(143 days)
No
The description details the use of the oscillometric method and a microcomputer for calculation, which are standard techniques for digital blood pressure monitors and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: The device is intended for measurement and monitoring of blood pressure, not for therapy or treatment.
No
The device is described as a noninvasive blood pressure measurement system intended to measure blood pressure and pulse rate, which are physiological parameters, not for diagnosing a disease or condition.
No
The device description clearly outlines hardware components like an inflatable cuff and a system that senses vibrating signals via a closed air pipe system, indicating it is a physical device with integrated software, not software-only.
Based on the provided text, 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. It measures blood pressure and pulse rate by using an inflatable cuff wrapped around the arm or wrist. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- No mention of samples: The text does not mention the collection or analysis of any biological samples.
Therefore, the YA HORNG Digital Upper Arm Blood Pressure Monitor and Digital Wrist Blood Pressure Monitor are medical devices, but they fall under the category of non-invasive physiological monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 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 wrist. The cuff circumference is limited to be 5.3" ~ 8.5" for Wrist type and 9.0" ~ 13.0" for Arm type.
Product codes
DXN
Device Description
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 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, Wrist
Indicated Patient Age Range
Adult individual, over age 18
Intended User / Care Setting
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 and EMC test reports:
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
Blood Pressure Cuff: Uses 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
Image /page/0/Picture/1 description: The image shows the word "YAHORNG" in large, bold, black letters. Below the main word, there is a smaller text that reads "Ya Horng CO., LTD". The text is also in black, but the font size is significantly smaller than the main word.
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.yahorng.com
FEB 25 2008
13
"510(k) Summary"
Submitter's Name: YA HORNG Electronic Co., Ltd.
Address: No. 35, Zaha Lun, Jon Zsha Village, Antin Shiang, Tainan, 74555, Taiwan, ROC
Telephone: 886-6-5932201
FAX: 886-6-5935870
Contact Person: Dr. Jen, Ke-Min
Date Summary October 1, 2007 Prepared:
Proprietary Name: Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J : Digital Wrist Blood Pressure Monitor BP-500, Bb-210
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 PC Compatible Blood Pressure Legally Marketed Monitor AK-4000TU, BP-410U, BP-410R; and ( Predicate ) Automatic Digital Wrist Blood Pressure Monitor Device : BP-420U, BP-420R
510(k) No: K051862
1
Image /page/1/Picture/0 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. The email address is lab@yahorng.com, and the website is http://www.yahorng.com.
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2/3
Description of the new device:
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 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-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510 are substantially equivalent to YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U. BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R. There is the same Owner, AMLUNK Inc., which FDA owner number is 9040892. Especially, there are the same design specifications, the same form and 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 only different vision appearance for the predicate devices.
2
Image /page/2/Picture/0 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. The email address is lab@yahorng.com, and the website is http://www.yahorng.com.
-
- The predicate devices can connect to the PC and the new devices are just for the general upper arm or wrist uses.
Thus there are substantially equivalent.
- The predicate devices can connect to the PC and the new devices are just for the general upper arm or wrist uses.
Test Summary:
ELECTRIC SAFETY and EMC 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 |
WOVEN COTTON SHEETING 2.
Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).
3. 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.
Kristen
Dr. Jen, Ke-Min official correspondent YA HORNG Electronic Co., Ltd.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
FEB 25 2008
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
K072860 Re:
Trade/Device Name: Digital Upper Arm Blood Pressure Monitor Models BP-100J, BP-110J; Digital Wrist Blood Pressure Monitor Models BP-500, Bb-210 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 17, 2008 Received: January 23, 2008
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.
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.
4
Page 2 - Dr. Jen Ke-Min
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
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Image /page/5/Picture/0 description: The image shows the text "YAHORNG Vo Horng CO., LTD". The text is in a bold, sans-serif font and is black. The letters are slightly distressed, giving the text a textured appearance. The words "Vo Horng CO., LTD" are smaller than the word "YAHORNG" and are located directly below it.
No. 35. Zsha Lun, Jon Z 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
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: YA HORNG ELECTRONIC CO., LTD.
Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J :
Digital Wrist Blood Pressure Monitor BP-500, BP-510
. Indications for use:
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 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 wrist. The cuff circumference is limited to be 5.3" ~ 8.5" for Wrist type and 9.0" ~ 13.0" for Arm type.
| 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) | |
|---|---|
| (Divisio | |
| Division of C... | |
| 510(k) Number | K072860 |
| Page | 1 of 1 |