(112 days)
No
The description focuses on standard oscillometric blood pressure measurement and basic irregular heartbeat detection based on interval variation, with no mention of AI/ML terms or methodologies. The performance study relies on equivalence to a predicate device using the same algorithm, not on AI/ML model training or validation.
No
The device is described as an over-the-counter blood pressure monitor for home use that measures blood pressure and heart rate and detects irregular heartbeats. It does not provide therapy for any condition.
Yes
Explanation: The device measures blood pressure and heart rate, and detects irregular heartbeats, which are diagnostic indicators of health conditions.
No
The device description explicitly mentions physical components like an air pump and sensor, and describes a physical measurement process using the oscillometric method during inflation, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The HL158TB measures blood pressure and heart rate directly from the human body (at the wrist) using a physical method (oscillometric). It does not analyze any biological samples taken from the body.
Therefore, based on the provided information, the HL158TB is a non-invasive medical device for measuring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HL158TB 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.
HL158TB 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 user tracking their blood pressure level.
Product codes
DXN
Device Description
HL158TB 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 ♥*~, 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.
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 / 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)
The subject device HL158TB and the predicated device HL158TA (K160336) have the same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm, so clinical study results can be transferred from the K160336 predicate to the subject device. In 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 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2019
Health & Life Co., Ltd. Js Hsu Manager 9F, No. 186, Jian Yi Road Zhonghe District, New Taipei City, 23553 TAIWAN
Re: K190134
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, HL158TB Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 3, 2019 Received: April 22, 2019
Dear Js Hsu:
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB
Indications for Use (Describe)
HL158TB 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.
HL158TB 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 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
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PREMARKET NOTIFICATION 510(K) SUMMARY (As Requirement 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: Date: _
-
Submitter: 1. 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: JS Hsu E-mail: js.hsu@hlmt.com.tw TEL: +886-2-8227-1300 ext.1201 FAX: +886-2-8227-1301 -
- Name of the Device:
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB 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
- Name of the Device:
-
Information for the 510(k) Cleared Device (Predicate Device): 3. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158TA (K160336)
-
- Device Description:
HL158TB 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.
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The device will display a symbol ♥*~, 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.
- ട. Intended Use
HL158TB 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.
HL158TB 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 Table 6.1 Product Specification Comparison Table of Subject Device HL158TB, and Predicate Device HL158TA (K160336)
| Item | Predicate Device
HL158TA (K160336) | Subject Device
HL158TB |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Method of
measurement | Oscillometric | 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 Beats/minute | Same as left |
Pulse 40
| Accuracy | Pressure $\pm$ 3mmHg
Pulse $\pm$ 5% | Same as left |
| Inflation | Automatic Inflation (Air Pump) | Same as left |
| Deflation | Automatic Air Release Control
Valve | Same as left |
| Pressure Changed Rate | 2~5mmHg/sec. | Same as left |
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| Display | Liquid Crystal Digital | Same as left |
|---|---|---|
| Power Supply | 2 "AAA(LR03)(1.5V)"Alkaline Batteries | Same as left |
| Storage/Transportation environment | -25°C | |
| ≤93% R.H. | Same as left | |
| Operating environment | 5°C ~ 40°C (41°F ~104°F), | |
| 15% ~ 93% R.H. | ||
| 700~1060 hPa | Same as left | |
| Material | ABS housing and ABS keys | Same as left |
| Sets of memory | 1*60, total 60 | Same as left |
| Number of push Button | 2 keys | |
| (Start/Stop, M(Memory)) | 3keys | |
| (Start/Stop, | ||
| M(Memory), | ||
| Date/Time(©)) | ||
| Cuff size | Wrist circumference approx. | |
| 135 ~ 195 mm | ||
| (Approx. 5.3~7.7 inches) | Same as left | |
| Unit weight | ||
| (excluding batteries) | Approx. 91.7 ± 10 g | Approx. 120 ± 10 g |
| Risk Category Indicator | AHA 2003 | AHA 2017 |
| Irregular Heartbeat Detector | Yes | Same as left |
| Error icon | EE & E1 & E2 & E3 | ("("&)") & EE & E1 & E2 & E3 |
Changes from the predicate devices HL158TA (K160336):
- Changing the 2 keys to the 3 keys.
-
- Update the Risk Category Indicator.
-
- Modifying error icon.
These additional features have been verified and validated and do not affect the safety and effectiveness of subject device HL158TB.
7. Discussion of Clinical Tests Performed
The subject device HL158TB and the predicated device HL158TA (K160336) have the same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm, so clinical study results can be transferred from the K160336 predicate to the subject device. In ISO 81060-2 Second Edition 2013-05-01 Non-invasive sphygmomanometers-Part 2: Clinical validation of automated measurement type, all the relevant
6
activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
-
- 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:
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows
-
EMC Test: a.
- . 19-8, IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
-
b. Safety Test
- . 19-4, 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
- . 19-14, IEC 60601-1-11 Edition 2.0 2015, Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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FCC Test C.
- . FCC 47 CFR Part 15, Subpart B
-
ರ. Biocompatibility Test
- . 2-220, ISO 10993-1 Edition 4:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 2-245, ISO 10993-5 Edition 3:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . 2-174, ISO 10993-10 Edition 3:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
Reliability Test e.
- . 3-123, IEC 80601-2-30 Edition 1.1:2013, Medical electrical equipment
7
-
Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
-
f. Risk Assessment
- . 5-40, ISO 14971 Edition 2:2007, Medical devices - Application of risk management to medical devices
-
Software Verification and Validation 8.
- . 13-79, IEC 62304 Edition 1.1:2015, Medical device software - Software life cycle processes
- . IEC 60601-1-4 Edith1.1:2000 , Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
-
h. Usability Validation ()
- . 5-114, IEC 62366-1 Edition 1.0:2015, Medical devices - Part 1: Application of usability engineering to medical devices
- . 5-89, IEC 60601-1-6 Edition 3.1:2013, Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
- 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.