-2

8. Comparison to Predicate Device

Trade Name	Digital Blood Pressure Monitor	Arm Automatic Blood Pressure Monitor
Model	JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20	BF1115
Indications for use	This device is intended to measure the blood pressure and pulse rate on upper arms of adults.	It is intended for measuring adult blood pressure and pulse rate.
Target population	Adult	Adult
Environment of use	Home	Home
Technology	Oscillometric method	Oscillometric method
Measurement Method	Non-invasive	Non-invasive
Measurement localization	Upper arm	Upper arm
Memory Space	2×30(BM20, JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600) / 1×99(JDS-700)/ 2×60(JDS-703, JDS-704)/ 2×50(JDS-800)	50 sets of measurement values( blood pressure and pulse rate) for each user( Memory 1 and Memory 2)
Measuring parameters	blood pressure (systolic and diastolic) and heart rate	blood pressure (systolic and diastolic) and heart rate

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Measurementrange	Pressure: 0 – 300 mmHgPulse: 40 –180 beats/min	Pressure: 0 to 280 mmHgPulse: 40 to 180 pulses/min
Measurementaccuracy	Pressure: ± 3 mmHgPulse: ± 5% of the displayed value	Pressure: ± 3 mmHgPulse: ± 5% of the displayed value
Inflation Mode	Automatic by Internal Pump	Automatic by Internal Pump
DeflationMode	Automatic by Valve	Automatic by Valve
Measurablecircumference	22-32cm	22-36cm
Display	LCD, digital display	LCD, digital display
Energy source	4 AA Alkaline batteries	4 AA Alkaline batteries or ACadaptor(AC 100~ 240V)
Operatingenvironment	+10~+40 °C , ≤85% RH	+5~+40°C , ≤93%RH
Storageenvironment	-5 ~ +50 °C, ≤85% RH	-25~+70°C,10~95%RH

The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

9. Conclusion

Digital Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device. Moreover, non-clinical testing & clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.

In a word, Digital Blood Pressure Monitor is substantial equivalent to the predicate device.

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).