(100 days)
The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.
Not Found
The provided text is a 510(k) premarket notification acceptance letter from the FDA to Rossmax International Ltd. for their Digital Sphygmomanometer MANDAUS II. It's a regulatory document and does not contain the detailed study results or acceptance criteria and device performance table typically found in scientific publications or clinical study reports.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific performance criteria or the study that demonstrates compliance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 3
Rossmax International Ltd c/o Mr. Tzu-Wei Li Center for Measurement Standards Building 16, 321 Kuang Fu Rd,. Sec. 2 Hsinchu, Taiwan 30042, R.O.C.
Re: K053006
Trade Name: Rossmax Digital Sphygmomanometer MANDAUS II Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ, LDE Dated: January 19, 2006 Received: January 24, 2006
Dear Mr. Li:
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.
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
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Page 2 - Mr. Tzu-Wei Li
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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Bhimnimon for
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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2. Statement of Indications for use
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K05 3006 510(k) Number:
Rossmax Digital Sphygmomanometer MANDAUS II Device Name:
Indications For Use:
The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use X
(Optional Format 1-2-96)
Blummmmor
Division Sign-Off
Division of Cardiovascular Devices
STORKI Numb
510(k) submission
, Page 7 of 36
Rossmax International Ltd.
§ 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).