Electronic Blood Pressure Monitor

K170151 · Shenzhen Pango Electronic Co., Ltd. · DXN · Oct 13, 2017 · Cardiovascular

Device Facts

• Record ID: K170151
• Device Name: Electronic Blood Pressure Monitor
• Applicant: Shenzhen Pango Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Indications for Use

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm.

Device Story

Battery-powered automatic non-invasive blood pressure monitor; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate; input via inflatable arm cuff; processes signals via internal MCU; outputs measurements to LCD; includes data storage for review; features WHO blood pressure classification indicator; used in medical facilities or home settings by patients or clinicians; aids in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 80601-2-30, and ISO 81060-2:2013.

Technological Characteristics

Battery-powered; oscillometric sensing; ABS enclosure/keys; nylon cuff; MCU-based processing; non-sterile; software level of concern: moderate. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 80601-2-30, ISO 81060-2:2013.

Indications for Use

Indicated for adult patients requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique using an upper arm cuff.

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

• Electronic Blood Pressure Monitor (K131558)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 13, 2017

Shenzhen Pango Electronic Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K170151

Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 14, 2017 Received: September 15, 2017

Dear Ms. Diana Hong:

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 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

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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 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.

M.A. Wilhelm

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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## Indications for Use

510(k) Number (if known) K170151

Device Name Electronic Blood Pressure Monitor

#### Indications for Use (Describe)

The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm~42 cm.

Type of Use (Select one or both, as applicable)

| | For use in a HUD-held or FHA-held Single Family Residence |
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| <div> <input checked="true" type="checkbox"/> </div> | Loan Type Conversion of a HUD-held Single Family Mortgage |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K170151

- 1. Date of Preparation: 03/9/2017
- 2. Sponsor Identification

### Shenzhen Pango Electronic Co.,Ltd.

No.25, 1st Industrial Park, Fenghuang Road, Xikeng, Henggang, Longgang District Shenzhen, Guangdong, 518115, China.

Establishment Registration Number: 3006792041

Contact Person: Ms. Xiaoyun Yang Position: Vice General Manager Tel: [phone] Fax: [phone] Email:[e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

# Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### Identification of Proposed Device 4.

Trade Name: Electronic Blood Pressure Monitor; Common Name: Arm Blood Pressure Monitor; Models: PG-800B22, PG-800B26, PG-800B26, PG-800B31, PG-800B32, PG-800B33, PG-800B35. PG-800B36. PG-800B37. PG-800B42 and PG-800B43

Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: II Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Indications for Use:

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm.

#### Device Description:

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed electronic blood pressure monitor has 12 models, including PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B42 and PG-800B43. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

The proposed device is intended to be used in medical facilities or at home.

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The product is provided non-sterile, and not to be sterilized by the user prior to use.

- న్. Identification of Predicate Device
510(k) Number: K131558 Product Name: Electronic Blood Pressure Monitor Manufacturer: Shenzhen Pango Electronic Co., Ltd

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility

IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

- 7. Substantially Equivalent

| ITEM | Proposed Device, Electronic Blood Pressure<br>Monitor | Predicate Device, PG-800B series<br>Electronic Blood Pressure Monitor,<br>K131558 |
|----------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Product Code | DXN | DXN |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Class | II | II |
| Intended Use | The Electronic Blood Pressure Monitor is<br>intended to measure the systolic and diastolic | PG-800B Electronic Blood Pressure Monitor<br>is intended to measure the systolic and |

Table 1 Substantially Equivalent Comparison

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| | blood pressure as well as the pulse rate of adult<br>person via non-invasive oscillometric<br>technique in which an inflatable cuff is<br>wrapped around the upper arm. It can be used<br>at medical facilities or at home. The intended<br>arm circumference includes: 22 cm~32 cm and<br>32 cm~42 cm. | diastolic blood pressure as well as the pulse<br>rate of adult person via non-invasive<br>oscillometric technique in which an<br>inflatable cuff is wrapped around the arm. It<br>can be used at medical facilities or at home.<br>The intended arm circumference is 22-32<br>cm. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement Type | Upper arm | Upper arm |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse<br>Rate | Systolic Pressure, Diastolic Pressure, Pulse<br>Rate |
| Principle | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries |
| arm circumference | 22~32cm and 32~42cm | 22~32cm |
| Blood Pressure<br>Range | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Pulse Rate<br>Range | 40-199 bpm | 40-199 bpm |
| Patient Contact | Cuff – Nylon | Cuff – Nylon |
| Material | Enclosure – ABS<br>Key - ABS | Enclosure – ABS<br>Key – ABS |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Particular<br>Performance | Comply with IEC<br>80601-2-30:2009 and ISO 81060-2:2013 | ANSI/AAMI SP10 |
| Software Level<br>Concern | Moderate | Moderate |

The propoed device and its predicate devices have the identical indented use, components, principle and performance. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.

The proposed device, Electronic Blood Pressure Monitor PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B36, PG-800B36, PG-800B37, PG-800B42 and PG-800B43, is determined to be Substantially Equivalent (SE) to the predicate device, PG-800B series Electronic Blood Pressure Monitor, (K131558), in respect of safety and effectiveness.