(254 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI/ML components or capabilities.
No
The device is described as a "medical assistant instrument" for measuring blood pressure and heart rate, which are diagnostic or monitoring functions, not therapeutic ones.
Yes
The device measures systolic and diastolic blood pressure and heart rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it 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." This clearly indicates the presence of hardware components (cuff, inflation mechanism, sensor for oscillometric method) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "fully automatic non-invasive blood pressure monitor" that measures blood pressure and heart rate by inflating a cuff on the wrist. This is a measurement taken on the body (in vivo), not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and heart rate as a "medical assistant instrument." This is a direct physiological measurement, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
DXN
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist (arm)
Indicated Patient Age Range
Adult population
Intended User / Care Setting
Home or in medical center
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The device complies with the ANSI/AAMI/ISO 81060-2:2009 standard and BS EN1060-4: 2004 in its entirety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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."
3
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:
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.
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
6
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.