DISPOSABLE BLOOD PRESSURE CUFF

K102823 · Wuxi Medical Instrument Factory · DXQ · Jan 7, 2011 · Cardiovascular

Device Facts

• Record ID: K102823
• Device Name: DISPOSABLE BLOOD PRESSURE CUFF
• Applicant: Wuxi Medical Instrument Factory
• Product Code: DXQ · Cardiovascular
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.

Device Story

Disposable blood pressure cuff; wraps around patient upper arm; interfaces with non-invasive blood pressure monitoring device. Used in clinical or home settings to facilitate blood pressure measurement. Provides mechanical interface for pressure transmission; enables non-invasive monitoring of patient hemodynamic status. Intended for neonate, pediatric, and adult populations.

Clinical Evidence

Bench testing only. Performance evaluated per AAMI SP10:2002+A1:2003+A2:2006 standards. Biocompatibility evaluated per ISO 10993 series.

Technological Characteristics

Disposable blood pressure cuff. Biocompatibility per ISO 10993. Performance testing per AAMI SP10:2002+A1:2003+A2:2006. Mechanical device; no energy source or software.

Indications for Use

Indicated for neonate, pediatric, and adult patients for use with non-invasive blood pressure monitoring devices to determine blood pressure parameters.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• Disposable Blood Pressure Cuff (K102823)

Submission Summary (Full Text)

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Premarket Notification Traditional Section 510(k) Submission . The device was tested per ISO 10993 series standards to evaluate its biocompatibility Testing Summary and AAMI SP10:2002+A1:2003+A2:2006 to evaluate its perfromance The proposed devices, Disposable blood Pressure Cuff, are claimed to be SE Conclusion Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Wuxi Medical Instruments Factory c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA

JAN - 7 2011

Re: K102823

Trade/Device Name: Disposable Blood Pressure Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: September 28, 2010 Received: September 29, 2010

Dear Ms. 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.

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 - Ms. Diana Hong

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

S 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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## Premarket Notification Traditional Section 510(k) Submission

Attachment I Indication for Use Statement

510(k) Number: K102823 Device Name: Disposable blood Pressure Cuff

- 7 2011 JAN

Indications for Use:

Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.

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)

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W.A. West.

in-Off) ardiovascular Devices

**510(k) Number** K102823