(7 days)
Not Found
No
The summary explicitly states that the subject device and the predicate device are the same in technological characteristics, and there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device measures blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic interventions.
No
The device is described as a blood pressure measurement system intended to measure blood pressure and pulse rate, which are physiological parameters. While these measurements can be used by a healthcare professional as part of a diagnostic process, the device itself is not explicitly stated to diagnose a disease or condition. It provides measurements, not a diagnosis.
No
The device description explicitly mentions an "inflatable cuff" and discusses hardware characteristics like "power supply, LCD display, range, accuracy, and operating environments, memory, dimensions, weight, and storage environments," indicating it is a physical device with hardware components, 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 blood pressure and pulse rate non-invasively using a cuff on the wrist. 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 and functionality of a blood pressure monitor.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 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 5.25" – 7.75".
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, memory, dimensions, weight, and storage environments. The only difference is the display layout.
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)
ELECTRIC SAFETY and EMC test reports:
- General safety EN 60601-1:1990+A1+A2+A11+A12+A13 PASS
- EMC conformity EN 60601-1-2: 1993 PASS
- PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-100, K030561
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
MYTECH TECHNOLOGY CO., LTD
MAY 1 7 2004
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
"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: | 5/7/2004 |
| Proprietary Name: | MYTECH WRIST BLOOD PRESSURE |
| MONITOR, HPL-200 | |
| 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): | MYTECH WRIST BLOOD PRESSURE |
| MONITOR, HPL-100 | |
| Device: | 510(k) No. K030561 |
510(k) No: K030561
1
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
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, memory, dimensions, weight, and storage environments. The only difference is the display layout. We present two photos for HPL-100 and HPL-200 respectively in the following page for comparison. Since we also did the relevant electric safety and EMC testing for HPL-200, 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 HPL-100 is substantially equivalent to HPL-200. I MYTECH HPL-100 is of generally the same form and intended to be used in the same manner as the substantially equivalent product; and is passed the relevant EMC and Safety standards. Thus there are substantially equivalent.
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
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: 1993 PASS
2. WOVEN COTTON SHEETING
Uses the 510K Blood-Pressure Cuff
- PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10
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.
JAMES WU
Submitter, 5/7/2004 General Manager MYTECH TECHNOLOGY CO., LTD.
3
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Mytech Technology Co., Ltd. c/o Dr. Ke-Min Jen Cro Dr. its its in mean Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K041228
K041220
Trade Name: Mytcch/Happy Life Blood Pressure Monitor, HPL-200 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 07, 2004 Received: May 10, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the devices in we nave reviewed your Section 910(t) premained is substantially equivalent (for the indications reletenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure to regars) at regally and the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costlience Act (Act) that do not require appt to the general controls provisions of the Act. The You may, therefore, market the dovices, sale, of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the research and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the con Inay be subject to suen additional vehicler , 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 Frease oc advised that I Dri 3 modalso wrough with other requirements of the Act
4
Page 2 – Dr. Ke-Min Jen
or any Federal statutes and regulations administered by other Federal agencies. You must of any i cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Free brequirements, while and manufacturing practice requirements as set CITY art 607), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oonal of to begin marketing your device as described in your Section 510(k) I ins icher witi anow you to begin maing of substantial equivalence of your device to a legally prematics notification: "The President on 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 desire specific acripliance at (301) 594-4648. Also, please note the regulation entitled, Contact the Office of Course 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 general information on your responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dimna R. Vochner
Image /page/4/Picture/5 description: The image shows a close-up of a signature. The signature is illegible, but it appears to be written in cursive. The signature is made up of a series of loops and curves. The signature is written in black ink.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
MYTECH TECHNOLOGY CO., LTD.
5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Fax: 886-2-2247 7024 Telephone: 886-2-2247 4816 Email: sale(@mytech.com.tw
510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________
Device Name: MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR_ HPL-200
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 individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around The cuff circumference is limited to be 5.25" – 7.75". the wrist.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (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)
Dring R. Volumes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number上04/228
Page 1 of 1 -