ELECTRONIC BLOOD PRESURE MONITOR

K102988 · Shenzhen Pango Electronic Co., Ltd. · DXN · Nov 9, 2010 · Cardiovascular

Device Facts

• Record ID: K102988
• Device Name: ELECTRONIC BLOOD PRESURE MONITOR
• Applicant: Shenzhen Pango Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

PG-800B 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 non-invasive blood pressure monitor; uses oscillometric technique via upper arm inflatable cuff. Inputs: pressure oscillations during cuff deflation. Processing: oscillometric signal analysis to determine systolic/diastolic pressure and pulse rate; includes WHO blood pressure classification indicator. Output: digital display of blood pressure and pulse rate; WHO classification bar. Used in home or clinical settings by patients or healthcare providers. Provides objective measurements to assist in monitoring cardiovascular health.

Clinical Evidence

Performance and clinical verification testing conducted per ANSI/AAMI SP10:2002+A1:2003+A2:2006. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; Biocompatibility per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Battery-powered; oscillometric sensing; upper arm cuff (22-32 cm circumference). Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ANSI/AAMI SP10 (performance), ISO 10993 (biocompatibility).

Indications for Use

Indicated for adult patients with arm circumference 22-32 cm for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique. Suitable for use in medical facilities or home settings.

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

• KD-595 Blood Pressure Monitor (K070828)

Submission Summary (Full Text)

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Premarket Notification
Traditional Sec. 510(k) Submission
PG-800B Electronic Blood Pressure Monitor
Sec. III 510(k) Summary

NOV - 9 2010

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Sec. III 510(k) Summary

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| This 510(k) Summary is prepared per the request of 21 CFR 807.92. The Assigned 510(k) Number is: | |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date | 20 JUL 2010 |
| Sponsor | Shenzhen Pango Electronic Co., Ltd |
| | No.25, 1st Industrial Park, Fenghuang Road, Xikeng Village, Henggang Town, |
| | Longgang District, Shenzhen, Guangdong, 518115, China |
| | Contact Person: Ms. Xiaoyun Yang, Vice General Manager |
| | T: [phone] F: [phone] E: [e-mail] |
| Submission | MS. Diana Hong / MR. Lee Fu |
| Correspondent | Shanghai Mid-Link Consulting Co., Ltd |
| | P.O.BOX 237-023, Shanghai, 200237, China |
| Proposed Device | Electronic Blood Pressure Monitor, PG-800B |
| Classification | System, Measurement, Blood-pressure, Non-invasive DXN 21 CFR 870.1130 Class II |
| Intended Use | PG-800B 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 Description | The proposed device, PG-800B Electronic Blood Pressure Monitor, is a battery driven automatic |
| | non-invasive blood pressure monitor. It 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. The device has the data storage function. It has an 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. |
| Testing | Electric Safety per IEC 60601-1:1988+A1:1991+A2:1995 / EMC per IEC 60601-1-2:2001+A1:2004 |
| | Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006 |
| | Biocompatibility per ISO 10993-5:2006 / ISO 10993-10:2002+AMD:2006 |
| Predicate Device | KD-595 Blood Pressure Monitor as cleared in K070828. |
| SE Conclusion | The proposed device, PG-800A Electronic Blood Pressure Monitor, measures the blood pressure via |
| | same principle, oscillometric, at the same site, upper arm, as the predicate device, Both of |
| | them are driven by batteries. The proposed device, PG-800B Electronic Blood Pressure Monitor, is |
| | claimed to be Substantially Equivalent (SE) to the predicate device, KD595 Blood Pressure Monitor as |
| | cleared in K070828, in aspect of safety and effectiveness. |

Shenzhen Pango Electronic Co., Ltd
Report SN: SHA01420100715-02

III-I

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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

Shenzhen Pango Electronic Co., Ltd. c/o Mr. Ned Devine Third Party reviewer Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, IL 60062

NOV - 9 2010

Re: K102988

Trade/Device Name: Electronic Blood Pressure Monitor, PG-800B Regulation Number: 21 CFR 870.1130 Regulation Name: Non invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 22, 2010 Received: October 28, 2010

Dear Mr. Devine:

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.

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.

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Page 2 - Ned Devine

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Dime R.V. Ines

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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## 1610

## PANGAO®

Premarket Notification Traditional Sec. 510(k) Submission PG-800B Electronic Blood Pressure Monitor Sec. II Indication for Use Statement

Indication for Use Statement Sec. II

510(k) Number: K102988 Device Name: PG-800B Electronic Blood Pressure Monitor

2010

Indications for Use:

PG-800B 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Duma b. V. Limes

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(novascular Devices

510(k) Number K10 2

Shenzhen Pango Electronic Co., Ltd Report SN: SHA01420100715-02

II-1