(79 days)
Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Rossmax MediPro Model 10 and 60, and MediCare Model 10 and 60 Blood Pressure Monitors. This type of document does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.
The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulation name, regulatory class, and product code. It also includes an "Indications for Use Statement" which specifies that the devices are "Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment."
To answer the requested questions, one would need to review the actual 510(k) submission (which is typically a much larger document than this clearance letter) or the clinical study reports submitted as part of that application. The clearance letter itself does not provide the specific performance data or study methodology.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Michael Yeh Managing Director Rossmax International Ltd. 12F., No. 189, Kang Chien Road Taipei, 114 TAIWAN
Re: K013583
Trade Name: Rossmax MediPro Model 10 and 60, MediCare Model 10 and 60 Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 22, 2001 Received: October 30, 2001
Dear Mr. Yeh:
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 - Mr. Michael Yeh
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 Of A Fat 6077, lacemig (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,
V. Walker Mitch
ram D. Zuckerman, M. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix ﺍ INDICATIONS FOR USE STATEMENT
510(K) Number:
| Device Name: | Rossmax MediPro model 10 and 60, MediCare 10 and 60Blood Pressure Monitor |
|---|---|
| Indications For Use: | Non-invasive blood pressure systems that measure systolic,diastolic, and pulse rates for adult consumers in a homeenvironment. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter Use /
Division of Cardiovascular & Respiratory Devices
510(k) Number K013583
§ 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).