AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR

K123882 · Ageless Health Industrial · DXN · Aug 14, 2013 · Cardiovascular

Device Facts

• Record ID: K123882
• Device Name: AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
• Applicant: Ageless Health Industrial
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left arm according to the instruction in the user's guide manual.

Device Story

Battery-powered automatic non-invasive blood pressure monitor; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Input: pressure oscillations detected via inflatable upper arm cuff. Processing: automated inflation/deflation and signal analysis to derive blood pressure and pulse values. Output: digital display of measurements. Used in clinical or home settings by medical professionals or patients. Provides objective data for monitoring cardiovascular status; aids in clinical decision-making regarding hypertension management.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ANSI/AAMI SP10 (performance).

Technological Characteristics

Battery-powered (6Vdc, 4 AA batteries); oscillometric measurement principle; upper arm cuff (24-34 cm); digital display; memory storage (2x90 sets). Biocompatible materials per ISO 10993-5/10. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP10.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive oscillometric technique using an upper arm cuff (circumference 24-34 cm).

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

• Arm Automatic Blood Pressure Meter (K110281)

Submission Summary (Full Text)

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## K123882 Page 1 of 5

Sponsor: Ageless Health Industrial Ltd. AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-803, Subject Device: BA-805, BA-806, BA-811, BA-812, BA-813 File No.: 510(k) submission report (V1.0), Chapter 6

Chapter 6. 510(k) Summary

#### 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: Ageless Health Industrial 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] / [e-mail] Web: www.agelh.com

#### 2. Subject Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|------------------------------------------------|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| Classification Name: | Noninvasive blood pressure measurement system |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |

#### 3. Predicate Device Information

| Sponsor: | Fudakang Industrial Co., Ltd. |
|--------------|------------------------------------------------|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | Arm Automatic Blood Pressure Meter |

Report by Ageless Health Industrial Ltd.

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K123882 Page 2 of 5

| Sponsor: | Ageless Health Industrial Ltd. | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------|--|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 | |
| File No.: | 510(k) submission report (V1.0), Chapter 6 | |
| 510(k) number: | K110281 | |
| Review Panel: | Cardiovascular | |
| Product Code: | DXN | |
| Regulation Number: | 21 CFR 870.1130 | |
| Regulation Class: | 2 | |

#### 4. Device Description

AGE Automatic Upper Arm 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 arm within its claimed range and accuracy via the oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.

#### 5. Intended Use

AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left arm according to the instruction in the user's guide manual.

#### 6. Test Summary

AGE Automatic Upper Arm 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, 1988+A1:1991+A2:1995
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
- � 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
- . ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008

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K123882

Page 3 of 5

| Sponsor: | Ageless Health Industrial Ltd. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803<br>BA-805, BA-806, BA-811, BA-812, BA-813 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |

#### 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 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | Ageless Health Industrial Ltd. | Fudakang Industrial Co., Ltd. | -- |
| Product Name | AGE Automatic Upper Arm Blood<br>Pressure Monitor | Arm Automatic Blood Pressure<br>Meter | -- |
| | Intended Use and Indications for Use | | |
| Intended Use | AGE Automatic Upper Arm Blood<br>Pressure Monitor is intended for<br>use by medical professionals or at<br>home to monitor and display<br>diastolic, systolic blood pressure<br>and pulse rate on adult each time,<br>with the cuff around the left arm<br>according to the instruction in the<br>user's guide manual. | Fudakang Arm Automatic Blood<br>Pressure Meter is intended for use<br>by medical professionals or at<br>home to monitor and display<br>diastolic, systolic blood pressure<br>and pulse rate on adult each time.<br>with the cuff around the left upper<br>arm according to the instruction in<br>the user's guide manual. | SE |
| Indications for<br>Use | AGE Automatic Upper Arm 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 upper arm. The cuff<br>circumference is limited to 24~34<br>cm. | Fudakang Arm Automatic Blood<br>Pressure Meter 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 upper arm. The cuff<br>circumference is limited to 22cm-<br>30cm. | SE<br>Note 1 |
| ELECTRICAL REQUIREMENT | | | |
| Power Supply | 6Vdc (4 "AA" batteries) | 6Vdc (4 "AA" batteries) | SE |
| | PERFORMANCE SPECIFICATION | | |
| Measuring<br>Method | Oscillometry | Oscillometry | SE |
| Measuring<br>Range | Pressure: 0~280 mmHg<br>Pulse: 40~199 beats/minute | Pressure: 0~300 mmHg<br>Pulse: 30~180 beats/minute | Note 2 |
| Accuracy | Pressure: ±3 mmHg<br>Pulse: ±5% | Pressure: ±3mmHg<br>Pulse: ±5% | SE |
| Patient<br>Population | Adult | Adult | SE |

Report by Ageless Health Industrial Ltd.

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K123882 Page 4 of 5

| Sponsor: | Ageless Health Industrial Ltd. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------|
| Measurement<br>Site of Body | Arm | Arm | SE |
| Cuff<br>Circumference | 24-34 cm | 22~30 cm | SE<br>Note 1 |
| Inflation and<br>Deflation | Automatic | Automatic | SE |
| Memory Size | 2 x 90 sets record | 60 or 90 sets record | SE<br>Note 3 |
| OPERATING & STORAGE CONDITIONS | | | |
| Storage<br>Environment | Temperature: -20℃ ~ +65℃<br>Humidity: 10~95%RH | Temperature: -20℃ ~ +60 ℃<br>Humidity: < 95%RH | Note 3 |
| Working<br>Environment | Temperature: 5℃~ 40℃<br>Humidity: 10~90%RH | Temperature: 5℃ ~ 40℃<br>Humidity: < 90%RH | 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 | SE |
| 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 -5, -10. | SE |
| Performance | AAMI SP10 | AAMI SP10 | SE |

#### Note 1

Although there is little difference for measurement cuff circumference of subject device and predicate device, both of them are complied with AAM SP10. 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. 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.

Report by Ageless Health Industrial Ltd.

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K123882 Page 5 of 5

| Sponsor: | Ageless Health Industrial Ltd. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |

#### 8. Conclusion

The subject device AGE Automatic Upper Arm 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

31 March 2013

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine, with a staff and two snakes.

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

August 14, 2013

Ageless Health Industrial c/o Mr. Victor Wan 3F, A 1 bldg, Dongshen Sima Industrial Area No. 33 Shenbai Road Changping, Dongguan, Guangdong, China 523570

Re: K123882

Trade/Device Name: AGE Automatic Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 27, 2013 Received: August 2, 2013

Dear Mr. Victor Wan:

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

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Page 2 - Mr. Victor Wan

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Owen P. Faris -S

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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| Sponsor: | Ageless Health Industrial Ltd. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 |
| File No.: | 510(k) submission report (V1.0), Chapter 5 |

Chapter 5. Statement of Indications for Use

#### Indications for Use

510(k) Number (if known): Applying

Device Name: AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813

Indications for Use:

AGE Automatic Upper Arm 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 upper arm. The cuff circumference is limited to 24~34 cm.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number_

Digitally signed by
Owen P. Faris -S
Date: 2013.08.14
15:45:49-04'00'

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