(53 days)
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No
The summary provides no indication of AI/ML technology; it describes a standard blood pressure monitor.
No
The device is used for measurement (diagnosis/monitoring), not for treating a condition, which is a characteristic of therapeutic devices.
Yes
Explanation: The device measures blood pressure (systolic and diastolic) and pulse rate, which are physiological parameters used to assess a person's health status and can aid in the diagnosis of conditions like hypertension or arrhythmias.
No
The device is described as an "Automatic Blood Pressure Monitor, Model MO701k," which is a physical hardware device. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Rossmax Automatic Blood Pressure Monitor, Model MO701k is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic, diastolic, and pulse rate for adult individuals in a home environment. This involves measuring physiological parameters directly from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening.
The description clearly indicates a device that interacts with the body externally to measure vital signs, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult
Intended User / Care Setting
individual in a home environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird-like figure is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006 APR
Rossmax Inernational Ltd. c/o Mr. Mark C.H. Lin Regulatory Affairs Manager 12 F., No. 189, Kang chien Road Taipei 114
TAIWAN
Re: K060342
Trade Name: Roossmax Automatic Blood Pressure Monitor, Model MO701k Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 08, 2006 Received: February 10. 2006
Dear Mr. Lin:
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.
1
Page 2 – Mr. Mark C.H. Lin
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 (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/cdrl/industry/support/index.html.
Sincerely yours,
Blummenthal
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
060342
2. Statement of Indications for use
Indications for Use
510(k) Number (if known):
Device Name: Rossmax Automatic Blood Pressure Monitor, Model MO701k
Indications For Use:
Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.
Prescription Use _______________ AND/OR
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bihmemema
(Division Sign-Off)
Division of Cardiovascular Devices
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