(120 days)
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.
HL888HD features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx. 9 inches to 17 inches (23 cm to 43 cm) and for home use.
The user is able to set the personal target values for blood pressure self-management. When the user's blood pressure readings exceed the self management pressure level, a RED LCD backlight of either systolic/diastolic or both will illuminate. If the readings are equal or lower than the preset values, the screen will illuminate BLUE LCD backlight.
User's measuring results can be automatically transmitted to the paired Bluetooth device via the built-in Bluetooth module once measurement completed.
The provided text describes the 510(k) premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL888HD. The primary study referenced is for compliance with the 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 Standard.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
According to the ANSI/AAMI SP10:2002 standard, the acceptance criteria for blood pressure monitors are typically:
- Pressure Accuracy: The mean difference between the device reading and the reference method should be ≤ ± 5 mmHg, with a standard deviation of ≤ 8 mmHg.
- Pulse Rate Accuracy: Usually specified as ± 5% or a similar tolerance compared to a reference standard.
The "Accuracy" section in the Product Specification Comparison Table directly states the device's performance against these criteria:
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance (HL888HD) |
|---|---|
| Pressure: Mean Difference ≤ ± 5mmHg, Standard Deviation ≤ 8mmHg | Pressure: +/- 3mmHg |
| Pulse: ± 5% (typical) | Pulse: +/- 5% |
Note: The "Pressure +/- 3mmHg" stated is often the mean difference accuracy. The text directly states the device meets this, implying it also meets the standard's statistical requirements (mean difference and standard deviation) for accuracy due to the claim "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical validation according to the ANSI/AAMI SP10 standard. The standard itself specifies the minimum number of subjects required for validation (e.g., typically at least 85 subjects with specific distributions across age, gender, and blood pressure ranges).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, clinical studies for medical device approval are generally prospective to ensure controlled data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts or their qualifications for establishing ground truth in the clinical validation. For oscillometric blood pressure monitors validated against a standard like ANSI/AAMI SP10, the "ground truth" (or reference standard) is typically established by trained observers using a mercury or auscultatory sphygmomanometer following a defined protocol, often in a double-blind fashion, as per the standard's requirements. These observers are highly trained healthcare professionals or technicians.
4. Adjudication Method for the Test Set
The text does not explicitly state the adjudication method used. For blood pressure validation studies using auscultatory reference, there are often two or more independent observers, and their readings are compared. If they differ by a certain amount, a third observer might be involved, or the readings averaged, but this specific detail is not in the provided summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done or reported. This type of study typically compares human reader performance with and without AI assistance, which is not applicable to a standalone blood pressure monitor.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was done. The device itself is an automated blood pressure monitor that measures blood pressure autonomously. The clinical tests performed "demonstrated that the predetermined acceptance criteria were fully met," indicating that the device's algorithm performs accurately without human intervention during the measurement process. The comparison of the device's readings against a human-obtained reference (as per ANSI/AAMI SP10) is a standalone performance assessment.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical validation is based on reference measurements obtained simultaneously by trained observers using a reference auscultatory method, generally following the protocols outlined in the ANSI/AAMI SP10 standard. This is implicitly confirmed by the device's claim of compliance with this standard.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for any training set. For devices like this, the "training set" would refer to data used for the development and calibration of the oscillometric algorithm. This information is typically proprietary and not usually disclosed in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. Similar to the test set, it would have been established through simultaneous measurements by trained observers using a reference auscultatory method.
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MAR - 1 2012
REMARKET NOTIFICATION
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: Date: NOV 01 2011 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 HL888HD Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21CFR 870.1130 Classification Panel: Cardiovascular Product Code: DXN
3. Information for the 510(k) Cleared Device (Predicate Device):
A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL868BF, K092161 B. A&D Medical UA-767PBT Digital Blood Pressure Monitor. K043217
4. Device Description:
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx. 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 values for blood pressure self-management. When the user's blood pressure readings exceed the self management pressure level, a RED LCD backlight of either systolic/diastolic or both will illuminate. If the readings are equal or lower than the preset values, the screen will illuminate BLUE LCD backlight.
User's measuring results can be automatically transmitted to the paired Bluetooth device via the built-in Bluetooth module once measurement completed.
5. Intended Use
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.
6. Comparison of device to predicate device:
Product Specification Comparison Table of Subject device HL888HD and predicate device HL868BF (K092161)
| Item | Subject deviceHL888HD | Predicate deviceHL868BF (K092161) |
|---|---|---|
| Method ofmeasurement | Oscillimetric | Oscillimetric |
| Range ofmeasurement | Pressure 0-300mmHg,Pulse 40-199 Beats/minute | Pressure 0-300mmHg,Pulse 40-199 Beats/minute |
| Accuracy | Pressure +/- 3mmHgPulse +/- 5% | Pressure +/- 3mmHgPulse +/- 5% |
| Inflation | Automatic inflation(Air pump) | Automatic inflation(Air pump) |
| Deflation | Automatic air releasecontrol valve | Automatic air releasecontrol valve |
| Exhaust | Automatic exhaust valve | Automatic exhaust valve |
| Display | Liquid Crystal DigitalDisplay | Liquid Crystal DigitalDisplay |
| Power Supply | 6V DC, 4 × "AA" (1.5V)Alkaline batteries | 6V DC, 4 × "AA" (1.5V)Alkaline batteriesor AC adapter (optional) |
| Storage/ | -20°C ~ +70°C | -20°C ~ +70°C |
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| TransportationTemperature | ( $-4$ °F~+158°F),$\le$ 90%RH | ( $-4$ °F~+158°F),$\le$ 90%RH |
|---|---|---|
| OperatingTemperature | 10℃ | 10℃ |
| Material | ABS housing andABS keys | ABS housing andrubber keys |
| Sets of memory | 1*99 | 3*80, total 240 |
| Number ofPush Bottom | 4 | 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 | 9.93 ± 0.35 oz (281.5 ± 10 g)(Cuff and Batteries excluded) | Approx. 17.5 oz ( includingbatteries ) |
Changes from the predicate device HL868BF (K092161):
*Changing of numbers of push buttons', push buttons' positions, exterior casing design and color
-
- Modify Personal Target Limits with BLUE/RED LCD backlight instead of SMILING symbol and flash on the screen
- Additional product feature of Bluetooth Data Transmission Function For the product feature of Bluetooth data transmission, was compared with the other predicate device A&D UA-767PBT (K043217).
7. Discussion of Clinical Tests Performed:
Subject device HL888HD is compliant to the 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 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 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
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- 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.
- c.FCC Test: FCC 47 CFR Part 15, Subpart B
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 10993-10:2002/Amd. 1:2006(E), Biological evaluation of medical devices --Part 10: Tests for irritation and delayed-type hypersensitivity amendment 1.
- 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.
- f. Risk Assessment: ISO 14971:2007 Medical devices Application of usability engineering to medical device.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
Health & Life Co., Ltd c/o Ms. Sarah Su Manager 9F, No. 186, Jian Yi Road Zhonghe District 23553, New Taipei City Taiwan
Re: K113238
Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888HD Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 23, 2012 Received: February 27, 2012
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. 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
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Page 2 - Ms. Sarah Su
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. Page 2 - Ms. Sarah 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillemann
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
K113238 510(k) Number (if known):
Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888HD
Indications for Use:
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.
HL888HD features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
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
M. A. Willelume
(Division Sign-Off)
Division of Cardiovascular Devices
10113238 510(k) Number_
§ 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).