(267 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.
Full Automatic (NIBP) Blood Pressure Monitor
The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, specifically referencing K990807, HL148, and HL168. This type of document is a regulatory approval, not a detailed study report. Therefore, it does not contain the kind of detailed information about acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment that you are requesting.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the necessary regulatory hurdles for market entry based on comparison to existing approved devices. It does not provide the specifics of the performance studies conducted to establish that equivalence or to meet specific performance acceptance criteria beyond the general statement of substantial equivalence.
To answer your questions, one would typically need access to the full 510(k) submission or the study reports cited within it, which are not part of this public clearance letter.
Therefore, I cannot provide the requested information based solely on the text provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 4 2010
Health & Life CO., Ltd. c/o Mr. Richard J. Stark Medisana, USA 801 East Morehead Street, Suite 305 Charlotte, NC 28202
- Re: K990807 HL148 and HL168 Regulatory Class: II (two) Product Code: DXN Dated: October 19, 1999 Received: October 27, 1999
Dear Mr. Stark:
This letter corrects our substantially equivalent letter of December 3, 1999.
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 (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 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. Richard J. Stark
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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PAGE 3 OF 4
510(K) Number (if known): K990807
Device Name: Full Automatic (NIBP) Blood Pressure Monitor
Intended for Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric manal 3 bystolic, Diastone blood pressure and heart
using the oscillometric method. All values can be read out in one LCD Panel.
The intended for use of this over-the-counter device is for age 16 and above.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( -Or (Per 21 CFR 801.109)
Over-the-Counter Use ( √ )
Bore L. Luyers Qe
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K990807
§ 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).