Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579

K170866 · Honsun (Nantong) Co., Ltd. · DXN · Feb 21, 2018 · Cardiovascular

Device Facts

• Record ID: K170866
• Device Name: Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
• Applicant: Honsun (Nantong) Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Scian Automatic Digital Blood Pressure Monitor LD-576, LD-579 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Device Story

Device is an automatic digital blood pressure monitor (models LD-575, LD-576, LD-579) for non-invasive measurement of systolic/diastolic blood pressure and pulse rate. Input: oscillometric pressure signals from an inflatable upper arm cuff. Operation: device inflates cuff, detects pressure oscillations during deflation, and calculates blood pressure/pulse rate. Output: digital display of systolic/diastolic pressure and pulse rate. Intended for over-the-counter use by adults in home or clinical settings. Provides objective measurements to assist users in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Battery-powered digital monitor with inflatable upper arm cuff. Microprocessor-based signal processing. Class II device (21 CFR 870.1130).

Indications for Use

Indicated for adult individuals for non-invasive measurement of systolic and diastolic blood pressure and pulse rate via 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

• Scian Automatic Digital Blood Pressure Monitor (K152636)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

February 21, 2018

Honsun (Nantong) Co., Ltd. Selina Qian QA Manager No. 8, Tongxing Road Nantong Economic &Technology Development Zone Nantong, 226009 CN

Re: K170866

Trade/Device Name: Scian Automatic Digital Blood Pressure Monitor, Model LD-575, LD-576 and LD-579 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 18, 2018 Received: January 22, 2018

Dear Selina Qian:

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

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Willhelm

for 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) K170866

Device Name

Scian Automatic Digital Blood Pressure Monitro, Model: LD-576, LD-575 & LD-579

Indications for Use (Describe)

The Scian Automatic Digital Blood Pressure Monitor LD-576, LD-579 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

| 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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