(20 days)
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Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention AI or ML.
No.
This device is for measuring blood pressure and heart rate, not for treating any medical condition.
Yes.
The device measures blood pressure and heart rate, which are physiological parameters used to assess a person's health status and aid in the diagnosis of conditions like hypertension.
No
The device description explicitly states it is a "Full Automatic (NIBP) Blood Pressure Monitor" and mentions an "LCD panel," indicating it is a physical hardware device that uses the oscillometric method to measure blood pressure. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device "Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method." This is a direct measurement of physiological parameters from the body, not an analysis of a sample taken from the body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples.
Therefore, this device falls under the category of a non-invasive medical device used for monitoring vital signs, not an in vitro diagnostic 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 use of this over-the-counter-device is for age 16 and above.
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
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Indicated Patient Age Range
age 16 and above
Intended User / Care Setting
over-the-counter-device
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, which is a common symbol used in US government seals.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2005
Health & Life Co., Ltd. c/o Mr. Paul Hung Manager 9F, No. 186, Jian Yi Road., Chung Ho City, Taipei Hsien (235), Taiwan R.O.C.
Re: K050714
Trade Name: HL168GA and HL168GS Full Automatic Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 17, 2005 Received: March 18, 2005
Dear Mr. Hung:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed 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 conninered provided in accordance with the provisions of the Federal Food, Drug, devices that have boon roomstiled in actre approval of a premarket approval application (PMA). and Costience Act (71ct) that do not require to the general controls provisions of the Act. The r ou may, mercere, manel of the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (boo ace royals. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff Inay be subject to subli additional connections, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Over in concerning your device in the Federal Register. publish lurner announcents vonce of a substantial equivalence determination does not mean Frease of advised that I DA 3 localites of the complies with other requirements of the Act
1
Page 2 – Mr. Paul Hung
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 may be obtained 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.B.tmmmoe for
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) :
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168GA, HL168GS
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 use of this over-the-counter-device is for age 16 and above.
Prescription USE ( ) (Per 21 CFR 801.109)
OR
Over-The-Counter Use( √ (Optional Format 1-2)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumman
(Division Sign-C Division of Cardiovascular Deylogs 510(K) N
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