(123 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement, irregular heartbeat detection based on a fixed percentage deviation, and data transfer, with no mention of AI or ML algorithms.
No.
The device is a blood pressure monitor intended for measurement and monitoring, not for treatment or therapy.
Yes
The device measures physiological parameters (blood pressure and heart rate) and also detects and indicates irregular heartbeats, which are key functions of a diagnostic device.
No
The device description explicitly mentions physical components like an LCD panel, a wrist measurement position, and a USB cable for data transfer, indicating it is a hardware device with integrated software.
No, 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 HL168KB is a blood pressure monitor that measures blood pressure and heart rate directly from the human body (at the wrist) using a physical method (oscillometric). It does not analyze samples taken from the body.
The information provided clearly describes a non-invasive medical device for measuring physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
HL168KB 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 over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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.
Product codes
DXN
Device Description
HL168KB 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 over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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 wordlis, 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
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
HL168KB 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
Accuracy: Pressure +/- 3mmHg, Pulse +/- 5% (as per comparison table)
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
K092163
$\frac{1}{4}$
PREMARKET NOTIFICATION
510(k) SUMMARY
NOV 1 6 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 HL168KB 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 HL168FV, K060729
· B. Digital Wrist Blood Pressure Monitor, Model HEM-609N, K042505
C. Wrist Blood Pressure monitor, Model WS-1100, K080177
4. Device Description:
HL168KB 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
1
over-the-counter device is for over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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 wordlis, 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
HL168KB 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 over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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:
| Item | HL168KB | Predicate
HL168FV (K060729) |
|--------------------------|---------------------------------------------------|---------------------------------------------------|
| Method of
measurement | Oscillimetric | Oscillimetric |
| Range of
measurement | Pressure 0- 300mmHg,
Pulse 40-199 Beats/minute | Pressure 0- 280mmHg,
Pulse 40-200 Beats/minute |
| Accuracy | Pressure +/- 3mmHg
Pulse +/- 5% | Pressure +/- 3mmHg
Pulse +/- 5% |
| Inflation | Automatic inflation
(Air pump) | Automatic inflation
(Air pump) |
| Deflation of
Pressure | Automatic air release
control valve | Automatic air release
control valve |
| Exhaust | Automatic exhaust valve | Automatic exhaust valve |
| Display | Liquid Crystal Digital
Display | Liquid Crystal Digital
Display |
Product Specification Comparison Table of HL168KB and HL168FV (K060729)
5-2
2
092163 3/4
| Sets of
| memory | 3*40, total 120 | 3*40, total 120 |
|---|---|---|
| Cuff size | Wrist circumference approx. | |
| 135 ~ 195 mm | ||
| (Approx. 5.3~7.7 inches) | Wrist circumference approx. | |
| 135 ~ 195 mm | ||
| Operating | ||
| Temperature | 10℃~40℃, | |
| (50°F~104°F), | ||
| 15%~90%R.H. | 10℃~40℃, | |
| 30%~85%R.H. | ||
| Storage | ||
| Temperature | - 20℃~+70℃, | |
| (- 4°F~+158°F), | ||
| ≤90%R.H. | - 20℃~+50℃, | |
| 10%~95%R.H. | ||
| Power Supply | 2 × "AAA" (1.5V) | |
| Alkaline battery | 2 × "AAA" (1.5V) | |
| Alkaline battery | ||
| Material | ABS housing and | |
| rubber keys | ABS housing and | |
| rubber keys | ||
| Number of | ||
| Push Bottom | 5 | 5 |
| Storage pouch | Yes | Yes |
| Unit Weight | Approx. 148g | |
| including batteries | Approx. 104g | |
| including batteries | ||
| Screen Cover | None | Yes |
Changes from the predicate devices HL168FV (K060729):
-
5 push buttons' positions, shapes, removing the cover of the screen
-
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 609N (K042505).
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:
HL168KB 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. Biocompațibility 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
-
- 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. -
- Conclusions:
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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is a simplified, abstract design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 6 2009
Health & Life Co., Ltd. c/o Mr. Tzu-Wei Li Manager, Senior Administrator 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: K092163 Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: October 29, 2009 Received: November 2, 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.
5
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/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB
Indications for Use:
HL168KB 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 over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Devices Evaluation (ODE)
Page 1 of 1
W.M.S
n of Cardiovascular Devices
510(k) Number K092163