(204 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms in medical devices. The description focuses on standard blood pressure measurement technology.
No.
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements, not therapeutic.
No
Explanation: The device is described as a blood pressure monitor intended to measure systolic and diastolic pressures and pulse rate. While this provides health information, it does not diagnose a disease or condition; it measures physiological parameters.
No
The device description explicitly states it is a "noninvasive blood pressure measurement system" that uses an "inflatable cuff wrapped around the arm," indicating it includes hardware components (the monitor and cuff) in addition to any potential software.
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 EIKON automatic digital blood pressure monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the arm. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "noninvasive blood pressure measurement system."
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EIKON automatic digital blood pressure monitor, Model HD-200M / HD-200, 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 arm. The cuff circumference is limited to be 7"-15".
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm
Indicated Patient Age Range
Over age 16
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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: K021240
Trade Name: Eikon Automatic Digital Blood Pressure Monitor, Model HD-200M/HD-200 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
8 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.
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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 vou 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 Neenulu for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EIKON Healthcare Device Co 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.
KO21240 510(k) Number ( if known):
Device Name: ElKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-200M / HD-200
Indications for use: .
The EIKON automatic digital blood pressure monitor, Model HD-200M / HD-200, 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 arm. The cuff circumference is limited to be 7"-15".
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
Dia Oluulu
Division of Cardiovascular & Respiratory Devices
510(k) Number: K021240
OR
Prescription Use
( Per 21 CFR 801.109 )
Over - The -- Counter -- Use X
( Optional Format 1-2-96 )