(37 days)
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No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components.
No
The device is for measuring blood pressure and pulse rates, which is a diagnostic function, not therapeutic. It does not treat or alleviate a medical condition.
Yes
The device is used to measure systolic and diastolic blood pressure and pulse rates, which are diagnostic indicators of a patient's health.
No
The device description explicitly states "Full Auto Wrist Digital Blood Pressure Monitor, SE-312," which indicates a physical hardware device (a blood pressure monitor with a wrist cuff) is involved, not just software.
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 and pulse rate. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside the body.
- Device Description: It's a blood pressure monitor, which is a medical device used for direct physiological measurement.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Product codes
DXN
Device Description
Full Auto Wrist Digital Blood Pressure Monitor, SE-312
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
wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
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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
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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).
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2001
Sein Electronics Co., Ltd. c/o Ms. Molly Bettger Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas. WA 98607-8542
Re: K012054
Trade Name: Full Auto Wrist Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: DXN Dated: July 27, 2001 Received: July 27, 2001
Dear Ms. Bettger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Ms. Molly Bettger
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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, (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Kark Till
James E. Dillard I Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known): | KO12054 |
|---|---|
| Device Name: | Full Auto Wrist Digital Blood Pressure Monitor, SE-312 |
| Indications for Use: | To measure of systolic and diastolic blood pressure and |
| pulse rates of adults using wrist cuff and oscillometric | |
| method. |
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K012054
Prescription Use _ (Per 21 CFR 801.109) or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
the state of the state of the status and the subject of