(77 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is intended for measurement, not for treatment or therapy. It measures blood pressure and pulse rate.
Yes
The device is described as a "noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate." Measuring vital signs like blood pressure and pulse rate is a diagnostic function because it provides information about the physiological state of an individual, which can be used to identify health conditions or monitor disease progression.
No
The description explicitly mentions an "inflatable cuff" which is a hardware component.
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 the device is a "noninvasive blood pressure measurement system" that measures blood pressure and pulse rate by wrapping an inflatable cuff around the wrist. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, using reagents, or detecting specific biomarkers.
Therefore, this device falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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 inclividual, 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".
Product codes
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)
Not Found
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Dr. Ke-Min Jen Roc Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, Roc
Re: K030561
Trade Name: Mytech/Happy Life Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 12, 2003 Received: February 21, 2003
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.
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
1
Page 2 - Dr. Ke-Min Jen
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) 594-4646. 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,
KOCATLM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
MYTECH TECHNOLOGY CO., LTD.
5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: 886-2-2247 4816 Fax: 886-2-2247 7024 Email: sale@mytech.com.tw
Applicant: Mytech Technology Co., Ltd..
510(k) Number ( if known):
Device Name: MYTECH / HAPPY LIFE / BLOOD PRESSURE MONITOR, HPL-100, HPL-100A
● 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 inclividual, 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".
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
| Concurrence of CDRH, office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K030561 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter-Use |
|---|---|---|
| ( Per 21 CFR 801.109 ) | ( Optional Format 1-2-96 ) |