(29 days)
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No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
Yes
The device measures blood pressure and heart rate, which are physiological parameters used for health monitoring and diagnosis, aligning with the definition of a therapeutic device designed to aid in medical treatment or diagnosis.
No
The device measures blood pressure and heart rate, which are physiological parameters. While these measurements can be used in a diagnostic process, the device itself, as described, does not provide a diagnosis. It provides data that a healthcare professional might use for diagnosis.
No
The device description explicitly states it is a "Full Automatic (NIBP) Blood Pressure Monitor" and measures blood pressure using the "oscillometric method," which requires hardware components like a cuff and pressure sensor. The mention of an "LCD Panel" further confirms the presence of hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device measures blood pressure and heart rate using the oscillometric method. This is a non-invasive measurement taken directly from the patient's arm. It does not involve analyzing samples taken from the body.
Therefore, based on the provided information, this blood pressure monitor is a non-IVD medical device.
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 .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
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
Arm
Indicated Patient Age Range
adult patients
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)
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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/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 • U.S." arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three parallel lines above them, resembling a stylized eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2003
Health & Life Coporation, Ltd. c/o Mrs. Susan Chen 9F. No. 186. Jian Yi Road Chung Ho City, Taipei, Hsien China (Taiwan) 235
Re: K031835
Trade Name: HL888RA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2003 Received: June 2, 2003
Dear Mrs. Chen:
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.
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
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Page 2 -- Mrs. Susan Chen
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 (301) 594-4646. 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,
Elisa D'Arrigo Sw
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K031835
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888RA
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 .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/6 description: The image shows the text "Prescription USE" on the first line and "(Per 21 CFR 801.109)" on the second line. The word "USE" has a line going through it, indicating that it has been crossed out. The text is in a simple, sans-serif font and is likely part of a form or document.
Prescription Use Only
OR
Over-The-Counter Use( √ )
(Optional Format 1-2)
(Division Sign-Off)
Division of Cordigugggulor Dodeso
510(k) Number
7