(204 days)
Not Found
Not Found
No
The summary describes a standard automatic digital blood pressure monitor and does not mention any AI or ML components or capabilities.
No
The device is intended for measurement and monitoring of blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not directly treat or alleviate a medical condition.
No
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used for monitoring. While this information can be used in diagnosis, the device itself is described as a measurement system and does not directly provide a diagnosis or interpret the measurements to determine the presence or absence of a disease.
No
The device description explicitly states it is an "automatic digital blood pressure monitor" and mentions an "inflatable cuff wrapped around the wrist," indicating the presence of hardware components beyond just software.
No, 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. They are used to examine these samples outside of the body.
- Device Function: The EIKON HD-400M is a non-invasive blood pressure monitor. It measures physiological parameters (blood pressure and pulse rate) directly from the body using a cuff on the wrist. It does not analyze samples taken from the body.
Therefore, based on the provided information, the EIKON HD-400M falls under the category of a non-invasive medical device rather than an IVD.
N/A
Intended Use / Indications for Use
The EIKON automatic digital blood pressure monitor, Model HD-400M, 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 16, 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
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
Adult individual, over age 16.
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)
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.
Not Found
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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eikon Healthcare Device Corp. c/o Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-CHU City Taiwan, ROC
Re: K021239
Trade Name: Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 5, 2002 Received: August 12, 2002
Dear Dr. Ke-Min:
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.
1
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Dia Mumbulu for
Benson D. Zakeu, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CIKON Healthcare Device Corp. TOMSON IND. Park, 5F-4, No. 14, Lane 609, Sec. 5, Chung-Shing Road, San-Chung City, Taipei Hsien, 241, Taiwan, ROC Telephone: 886-2-29995373 Fax: 886-2-29995483 Email: honbin@ms27.hinet.net
Applicant: EIKON Healthcare Device Corp. Ko21239 510(k) Number ( if known): __ TBA Device Name: EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-400M
0 Indications for use:
The EIKON automatic digital blood pressure monitor, Model HD-400M, 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 16, 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".
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
Number K021239
Dra Jluulee
Prescription Use
OR
Over-The-Counter-Use X
( Per 21 CFR 801.109 )
( Optional Format 1-2-96 )