(30 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement, irregular heartbeat detection based on interval variation, and a wrist position guide. There is no mention of AI, ML, or any learning algorithms.
No
The device is a blood pressure monitor intended for measurement and tracking, not for treating or providing therapy for a condition.
Yes
The device measures blood pressure and heart rate, detects irregular heartbeats, and provides a risk category indicator, all of which are functions associated with providing information for the diagnosis or management of a condition.
No
The device description explicitly mentions hardware components like an LCD panel, a START/STOP button, and a built-in Wrist Position Guide, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The HL158UA is a blood pressure monitor that measures blood pressure and heart rate directly from the human body (specifically, the wrist) using a physical method (oscillometric). It does not analyze samples taken from the body.
The device description clearly indicates it's a non-invasive device for measuring physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
HL158UA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.
HL158UA 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.
Product codes
DXN
Device Description
HL158UA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 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, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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)
HL158UA 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. 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).
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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 design of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Health & Life Co., Ltd. Sarah Su Director 9F, No.186, Jian Yi Road Zhonghe District, New Taipei City, 23553 TW
Re: K162338
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor model HL158UA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 19, 2016 Received: August 22, 2016
Dear 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 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 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.
1
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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162338
Device Name
Full Automatic (NIBP) Blood Pressure Monitor, Model HL158UA
Indications for Use (Describe)
HL158UA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.
HL158UA 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 19 2016 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ 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 HL158UA 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):
Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158VA (K160557)
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4. Device Description:
HL158UA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 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, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.
5. Intended Use
HL158UA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.
HL158UA 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.
6. Comparison of device to predicate device:
- A. Product Specification Comparison Table of Subject Device HL158UA, and Predicate Device HL158VA (K160557)
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| Item | Predicate Device
HL158VA (K160557) | Subject Device
HL158UA | | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Method of
measurement | Oscillimetric | Same as left | | |
| Measurement Type | During inflation | Same as left | | |
| Range of
measurement | Rated Range of Cuff
Pressure: 0~ 300mmHg,
Rated Range of
Determination:
40280mmHg,199
Pulse 40
Beats/minute | Same as left | | |
| | Accuracy | | Pressure ± 3mmHg
Pulse ± 5% | Same as left |
| | | | Inflation | |
| | Deflation | | Automatic
(Passive Exhaust Valve) | Same as left |
| | Pressure
Changed Rate | | 2-5 mmHg/sec.
(from 90mmHg to 150mmHg) | Same as left |
| | Display | | Liquid Crystal Digital | Same as left |
| | Power Supply | | 2 "AAA(LR03)(1.5V)"
Alkaline Batteries | Same as left |
| Storage/
Transportation
Environment | - 25°C ~ + 70°C
(- 13°F~ +158°F),
$\leq$ 93% R.H. | Same as left | | |
| Operating
Environment | 5°C ~ 40°C
(41°F104°F),1060 hPa | Same as left | | |
15% ~ 93% R.H.
700
| | Material | | ABS housing and
ABS keys | Same as left |
| | | | Sets of memory | |
| | Number of
Push Button | | 6 keys
(Start/Stop,
M(Memory) ,Date/Time (🕰),
Set ( + ), User(👤/👥) ,Bluetooth
button ( 🛜 )) | 5 keys
(Start/Stop,
M(Memory) ,Date/Time (🕰), Set
(+), User(👤/👥)) |
| Storage pouch | Yes
(Storage Pouch) | Yes
(Storage Case) | | |
| Cuff size | Wrist circumference
approx.
135 ~ 195 mm
(Approx. 5.3~7.7 inches) | Same as left | | |
| Unit Weight
(excluding batteries) | Approx. 128 ± 10 g | Approx. 120 ± 5 g | | |
| Risk Category
Indicator | Yes | Same as left | | |
| Irregular Heartbeat
Detector | Yes | Same as left | | |
| Bluetooth Data
Transmission
Function | Yes | No | | |
| Wrist Position Guide | Yes | Yes | | |
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Changes from the predicate devices HL158VA (K160557):
-
Changing the memory of 240 (2120, total 240) to 200 (2100, total 200).
-
Changing the 6 keys to the 5 keys.
-
Removing the Bluetooth Data Transmission Function.
These additional features have been verified and validated and do not affect the safety and effectiveness of subject device HL158UA. Please refer to Section 12. Substantial Equivalence Discussion for detail information.
7. Discussion of Clinical Tests Performed:
HL158UA is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01
7
Non-invasive 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+A1:2012/ AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, 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
d. 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
8
e. Reliability Test:
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
- Risk Assessment: ISO 14971:2007 Second Edition, Medical devices f. Application of risk management to medical devices
g. Software Verification and Validation:
-IEC 62304 Ed.1.1 (2015), 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 62366:2014 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.