(207 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor with basic features like memory storage, irregular heartbeat detection, and averaging. There is no mention of AI, ML, or any advanced algorithms that would suggest the use of such technology. The performance testing is based on established standards for blood pressure monitors, not on AI/ML model validation. The statement that the measurement algorithm and program codes remain unchanged from the predicate device further supports the absence of new AI/ML development.
No.
The device is intended to measure blood pressure and heart rate, which are diagnostic functions, not therapeutic.
Yes
The device is intended to measure blood pressure and heart rate, and can detect irregular heartbeats, which are all diagnostic indicators.
No
The device description explicitly mentions hardware components like an inflatable cuff, LCD, and USB cable, and the performance studies include testing for mechanical and electrical reliability.
No, 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 BP210 Wrist Blood Pressure Monitor measures blood pressure and heart rate non-invasively from the wrist using the oscillometric method. It does not analyze any samples taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and heart rate from the wrist.
- Device Description: The description reinforces that it's a non-invasive technique using an inflatable cuff.
Therefore, based on the provided information, the BP210 Wrist Blood Pressure Monitor is a non-invasive medical device for measuring vital signs, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
The cuff circumference is limited to 13.5cm - 21.5cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".
The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting the device with the PC via USB cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adult population
Intended User / Care Setting
Not Found
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)
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Testing information demonstrating safety and effectiveness of BP210 Wrist Digital Blood Pressure Monitor in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.
The following testing was conducted:
- a. Reliability Test Storage test according to ANSI/AAMI SP10:2002/A1:2003/4.2.1 and EN 1060-1:1996/7.1.2.1
- b. Reliability Test Operating test according to ANSI/AAMI SP10:2002/A1:2003/4.2.2 and EN 1060-1:1996/7.1. 1
- c. Reliability Test Vibration test according to ANSI/AAMI SP10:2002/A1:2003/4.2.3 and EN 1060-1:1996/7.2. 2
- d. Reliability Test Drop test according to ANSI/AAMI SP10:2002/A1:2003/4.5.4.1B and EN 1060-3:1996/7.4. 1
- e. Reliability Test Life test according to ANSI/AAMI SP10:2002/A1:2003/4.2.4.2 and EN 1060-3:1997/7.6
- EMC Test according to IEC 60601-1-2:2007 (Third edition) f.
- Safety Test according to IEC 60601-1:1988+A1:1991+A2:1995
- Performance Test-according to EN1060-1:1995/A1:2002 and EN 1060-3:1997/A1:2005
- Biocompatibility Test Report according to ISO 10993-5:2009 and ISO 10993-10:2002/Amd.1:2006
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that BP210Wrist Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed:
ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP210 met all relevant requirements of this standard, as applicable to our modified device. The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device. Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
KI12042
3
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor
Annex 04
510(k) Summary
(as required by 21 CFR 807.92)
1. Submitter's Identification
| Submitter's Name: | Shenzhen Kingyield Technology Co.,Ltd. |
|---|---|
| Address: | Section C1 C2, Fuhai Industrial Zone, Fuhai Road, |
| Fuyong Town, Baoan District, Shenzhen, PR China | |
| Phone: | +86-755-27326734 |
| Fax: | +86-755-27331856 |
| E-mail: | kingyield@kingyield.com |
| Contact person: | Mr. Dacheng Gong, General Manager |
| Date of Summary: | Jan, 10,2012 |
2. Product Classification
| Trade Name: | BP210 Wrist Blood Pressure Monitor |
|---|---|
| Common Name: | Wrist Blood Pressure Monitor |
| Classification Name: | System, Measurement, Blood Pressure, Non-Invasive |
| Class: | II |
| Regulation number: | 870.1130 |
| Product code: | DXN |
| Panel: | Cardiovascular |
3. Identification of the legally marketed device
| 510(k) number: | 083043 |
|---|---|
| Trade Name: | BP201 Wrist Blood Pressure Monitor |
| Product Code: | DXN |
4. Device Description:
BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".
The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting
1
the device with the PC via USB cable.
5. Indications for Use:
BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
The cuff circumference is limited to 13.5cm - 21.5cm.
6. Summary of Technological Characteristics Compared to the Predicate Device:
The modified device BP210 and the predicate device BP201 use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Wrist cuff is inflated with the constant speed automatically, and the inflation pressures are transferred via tubing to one sensor.
The major differences between the two models are the additional features such as PC link function, blood pressure classification and bigger memory size.
Predicate Device:
Cleared Device Model: BP201, K083043 which is designed and manufactured by the same company and facility as the BP210 Wrist Blood Pressure Monitor
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Testing information demonstrating safety and effectiveness of BP210 Wrist Digital Blood Pressure Monitor in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.
The following testing was conducted:
- a. Reliability Test Storage test according to ANSI/AAMI SP10:2002/A1:2003/4.2.1 and EN 1060-1:1996/7.1.2.1
- b. Reliability Test Operating test according to ANSI/AAMI SP10:2002/A1:2003/4.2.2 and EN 1060-1:1996/7.1. 1
- c. Reliability Test Vibration test according to ANSI/AAMI SP10:2002/A1:2003/4.2.3 and EN 1060-1:1996/7.2. 2
7/3
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SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor
- d. Reliability Test Drop test according to ANSI/AAMI SP10:2002/A1:2003/4.5.4.1B and EN 1060-3:1996/7.4. 1
- e. Reliability Test Life test according to ANSI/AAMI SP10:2002/A1:2003/4.2.4.2 and EN 1060-3:1997/7.6
- EMC Test according to IEC 60601-1-2:2007 (Third edition) f.
- Safety Test according to IEC 60601-1:1988+A1:1991+A2:1995 ದ.
- Performance Test-according to EN1060-1:1995/A1:2002 and EN 1060-3:1997/A1:2005 ﻏ
- Biocompatibility Test Report according to ISO 10993-5:2009 and ISO ..... 10993-10:2002/Amd.1:2006
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that BP210Wrist Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP210 met all relevant requirements of this standard, as applicable to our modified device. The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device. Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.
9. Conclusions:
We have demonstrated that there are no significant differences between BP210 Wrist Blood Pressure Monitor and the predicate devices, Model BP201, in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA DCRND November 1993
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 resembling an eagle or bird in flight, with three stylized strokes forming the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 0 2012
Shenzhen KingYield Technology Co., Ltd c/o Mr. Michael S. Ogunleye TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470
K112042 Re:
Trade/Device Name: King Yield Wrist Blood Pressure Monitor, Model 210 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: January 13, 2012 Received: January 24, 2012
Dear Mr. Ogunleye:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to Commerce prior to may 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assessment approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the device, bacycer to the connects for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and devices, good manufacturing places, as othing in and information related to contract liability adulteration. Tease note: CDTCP does not over 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 If your device is classified (soc above) investigations affecting your device can be
4
Page 2 - Mr. Michael S. Ogunleye
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. Page 2 – Ms. Sarah Su
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be devised that I DTT 3 lesames a sour device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must of any I coeral statures and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it Fart 607), acceing (21 CFR 803); good manufacturing practice requirements as set de rice-relation daverse overse overse) (2) CFR Part 820); and if applicable, the electronic form in the quality by evens (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 11 you desire specific ad rios or you /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 note the regulations 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 Tou may obtain other generers, 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,
R. Fletcher, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor
Annex 03
Indications for Use Statement
12042
510(k) number: Device Name: Indications for Use:
BP210 Wrist Blood Pressure Monitor
BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
lt can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
The cuff circumference is limited to 13.5cm - 21.5cm.
(Part 21 CFR 801 AND/OR Over-The-Counter Use Prescription Use _ Subpart D) (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) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
(Division Sign On)
Division of Cardiovascular Devices
03-1