(13 days)
K 042505
K 042505
No
The description focuses on the oscillometric method and standard blood pressure measurement techniques, with no mention of AI or ML.
No
Explanation: A therapeutic device is used for treatment. This device is used for measuring blood pressure and heart rate, which are diagnostic measurements, not treatments.
No
The device measures systolic and diastolic blood pressure and heart rate, which are vital signs, but it does not diagnose a condition. It provides measurements that a healthcare professional might use as part of a diagnostic process.
No
The device description explicitly states it is a "fully automatic non-invasive blood pressure monitor" that uses an "inflatable cuff" and a "built-in air pump," 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:
- 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the BP201 Wrist Blood Pressure Monitor is a non-invasive device that measures blood pressure and heart rate by inflating a cuff on the wrist. This is a direct measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for measuring blood pressure and heart rate, which are physiological parameters measured directly from the patient.
Therefore, the BP201 Wrist Blood Pressure Monitor falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BP201 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 not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
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 the other 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.
Product codes
DXN
Device Description
BP201 Wrist 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.
BP201 Wrist 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 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" 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
medical assistant instrument at 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
Not Found
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 BP201. The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable.
The device complies with the ANSI/AAMI SP10:2002 standard and BS EN1060-4: 2004 in its entirety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 042505
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
K083043
P1/4
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary
510(k) Summary
l . Submitter's Name: Mr. Dacheng Gong, Manager
OCT 2 7 2008
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
Address: Section CI-2, Fu'Hai Industrial Zone, Fu'Yong Street,
Bao'An District, Shenzhen, PR China
Phone: +86-755-27371997
Fax: +86-755-27331856
E-mail: kingyield@kingyield.com
Contact person:
Name1: Mr. Dacheng Gong,
Title: Manager
Name2: Ms. Xuecai Wang
Title; Asistant manager
Phone: +86-755-27371997
Fax: +86-755-27331856
e-mail: kingyield@kingvield.com
Date of Summary: Jan. 12 2007
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Trade Name: BP201 Wrist Blood Pressure Monitor
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Classification Name
Non-invasive Blood Pressure Measurement System.
Regulation Number: 21 CFR 870.1130
Class: II
1
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Product Code: DXN
-
Classification Panel: Cardiovascular
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Predicate Device: IEM-609N Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC.
K 042505 (Predicate)
7. Device Description:
BP201 Wrist 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.
The Intended use:
BP201 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 not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
8. Performance and Technological Characteristics :
8.1 Performance Summary
In terms of operating specification, Safety & EMC requirements, the
2
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary
device conform to applicable standards including ANSI/AAMI SP10:2002, BS EN1060-4: 2004, IEC60601-1:1998+A1:1991+A2:1995 IEC 60601-1-2:2001/A1:2004. A comparison study with a device that uses auscultatory method used by trained observers was performed to validate the performance of BP201. The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable.
8.2 Technological Characteristics
BP201 Wrist 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 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
9. Substantial equivalence discussion
9.1. About the non-clinical tests
BP201 Digital Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device HEM-609N, such as Measurement localization, Measuring parameters, Measurement range, Measurement Accuracy, Inflation, Deflation, Measurable
4
3
circumference of wrist, Power source, Battery life, Operate environment, Preservation environment.
The main differences are the physical size, shape and weight, 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, BP201 is equivalent to the predicate device for the non-clinical performance.
9.2. About the clinical tests
The device complies with the ANSI/AAMI SP10:2002 standard and BS EN1060-4: 2004 in its entirety. Thus BP201 & the predicate device HEM-609N are substantially equivalent.
10. Conclusion
BP201 Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate devicc HEM-609N 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, BP201 is substantial equivalent to the predicate device HEM-609N
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
Shenzhen Kingyield Technology Co., Ltd. c/o TUV Rheinland of North America, Inc. Mr. Tamas Borsai Division Manager, Medical Division 12 Commerce Rd. Newton, CT 06470
Re: K083043
Trade/Device Name: BP201 Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 10, 2008 Received: October 14, 2008
Dear Mr. Borsai:
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 such 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
5
Page 2 - Mr. Tamas Borsai
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entifled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Wachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SHENZHEN KINGY(ELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Anne37 Indication for Use Statement
Indications for Use Statement
510(k) Number (if known): K083043
Device Name: BP201 Wrist Blood Pressure Monitor
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 the other 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.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 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)
uma R. Schmer
(Division Sign-Off)
Division of Cardiovascular Devices
KOB3043 510(k) Number