(59 days)
Not Found
No
The description details a standard oscillometric blood pressure measurement method using a microcomputer for calculation, which is a traditional approach and does not indicate the use of AI or ML.
No
The device is intended for measurement and monitoring of blood pressure, not for therapy or treatment.
Yes
This device is a diagnostic device because it measures blood pressure and pulse rate, which are used to assess an individual's health status. While it's intended for home use, the act of measuring and providing these physiological parameters for health assessment falls under the definition of diagnostic purposes.
No
The device description explicitly mentions an "inflatable cuff" and the use of the "Oscillometric method" which involves sensing vibrating signals via a "closed air pipe system". These are hardware components and physical measurement techniques, indicating the device is not software-only.
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 description clearly states that this device is a "noninvasive blood pressure measurement system" that measures blood pressure and pulse rate by using an inflatable cuff wrapped around the wrist. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Method: The device uses the "Oscillometric method," which is a non-invasive technique based on detecting pressure oscillations in the cuff. This is not an in vitro diagnostic method.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device as a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"-7.75".
Product codes
DXN
Device Description
APM BP108A uses the Oscillomeric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse Through simple calculation, clinically proven, the reading can reflect the signal. accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
over age 18
Intended User / Care Setting
adult individual, at home
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)
Electric Safety Requirement Test Report of EN 60601-1:1990 & EN 1060-1/ EN1060-3, and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995)
ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 - 2004
Asia Pacific Microsystems, Inc. c/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No 2, R&D Road 6, Hsin Chu Science-Based Industrial Park Hsin Chu, (TAIWAN) 300
Re: K040159 APM Blood Pressure Monitor, BP108A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 10, 2004 Received: January 23, 2004
Dear Dr. Jen:
This letter corrects our substantially equivalent letter of March 22, 2004 regarding the incorrect spelling of the name of your company.
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.
1
Page 2 -- Ke-Min Jen, Ph.D.
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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):K040159
Device Name: APM Blood Pressure Monitor, BP108A
Indications For Use:
The device as a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"-7.75".
Prescription Use (Part 21 CFR 801 Subpart D)
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)
schma R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K040159
Page 1 of 1
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K040159
p1/i-
January 10, 2004
Asia Pacific Microsystems, Inc
No.2,R&D Road 6, Hsinchu Science-based Industrial Park Hsin Chu, Taiwan, R.O.C. Tel : +886-3-666-1188 Fax : +886-3-666-1199 e-mail : mslin@apmsinc.com http//: www.apmsinc.com
510(k) SUMMARY " હ્ન
Asia Pacific Microsystems, Inc. Submitter's Name:
No.2,R&D Road 6, Hsinchu Science-based Industrial Park Hsin Chu, Taiwan, R.O.C Fax: 886-3-666-1199 Telephone: 886-3-666-1188 e-mail : mslin@apmsinc.com
Date summary propared:
Device Name:
APM Blood Pressure Monitor, BP108A Proprietary Name: NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Common or Usual Name: Blood Pressure Monitor, Class II, Classification Name: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use:
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".
Description of the device:
APM BP108A uses the Oscillomeric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse Through simple calculation, clinically proven, the reading can reflect the signal. accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
MAR 2 2 2004
4
KO-40:52
f. - 12
Asia Pacific Microsystems, Inc No.2,R&D Road 6, Hsinchu Science-based Industrial Park Hsin Chu, Taiwan, R.O.C Tel : +886-3-666-1188 Fax : +886-3-666-1199 e-mail:mslin@apmsinc.com
http://: www.apmsinc.com
Performance Testing:
Electric Safety Requirement Test Report of EN 60601-1:1990 & EN 1060-1/ EN1060-3, and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995)
ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers
Legally marketed device for substantial equivalence comparison:
Eikon Automatic Digital Blood Pressure Monitor, HD-400M (K021239)
Summary for substantial equivalence comparison:
Same characteristics: intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments.
Different characteristics: memory, dimensions, weight, and storage environments.
As we can understand, the memory feature is to memorize the measurement data 1. taken previously and is related to the usage convenience, not to raise any safety or effectiveness hazard.
- The differences between dimensions and weight are related to the designing aspects. 2. These differences are not to raise any safety or effectiveness aspect.
They are decided to be substantially equivalent.