AGE Automatic Wrist Blood Pressure Monitor

K151281 · Dongguan Ageless Health Industrial Co., Ltd. · DXN · Jun 30, 2015 · Cardiovascular

Device Facts

• Record ID: K151281
• Device Name: AGE Automatic Wrist Blood Pressure Monitor
• Applicant: Dongguan Ageless Health Industrial Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm~19.5cm.

Device Story

Battery-powered automatic wrist blood pressure monitor; utilizes oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Device consists of an inflatable cuff (13.5-19.5 cm circumference) and a main unit with an LCD display. Operated by medical professionals or patients at home. User wraps cuff around wrist; device automatically performs inflation/deflation cycles; processes pressure oscillations to calculate blood pressure and pulse rate; displays results on LCD. Includes low-voltage battery indicator. Provides objective physiological data to assist clinicians or patients in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. Device evaluated for safety and performance per IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and AAMI/ANSI/ISO 81060-2 (clinical validation of automated measurement).

Technological Characteristics

Battery-powered (3Vdc, 2x AAA) wrist-worn oscillometric monitor. Cuff circumference 13.5-19.5 cm. Pressure range 0-294 mmHg; pulse range 40-199 bpm. Accuracy: ±3 mmHg (pressure), ±5% (pulse). Materials evaluated for biocompatibility per ISO 10993-5 and -10. Standards: IEC 60601-1, IEC 60601-1-2, ISO 81060-2.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via wrist-cuff oscillometry. Suitable for use by medical professionals or at home.

Regulatory Classification

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.

Predicate Devices

• Full Automatic (NIBP) Blood Pressure Monitor, Model HL158LA (K130564)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Dongguan Ageless Health Industrial Co., Ltd c/o Ms. Cecilia Ceng Regulatory Manager Suite 306, Kecheng Mansion, No.121 Science Road, Guahgzhou Science Park Guangzhou, 510663 CN

Re: K151281

> Trade/Device Name: AGE Automatic Wrist Blood Pressure Monitor, Models BW-601, BW-602. BW-603. BW-605. BW-606. BW-611. BW-612. BW-613 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 20, 2015 Received: May 14, 2015

Dear Ms. Cecilia Ceng,

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

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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

for 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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K151281

Page __ 1_ of _1_

510(k) Number (if known): K151281

De vice Name : 605, BW -606, BW -611, BW -612, and BW -613

Indications For Use: AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 870.1130.

#### 1. Submitter Information

Sponsor Name: Dongguan Ageless Health Industrial Co.,Ltd. Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: [phone] Fax: [phone] E-mail: [e-mail]

### Application Correspondent:

Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. Tel: [phone] Email: [e-mail]

#### Subject Device Information 2.

| Type of 510(k): | Traditional |
|-----------------|-------------|
|-----------------|-------------|

Common Name: Noninvasive blood pressure measurement systems

Trade Name: AGE Automatic Wrist Blood Pressure Monitor, Models BW-601,

BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613

Classification Name: Noninvasive brood pressure measurement system

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# K151281 Page 2 of 6

| Review Panel: | Cardiovascular |
|--------------------|-----------------|
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |

#### 3. Predicate Device Information

| Sponsor: | Health & Life Co.,Ltd. |
|--------------------|-------------------------------------------------------------|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | Full Automatic (NIBP) Blood Pressure Monitor, Model HL158LA |
| 510(k) number: | K130564 |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |

#### 4. Device Description

AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.

#### 5. Intended Use

AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.

### 6. Test Summary

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K151281 Page 3 of 6

AGE Automatic Wrist Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards:

- � IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances -Requirements and tests, 2014
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- ◆ AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. (Cardiovascular)

#### 7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Product Name | AGE Automatic Wrist Blood<br>Pressure Monitor | Full Automatic (NIBP) Blood<br>Pressure Monitor, Model HL158LA | -- |
| Intended Use and Indications for Use | | | |
| Intended Use | AGE Automatic Wrist Blood<br>Pressure Monitor is intended for use<br>by medical professionals or at home<br>to monitor and display diastolic,<br>systolic blood pressure and pulse<br>rate on adult each time, with an air<br>cuff buckled around one's wrist | HL158LA automatically measures<br>human's Systolic, Diastolic blood<br>pressure and heart rate by using the<br>oscillometric method. All values can<br>be read out in one LCD panel.<br>Measurement position is at human<br>being's wrist. The intended use of | SE<br>Note 1 |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Indications for<br>Use | according to the instruction in the<br>user's guide manual. | this over-the-counter device is for<br>use by people over the age of 18<br>with wrist circumference ranging<br>from approx. 5.3 to 7.7 inches(13.5<br>cm to 19.5 cm) and for home use. | |
| | AGE Automatic Wrist Blood<br>Pressure Monitor is for use by<br>medical professionals or at home<br>and is a non-invasive blood<br>pressure measurement system<br>intended to measure the diastolic<br>and systolic blood pressures and<br>pulse rate of an adult individual by<br>using a non-invasive technique in<br>which an inflatable cuff is wrapped<br>around the wrist. The cuff<br>circumference is limited to<br>13.5cm~19.5cm. | HL158LA automatically measures<br>human's Systolic, Diastolic blood<br>pressure and heart rate by using the<br>oscillometric method. All values can<br>be read out in one LCD panel.<br>Measurement position is at human<br>being's wrist. The intended use of<br>this over-the-counter device is for<br>use by people over the age of 18<br>with wrist circumference ranging<br>from approx. 5.3 to 7.7 inches(13.5<br>cm to 19.5 cm) and for home use. | SE<br>Note 1 |
| | | | |
| ELECTRICAL REQUIREMENT | | | |
| Power Supply | 3Vdc (2 "AAA" batteries) | 3Vdc (2 "AAA" batteries) | SE |
| PERFORMANCE SPECIFICATION | | | |
| Measuring<br>Method | Oscillometry | Oscillometry | SE |
| Measuring<br>Range | Pressure: 0~294 mmHg<br>Pulse: 40~199 beats/minute | Pressure: 0~300 mmHg<br>Pulse: 40~199 beats/minute | SE<br>Note 2 |
| Accuracy | Pressure: ±3 mmHg<br>Pulse: ±5% | Pressure: ±3mmHg<br>Pulse: ±5% | SE |
| Patient<br>Population | Adult | Adult | SE |
| Measurement<br>Site of Body | Wrist | Wrist | SE |
| Cuff<br>Circumference | 13.5 ~ 19.5 cm | 13.5 ~ 19.5 cm | SE |
| Inflation and<br>Deflation | Automatic | Automatic | SE |
| Memory Size | 2 x 90 sets record | 3×40 sets record | SE<br>Note 3 |
| Storage<br>Environment | OPERATING & STORAGE CONDITIONS | | |
| | Temperature: -20°C ~ +65°C<br>Humidity: 15~95%RH<br>Atmospheric Pressure:86 kPa~106 | Temperature: -25°C ~ +70 °C<br>Humidity: ≤ 93%RH | SE<br>Note 3 |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| | kPa | | |
| Working<br>Environment | Temperature: 5°C ~ 40°C<br>Humidity: 15~90%RH<br>Atmospheric Pressure:86 kPa~106 kPa | Temperature: 5°C ~ 40°C<br>Humidity: 15~93%RH | SE<br>Note 3 |
| COMPLIANCE STANDARDS | | | |
| Electrical,<br>Mechanical and<br>Thermal<br>Evaluation | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-11 | SE<br>Note 4 |
| Biocompatibility<br>Evaluation | All the patient contracting materials<br>are evaluated by the<br>biocompatibility standard ISO<br>10993 -5, -10. | All the patient contracting materials<br>are evaluated by the<br>biocompatibility standard ISO<br>10993 -1, 5, -10. | SE<br>Note 5 |
| Performance | ISO 81060-2 | AAMI SP10 | SE<br>Note 6 |

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# Note 1

Although there is little difference for measurement cuff circumference of subject device and predicate device, both of them are complied with AAMI SP10 or ISO 81060-2. This difference does not affect the safety and effectiveness.

# Note 2

Although the measuring range of pressure and pulse of subject device and predicate device are different, both of them are complied with AAMI SP10 or ISO 81060-2. The difference of their measuring range does not affect the safety and effectiveness.

### Note 3

Although some specifications of operating & storage conditions, memory size are different for subject device and predicate device, they are both complied with IEC 60601-1. The differences do not affect the safety and effectiveness.

### Note 4

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# K151281 Page 6 of 6

Although the electrical, mechanical and thermal evaluation of subject device and predicate device are different, they are both complied with IEC 60601-1 and IEC 60601-1-2. The differences do not affect the safety and effectiveness.

### Note 5

Although the biocompatibility evaluation of subject device and predicate device are different, they are both complied with ISO 10993-5 and ISO 10993-10. The differences do not affect the safety and effectiveness.

### Note 6

Although the standards of performance have updated and substituted from AAMI SP10 to ISO 81060-2, all of the requirements in these three standards are intended for blood pressure monitor. Therefore, both of them met the requirements. The differences do not affect the safety and effectiveness.

### 8. Conclusion

The subject device AGE Automatic Wrist Blood Pressure Monitor has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

### 9. Summary Prepared Date

29 June 2015