(8 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML terms or capabilities.
No
The device measures blood pressure and heart rate, which are diagnostic/monitoring functions, not therapeutic ones.
Yes
The device measures blood pressure and heart rate, which are physiological parameters used to assess a person's health status and can aid in diagnosing conditions like hypertension.
No
The device description is not found, but the intended use clearly describes a device that measures blood pressure using the oscillometric method and has an LCD panel for readout. This strongly implies a hardware device with integrated software, not a standalone 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 direct measurement of physiological parameters within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device does not perform such tests.
Therefore, this device falls under the category of 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 with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ).
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)
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Health & Life Co., Ltd. c/o Dr. Tzu-Wei Li Industrial Technology Research Institute Center for Measurement Standards Bldg. 16, 321 Kuang Fu Rd., Sec.2 Hsinchu, Taiwan 30042 CHINA
Re: K042265
K042203
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 17, 2004 Received: August 23, 2004
Dear Dr. Li :
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(x) pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosule) to regally management date of the Medical Device American Frank Food. Drya commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accerdance was a proval approval application (PMA). and Cosmetic Ac. (Act) that to not require appent of the general controls provisions of the Act. The You may, utcrefore, manect the do rece, belyer to the more of annual registration, listing of general controls provisions of the recess 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 (500 a0070) into existing major regulations affecting your device can may be subject to such adultional controller Entrologically on 898. In addition, FDA may oc found in the Court concerning your device in the Federal Register.
1
Page 2 - Dr. Tzu-Wei Li
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA s issuation of a but complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that FDA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations damandverse of of not limited to: registration and listing (21 comply with an the Act 3 requirements, news 801);
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice destractively at any CFK Part 807); labeling (21 CFR Part 801); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 CFR 1800 form in the quality systems (QB) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of Persons of Persons on your Section 510(k)
This letter will allow you to begin marketing your device as described in your devi I his letter will anow you to ocgain mailioting your antial equivalence of your device to a legally premarket notheation. The PDA midning of bassification 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 If you desire specific advice for your as not 100 % 2008 . Also, please note the regulation entitled, and Comaci the Office of Compilance an (est notification" (21CFR Part 807.97). You may obtain Misoranding of Icrerchee to promation on your responsibilities under the Act from the Division of Small other gelleral informational 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,
Neil R.P. Ogden
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) :
: Full Automatic (NIBP) Elood Pressure Monitor Device Name : HL888 Trade Name
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 24cm -- 44cm (approx. 9.4" to 17.5" ) .
| Prescription Use ( )
(per 21 CFR 801.109) | or | Over-The-Counter Use ( V )
(Optional format 1-2) |
| ---------------------------------------------- | ---- | ------------------------------------------------------------ |
|---|
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K042265 |
|---|---|
| --------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)