(252 days)
The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.
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The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use and FDA clearance, but it does not contain the detailed study information needed to answer your request about acceptance criteria and study proving device performance.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Information about the sample size, data provenance, number of experts, adjudication method, or ground truth used for performance studies.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Details regarding the training set size or how its ground truth was established.
This document primarily serves as an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. To get the information you asked for, you would need to consult a different document, such as the actual clinical or performance study report submitted to the FDA, which is not provided here.
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October 25, 2017
Honsun(nantong) Co., Ltd. Selina Oian QA Manager No. 8, Tongxing Road, Nantong Economic & Technology Development Zone Nantong, 226009 CN
Re: K170454
Trade/Device Name: Scian Automatic Blood Pressure Monitor, Models LD-562U, LD-588U & LD-5330 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 26, 2017 Received: September 26, 2017
Dear Selina Qian:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,
M.A. Willemsen
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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Indications for Use
510(k) Number (if known) K170454
Device Name
Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U
Indications for Use (Describe)
Indication for Use:
The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 201.Subject to) | |
|---|---|
| In-Vitro Contract Use (21 CFR 201.Subject to) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).