(76 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and basic data transfer/display features. There is no mention of AI/ML algorithms for analysis, prediction, or enhanced interpretation. The irregular heartbeat detection is described as a simple threshold comparison.
No
Explanation: A therapeutic device is used for treatment. This device measures blood pressure and heart rate, providing diagnostic information (especially with irregular heartbeat detection) rather than directly treating a condition.
Yes
The device measures physiological parameters (blood pressure and heart rate) and provides an indication of irregular heartbeats, which are used to assess a health condition.
No
The device description explicitly mentions physical components like an LCD panel, a measurement position at the upper arm, and the ability to transfer data via a USB cable, indicating it is a hardware device with integrated software.
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 HL868BF measures blood pressure and heart rate using the oscillometric method on the upper arm. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for measuring blood pressure and heart rate for home use. This aligns with a general medical device, not an IVD.
Therefore, the HL868BF is a blood pressure monitor, which is a type of medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HL868BF 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
HL868BF 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.
The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Also, 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 device will display a symbol of ****ordes, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
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)
HL868BF is compliant to the ANSVAAMI 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): 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
09216
REMARKET NOTIFICATION
510(k) SUMMARY
SEP 30 2009
(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:
Date: 2008.08.27
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 HL868BF Common Name: Blood Pressure Monitor Classification Name: Noninvasive Blood Pressure Measurement System Classification: Class II, 21CFR 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 HL888SF, K060835
B. Automatic Blood Pressure Monitor, Model HEM 780N3, K061822
C. Wrist Blood Pressure monitor, Model WS-1100, K080177
4. Device Description:
HL868BF 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
1
over-the-counter device is for over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.
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The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Also, 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 device will display a symbol of ****ordes, 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.
5. Intended Use
HL868BF 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (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 storage data be transferred to the connected personal computer (PC) via USB cable.
6. Comparison of device to predicate device:
Product Specification Comparison Table of HL868BF and HL888SF (K060835)
| Item | HL868BF | Predicate
HL888SF (K060835) |
|--------------------------|---------------------------------------------------|---------------------------------------------------|
| Method of
measurement | Oscillimetric | Oscillimetric |
| Range of
measurement | Pressure 0- 300mmHg,
Pulse 40-199 Beats/minute | Pressure 0- 280mmHg,
Pulse 40-199 Beats/minute |
| Accuracy | Pressure +/- 3mmHg
Pulse +/- 5% | Pressure +/- 3mmHg
Pulse +/- 5% |
| Inflation | Automatic inflation
(Air pump) | Automatic inflation
(Air pump) |
| Deflation of | Automatic air release | Automatic air release |
| Pressure | control valve | control valve |
| Exhaust | Automatic exhaust valve | Automatic exhaust valve |
| Display | Liquid Crystal Digital
Display | Liquid Crystal Digital
Display |
2
| Power Supply | 6V DC, 4 x "AA" (1.5V)
Alkaline batteries
or AC adapter (optional) | 6V DC, 4 x "AA" (1.5V)
Alkaline batteries
or AC adapter (optional) |
|--------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Storage
Temperature | -20℃ ~ +70℃
(-4°F ~ +158°F),
$\leq$ 90%RH | -20℃ ~ +50℃,
30 ~ 85%RH |
| Operating
Temperature | 10℃ ~ 40℃
(50°F ~ 104°F),
15% ~ 90%RH | 10℃ ~ 40℃,
15% ~ 95%RH |
| Material | ABS housing and
rubber keys | ABS housing and
rubber keys |
| Temperature value | Yes | Yes |
| Sets of memory | 380, total 240 | 330, total 90 |
| Number of
Push Button | 5 | 5 |
| Storage pouch | Yes | Yes |
| Cuff size | Arm circumference approx.
23-43 mm(9-17 inches) | Arm circumference approx.
23-43 mm(9-17 inches) |
| Unit Weight | Approx. 400g
including batteries | Approx. 265g
excluding batteries |
Changes from the predicate devices HL888SF (K060835):
-
5 push buttons' positions, shapes, changing of exterior casing design
-
Additional product features of Irregular Heartbeat Detector, Personal Target Limits, and PC Link functions
For the product features of irregular heartbeat detector, was compared with the other predicate device Omron HEM 780N3 (K061822).
For the product features of Personal Target Limits, was compared with the other predicate device Nissei WS-1100 (K080177).
7. Discussion of Clinical Tests Performed:
HL868BF is compliant to the ANSVAAMI 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.
3
-
- 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:
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
-
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. Biocompatibility Test: ISO 10993-1:2003 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
-
d. Biocompatibility Test: ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
e. Biocompatibility Test: ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
-
f. Reliability Test: ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers
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.
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4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Health & Life Co., Ltd. c/o Mr. Tzu-Wei Li Center for Measurement Standards Industrial Technology Research Institute Rm. 30A, Bldg. 16 321, Sec. 2 Kuang Fu Rd. Hsinchu, Taiwan 30011 R.O.C.
Re: K092161
Trade/Device Name: Fully Automatic (NIBP) Blood Pressure Monitor, Model HL868BF Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 28, 2009 Received: August 31, 2009
SEP 3 0 2009
Dear Mr. Li:
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.
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Page 2 - Mr. Tzu-Wei Li
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/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,
Barry D. Zuckerman, M.
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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Indication for Use
9216 510(k) Number (if known):
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868BF
Indications for Use:
HL868BF Measures automatically 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (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)
Page 1 of 1
(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number_
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