(30 days)
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Not Found
No
The summary describes a standard automatic blood pressure monitor using the oscillometric method and does not mention any AI or ML capabilities.
No.
The device is a blood pressure monitor used for measurement and monitoring, not for treating any condition.
No
The device measures blood pressure and heart rate, which are vital signs, but it does not diagnose a condition or disease. It provides data that a healthcare professional might use for diagnosis, but it is not a diagnostic device itself.
No
The device description explicitly states it is a "Full Automatic (NIBP) Blood Pressure Monitor HL168ET" and measures blood pressure using the "oscillometric method," which requires hardware components like a cuff and pressure sensor. The summary also mentions an "LCD panel" for readout. These are all physical components, indicating it is not a software-only device.
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 heart rate using the oscillometric method. 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).
- Device Description: It's described as a "Blood Pressure Monitor," which is a device for measuring a physiological parameter.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any tests performed in vitro.
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
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional).
Product codes
DXN
Device Description
Full Automatic (NIBP) Blood Pressure Monitor HL168ET
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
age 16 and above.
Intended User / Care Setting
Over-The-Counter Use
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)
Not Found
Reference Device(s)
Not Found
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its wings or body.
JAN 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Health & Life Co., Ltd. c/o Mr. Paul Hung Manager 9F, No. 186, Jian-Yi Road Chung Ho City, 235 Taiwan, Province of China
Re: K043437
K045437
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor HL168ET Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: December 06, 2004 Received: December 13, 2004
Dear Mr. Hung:
We have reviewed your Section 510(k) premarket notification of intent to market the device t We nave reviewed your Security promainer is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interestate referenced above and nave determined the arrood predicate devices marketed in interstate for use stated in the enclosure) to tegally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any lie devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosment Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the good if the gold be and general controls provisions of the fields of the eliment against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Code of I sacra. Its gening your device in the Federal Register.
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Page 2 – Mr. Paul Hung
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/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Benima fer
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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510(k) Number (if known) : K ~ 043437
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168ET
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional).
The intended use of this over-the counter device is for age 16 and above.
i
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription USE (Per 21 CFR 801.109) | OR | Over-The-Counter Use( √ ) (Optional Format 1-2) |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------------------- |
Bm
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ardiovascular Devices
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