(101 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement, basic data display, irregular heartbeat detection based on interval differences, and data transfer. There is no mention of AI, ML, or any complex algorithms that would typically fall under those categories. The performance studies reference a standard for sphygmomanometers, not AI/ML validation.
No
The device is described as an automatic blood pressure and heart rate monitor that uses the oscillometric method to measure blood pressure. Its primary function is measurement and information display, not direct therapeutic intervention or treatment.
Yes
The device measures blood pressure and heart rate, and detects irregular heartbeats, providing data that can indicate medical conditions, which are characteristics of a diagnostic device.
No
The device description explicitly mentions hardware components like an LCD panel, a USB cable for data transfer, and the use of the oscillometric method, which requires physical components like a cuff and pressure sensor. It is a physical medical device with some software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- This device directly measures a physiological parameter (blood pressure and heart rate) from the human body using a non-invasive method (oscillometric method on the upper arm). It does not analyze a sample taken from the body.
The device is a non-invasive blood pressure monitor intended for home use to measure blood pressure and heart rate.
N/A
Intended Use / Indications for Use
This device automatically measures human's Systolic 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.
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.
Product codes
DXN
Device Description
HL868RT 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 additional optional talking function equipped of this device can help the user to know how to use the device to measure the blood pressure and the pulse step by step, and let the user know the measurement results by hearing. Besides, the device will display a symbol ****************************************************************************************************************************************************************************** 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. Furthermore, the 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.
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
Not Found
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)
HL868RT is compliant to the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 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)
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).
0
PREMARKET NOTIFICATION
MAR 2 5 2010
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: K093831
DEC 0 9 2009 Date:
1. Submitter:
Health & Life Co., Ltd. 9F, No.186, Jian Yi Road, Chung Ho City, Taipei County, Taiwan, R.O.C. TEL: +886-2-8227-1300 FAX: +886-2-3234-9601
Contact person: Sarah Su/ Regulatory Affairs Dept. E-mail: sarah.su@hlmt.com.tw Tel: 886-2-8227-1300 ext. 1201 Fax: 886-2-3234-9601
2. Name of the Device:
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT Common Name: Blood Pressure Monitor Classification Name: Noninvasive Blood Pressure Measurement System Classification: Class II Regulation Number: 21 CFR 870.1130 Product Code: DXN Panel: Cardiovascular
3. Information for the 510(k) Cleared Device (Predicate Device):
A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL868BF, K092161 B. H&L Full Automatic Blood Pressure Monitor, Model 168ET, K043437
1
4. Device Description:
HL868RT 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 additional optional talking function equipped of this device can help the user to know how to use the device to measure the blood pressure and the pulse step by step, and let the user know the measurement results by hearing. Besides, the device will display a symbol ****************************************************************************************************************************************************************************** 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. Furthermore, the 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.
5. Intended Use
This device automatically measures human's Systolic 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.
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.
6. Comparison of device to predicate device:
| Item | Predicate
HL868BF (K092161) | HL868RT |
|--------------------------|--------------------------------|--------------|
| Method of
measurement | Oscillimetric | Same as left |
2
| 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 of
Pressure | Automatic air release
control valve | Same as left |
| Exhaust | Automatic exhaust valve | Same as left |
| Display | Liquid Crystal Digital
Display | Same as left |
| Power Supply | 6V DC, 4 × "AA" ( 1.5V )
Alkaline batteries
or AC adapter (optional) | Same as left |
| Storage
Temperature | - 20℃ ~ + 70℃
(-4°F~ +158°F),
≤ 90%RH | Same as left |
| Operating
Temperature | 10℃40℃104°F),
(50°F
15% ~ 90%RH | Same as left |
| Sets of memory | 380, total 240 | 260, total 120 |
| Number of
Push Bottom | 5 | 7 |
| Storage pouch | Yes | Same as left |
| Cuff size | Arm circumference approx.
23-43 cm (9~17 inches) | Same as left |
| Unit Weight | Approx. 312g
excluding batteries | Approx. 293 ± 5g
excluding batteries |
Changes from the predicate devices HL868BF (K092161):
-
7 push buttons, changing of exterior casing design
-
Additional product features of Risk Category Indicator, and Talking Function For the product feature of Talking Function, was compared with the other predicate device H&L Full Automatic Blood Pressure Monitor, Model 168ET(K043437)
3
K093831
p4/4
7. Discussion of Clinical Tests Performed:
HL868RT is compliant to the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 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. 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. Safety Test: IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- b. EMC Test: IEC 60601-1-2:2001+A1:2004 Medical Electrical Equipment Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and Test
- c. Reliability Test: ANSI/AAMI SP-10:2002+A1:2003+A2:2006
- d. Risk Assessment: ISO 14971:2007 Medical devices Application of risk management to medical devices
- e. Software Verification and Validation: IEC 62304 Ed. 1.0, Medical device software -Software life cycle processes. (Software/Informatics) and IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety --Collateral standard: Programmable electrical medical systems
- f. Usability Validation: IEC 62366 Medical devices Application of usability engineering to medical devices
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 devices.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 2 5 2010
Health and Life Co., Ltd. c/o Ms. Sara Su Deputy Manager 9F., No. 186, Jian Yi Road Chung Ho City, Taipei County TAIWAN 235 R.O.C.
Re: K093831
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 7, 2010 Received: January 25, 2010
Dear Ms. 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.
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.
5
Page 2 - Ms. Sara Su
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 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.
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.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 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,
Lara Bram D. Zuckerman, M.D.
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K093831
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT
Indications for Use:
This device automatically measures human's Systolic 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.
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ 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) |
|---|
| --------------------------------------------------------- |
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(Division Sign-Off)
of Cardiovascular Devices
510(k) Number K093283
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