(142 days)
None
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML, and the intended use is a standard physiological measurement.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used for monitoring or diagnosing medical conditions, fitting the definition of a therapeutic device.
Yes
The device measures blood pressure and pulse rate, which are used to assess the state of a patient's health and can indicate the presence of certain conditions, fitting the definition of a diagnostic device.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Measure blood pressure (systolic and diastolic) and pulse rate." This is a physiological measurement taken directly from the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Performing tests on these samples.
- Providing diagnostic information based on the analysis of samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physical parameter directly from the patient.
N/A
Intended Use / Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes
DXN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 19, 2014
Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua, General Manager Building 2, No.202, Zhenzhong Road, West Lake Economy &. Technology Zone Hangzhou, Zhejiang CHINA 310030
Re: K141755
Trade/Device Names: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: November 20, 2014
Dear Mr. Ren:
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. 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.
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Page 2 – Mr. Ren Yunhua
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,
Melissa A. Torres -S
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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Image /page/2/Picture/1 description: The image shows the word "SEJOY" in blue, with a small yellow triangle above the "J". The letters are bold and slightly italicized. There is a period after the "Y".
世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.
Indications for Use
510(k) Number (if known):
Blood Pressure Monitors BP-35 Device Name:
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use √ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)