(90 days)
Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure
Ri-Mega is a sphygmomanometer
This looks like a 510(k) clearance letter from the FDA for a blood pressure measuring device (sphygmomanometer) called "RI-Mega."
Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a regulatory approval letter, specifically a 510(k) clearance, which states that the device is "substantially equivalent" to a legally marketed predicate device. This type of letter generally references the 510(k) submission, where the performance data and acceptance criteria would typically reside.
Therefore, I cannot provide the requested table and study details based solely on the provided text.
To answer your questions, I would need access to the actual 510(k) submission document for K972377, which would include the performance data, acceptance criteria, study design, and ground truth information.
However, I can deduce some general characteristics about this type of device and its typical evaluation:
Given it's a sphygmomanometer, the performance criteria would likely revolve around:
- Accuracy: How close the device's blood pressure readings are to a reference standard.
- Precision/Reproducibility: How consistent the device's readings are when measured multiple times under similar conditions.
- Bias: Systematic deviation from the reference.
- Safety: General safety characteristics, though for a manual sphygmomanometer, this is generally well-established.
The studies would typically involve:
- Comparing the device's readings against a recognized standard (e.g., auscultatory method by trained observers).
- Recruiting a diverse range of subjects.
Without the actual 510(k) submission, I must state that the requested information is not available in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Patricia Riester-Freudenmann Rudolf Riester GmbH & CO. KG P.O. Box 35 Bruckstraße 31 D-72417 Jungingen, Germany
SEP 2 4 1997
Re: K972377 RI-MEGA Requlatory Class: II (Two) Product Code: DXQ Dated: June 13, 1997 Received: June 26, 1997
Dear Ms. Riester Freudenmann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Patricia Riester Freudenmann
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas f. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_K972377
Device Name: RI-Mega
Indications For Use:
Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dee Campbell
Division Sign-Off) (Division Sign-Oir)
Division of Cardiovascular, Respiratory, Divisionrological Devices 510(k) Number_KazZ377
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).