(42 days)
Not Found
No
The summary describes a standard non-invasive blood pressure monitor and explicitly states the new devices are "basically the same" as the predicate device with minor differences in memory, display layout, and added features like a USB port or voice prompt. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a noninvasive blood pressure measurement system intended to measure blood pressure and heart rate, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as a "Blood Pressure Monitor" which measures "systolic and diastolic blood pressures and pulse rate." These are diagnostic measurements used to assess a patient's health status.
No
The device description explicitly mentions hardware components like an inflatable cuff, LCD display, USB port, and LED warming lights, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic and diastolic blood pressure and pulse rate non-invasively by wrapping a cuff around the arm. This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the physical characteristics, measurement method (inflatable cuff), and display of the results. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies listed are related to electrical safety, EMC conformity, and blood pressure measurement standards (AAMI / ANSI SP10), which are typical for non-invasive medical devices, not IVDs.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not perform such analysis.
N/A
Intended Use / Indications for Use
The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor,, Model HPL-301, HPL-302, HPL-310, 180310 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 arm.
The cuff circumference is limited to be 7"-15".
Product codes
DXN
Device Description
Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, dimensions, weight, and storage environments. The minor differences are the memory and display layout. That means the predicate device has 60 memory capacities and the new devices have 60 memory capacities. Besides, the new devices add 3 colors LED warming lights for the visional appearance.
The main differences of the new devices are:
- HPL-301 is the representative model of the new devices;
- HPL-302 is same as the HPL-301, add USB port for PC-LINK function; ●
- HPL-310 is same as the HPL-301, add voice prompt function for arm; ●
- 180310 is all the same as HPL-310, just using another model name. ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
over age 18 (adult individual)
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 and EMC test reports, 1.
General safety EN 60601-1:1990+A1+A2+A11+A12+A13 PASS
EMC conformity EN 60601-1-2: 2001 PASS
2. WOVEN COTTON SHEETING
Uses the 510K Blood-Pressure Cuff
PERFORMANCE & CLINICAL TEST 3.
AAMI / ANSI SP10 The new devices use the same software as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
"510(k) Summary"
| Submitter's Name: | MYTECH TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 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 |
| Contact Person: | Dr. Jen, Ke-Min |
| Date Summary | |
| Prepared: | 7/3/2006 |
| Proprietary Name: | MYTECH / HAPPY LIFE / MAXIAIDS |
| ARM BLOOD PRESSURE MONITOR, | |
| HPL-301, HPL-302, HPL-310, 180310 | |
| 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 |
| Legally Marketed | |
| ( Predicate ) | |
| Device : | MYTECH / HAPPY LIFE ARM BLOOD |
| PRESSURE MONITOR, HPL300 / HPL300A | |
| 510(k) No: K030221 |
. .
EI
1 1
:
1
Description of the new device:
Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, dimensions, weight, and storage environments. The minor differences are the memory and display layout. That means the predicate device has 60 memory capacities and the new devices have 60 memory capacities. Besides, the new devices add 3 colors LED warming lights for the visional appearance.
The main differences of the new devices are:
- HPL-301 is the representative model of the new devices;
- HPL-302 is same as the HPL-301, add USB port for PC-LINK function; ●
- HPL-310 is same as the HPL-301, add voice prompt function for arm; ●
- 180310 is all the same as HPL-310, just using another model name. ●
Since we also did the relevant electric safety and EMC testing for the new devices, the safety and effectiveness aspects are not raised.
They are decided to be substantially equivalent.
Technological Characteristics of our new device compared to the
predicate device:
The technological characteristic of MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 are substantially equivalent to the predicate device. The new devices are of generally the same form and intended to be used in the same manner as the substantially equivalent product; and are passed the relevant EMC and Safety standards. Thus there are substantially equivalent.
E2
2
Test Summary:
ELECTRIC SAFETY and EMC test reports, 1.
| General safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASS |
|---|---|---|
| EMC conformity | EN 60601-1-2: 2001 | PASS |
2. WOVEN COTTON SHEETING
Uses the 510K Blood-Pressure Cuff
PERFORMANCE & CLINICAL TEST 3.
AAMI / ANSI SP10
The new devices use the same software as the predicate device.
MYTECH TECHNOLOGY 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.
E3
Jen, Ke-Min -
Submitter, 7/3/2006 Official Correspondent MYTECH TECHNOLOGY CO., LTD.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing care and protection. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2006
MYTECH Technology Co., LTD c/o Dr. Ke-Min Jen ROC Chinese European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City CHINA (TAIWAN)
Re: K061959
Trade Name: MYTECH HAPPY LIFE/MAXIAIDS Arm Blood Pressure Monitor, Model HPL-301, HPL-302, HPL-310, and 180310 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: July 3, 2006 Received: July 11, 2006
Dear Dr. Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your seeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bated in the 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). and Cosmoto Prov, I rot, and the device, subject to the general controls provisions of the Act. The rou may, after sy since 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. Ke-Min Jen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devilode that i Dr. bration that your device complies with other requirements of the Act that I Dri has intates and regulations administered by other Federal agencies. You must or uny Federal battlesburgents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by books (Sections 531-542 of the Act); 21 CFR 1000-1050. production of the reader to begin marketing your device as described in your Section 510(k) This tetter will and in your he FDA finding of substantial equivalence of your device to a legally prematics notication " 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 If you attitle 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 other golders, 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,
Bzimmerma fr
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:
Device Name: MYTECH TECHNOLOGY CO., LTD.
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
● Indications for use:
The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor,, Model HPL-301, HPL-302, HPL-310, 180310 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 arm.
The cuff circumference is limited to be 7"-15".
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)
Bhammuma
ardlovascular Devices 510íki Number
CI