(248 days)
K 001670
Not Found
No
The description focuses on the oscillometric method and standard blood pressure measurement techniques, with no mention of AI or ML.
No
The device is solely intended for measurement and monitoring of blood pressure and heart rate, which are diagnostic functions. It does not provide any therapeutic intervention or treatment.
No
The device measures physiological parameters (blood pressure and heart rate) but does not provide a diagnosis or aid in the diagnosis of a disease or condition. It is described as a "medical assistant instrument" for measurement.
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... by inflating an inflatable cuff on the upper arm." This indicates the presence of hardware components (cuff, inflation mechanism, sensor) beyond just software.
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 BP101 Digital Blood Pressure Monitor measures blood pressure and heart rate directly from the upper arm using a non-invasive method (oscillometric). It does not analyze samples taken from the body.
The device is a non-invasive medical device used for physiological measurement.
N/A
Intended Use / Indications for Use
BP101 Digital Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm using the oscillometric method.
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 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.
Product codes
DXN
Device Description
BP101 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 upper arm.
BP101 Digital Blood Pressure Monitor uses an inflated cuff which is The systolic and diastolic blood pressures are determined by Oscillometric method. The deflation rate is controlled by an automatic air-release valve at a constant rate 2~7mmHg/second. The user can deflate 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
upper arm
Indicated Patient Age Range
adult population
Intended User / Care Setting
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 BP101. The comparison study demonstrated that the clinical repeatability of BP101 is statistically and clinically acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 001670
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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510(k) Summary
- Submitter's Name: Mr. Dacheng Gong, Manager
MAR 2 3 2007
KINGYIELD HONGKONG LIMITED
Address: 12 Floor, No. 180 Electric Road, North Point, Hong Kong.
Phone: +86-755-27371997
Fax: +86-755-27331856
E-mail:kyield@szonline.net
Contact: Mr. Dacheng Gong, Manager
Date of Summary: Jan. 18 2006
-
Trade Name: BP101 Digital Blood Pressure Monitor
-
Classification Name
Non-invasive Blood Pressure Measurement System.
Regulation Number: 21 CFR 870.1130
Class: II
4.Product Code: DXN
5.Classification Panel: Cardiovascular
- Predicate Device: HEM-757 Automatic Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC.
K 001670 (Predicate)
7.Device Description:
BP101 Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood
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pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the upper arm.
The Intended use:
BP101 Digital Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm using the oscillometric method.
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 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 device conform to applicable standards including ANSI/AAMI SP-10:2002, EN 1060-1, EN-1060-3, and IEC60601-1-1-2 requirements.
A comparison study with a device that uses auscultatory method used by trained observers was performed to validate the performance of BP101. The comparison study demonstrated that the clinical repeatability of BP101 is statistically and clinically acceptable.
8.2 Technological Characteristics
BP101 Digital Blood Pressure Monitor uses an inflated cuff which is
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The systolic and diastolic blood pressures are determined by Oscillometric method. The deflation rate is controlled by an automatic air-release valve at a constant rate 2~7mmHg/second. The user can deflate the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
Clark -
9.Conclusion
BP101 Digital Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device HEM-757, Moreover, non-clinical testing & clinical testing contained in this submission demonstrated that any difference in their technological characteristics doesnot raise any new issues of safety and effectiveness. In a word, BP101 is substantial equivalent to the predicate device HEM-757.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2007
Welch Allyn Protocol, Inc. c/o Mr. Tamas Borsai Program Manager, Third Party Review Program 12 Commerce Rd. Newton, CT 06470
Re: K062033
Trade/Device Name: BP101 Digital Blood Pressure Measurement System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: March 8, 2007 Received: March 12, 2007
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.
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Page 2 - Mr. Borsai
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); 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 entitled, "Misbranding by reference to premarket 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,
Blymnemon 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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Indications for Use Statement
510(k) Number (if known): K062033
Device Name: BP101 Digital 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 arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Prescription 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)
B. Almon
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