(329 days)
No
The description details standard oscillometric blood pressure measurement and basic data analysis (pulse rate, pulse pressure, WHO classification, cuff condition, body movement) without mentioning AI or ML algorithms. The performance studies rely on non-clinical tests and equivalence to predicate devices, not AI/ML model validation.
Yes.
This device measures, monitors, and calculates blood pressure and pulse rate to assist in evaluating and managing a patient's health condition.
Yes
The device is described as a "Blood Pressure Monitor" which measures and determines blood pressure, pulse rate, and pulse pressure, and detects irregular pulse rhythms. These measurements and detections are used to assess the physiological state related to cardiovascular health, aligning with the definition of a diagnostic device that identifies or characterizes a disease or condition.
No
The device description explicitly states it consists of a "main unit and the nylon cuff" and is "powered by four AA alkaline batteries or AC adaptor," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for noninvasive measurement of blood pressure and pulse rate in adults. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The device uses an oscillometric method with a cuff applied to the upper arm. This is a standard method for measuring blood pressure in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on materials taken from the patient.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
Blood Pressure Monitor DSK-1031 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) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Product codes
DXN
Device Description
Blood Pressure Monitor DSK-1031 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm 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 nylon cuff that is applicable to arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm) and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose 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
upper arm
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
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
Not Found
Predicate Device(s)
Model DS-181 Digital Blood Pressure Monitor, K993890, Model DSK-1011 Blood Pressure Monitor, K112691, Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177, Model HEM-789N3/BP785/BP760 Blood Pressure Monitor, K061822
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).
0
K112620
P'1/7
2 2012
AUG
5. 510(K) Summarv
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: July 23,2012
(2) Trade name of the device: Blood Pressure Monitor DSK-1031 Common name: Blood pressure monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class 11
- (3) Predicate devices: Model DS-181 Digital Blood Pressure Monitor, K993890/Model DSK-1011 Blood Pressure Monitor, K112691/Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177 manufactured by Nohon -Seimitsu Sokki Co., Ltd. and Model HEM-789N3/BP785/BP760 Blood Pressure Monitor, K061822 manufactured by OMRON HEALTHCARE Co., Ltd.
- (4) Description of the device:
Blood Pressure Monitor DSK-1031 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm 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 nylon cuff that is applicable to arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm) and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.
1
- (5) Intended use of the device:
DSK-1031 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 guideline' display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
The indication for use of DSK-1031 system is not exactly same with but similar to the predicate device. Model DSK-1011 Blood Pressure Monitor and Wrist blood Pressure Monitor, Model WS-1100/WS-1100PV. However, 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. Model DS-181 Digital Blood Pressure Monitor and Model DSK-1011 Blood Pressure Monitor. Both devices consist of the main unit and the cuff for upper arm and powered with four AA alkaline batteries or designated AC adaptor. The patient contacting materials used for the subject device had been used with either one of the predicate devices; Model DS-181 and DSK-1011 or WS-1100/WS-1100PV and these materials do not go through anv different process from the predicate devices. The list of patient contacting materials and components is included in the relevant section of this application.
- The following devices comparison table shouws the derails of differences between the subject device and the claimed predicats.
5.2
2
| | DSK-1031, the subject device | WS-1100/WS-1100PV | DS-181 | HEM-780N3/BP785/BP760 | DSK-1011 | Note | Site and applicable circumference | Power source | Inflation | Deflation | Exhaust | Illustrational image of the device | Display | Device setting by the user | Supplemental product features | Memory
Features | H.D.M.S Mode
Exporting The Saved
Readings to Your PC | Auxiliary
feature | Main unit | Cuff | Reference
standard(s) | Irregular Heartbeat Symbol
Morning Hypertension
Symbol
Moring Average Symbol
Evening Average Symbol
Calibration Check System
Blood Pressure Level
Indicator | Substantial
Equivalence
Discussion". |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------|----------------------------------|-------------------------------|------------------------------------|-----------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 510(K)No. | K112620 | K080177 | K993890 | K061822 | K112691 | | Approximately 8.7 to 16.5 inches (220 to 420 mm) | 4 AA alkaline batteries or 100-240V 50/60Hz AC adaptor | Automatic air pump | Automatic electric control valve | Automatic quick exhaust valve | Image: Blood pressure monitor | 15 digits liquid crystal display | Date and time | Irregular Pulse Rhythm Symbol
Body Motion Symbol
Cuff Symbol
WHO Classification Symbol
Pulse Pressure Display Symbol | 2 memory banks to save
60 measurement 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 | None | Size: approximately W;4.5,
D;2.6, H;4.5 inches
Weight: approximately 8.8
oz. | Material: ABS and PMMA
Preformed nylon cuff | IEC 60601-1:1998 +
A1:1991 + A2:1995
IEC 60601-1-2, 2001 +
A1:2004/IEC60601-1-2
CISPR 11:2003 + A1:2004
- A2:2006
IEC 61000-4-2,-3,-8
ANSI/AAMI SP-10-2002 | A single memory bank to
save 30 blood pressure
readings; readings are
deleted at battery
replacement. | Same as
DSK-1011. |
| Intended use | DSK-1031 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 cuff condition,
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. | Noninvasive measurement
of systolic and diastolic
blood pressure and
determination of pulse rate
in adult patients, age 18
and above | The device is a digital
monitor intended for use in
measuring blood pressure
and pulse rate in adult
patient population with arm
circumference ranging from
9 inches to 17 inches
(22cm - 42cm).
The device detects the
appearance of irregular
heartbeats during
measurement and gives a
warning signal with
readings.
The blood pressure monitor
compares average blood
pressure results to
pre-established AHA
(American Heart
Association) hypertension
guideline of 135/85 mmHg.
The Omron 780N3 model
is not intended to be a
diagnostic device. Contact
your physician if
hypertensive values are
indicated. | Blood Pressure Monitor
DSK-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
accounts to save
measurement results. | Refer to "12.
Substantial
Equivalence
Discussion". | Approximately 4.9 to 8.0 inches (125 to 205 mm) | 2AAA alkaline batteries | Automatic air pump | Automatic electric control valve | Automatic quick exhaust valve | Image: Blood pressure monitor | 15 digits liquid crystal display
Date and time display | Personal target limits of blood pressure values | Irregular Pulse Rhythm Symbol
None
None
JNC-7 Classification Symbol
None | | | Position guide
Lock Key | Approximate size: W; 2.79,
D; 2.56, H; 1.18 inches
Approximate weight: 4.09
oz. | Material: ABS and PMMA
Preformed nylon cuff | 36.202 of
EN60601-1-2:1993(EMS)
EN55011:3.1991(EMI) | 2 memory banks to save
100 measurement results
with date and time, when
the clock is activated; the
saved readings can be
intentionally deleted by the
user. | |
| Operation
principle | Oscillometric method | Oscillometric method | Oscillometric method | Oscillometric method | Oscillometric method | Same | Standard Approximately 9.1 to 12.6 inches (230 to 320 mm)
Large Approximately 12.6 to 16.5 inches (320 to 420mm) | 4 AA alkaline batteries or 6VDC AC adaptor | Automatic air pump | Automatic electric control valve | Automatic quick exhaust valve | Image: Blood pressure monitor | 7 digits liquid crystal display | None | None
None
None
None
None | | | None. | Approximate size: W; 6,23,
D; 3.94, H; 2.05 inches
Approximate weight: 9.35
oz. | Material: ABS and PC
Nylon flat arm cuff | ANSI/AAMI SP-10-2002 | 2 memory banks to save 60
measurement results with
date and time, when the
clock is activated; the
saved readings can be
intentionally deleted by the
user. | Same as
WS-1100/
WS-1100PV |
| Pressure
indication
range | 3 to 300 mmHg | 0 to 300 mmHg | 0 to 300 mmHg | 0 to 299 mmHg | 3 to 300 mmHg | Same as
DSK-1011. | Approximately 9 to 17 inches (220 to 420 mm) | 4 AA batteries or 120V 60Hz AC adaptor | Automatic by electric pump | Automatic pressure release valve | Automatic quick exhaust | Image: Blood pressure monitor | 13 digits liquid crystal display
Date and time display | Date and time TRURED™ MODE | None
Movement Error Symbol
Cuff Wrap Guide Symbol
None
None | | | None | Approximate size: W; 4 7/8,
D; 6 1/4, H; 3 5/16 inches
Approximate weight: 15 1/8
oz. | Material: ABS and PC
Preformed nylon cuff | | None | |
| Measurement | Upper arm | Wrist | Upper arm | Upper arm | Upper arm | Same as DS-181
and DSK-1011 | Standard-Large size (Approximately 8.7 to 16.5 inches; 220 to 420 mm) | 4 AA alkaline batteries or 100-240V 50/60Hz AC adaptor | Automatic air pump | None | Automatic quick exhaust valve | Image: Blood pressure monitor | 15 digits liquid crystal display
Date and time display | Date and time | Same as WS-1100/ WS-1100PV and DSK-1011
Same
Body movement and Cuff winding are the same as HEM-780N3/BP785/BP760 and DSK-1011.
None
Refer to "12. | | | None | Size: approximately W:4.5,
D;2.6, H;4.5 inches
Weight: approximately 8.8 oz. | Material: ABS and PMMA
Nylon flat arm cuff | IEC 60601-1:1998 +
A1:1991+A2:1995
IEC 60601-1-2, 2001 +
A1:2004/IEC60601-1-2
CISPR 11:2009+ A1:2010
IEC
61000-3-2:2005+A1+A2:20
09
IEC 61000-3-3:2008 | None | |
| Same as DS-181 and DSK-1011 | Same | Same | Same | | | | | | | | | | | | | | | | | | | | |
Device comparison tabl
5.3
3
5.4
.
K112620
P47
4
5.5
:
$\xi$
K112620
p5/7
5
| IEC61000-4-2:2008
IEC61000-4-3:2006+A1:20
07+A2:2010
IEC61000-4-4:2004+A1:20
10
IEC61000-4-5:2005
IEC61000-4-6:2008
IEC61000-4-8:2009
IEC61000-4-11:2004
ANSI/AAMI SP10:2002 | | IEC61000-4-2:2008
IEC61000-4-3:2006+A1:20
07+A2:2010
IEC61000-4-4:2004+A1:20
10
IEC61000-4-5:2005
IEC61000-4-6:2008
IEC61000-4-8:2009
IEC61000-4-11:2004
ANSI/AAMI SP10:2002 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | | |
| 5.6 | | |
| | | K112620
P6/7 |
:
6
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.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle or other bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 2012 AUG
Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Koji Kubo Manager Cosmos Corporation 2F, 6-5-3 Komagome Bunkyo-ku Tokyo 113-0021 JAPAN
Re: K112620
Trade/Device Name: Digital Blood Pressure Monitor, Model DSK-1031 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 9, 2012 Received: July 10, 2012
Dear Mr. Kubo:
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.
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.
8
Page 2 – Mr. Koji Kubo
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.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
510(K) Number: K112620
Blood Pressure Monitor DSK-1031 Device Name:
Indications for Use:
Blood Pressure Monitor DSK-1031 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) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Prescription Use (Per 21 CFR 801.109 Subpart D)
(21 CFR 807 Subpart C)
X
AND / OR Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112620