(57 days)
Not Found
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML terms or functionalities.
No
The device measures blood pressure and heart rate, which are diagnostic measurements for monitoring health, not for treating a condition.
Yes
Explanation: The device measures blood pressure and heart rate, which are physiological parameters used to diagnose health conditions, making it a diagnostic device.
No
The description explicitly states the device uses the oscillometric method and has an LCD panel, indicating it is a hardware device with integrated software, 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device "Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method." This is a non-invasive measurement taken directly from the body (the arm), not a test performed on a sample outside the body.
- Lack of IVD Indicators: The description does not mention analyzing biological samples, detecting biomarkers, or any other activities typically associated with IVDs.
Therefore, this device is a non-invasive medical device used for measuring physiological parameters, 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 for use of this over-the-counter device is for adult patients with arm circumference between 24-32cm (approx. 8.7" to 12.6").
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
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
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).
0
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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2003
Health & Life Co., Ltd. c/o Mr. Tzu-Wei Li Manager Center for Measurement Standards/Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd., Sec. 2 Hsinchu 30042 TAIWAN, R.O.C.
Re: K023834
Trade Name: HL 888 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 24, 2002 Received: December 30, 2002
Dear Mr. Li:
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 mav publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Tzu-Wei Li
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 (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 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,
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 : HL888
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 with arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ( | ) | or | Over-The-Counter Use ( | v | ) |
|---|---|---|---|---|---|
| (per 21 CFR 801.109) | (Optional format 1-2) |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | 1623834 |
|---|---|
| --------------- | --------- |
9