(52 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement, irregular heartbeat detection based on interval variation, and data transmission via Bluetooth. There is no mention of AI or ML algorithms for data analysis, prediction, or interpretation beyond basic calculations and threshold comparisons.
No
This device is a blood pressure monitor used for measurement and monitoring, not for treating or preventing a disease or condition.
Yes
The device measures blood pressure and heart rate, detects irregular heartbeats, and provides a risk category indicator, which are all diagnostic functions aimed at assessing the user's health status.
No
The device description clearly indicates it is a physical blood pressure monitor that uses the oscillometric method and has an LCD panel for displaying readings. While it has a Bluetooth function and associated software, the core medical device functionality is hardware-based.
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 HL858CC is a blood pressure monitor that measures physiological parameters (blood pressure and heart rate) directly from the human body using a non-invasive method (oscillometric). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and heart rate on the upper arm for home use by adults. This is a direct physiological measurement, not an in vitro test.
Therefore, the HL858CC falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HL858CC automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
HL858CC detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, user could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
Product codes
DXN
Device Description
HL858CC automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
The device will display a symbol wor ma to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, When Triple Check mode is turned on by user, the symbol (& THE) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed, LCD will display the average values of the three measurements. And this device is designed with Rest Assure function as a countdown timer to help user in relax state for 5 minutes before taking measurement. Furthermore, the user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human being's upper arm
Indicated Patient Age Range
adults aged 18 years and older
Intended User / Care Setting
home 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)
HL858CC is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CC in the group of 105 subjects with qualified distribution. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with no facial details.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2016
Health & Life Co., Ltd. Ms. Sarah Su Director 9f, No. 186, Jian Yi Road Zhonghe District, New Taipei City, 23553 TW
Re: K160145
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CC Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 20, 2016 Received: January 21, 2016
Dear Ms. Sarah Su.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FDA
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160145
Device Name
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CC
Indications for Use (Describe)
HL858CC automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
HL858CC detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, user could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K160145
Page 1 of 7
510(k) SUMMARY
(As Required By 21 CFR 807.92)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: __ K160145 Date:
1. Submitter:
Health & Life Co., Ltd. 9F. No.186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan, R.O.C TEL: +886-2-8227-1300 FAX: +886-2-8227-1301
Contact person: Sarah Su/ RA & QA Division. E-mail: sarah.su@hlmt.com.tw Tel: 886-2-8227-1300 ext.1201 Fax: 886-2-8227-1301
2. Name of the Device:
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CC Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21 CFR 870.1130 Classification Panel: 74 Cardiovascular Product Code: DXN
4
3. Information for the 510(k) Cleared Device (Predicate Device):
A. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858CB (K142968)
4. Device Description:
HL858CC automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
The device will display a symbol wor ma to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, When Triple Check mode is turned on by user, the symbol (& THE) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed, LCD will display the average values of the three measurements. And this device is designed with Rest Assure function as a countdown timer to help user in relax state for 5 minutes before taking measurement. Furthermore, the user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
5
K160145 Page 3 of 7
5. Intended Use
HL858CC automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
HL858CC detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, user could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek application software with the paired Bluetooth-enabled device.
6. Comparison of device to predicate device:
Product Specification Comparison Table of Subject Device HL858CC, and Predicate Device HL858CB (K142968)
| Item | Predicate Device
HL858CB (K142968) | Subject Device
HL858CC | |
|-------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------|
| Method of measurement | Oscillimetric | Same as left | |
| Measurement Type | During deflation | During inflation | |
| Range of measurement | Pressure 0- 300mmHg,
Pulse 40-199
Beats/minute | Same as left | |
| Accuracy | Pressure ± 3mmHg
Pulse ± 5% | Same as left | |
| Pressure
Changed Rate | 25mmHg/sec. | Same as left | |240V, AC,
| Exhaust | Automatic exhaust valve | Same as left | |
| Display | Liquid Crystal Digital | Same as left | |
| Power Supply | 6V 1A, 4 × AA/1.5V
(LR6) Alkaline batteries | Same as left | |
| | Input: 100
5060 Hz, 400mA | Input: 100240V, AC,
4763 Hz, 0.4-0.2A | | +158°F),
| | Output: 6V, DC,1A | Output: 5.99V, DC, 2A | |
| | AC adapter (optional) | AC adapter (optional) | |
| Storage/
Transportation
Environment | - 25°C ~ + 70°C
(- 13°F
≤ 93% R.H. | Same as left | |
| | Operating Environment | 5°C ~ 40°C
(41°F104°F),43cm / 9~17
15% ~ 93% R.H. | Same as left |
| | Material | ABS housing and
ABS keys | Same as left |
| Sets of memory | 2*120, total 240 | Same as left | |
| Number of
Push Button | 7 +
2 switch control
( Triple check, Rest
assure) | Same as left | |
| Storage pouch | Yes | Same as left | |
| Cuff size | Arm circumference
approx.
23
inch(Universal cuff) | Same as left | |
| Unit Weight | Approx. 393 ± 10g
(Excluding cuff and
Batteries ) | Same as left | |
| Risk Category Indicator | Yes | Same as left | |
| Irregular Heartbeat
Detector | Yes | Same as left | |
| Triple-Check
(Multi-Read) Function | Yes | Same as left | |
| Rest Assure Function | Yes | Same as left | |
| Bluetooth Data
Transmission Function | Measurement Data
Transmission | 1. Measurement Data
Transmission
2. Date/Time
Synchronization
3. Battery Status Check | |
6
7
Changes from the predicate devices HL858CB (K142968):
-
- Modifying the measurement type from "during deflation" into "during inflation".
-
- Changing the supplier of AC adapter.
-
- Adding the 2 simple tools of Bluetooth Data Transmission for date/time synchronization and battery status check.
These additional features have been verified and validated and do not affect the safety and effectiveness of subject device HL858CC. Please refer to Section 12. Substantial Equivalence Discussion for detail information.
7. Discussion of Clinical Tests Performed:
HL858CC is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CC in the group of 105 subjects with qualified distribution. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
8
K160145
Page 6 of 7
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
The subject device was tested to evaluate its safety and effectiveness, including the followings:
- EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment a. Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
b. Radio Frequency Wireless Test:
-ETSI EN 300 328, Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
-ETSI EN 301 489-1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
-ETSI EN 301 489-17, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electro Magnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems
c. Safety Test:
-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment
d. FCC Test:
FCC 47 CFR Part 15, Subpart B & FCC 47 CFR Part 15, Subpart C
9
K160145 Page 7 of 7
e. Biocompatibility Test:
-ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
-ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
-ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
Reliability Test: f.
IEC 80601-2-30 Edition1.1 2013-07 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- g. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -Application of risk management to medical devices
h. Software Verification and Validation:
-IEC 62304 Ed.1.0 (2006), Medical device software - Software life cycle processes.
-IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems, edition 1.1.
Usability Validation: i.
-IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
-IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
9. Conclusions:
The subject device was tested and fulfilled the requirements of those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.