(162 days)
No
The description focuses on standard oscillometric blood pressure measurement and basic signal analysis (pulse rhythm, body movement) without mentioning AI/ML terms or complex learning algorithms.
No
The device is a diagnostic tool, not intended for treating or alleviating a disease or condition. Its purpose is to measure physiological parameters (blood pressure and pulse rate).
Yes
The device is a diagnostic device because it measures blood pressure and pulse rate, determines irregular pulse rhythm, and classifies blood pressure values against WHO guidelines. These functions provide information used for diagnosis or detection of a disease or condition.
No
The device description explicitly states it consists of a "main unit and the cuff" and is powered by batteries, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Wrist Blood Pressure Monitor WSK-1011 measures blood pressure and pulse rate non-invasively from the wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use is for noninvasive measurement of physiological parameters (blood pressure and pulse rate) in adults in a homecare environment. This is a direct measurement on the body, not an analysis of a sample.
Therefore, the device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
Product codes
DXN
Device Description
Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adults
Intended User / Care Setting
Homecare environment
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety. The detailed information of reference standards is provided in the relevant sections of this submission.
Clinical tests: No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance.
Key results: It is concluded from the non-clinical tests conducted that the subject device is not only as safe and as effective as the predicate devices but is also safer and more effective than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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5. 510(K) Summary
This document was prepared in accordance with 21 CFR 807.92.
Section (a)
- (1) Name of the submitter: Nihon Seimitsu Sokki Co., Ltd. Address: 2508-13 Nakago, Shibukawa, Gunma 377-0293, Japan Telephone number: 81-279-20-2311 Contact person: Mitsuo Kanai Date of documentation: September 14, 2011
- (2) Trade name of the device: Blood Pressure Monitor WSK-1011 Common name: Blood pressure monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class II
- (3) Predicate devices: Wrist blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177, Nihon Seimitsu Sokki, Co., Ltd.
(4) Description of the device:
Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
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- (5) Intended use of the device:
WSK-1011 system is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
The indication for use of WSK-1011 system is not exactly same with but similar to the predicate device. The fundamental intended use, which is to measure adults' blood pressure non-invasively in home care environment, remains the same. The difference between the indications for use of the subject device and the predicate device lies in supplemental product features of the predicate device are not provided with the new device and some new features are introduced with the subject device. As demonstrated in relevant sections of this submission, these features are concluded not to affect the device safety and effectiveness.
- (6) Technological characteristics of the subject device and the predicate device:
The subject device holds the same technological fundamentals with the predicate device. Both devices consist of the single-mounted main unit and cuff for wrist and powered with two AAA alkaline batteries. The patient contacting materials used for the subject device had been used with the predicate device and these materials do not go through any different process from the predicate devices. The list of patient contacting materials and components is included in the relevant section of this application.
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(7) The following Device comparison table,shows the details of differences between the subject device and the claimed predicats.
| | WSK-1011, the subject device | WS-1100/WS-1100PV
(K080177) | Note |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended use | WSK-1011 system is intended for
noninvasive measurement of systolic and
diastolic blood pressure, determination of
pulse rate and calculation of pulse
pressure in adults in a homecare
environment.
The device features include display of
irregular pulse rhythm detection,
classification display of measured blood
pressure values against WHO (World
Health Organization) guidelines, display
of body movement detection and two
memory account to save measurement
results. | WS-1100/WS-1100PV system is
intended for noninvasive
measurement of systolic and
diastolic blood pressure and
determination of pulse rate in adults
in a homecare environment.
The device features include the
display of irregular pulse rhythm
detection, the classification display of
measured blood pressure values
against the guideline by World Health
Organization or equivalent guideline,
the personal setting for individual
blood pressure target values, the two
memory banks to save the
measurement results with date and
time of measurement and the
transferring the saved results to
personal computers. | |
| Operation
principle | Oscillometric method | Oscillometric method | Same |
| Pressure
indication
range | 3 to 300 mmHg | 0 to 300 mmHg | |
| Measurement
site and cuff
size | Wrist
Regular size (Approximately 4.9 to 8.9
inches; 125 to 225 mm) | Wrist
Regular size (Approximately 4.9 to
8.0; 125 to 205 mm) | Same |
| Power source | 2 AAA alkaline batteries | 2AAA alkaline batteries | Same |
| Inflation | Automatic air pump | Automatic air pump | Same |
| Deflation | Automatic electric control valve | Automatic electric control valve | Same |
| Exhaust | Automatic quick exhaust valve | Automatic quick exhaust valve | Same |
| Display | 15 digits liquid crystal display
Date and time display | 15 digits liquid crystal display
Date and time display | Same |
| Device setting
by the user | Date and time | Date and time
Personal target limits of blood
pressure values | |
| Memory
features | 2 memory banks to save 60
easurement results with date and time,
when the clock is activated; the saved
readings can be intentionally deleted by
the user. | 2 memory banks to save 60 blood
pressure and pulse rate readings
each with date and time; saved
reading(s) can be intentionally
deleted by the user.
Mode to view AM and PM readings
separately
Exporting saved readings to personal
computers using the designated USB
cable | |
| Main unit | Size: approximately W;2.76 x D;1.06 x
H;2.76 inches
Weight: approximately 3.9 oz.
Material: ABS and PMMA | Approximate size: W; 2.79, D; 2.56,
H; 1.18 inches
Approximate weight: 4.09 oz.
Material: ABS and PMMA | |
| Cuff type | Preformed nylon cuff | Preformed nylon cuff | Same |
Device comparison table
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Section (b)
(1) Non-clinical tests
The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety. This is why some reference standards were added to test the subject device when compared to the predicated devices. The detailed information of reference standards is provided in the relevant sections of this submission.
(2) Clinical tests
No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance.
(3) Conclusions drawn from non-clinical tests
It is concluded from the non-clinical tests conducted that the subject device is not only as safe and as effective as the predicate devices but is also safer and more effective than the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2012
Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Koji Kubo Manager Cosmos Corporation 6-5-3 Beaunce Honkomagome 2F, Honkomagome Bunkyo-ku, Tokyo
JAPAN 113-0021
Re: K112690
Trade/Device Name: Blood Pressure Monitor, Model WSK-1011 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 14, 2012 Received: February 16, 2012
Dear Mr. Kubo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American son to cominerce prov to May 20, 1970, the enaocance 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 You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110t liveling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Frease note: CDNT does not evaluate in the truthful and not misleading.
5
Page 2 - Mr. Koji Kubo
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 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.
-fs
Sincerely yours,
Brom D. Zuckerman, M.D.
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) Number: K112690
Blood Pressure Monitor WSK-1011 Device Name:
Indications for Use:
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
Prescription Use (Per 21 CFR 801.109 Subpart D)
X AND / OR Over-The Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Čardiovascular Device
510(k) Number K112690