(46 days)
Empty
No
The summary describes a standard blood pressure monitor and does not mention any AI or ML capabilities, image processing, or provide details about training or test sets typically associated with AI/ML devices.
No
The device is described as a blood pressure monitor intended to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones.
Yes
The device is described as a "blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate." Measuring these vital signs for an individual is a form of diagnosis, as it provides information about the state of their health.
No
The device description explicitly mentions "noninvasive blood pressure measurement systems" and "an inflatable cuff is wrapped around the wrist," indicating hardware components are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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... by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist."
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Nature of Measurement: This device measures blood pressure and pulse rate directly from the body using a physical cuff, not by analyzing a sample taken from the body.
Therefore, this device falls under the category of a non-invasive medical device rather than an IVD.
N/A
Intended Use / Indications for Use
The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R 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".
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Not Found
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
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)
Not Found
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
K0518627
AUG 2 3 2005
YAHORNG
Ya Horng CO., LTD.
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
"510(k) Summary"
Submitter's Name: YA HORNG Electronic Co., Ltd.
Address: No. 35, Zaha Lun, Jon Zsha Village, Antin Shiang, 745, Taiwan, ROC
Telephone: 886-6-5932201
FAX: 886-6-5935870
Contact Person: Dr. Jen, Ke-Min
Date Summary July 4, 2005 Prepared:
Proprietary Name: PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R ; Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R
- 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
AMLUCK AUTOMATIC DIGITAL WRIST BLOOD Legally Marketed PRESSURE MONITOR AK-3000 / AK-4000 ( Predicate ) Device : 510(k) No: K012796
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2005
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 CHINA (TAIWAN) 300
Re: K051862
Trade Name: Amluck Ya Horng PC Compatible Blood Pressure Monitor, AK-4000TU, BP-410U,BP-410R; and, Automatic Digital Wrist Blood Pressure Monitor, BP-420U, BP-420R Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 4, 2005 Received: July 8, 2005
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 interested commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federall 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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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 (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 Dl 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/3/Picture/0 description: The image shows the logo for Ya Horng CO., LTD. The logo is in black and white, with the words "YA HORNG" in large, bold letters. Below the large text is the company name "Ya Horng CO., LTD" in a smaller font. The logo is simple and easy to read.
No. 35, Zsha Lun, Jon Antin Shiang, Tainan, Taiwan, ROC Tel: 886-6-5932201 Fax: 886-6-5935870 http:// www.yahorng.com E-mail: lab@yahorng.com
Indications for Use
510(k) Number:
Device Name: YA HORNG ELECTRONIC CO., LTD. PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R : Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R
● Indications for use:
The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R 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".
. Note:
BP-410R , BP-420R : Data Transmission: Connection to PC using RS232 cable. AK-4000TU, BP-410U, BP-420U: Data Transmission: Connection to PC using USB cable
| 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 | K051862 |