(104 days)
No
The description details the use of the oscillometric method and a microcomputer for signal processing and calculation, which are standard techniques for digital blood pressure monitors and do not inherently involve AI or ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a blood pressure monitor, which measures blood pressure and pulse rate, but does not provide therapy or treatment.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressures and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states it is a "non-invasive technique in which an inflatable cuff is wrapped around the upper arm" and uses the "Oscillometric method," which involves sensing "vibrating signal via the closed air pipe system." These are descriptions of hardware components and physical measurement methods, not solely 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The description clearly states that this device is a "noninvasive blood pressure measurement system" that measures blood pressure and pulse rate by wrapping an inflatable cuff around the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Lack of mention of samples: There is no mention of collecting or analyzing any biological samples (blood, urine, etc.).
Therefore, the YA HORNG Digital Upper Arm Blood Pressure Monitor is a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB are noninvasive blood pressure measurement systems 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 upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.
※ Optional model: BP-700U, BP-700UB, and BP-700TUB, software in the PC for record archiving and printing purposes only.
Product codes
DXN
Device Description
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB use the Oscillometric 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 signal. Through simple calculation, the reading can reflect the 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
upper arm
Indicated Patient Age Range
over age 18
Intended User / Care Setting
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, EMC and FCC test reports, 1.
General safety EN 60601-1:1990+A1+A2+A11+A12+A13 PASS
EN 1060-1:1995, EN 1060-3:1997 PASS
EMC conformity EN 60601-1-2: 1993 PASS
FCC conformity ANSI C63.4: 2003 PASS
-
WOVEN COTTON SHEETING: (Same as the predicate devices)
Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539). -
PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Ko 9005-f
Image /page/0/Picture/1 description: The image displays the text "YAHORNG" in large, bold, black letters. Below this, in a smaller font, is the text "Ya Horng CO., LTD.". The text is simple and clear, with a focus on the company name.
No. 35, Zsha Lun, Jon Zsha village Antin Shiang, Tainan, Taiwan, ROC Tel: 886-6-5932201 Fax: 886-6-5935870 E-mail: lab@yahorng.com http:// www.yahomg.com
APR 2 2 2009
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"510(k) Summary"
Submitter's Name: YA HORNG Electronic Co., Ltd.
Address: No. 35, Zsha Lun, Jon Zsha Village, Antin Shiang, Tainan, 74555, Taiwan, ROC
Telephone: 886-6-5932201
886-6-5935870 FAX:
Contact Person: Dr. Jen, Ke-Min
March 1, 2008 Date Summary Prepared:
Proprietary Name: Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
Common Name: BLOOD PRESSURE MONITOR
Classification Name: NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM
( per 21CFR section 870.1130)
Device Class: Class II (performance standards)
Specialty: CARDIOVASCULAR
Product code: DXN
YA HORNG Digital Upper Arm Blood Pressure Legally Marketed ( Predicate ) Device : Monitor BP-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510
510(k) No: K072860
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Image /page/1/Picture/1 description: The image shows the company name "YAHORNG" in large, bold letters, followed by "Ya Horng CO., LTD." in a smaller font. Below that is the address "No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC". The text is clear and easy to read, with a simple, professional layout.
Tel: 886-6-5932201 Fax: 886-6. E-mail: lab@yahorng.com http:// www.yahorng.com
Description of the new device: (Same as the predicate devices)
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB use the Oscillometric 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 signal. Through simple calculation, the reading can reflect the 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.
Technological Characteristics of our new device compared to the predicate device:
The technological characteristics of YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB are substantially equivalent to YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510 (K072860). There is the same Owner. YA HORNG Electronic Co., Ltd., which FDA owner number is Especially, there are the same design specifications, the same form and 9040892. intended to be used in the same manner that means the new devices are same as the predicate devices.
The mainly different are:
-
- The new devices are different vision appearance and memory capacity for the predicate devices.
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7/3
Image /page/2/Picture/1 description: The image shows the logo and contact information for Ya Horng CO., LTD. The address is No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC. The telephone number is 886-6-5932201 and the fax number is 886-6-5935870.
E-mail: lab@yahorng.com http:// www.vahomg.com
-
- The new devices just for the general upper arm use and the predicate devices are either for the general upper arm or wrist use.
-
- The subject devices BP-700 series are the identical device with the optional functions including connects to the PC, backlight, and the voice function for the general upper arm use.
Thus there are substantially equivalent.
Test Summary:
.
ELECTRIC SAFETY, EMC and FCC test reports, 1.
| General safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASS |
|---|---|---|
| EN 1060-1:1995, EN 1060-3:1997 | PASS | |
| EMC conformity | EN 60601-1-2: 1993 | PASS |
| FCC conformity | ANSI C63.4: 2003 | PASS |
-
- WOVEN COTTON SHEETING: (Same as the predicate devices)
Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).
- WOVEN COTTON SHEETING: (Same as the predicate devices)
-
- PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10
YA HORNG Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.
- PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10
Keizila
Dr. Jen, Ke-Min official correspondent YA HORNG Electronic Co., Ltd.
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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 stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
APR 2 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ya Horng Electronic Co., Ltd. c/o Dr. Jen. Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, 30067 Taiwan, ROC
Re: K090058
Trade/Device Name: Ya Horng Digital Upper Arm Blood Pressure Monitor, Models BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB and BP-700TUB. Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: April 10, 2009 Received: April 16, 2009
Dear Dr. Jen:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2 - Dr. Jen, Ke-Min
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 Pours,
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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Image /page/5/Picture/0 description: The image shows the text "YAHONG Ya Hong CO., LTD." in a bold, sans-serif font. The text is black and appears to be slightly distressed or textured. The words "Ya Hong CO., LTD." are smaller and located directly below the word "YAHONG".
No. 35, Zsha Lun, Jon Antin Shiang, Tainan, Taiwan, ROC Tel: 886-6-5932201 Fax: 886-6-5935870 E-mail: lab@yahorng.com http:// www.yahorng.com
Indications for Use
K080671 K090058 510(k) Number:
Device Name: YA HORNG ELECTRONIC CO., LTD.
Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
. Indications for use:
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB are noninvasive blood pressure measurement systems 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 upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.
※ Optional model: BP-700U, BP-700UB, and BP-700TUB, software in the PC for record archiving and printing purposes only.
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) | |
|---|---|
| ------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices |
| 510(k) Number | KU90058 |
|---|---|
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| Page | 1 of 1 |
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