PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6

K131558 · Shenzhen Pango Electronic Co., Ltd. · DXN · Aug 30, 2013 · Cardiovascular

Device Facts

• Record ID: K131558
• Device Name: PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
• Applicant: Shenzhen Pango Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 is 22-32 cm.

Device Story

Battery-powered automatic blood pressure monitor; uses oscillometric technique via inflatable upper arm cuff; measures systolic/diastolic blood pressure and pulse rate. Used in medical facilities or home settings by adults. Device automatically manages inflation and measurement cycles. User selects measurement units (mmHg or KPa). Output displayed for user to monitor blood pressure and pulse. Assists in routine health monitoring and clinical decision-making regarding cardiovascular status.

Clinical Evidence

Bench testing only. Device performance verified against AAMI SP10:2002/(R) 2008 & A1:2003 standards for electronic sphygmomanometers. Safety and electromagnetic compatibility verified per IEC 60601-1:2005 and IEC 60601-1-2:2007.

Technological Characteristics

Battery-powered (4x AA/LR6) electronic monitor. Oscillometric measurement principle. Upper arm cuff (49.5 cm x 14.9 cm). Intended for arm circumferences 22-32 cm. BP range 30-280 mmHg; pulse range 40-199 bpm. Accuracy ±3 mmHg. Software level of concern: Moderate.

Indications for Use

Indicated for adult patients for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm oscillometric 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, PG-800B (K102988)

Submission Summary (Full Text)

{0}------------------------------------------------

Additional Information I for K131558 - Exhibit #4 510(k) Summary

# Exhibit #4 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

- l. Date of Submission: December 20, 2012
- 2. Sponsor

Shenzhen Pango Electronic Co., Ltd No.25, 136 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. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- 4. Proposed Device Identification

Proposed Device Name: Electronic Blood Pressure Monitor; Proposed Device Model: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6D, PG-800B6-1, PG-800B6-2, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25

Classification Name: System, measurement, blood-pressure, non-invasive:

AUG 30 2013

{1}------------------------------------------------

### K131558

#### Additional Information I for K131558 - Exhibit #4 510(k) Summary

Common Name: Electronic Blood Pressure Monitor; Classification: 2 Product Code: DXN: Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular:

#### Intended Use Statement:

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 is 22-32 cm.

- 5. Predicate Device Identification
510(k) Number: K102988 Product Name: Electronic Blood Pressure Monitor, PG-800B Manufacturer: Shenzhen Pango Electironic Co., Ltd

- Device Description 6.
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

- 7. Non-Clinical Test Conclusion
Bench 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, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers.

E4-2

{2}------------------------------------------------

### 8. Substantially Equivalent

| Table III-1 Substantially Equivalent Comparison | | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| ITEM | Proposed Device<br>Electronic Blood Pressure Monitor | Electronic Blood Pressure<br>Monitor, PG-800B, K102988 |
| Product Code | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | Same |
| Class | II | Same |
| Intended Use | Electronic Blood Pressure Monitor is<br>intended to measure the systolic and<br>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 upper<br>arm. It can be used at medical facilities or at<br>home. The intended arm circumference is<br>22-32 cm. | Same |
| Measurement<br>Type | Arm | Same |
| Patient<br>Population | Adult | Same |
| Measurement<br>Item | SYS, DYS, Pulse Rate | Same |
| Principle | Oscillometric | Same |
| BP Range | 30 ~ 280 mmHg | Same |
| BP Accuracy | $\pm$ 3 mmHg | Same |
| PR Range | 40-199 bpm | Same |
| Cuff Size | 49.5 cm (length) x 14.9 cm (width) | Same |
| Power Supply | four AA or LR6 batteries | Same |
| Software Level<br>Concern | Moderate | Same |

Table III-1 Substantially Equivalent Comparison

The proposed device, Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor PG-800B (k102988), in respect of safety and effectiveness.

{3}------------------------------------------------

Public Health Service

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

August 30, 2013

Shenzhan Pango Electronic Co., Ltd. c/o Mr. Jeffrey D. Rongero, Senior Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive, Research Triangle Park, NC 27709

Re: K131558

> Trade/Device Names: Electrical Blood Pressure Monitor with 18 models: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6D, PG-800B6-1, PG-800B6-2, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 9, 2013 Received: August 15, 2013

Dear Mr. Rongero:

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

{4}------------------------------------------------

Page 2 - Mr. Jeffrey D. Rongero

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 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/Resourcesfor You/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-Paris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Exhibit #3 Indications for Use

510(k) Number:

Device Name: Electronic Blood Pressure Monitor Models: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B4, PG-800B4D, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6-1, PG-800B6-1, PG-800B9, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25

Indications for Use:

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 upper arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) ZOVER-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)

Digitally signed by
Owen P. Faris -S
Date: 2013.08.30
14:58:14 -04'00'

Page 1 of 1

E3-1