(204 days)
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".
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-400M
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and study details. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, confirming its substantial equivalence to a predicate device. It briefly mentions the device name, regulation number, and intended use, but it does not include:
- A table of acceptance criteria and reported device performance.
- Details about the sample size for test sets or data provenance.
- Information on experts used to establish ground truth or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance data.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
The document essentially states that the device can be marketed due to its substantial equivalence to previously approved devices, rather than providing a detailed technical or clinical validation study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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 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
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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 )
§ 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).