(8 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 8 inches to 13 inches (20 cm 33 cm).
Not Found
This document is a marketing authorization letter for the Omron Healthcare, Inc. Model HEM-906 Oscillometric Digital Blood Pressure Monitor, and it does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.
The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about any specific study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).
The "Indications for Use Statement" (page 2) describes the intended use of the device but does not specify performance metrics or study results.
To obtain the information you're looking for, you would typically need to consult the original 510(k) submission
summary or the full 510(k) submission provided by Omron Healthcare, Inc. to the FDA, which would contain the
technical and clinical data supporting the substantial equivalence claim.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Omron Healthcare, Inc. c/o Mr. Larry Lepley Manager, Regulatory/Clinical Affairs 1200 Lakeside Drive Bannockburn, IL 60015-1243
Re: K043018
Trade Name: Omron Healthcare, Inc. Model HEM-906 Oscillometric Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 01, 2004 Received: November 02, 2004
Dear Mr. Lepley:
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 10 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 - Mr. Larry Lepley
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. 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 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,
Blummerfor
R. Zukerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OMRON
Indications for Use Statement
| 510(k) Number | K043018 |
|---|---|
| Device Name | OMRONDIGITAL BLOOD PRESSURE MONITORMODEL: HEM-906 |
| Indication for Use | The device is a digital monitor intended for use in measuringblood pressure and pulse rate in adult patient population witharm circumference ranging from 8 inches to 13 inches (20 cm33 cm). |
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummoor
19
(Division Sign-Off) (Division of Cardiovascular Devices
Division of Cardiovascular Devices 510(k) Number
§ 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).