It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.

The device is intended for use in only adult population, not applied to ther populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Device Description

Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist. Digital Blood Pressure Monitor JWS-1000, JWS-970, JWS-950, JWS-940, JWS-706, JWS-705. JWS-704. JWS-703. JWS-701. JWS-700. JWS-600. BC20. BC40 have the same technology, main function, performance and intended use, and they are consistent in product structure and material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Digital Blood Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Therefore, many of the requested details, such as specific performance metrics with acceptance criteria, sample sizes for test and training sets, details on expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not explicitly provided in this type of regulatory document.

However, based on the information available, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document states that the device conforms to several standards, implying that the acceptance criteria are those specified in these standards. The device's performance is reported as meeting these standards and being "statistically and clinically acceptable."

Acceptance Criteria (Inferred from Standards)	Reported Device Performance
IEC80601-2-30:2009 +Amendment 1:2013	Conforms to standard
ANSI/AAMI/ISO 81060-2:2009	Conforms to standard (specifically mentions "in its entirety" for the clinical study)
BS EN1060-4: 2004	Conforms to standard (specifically mentions "in its entirety" for the clinical study)
AAMI / ANSI ES 60601-1:2005/(R)2012 +A1: 2012 and C1:2009/(R)2012 and, a2:2010/(r)2012	Conforms to standard
IEC 60601-1-2 Edition 3: 2007-03	Conforms to standard
Clinical repeatability	Statistically and clinically acceptable
Measurement Accuracy	Stated as equivalent to predicate device (which adheres to the above standards)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in the document. The document only mentions "A comparison study" was performed. Standards like ANSI/AAMI/ISO 81060-2 usually specify minimum sample sizes for validation (e.g., typically at least 85 subjects).
Data Provenance: Not explicitly stated. The manufacturer is based in China, so it's possible the study was conducted there, but this is not confirmed.
Retrospective or Prospective: Not explicitly stated. Clinical validation studies for blood pressure monitors are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The clinical study involved a "comparison study with a device that uses auscultatory method used by trained observers."
Number of Experts/Observers: Not explicitly stated (the standard ANSI/AAMI/ISO 81060-2:2009 typically requires at least two trained observers).
Qualifications of Experts: Described as "trained observers." No further details on their specific qualifications or years of experience are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document implies adherence to ANSI/AAMI/ISO 81060-2:2009, which outlines specific methodologies for comparing automated blood pressure measurements with those obtained by trained observers using a reference method (auscultation). This typically involves multiple readings and a procedure for handling discrepancies, often implicitly using a consensus or comparison against a standard. However, the specific adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.

5. 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 MRMC study was mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, this question is not applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The entire clinical study described is a standalone validation of the device's accuracy ("clinical repeatability") against a reference method (auscultatory method by trained observers). The device itself operates as an algorithm determining blood pressure without human intervention in the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Expert comparison/reference method: The ground truth was established by "a device that uses auscultatory method used by trained observers." The auscultatory method, employing a stethoscope and manometer, is the traditional reference standard for non-invasive blood pressure measurement.

8. The sample size for the training set

Not applicable / not provided. This document describes a medical device clearance based on demonstrable performance against a predicate and recognized standards. It's not a submission for an AI/ML model that typically details training sets for deep learning or similar algorithms. The "training" for such a device is in its design and calibration, not in a separate machine learning training set as might be asked for an AI diagnostic algorithm.

9. How the ground truth for the training set was established

Not applicable / not provided. As mentioned above, this is not an AI/ML model submission that would involve a distinct "training set" with ground truth established through labeled data for an algorithm to learn from.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

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

May 6, 2016

Suzhou Sunspirit Co., Ltd. % Long Yang COO Shenzhen Hlongmed Biotech Company Limited R150-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, 518054 CN

Re: K152415

Trade/Device Name: Digital Blood Pressure Monitor models JWS-1000. JWS-970. JWS-950, JWS-940, JWS-706, JWS-705, JWS-704, JWS- JWS-703, JWS-701, JWS-700, BC20, and BC40 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 30, 2016 Received: April 5, 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 (reporting of medical devicerelated 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 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. Shawn W. Forrest -S 2016.05.06 17:10:25 -04'00'

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) K152415

Device Name Digital Blood Pressure Monitor Models: JWS Series, including: JWS-1000, JWS-970, JWS-950, JWS-706, JWS-705, JWS-703, JWS-703, JWS-703, JWS-701, JWS-700,JWS-600, BC20, BC40

Indications for Use (Describe)

It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.

The device is intended for use in only adult population, not applied to ther populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

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."

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510(k) Summary

Date Prepared: July 31, 2015

1. Submitter:

SUZHOU SUNSPIRIT CO., LTD.

No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 Establishment Registration Number: 3010271644 Contact Person: Ms. Jing Zhang (OA manager) Tel: 0086-512-68238996 Fax: 0086-512-68234280 E-mail: jing.zhang@ssmedical.com.cn

2. Submission Correspondent

Ms. Jing Zhang (QA manager) SUZHOU SUNSPIRIT CO., LTD. No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 Tel: 0086-512-68238996 Fax: 0086-512-68234280 E-mail: jing.zhang(@ssmedical.com.cn

2) Mr. Long Yang (COO)

Shenzhen Hlongmed Biotech Company Limited R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District, Shenzhen, P.R. China Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com

3. Proposed Device Information:

Trade name: Digital Blood Pressure Monitor Model: JWS Series, including: JWS-1000, JWS-970, JWS-950, JWS-940, JWS-706, JWS-705, JWS-704, JWS-703, JWS-701, JWS-700, JWS-600, BC20, BC40

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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

4. Predicate Device Information:

Company Name: SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. Device Name: BP201 Wrist Blood Pressure Monitor 510(k) number: K083043

5. Device Description:

6. Intended use:

Digital Blood Pressure Monitor is intended to be used as a medical assistant instrument at home or in a medical center for adult populations for measuring blood pressure and heart rate. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

It cannot be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

7. Performance and Technological Characteristics:

7.1 Performance Summary

In terms of operating specification, Safety & EMC requirements, the device conform to

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IEC80601-2-30: applicable standards including 2009 -+Amendment 1:2013, ANSI/AAMI/ISO 81060-2:2009、 BS EN1060-4: 2004, AAMI / ANSI ES 60601-1:2005/(R)2012 +A1: 2012 and C1:2009/(R)2012 and, a2:2010/(r)2012, IEC 60601-1-2 Edition 3: 2007-03, A comparison study with a device that uses auscultatory method used by trained observers was performed to validate the performance of Digital Blood Pressure Monitor. The comparison study demonstrated that the clinical repeatability of Digital Blood Pressure Monitor is statistically and clinically acceptable.

7.2 Technological Characteristics

Digital Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist. The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate. The user can release the cuff to stop measuring by pressing the "ON/OFF" button at any time while measuring. The measuring result is displayed in LCD.

8. Substantial equivalence discussion

8.1. About the non-clinical tests

Digital Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device BP201, such as Measurement localization, Measuring parameters, Measurement range, Measurement Accuracy, Inflation, Deflation, Power source.

The main differences are the physical size, shape and weight, Memory space

Measurable circumference of wrist, Operate environment, Storage environment and there is no any new issue of safety and effectiveness.

So the non-clinical performance information demonstrates the equivalence of the non-clinical performance.

In a word, Digital Blood Pressure Monitor is equivalent to the predicate device for the non-clinical performance.

8.2. About the clinical tests

The device complies with the ANSVAAMI/ISO 81060-2:2009 standard and BS

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EN1060-4: 2004 in its entirety. Thus Digital Blood Pressure Monitor & the predicate device BP201 are substantially equivalent.

9. Conclusion

Digital Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device BP201. 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 BP201.

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).