Electronic Blood Pressure Monitor

K161845 · Shenzhen Pango Electronic Co., Ltd. · DXN · Jul 31, 2017 · Cardiovascular

Device Facts

• Record ID: K161845
• Device Name: Electronic Blood Pressure Monitor
• Applicant: Shenzhen Pango Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 31, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adults (at least 22 years of age).

Device Story

Battery-powered automatic wrist blood pressure monitor; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Device consists of LCD, keys, cuff, MCU, pump, and transducer. Used in medical facilities or home settings by adults and transition adolescents. User wraps inflatable cuff around wrist; device automatically inflates and performs measurement. Output displayed on LCD; allows selection of mmHg or Kpa units. Data storage provided for two-patient mode. Healthcare providers use output for routine blood pressure monitoring; assists in clinical decision-making regarding hypertension management. Benefits include convenient, non-invasive, self-administered blood pressure tracking.

Clinical Evidence

Bench testing only. Compliance verified with IEC 60601-1 (safety), IEC 60601-1-11 (home healthcare), IEC 60601-1-2 (EMC), IEC 80601-2-30 (automated sphygmomanometers), and ISO 81060-2:2013 (clinical validation of automated measurement). Biocompatibility testing per ISO 10993 confirmed no cytotoxicity, irritation, or sensitization.

Technological Characteristics

Battery-powered, automatic oscillometric wrist monitor. Materials: Nylon cuff, ABS enclosure/keys. Components: LCD, MCU, pump, transducer. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 80601-2-30, ISO 81060-2, ISO 10993. Measurement range: 30-280 mmHg (BP), 40-199 bpm (pulse).

Indications for Use

Indicated for adults (at least 22 years old) and transition adolescents (18 to <22 years old) for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via wrist-worn oscillometric cuff. Intended for medical facilities or home use. Wrist circumference 13.5-19.5 cm. Contraindicated for adolescents aged 12 to <18 years.

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

• PG-800A Series Electronic Blood Pressure Monitor Models: PG-800A5, PG-800A5D (K131569)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human profile. The logo is black and white.

## 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

July 31, 2017

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

Re: K161845

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: July 3, 2017 Received: June 27, 2017

Dear 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

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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 (OS) 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,

M.A. Hilleman

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K161845

#### 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 wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).

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

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: K161845

- 1. Date of Preparation: 7/11/2017
- 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]

- 4. Identification of Proposed Device
Trade Name: Electronic Blood Pressure Monitor; Common Name: Wrist Blood Pressure Monitor; PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, Models: PG-800A36 and PG-800A37

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Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

#### Intended Use Statement:

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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.

The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adults (at least 22 years of age).

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 wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or Kpa.

The proposed electronic blood pressure monitor has eight models, including PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A36 and PG-800A37. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance.

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

#### Identification of Predicate Device 5.

510(k) Number: K131569 Product Name: PG-800A Series Electronic Blood Pressure Monitor Models: PG-800A5, PG-800A5D Manufacturer: Shenzhen Pango Electronic Co., Ltd

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#### Non-Clinical Test Conclusion 6.

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+ A1:2002, 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 non-invasive sphygmomanometers

ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.

| Table 1 Substantially Equivalent Comparison | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | Proposed Device | Predicate Device<br>K131569 |
| Models | PG-800A25, PG-800A27, PG-800A31,<br>PG-800A32, PG-800A33, PG-800A35,<br>PG-800A36 and PG-800A37 | PG-800A5, PG-800A5D |
| Product Code | DXN | DXN |
| Class | II | II |
| Intended Use | The Electronic Blood Pressure Monitor is<br>intended to measure the systolic and<br>diastolic blood pressure as well as the<br>pulse rate of adult person via non-invasive<br>oscillometric technique in which an<br>inflatable cuff is wrapped around the<br>wrist. It can be used at medical facilities or<br>at home. The intended wrist circumference<br>is 13.5-19.5 cm.<br>The patient population does not include | The PG-800A Series Electronic Blood Pressure<br>Monitor is intended to measure diastolic, systolic blood<br>pressure as well as the pulse rate of adult person via<br>non-invasive technique in which an inflatable cuff is<br>wrapped around the wrist.<br>It can be used at medical facilities or at home.<br>The intended wrist circumference is 13.5cm-19.5cm. |
| adolescents aged 12 to <18 years of age.<br>The patient population includes transition<br>adolescent B (18 to < 22 years of age but<br>treated like adult) and adults (at least 22<br>years of age). | | |
| Measurement Type | Wrist | Wrist |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse Rate | Systolic Pressure, Diastolic Pressure, Pulse Rate |
| Principle | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump /Transducer/ Batteries | LCD / Key / Cuff / MCU / Pump /Transducer/ Batteries |
| Blood Pressure | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Range | | |
| Pulse Rate | 40-199 bpm | 40-199 bpm |
| Range | | |
| Intended wrist<br>circumference | 13.5cm~19.5cm | 13.5cm~19.5cm |
| Records Quantity | Double patients mode: 60/60 records | Single patient mode: 90 records for PG-800A5<br>Double patient mode: 60/60 records for PG-800A5D |
| | | |
| Operating condition | +5 °C~+40°C<br>30%RH~80%RH;<br>Atomospheric pressure | +5 °C~+40°C<br>30%RH~80%RH;<br>Atomospheric pressure |
| | | |
| | | |
| Storage condition | -20°C~+55°C;<br>10%RH~93%RH;<br>Atomospheric pressure | -20°C~+55°C;<br>10%RH~93%RH;<br>Atomospheric pressure |
| | | |
| | | |
| Patient Contact | Cuff – Nylon | Cuff – Nylon |
| Material | Enclosure - ABS<br>Key - ABS | Enclosure - ABS<br>Key - ABS |
| Bicompatibility | Comply with ISO10993 series standards<br>No cytotoxicity;<br>No irritation to skin;<br>No significant evidence of sensitization | Comply with ISO10993 series standards<br>No cytotoxicity:<br>No irritation to skin;<br>No significant evidence of sensitization |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2:2007 | Comply with IEC 60601-1-2:2007 |
| Particular<br>Performance | Comply with IEC<br>80601-2-30:2009 and ISO 81060-2:2013 | ANSI/AAMI SP10 |

#### Substantially Equivalent 7.

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# Product Comparison Summary

The propoed device and its predicate devices have the similar indented use, mechanism of action, principle of operation, algorithm and cuff. The proposed devices are different than the predicate device in that the proposed device integrates the Key function of both PG-800A5 and PG-800A5D, same Record quantity as that of PG-800A5D, different Product appareance, modified product label

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and software which is modified to applicable to the proposed devices; addtitionally the proposed device details the patient populations. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.

- 8. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.