(13 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a pressure sensor and signal analysis, with no mention of AI or ML terms, training data, or complex algorithms beyond basic signal processing.
No
The device is strictly for diagnostic purposes (measuring blood pressure and pulse rate) and does not provide any therapy or treatment.
Yes
Explanation: The device measures systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a person's health status and aid in diagnosing certain conditions (e.g., hypertension).
No
The device description explicitly mentions hardware components such as an inflatable cuff, electronic capacitive pressure sensor, and an LCD panel, indicating it is a physical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that this device measures blood pressure and pulse rate by placing a cuff on the upper arm and using the oscillometric method. This is a measurement taken directly from the living body (in vivo).
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, based on the provided information, the Arm Type Digital Blood Pressure Monitor is a medical device used for physiological measurement in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arm Type Digital Blood Pressure Monitor is a table top AC/DC powered operated arm type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the upper arm and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) blood pressure: 20 to 280 mmHg (2) pulse : 40 to 200 pulses/minutes.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Ya Horng Arm Type Digital Blood Pressure Monitors, Types BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB , BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by oscillometric method in which an inflatable cuff is wrapped around the upper arm. It uses an electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate. Some models are with RS232 or USB ports to connect to the personal computer to store the measured data.
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
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)
Following functional and performance testing were conducted to assess the safety and effectiveness of these Arm Digital Blood Pressure Monitor . All results are satisfactory.
- a. Reliability Test Storage Test
- b. Reliability Test Operation Test
- c. Reliability Test Vibration Test
- d. Reliability Test Drop Test
- e. Reliability Test Life Test
- f. EMC Test
None of the tests demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazard.
The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002.
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
K081590 11/3
510K Summary
JUN 1 9 2008
1. SUBMITTER'S IDENTIFICATION
Ya Horng Electronic Co., Ltd. James Kuo No. 35, Zsha Lun, Jon Zsha Village, Antin Shiang, Tainan, Taiwan, R.O.C. Tel : 886-6-593-2201 Fax : 886-6-593-0030 Email : jmkuo@yahorng.com
DATE PREPARED : May 28, 2007
2. DEVICE NAME
Trade Name : Ya Horng Arm Type Digital Blood Pressure Monitor Model No. : BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB ,BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ Common/Usual Name : Blood Pressure Monitor Classification Name : Non-invasive Blood Pressure Measurement System 21CFR 870.1130, DXN
3. PREDICATED DEVICE
It is substantially equivalent to the following device : Microlife Intellectual Property GmbH, Model BP3AC1-1PC, FDA 510K, K060686, issued on June 9, 2006
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4. DEVICE DESCRIPTION AND INTENDED USE
The Ya Horng Arm Type Digital Blood Pressure Monitors, Types BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB , BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by oscillometric method in which an inflatable cuff is wrapped around the upper arm. It uses an electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate. Some models are with RS232 or USB ports to connect to the personal computer to store the measured data.
5. COMPARISON TO THE PREDICATE DEVICE-
Both models use the oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and the pulse rate. An upper arm cuff is inflated automatically; deflate rate is controlled by a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both models. Moreover, both models have PC link function, the memory function and auto power off function.
6. DISCUSSION OF NON-CLINICAL TESTS PERFORMED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE ARE AS FOLLOWS:
Following functional and performance testing were conducted to assess the safety and effectiveness of these Arm Digital Blood Pressure Monitor . All results are satisfactory.
- a. Reliability Test Storage Test
- b. Reliability Test Operation Test
- c. Reliability Test Vibration Test
- d. Reliability Test Drop Test
2
- e. Reliability Test Life Test
- f. EMC Test
None of the tests demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazard.
7. DISCUSSION OF CLINICAL TESTS PERFORMED:
The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002.
8. CONCLUSION
When compared to the predicate device, the equipment does not incorporate any significant changes in the intended use, method of operation, material or design that could affect safety and effectiveness.
3
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Ya Horng Electronic Co., Ltd. c/o Mr. Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, IL 60062
Re: K081590
Ya Horng Arm Type Digital Blood Pressure Monitor, Model Numbers BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ. Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 29, 2008 Received: June 6, 2008
Dear Mr. Devine:
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. Ned Devine
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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K081590
Device Name: Arm Type Digital Blood Pressure Monitor, Types BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ.
Indications for Use:
The Arm Type Digital Blood Pressure Monitor is a table top AC/DC powered operated arm type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the upper arm and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) blood pressure: 20 to 280 mmHg (2) pulse : 40 to 200 pulses/minutes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ellmal
(Division Sign-Off)
Division of Cardiovascular Devices
KO81590 510(k) Number.