(66 days)
Not Found
No
The description details 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, interpretation, or prediction.
No
This device is for measuring blood pressure and heart rate, which are diagnostic indicators, not for directly treating a medical condition.
Yes
The device measures blood pressure and heart rate, and detects irregular heartbeats, which are used to assess a health condition.
No
The device description clearly indicates it is a physical blood pressure monitor with an LCD panel, cuff for the upper arm, and uses the oscillometric method, which are all hardware components. While it has a Bluetooth function for data transmission, the core measurement and display are 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 HL858CB is a blood pressure monitor that measures blood pressure and heart rate using the oscillometric method. This is a non-invasive measurement taken directly from the human body (upper arm).
- Intended Use: The intended use is for measuring blood pressure and heart rate in adults at home. This is a physiological measurement, not a diagnostic test performed on a sample.
The device's function, intended use, and the method of measurement (non-invasive, directly on the body) clearly indicate that it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HL858CB automatically measuers human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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.
HL858CB detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring reading. And the device features a built-in "Bluetooth Data Transmission'' function, which enables the device automatically transmit measuring results to paired Bluetooth device.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
HL858CB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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 or 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 ( & TIME ) 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.
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
18 years and older
Intended User / Care Setting
over-the-counter device ... for 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)
HL858CB is compliant to the standard of ISO 81060-2: First Edition 2009-05-01 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 HL858CB in the group of 90 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): 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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
August 10, 2021
Health & Life Co.,Ltd. Sarah Su Director 9F, No. 186, Jian Yi Road Zhonghe District , New Taipei City, Taiwan 23553 Taiwan
Re: K142968
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN
Dear Sarah Su:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 19, 2014. Specifically, FDA is updating this SE Letter as an administrative correction for an incorrect 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, (240) 402-5241, stephen.browning@fda.hhs.gov.
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a human figure. The figure is composed of three overlapping profiles, suggesting a sense of community and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Health & Life Co., Ltd. % Ms. Sarah Su Director Regulatory Affairs 9F, No. 186, Jian Yi Road Zhonghe District , New Taipei City, 23553 TW
K142968 Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CB Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 15, 2014 Received: October 20, 2014
Dear Ms. Sarah Su,
Re:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
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,
Melissa A. Torres -S
Bram D. Zuckerman, M.D. For Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page __ 1__ of__1__
510(k) Number (if known): K142968
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CB
Indications For Use:
HL858CB automatically measuers human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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.
HL858CB detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring reading. And the device features a built-in "Bluetooth Data Transmission'' function, which enables the device automatically transmit measuring results to paired Bluetooth device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The-Counter Use
4
K142968 Page 1 of 7
PREMARKET NOTIFICATION
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: K142968 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/ Regulatory Affairs Dept. 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 HL858CB 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
3. Information for the 510(k) Cleared Device (Predicate Device):
5
A. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858CA (K131121) B. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL888HD (K113238)
4. Device Description:
HL858CB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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 or 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 ( & TIME ) 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.
5. Intended Use
HL858CB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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.
6
HL858CB detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device.
6. Comparison of device to predicate device: Product Specification Comparison Table of Subject Device HL858CB, and Predicate Device HL858CA(K131121)
| Item | Predicate Device
HL858CA (K131121) | Subject Device
HL858CB |
|-------------------------------------------|-----------------------------------------------------------------------------|---------------------------|
| Method of
measurement | Oscillimetric | Same as left |
| Range of
measurement | Pressure 0- 300mmHg,
Pulse 40-199 Beats/minute | Same as left |
| Accuracy | Pressure ± 3mmHg
Pulse ± 5% | Same as left |
| Inflation | Automatic inflation
(Air pump) | Same as left |
| Deflation | Automatic air release
control valve | Same as left |
| 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, or
AC adapter (optional) | Same as left |
| Storage/
Transportation
Environment | - 25°C
~ + 70℃ (- 13°F~ +158°F),
≤ 93% R.H. | Same as left |
| Operating | 5℃40℃ (41°F104°F), | Same as left |
7
| Environment | 15% ~ 93% R.H. | |
|---|---|---|
| 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 | ||
| 33 | Arm circumference | |
| approx. | ||
| 23 | ||
| (Universal cuff) | ||
| 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 |
| Data Link | ||
| function | Yes | |
| (Via USB cable) | Yes | |
| (Via Bluetooth) |
Changes from the predicate devices HL858CA (K131121):
-
- Changing the cuff size from Normal cuff (9
13 inches/23-33cm) and Large cuff (1317 inches/33-43cm) to Universal cuff (917 inches/2343cm).
- Changing the cuff size from Normal cuff (9
-
- Modifying the Data Link Function from USB into Bluetooth Data Transmission Function.
These additional feature has been verified and validated and do not affect the safety and effectiveness of subject device HL858CB.
For the product feature of Bluetooth data transmission, was compared with the other our own predicate device HL888HD (K113238).Please refer to Section 12. Substantial Equivalence Discussion for detail information.
8
K142968 Page 5 of 7
7. Discussion of Clinical Tests Performed:
HL858CB is compliant to the standard of ISO 81060-2: First Edition 2009-05-01 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 HL858CB in the group of 90 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. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The subject device was tested to evaluate its safety and effectiveness, including the followings:
- a. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment -Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
Radio Frequency Wireless Test: b.
-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 Svstems
9
c. Safety Test:
-IEC 60601-1:2005, 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
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
f. Reliability Test:
IEC 80601-2-30 Edition1.1 2013-07 Medical electricalequipment-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
i. Usability Validation:
-IEC 62366:2007 Medical devices - 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
10
K142968 Page 7 of 7
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.