(204 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 9 inches to 17 inches (from 22 cm to 42 cm).
The device is a digital monitor intended for use in measuring blood pressure and pulse rate.
This appears to be an FDA clearance letter for a medical device, specifically an Omron Automatic Blood Pressure Monitor (Model HEM-773AC). The provided text describes the regulatory clearance process and includes an "Indication for Use" statement.
However, the document does not contain any information regarding acceptance criteria for device performance or a study proving that the device meets those criteria.
This type of FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not typically include the detailed study results or performance metrics that would be part of a submission to demonstrate safety and effectiveness. Those details would be in the original 510(k) submission document itself, which is not provided here.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three bars above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 12 2002
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 300 Lakeview Parkway Vernon Hills, Illinois 60061
Re: K021682
Trade Name: Omron Automatic Blood Pressure Monitor with IntelliSense™, Model HEM-773AC
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 11, 2002 Received: September 13, 2002
Dear Mr. Kojima:
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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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 (OS) 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,
Bram D. Zuckerman, M.D.
1 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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Indication for use statement a.
Following is the new indication for use statement for the HEM-773AC
Applicant: 510(k) Number: Device Name:
OMRON HEALTHCARE, INC.
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE™, Model HEM-773AC
Indication for Use:
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 9 inches to 17 inches (from 22 cm to 42 cm).
(Division Sign-Off) Division of Cardiovascular and Respiratory Devices
510(k) Number K021682
Non-prescription use ✓
§ 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).