(107 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement, irregular heartbeat detection based on a fixed percentage deviation, and classification based on pre-defined WHO categories. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML.
No
The device measures blood pressure and heart rate, provides information on irregular heartbeats, and classifies blood pressure based on WHO guidelines, but it does not treat or alleviate any condition. Its use is solely for measurement and informational purposes.
Yes
This device measures blood pressure and heart rate using the oscillometric method, and it includes features like an irregular heartbeat detector and a risk category indicator based on WHO classifications. These functions provide information that aids in assessing health status, which falls under the definition of a diagnostic device.
No
The device description clearly states it uses the oscillometric method and measures blood pressure at the wrist, indicating the presence of hardware components like a cuff, sensor, and pump, in addition to software for processing and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- This device's function: The HL158LA is a blood pressure monitor that measures blood pressure and heart rate directly from the human body (specifically, the wrist) using the oscillometric method. This is a non-invasive measurement performed on the body, not on a specimen taken from the body.
Therefore, based on the provided information, the HL158LA falls under the category of a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HL158LA 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.
Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
HL158LA 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 wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (13.5 ~ 19.5 cm).
The device is equipped with Irregular Heartbeat Detector function. It will display a symbol of order to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.
Besides, user can save and manage the measurement data by transferring the measured readings of blood pressure to the connected personal computer (PC) via USB cable. Additionally, the Risk Category Indicator (Six Levels) feature will classify the blood pressure results with WHO (World Health Organization) Classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, Normal, and Optimal. The Corresponding LCD segment will be turned on along with the systolic, diastolic, and heart rate information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human being's wrist
Indicated Patient Age Range
over the age of 18
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)
HL158LA is compliant to the ANSI/AAM1 SP10:2002/(R)2008 & ANSI/AAM1 SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard for Manual, electronic, or automated sphygmomanometers. 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
K130564 PREMARKET NOTIFICATION
JUN 1 9 2013
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.
Date: March 01 2013 The assigned 510(k) number is:
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 HL 158LA Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21CFR 870.1130 Product Code: DXN Panel: 74 Cardiovascular
3. Information for the 510(k) Cleared Device (Predicate Device):
A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT, K093824 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967
4. Device Description:
HL158LA 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 wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (13.5 ~ 19.5 cm).
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K130564
The device is equipped with Irregular Heartbeat Detector function. It will display a symbol of order to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.
Besides, user can save and manage the measurement data by transferring the measured readings of blood pressure to the connected personal computer (PC) via USB cable. Additionally, the Risk Category Indicator (Six Levels) feature will classify the blood pressure results with WHO (World Health Organization) Classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, Normal, and Optimal. The Corresponding LCD segment will be turned on along with the systolic, diastolic, and heart rate information.
5. Intended Use
HL158LA 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 cm) and for home use.
6. Comparison of device to predicate device:
Product Specification Comparison Table of HL158LA and HL158BT (K093824)
| Item | Predicate Device
HL158BT (K093824) | Subject Device
HL158LA |
|--------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Method of
measurement | Oscillometric | Same as left |
| Measurement
range of | Pressure 0- 300mmHg
Pulse 40-199 beats/minute | Rated range of cuff pressure:
0-300 mmHg
Rated range of determination:
40-280mmHg
Pulse: 40-199 beats/minute |
| Accuracy | Pressure +/- 3 mmHg
Pulse +/- 5% | Same as left |
| Inflation | Automatic inflation (Air pump) | Same as left |
| Deflation of
pressure | Automatic air release
control valve | Same as left |
| Display | Liquid Crystal Display | Same as left |
.
2
| Memory | 60 memory * 2 users
(120 memory total) | 40 memory * 3 users
(120 memory total) |
|-------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|
| Cuff size | Wrist circumference
approx. 5.37.7 inch19.5 cm) | Same as left |
(13.5
| Operation
environment | 50°F ~ 104°F (10°C ~ 40°C),
15%90%R.H. | 41°F104°F (5°C ~ 40°C),
15%93% R.H. |+158°F (-25°C ~ +70°C),
| Storage/
Transportation
environment | -4°F ~ +158°F (-20°C ~ +70°C),
≤ 90% R.H. | - 13°F
≤93%R.H. |
| Power Supply | 2 × "AAA" (1.5V)
Alkaline battery | Same as left |
| Material | ABS housing and
rubber keys | ABS housing and
ABS keys |
| Number of
Push Button | 7 | 4 |
| Storage case | Yes | Same as left |
| Unit Weight | Approx. 106 ± 5 g
(Excluding batteries) | Approx. 119 ± 5 g
(Excluding cuff and batteries) |
Changes from the predicate devices HL158BT (K093824):
-
4 push buttons, changing of exterior casing design and sets of memory
-
Additional modified feature of Risk Category Indicator (Six Levels)
For the modified feature of Risk Category Indicator (Six Levels), was compared with the other predicate device A&D UB-512 (K042967).
7. Discussion of Clinical Tests Performed:
HL158LA is compliant to the ANSI/AAM1 SP10:2002/(R)2008 & ANSI/AAM1 SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard for Manual, electronic, or automated sphygmomanometers. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
8. Discussions 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. Safety Test
- IEC 60601-1:2005, Medical electrical equipment Part 1: General r requirements for basic safety and essential performance.
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K130564
- IEC 60601-1-11:2010, 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.
- b. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests.
- FCC Test: FCC 47 CFR Part 15, Subpart B:2011 C.
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
- e. Reliability Test: ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10: 2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers.
- ೆ. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -Application of risk management to medical devices.
9. Conclusions:
The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings forming three curved lines.
June 19, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Health & Life Co., Ltd. Sarah Su 9f. No.186. Jian Yi Road Zhonghe District, New Taipei City, 23553 TW
Re: K130564
Trade/Device Name: Full automatic (nibb) blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: May 14, 2013 Received: May 20, 2013
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); fabeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance 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,
Owen P Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K130564
Indication for Use
510(k) Number (if known):
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL 158LA
Indications for Use:
HL158LA 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.
Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE) ven P. Faris -S Page 1 of 1 13.06.19 16:03:41 4-1