(145 days)
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No
The description focuses on standard oscillometric blood pressure measurement, irregular heartbeat detection based on specific patterns, and Bluetooth data transmission. There is no mention of AI or ML algorithms for data analysis, prediction, or learning. The "Advanced IHB detection feature" is described as collecting and analyzing pulses to detect "specific irregular heartbeats," which suggests rule-based or threshold-based detection rather than ML.
No
Explanation: This device is for measuring blood pressure and heart rate, and providing information about potential irregularities, but it does not claim to treat or cure any condition. Therefore, it is a diagnostic/monitoring device, not a therapeutic one.
Yes
The device measures blood pressure and heart rate, provides a BP Category Indicator, and features Irregular Heartbeat (IHB) detection, indicating potential cardiovascular issues to the user. While it doesn't make a definitive diagnosis, it provides information that can be used to monitor health and identify potential health problems, aligning with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like an LCD panel, an arm cuff for oscillometric measurement, and a physical device (HL858DM) that performs the blood pressure measurement. While it has Bluetooth transmission and associated software (DailyChek® application), the core medical device functionality is performed by hardware.
Based on the provided text, 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 clearly states that this device measures blood pressure and heart rate using the oscillometric method on the human arm. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
- No Mention of Samples: There is no mention of collecting or analyzing any biological samples.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s arm. All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DM features BP Category Indicator that will show the information with the readings on the user tracking their blood pressure level. HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. Besides, the device features a built-in “Bluetooth Transmission” function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.
Product codes
DXN
Device Description
HL858DM 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 has the Risk Category Indicator, Irregular Heartbeat Detector, Bluetooth data transmission functions. When the symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement. Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, HL858DM featured with an IHB feature can identify the specific irregular heartbeats that may cause deviated blood pressure reading.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human being's arm, human being's upper arm
Indicated Patient Age Range
adults aged 18 years and older
Intended User / Care Setting
Over-The-Counter Use; 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)
The subject device HL858DM is compliant to the standard of ISO 81060-2:2018 Noninvasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. 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.)
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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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 8, 2021
Health & Life Co., Ltd Peggy Su RA/QA Div. Manager 9F, No. 186, Jian Yi Road, Zhonghe District New Taipei City, 23553 Taiwan
Re: K211127
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 6, 2021 Received: August 9, 2021
Dear Peggy 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
Enclosure
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Indications for Use
510(k) Number (if known) K211127
Device Name
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
Indications for Use (Describe)
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's arm.
All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.
HL858DM features BP Category Indicator that will show the information with the readings on the user tracking their blood pressure level.
HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.
Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor 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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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.
AUG 06 2021 Date: The assigned 510(k) number is: K211127 --------
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: Peggy Su / RA & QA Div. Manager E-mail: Peggy Su@hlmt.com.tw Tel: 886-2-8227-1300 ext. 11203 Fax: 886-2-8227-1301
2. Name of the Device:
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM 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):
A. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858DK (K180240)
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4. Device Description:
HL858DM 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 has the Risk Category Indicator, Irregular Heartbeat Detector, Bluetooth data transmission functions.
When the symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement.
Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, HL858DM featured with an IHB feature can identify the specific irregular heartbeats that may cause deviated blood pressure reading.
5. Intended Use
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate.
The measurement position is at human being's arm.
All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.
HL858DM features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.
HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.
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Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users 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 HL858DM, and Predicate Device HL858DK (K180240)
| Item | Predicate Device
HL858DK (K180240) | Subject Device
HL858DM |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Method of
measurement | Oscillimetric | Same as left |
| Measurement
Type | During inflation | 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. 158 °F),
(from 90mmHg to 150mmHg) | Same as left |
| Display | Liquid Crystal Digital | Same as left |
| Power Supply | 4 × AAA/1.5V (LR03)
Alkaline batteries, or
AC Adapter (Model: SINPRO,
HPU15-102 Input: 100-240V
AC 47-63Hz / Output: 5.99V,
DC, 2A) | Same as left |
| Storage/
Transportation
Environment | - 25 °C ~ 60 °C (- 13 °F
≤ 93% R.H. | Same as left |
| Operating
Environment | 5 °C ~ 40 °C (41 °F~104 °F),
15% ~ 93% R.H. | Same as left |
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| 700~1060hPa | |||
|---|---|---|---|
| Material | ABS housing and | ||
| ABS keys | Same as left | ||
| Sets of | |||
| memory | 3*40,total 120 | Same as left | |
| Number of | |||
| Push Button | 5 keys control | ||
| (Start/Stop, Memory, Up, Down, | |||
| Time () button) | Same as left | ||
| Storage pouch | Yes | Same as left | |
| Cuff size | Arm circumference approx. | ||
| 23 | |||
| (Universal cuff) | Same as left | ||
| Unit Weight | Approx. 320 ± 5g | ||
| (Excluding cuff and Batteries ) | Same as left | ||
| Risk/BP | |||
| Category | |||
| Indicator | Yes | ||
| (BP Category Indicator, Six Levels) | Same as left | ||
| Irregular | |||
| Heartbeat | |||
| Detector | Yes | Same as left | |
| Bluetooth Data | |||
| Transmission | No | 1. |
- | Measurement Data
Transmission
Date/Time
Synchronization
Battery Status Check |
Changes from the predicate devices HL858DK (K180240):
- Add Data Link Function (Bluetooth Data Transmission)
The subject device HL858DM adds Bluetooth technology function. It provides users an optional choice to log, track and store their measurement data.
This feature doesn't directly affect the safety and effectiveness of blood pressure measurement. Relevant evaluations such as software verification and validation, risk management activities and usability engineering validation were performed accordingly, and the results show that the Bluetooth Data Transmission function of
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the subject device HL858DM could operate properly as intended.
Please refer to Section 14. Substantial Equivalence Discussion for detail information.
7. Discussion of Clinical Tests Performed:
The subject device HL858DM is compliant to the standard of ISO 81060-2:2018 Noninvasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. 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 is as follows:
The subject device was tested to evaluate its safety and effectiveness, including the followings:
- a. EMC Test: IEC 60601-1-2 Edition 4:2014, Medical Electrical Equipment Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
b. Safety Test:
-IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-11:2015, 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
c. FCC Test:
FCC 47 CFR Part 15, Subpart B, C
d. Biocompatibility Test:
-ISO 10993-1:2018, 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
- e. Reliability Test:
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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.
f. Risk Assessment:
ISO 14971:2007 Second Edition, Medical devices - Application of risk management to medical devices
g. 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
h. Usability Validation:
-IEC 62366:2015 Medical devices - Application of usability engineering to medical devices
-IEC 60601-1-6:2013 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.