UNIMED BLOOD PRESSURE CUFF

K112544 · Unimed Medical Supplies, Inc. · DXQ · Nov 22, 2011 · Cardiovascular

Device Facts

• Record ID: K112544
• Device Name: UNIMED BLOOD PRESSURE CUFF
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Nov 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Unimed Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Story

Device consists of inelastic sleeve with integrated inflatable bladder, tubing, and hook-and-loop closure; wraps around patient limb. Connects to non-invasive blood pressure measurement system to facilitate indirect blood pressure monitoring. Used in clinical settings; operated by healthcare professionals. Cuff inflates to occlude artery and deflates to allow system to detect pressure oscillations. Output is pressure data processed by the connected measurement system to determine systolic/diastolic blood pressure. Benefits include non-invasive, reusable blood pressure monitoring across diverse patient sizes (neonatal to adult).

Clinical Evidence

Bench testing only. Device tested for performance per ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008) and biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. No clinical data presented.

Technological Characteristics

Materials: PU synthetic leather cuff, TPU film bladder, PVC tubing, molded nylon hook/loop. Dimensions: Neonatal to adult thigh sizes (6-66cm). Connectivity: Pneumatic connection to non-invasive blood pressure monitor. Pressure limit: 0-300mmHg. Reusable; non-sterile. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for indirect blood pressure measurement in pediatric and adult patient populations when used with compatible non-invasive blood pressure measurement systems.

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

• Sensa-Cuff (K022482)

Submission Summary (Full Text)

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Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.unimed.cn

# Section 3

# 510(K) Summary

Summary prepared Date: April 2, 2011

### Submitter Information:

Unimed Medical supplies Inc.

No.37, Yanshan Road, Shekou, Shenzhen, China 518067

#### Contact Person:

Xinmei Tan, QA manager No.37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Email: [e-mail], [e-mail]

### Device Name

Trade Name: Unimed Blood Pressure Cuff Common Name: Non-invasive Blood pressure cuff Product Code/Classification: DXQ/21 CFR870.1120 Review Panel: Cardiovascular

## Predicate Device

Sensa-Cuff (K022482) GE Medical Systems Information Technologies

### Intended Use

The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive

Confidential

Unimed Blood Pressure Cuff - 510(k) Submission

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Image /page/1/Picture/0 description: The image is a logo for MedUni. The logo is in a rectangular shape with rounded corners. The text "Med" is on the top line, and the text "Uni" is on the bottom line. There is a horizontal line separating the two lines of text.

Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

# Device Description

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

| Features | Unimed Medical | GE Medical |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Indirect measurement of<br>blood pressure | Indirect measurement of<br>blood pressure |
| Patient Populations | Adults/Pediatrics | Adults/Pediatrics |
| Material | Cuff: PU Synthetic Leather<br>Bladder: Transparent<br>Polyurethane (TPU Film)<br>Tubing: PVC<br>Hook: Molded Nylon<br>Loop: Nylon | Cuff: Woven nylon<br>Film (bladder): Ethylene vinyl<br>acetate copolymer (EVA)<br>Tubing: PVC<br>Ribbon: Textured polyester<br>Hook: Molded Nylon<br>Loop: Nylon |
| Tube Configuration | One or two tube | One or two tube |
| Size<br>(Range in cm) | Conform to AHA bladder sizes<br>recommendations<br>Neonatal (6-11cm)<br>Infant (10-19cm) | Conform to AHA bladder sizes<br>recommendations<br>Infant (8-13cm)<br>Child (12-19cm) |

# Comparison to the Predicate Device

Confidential

UnImed Blood Pressure Cuff - 510(k) Submission

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Image /page/2/Picture/0 description: The image shows a logo with the text "Med Uni" in a bold, sans-serif font. The text is arranged in two lines, with "Med" on the top line and "Uni" on the bottom line. The logo is enclosed in a rounded rectangle with a thick black border. The background of the logo is white, while the text is black.

Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

| | Pediatric (18-26cm) | Small Adult (17-25) |
|--------------------|------------------------------|------------------------------|
| | Small Adult (20-28cm) | Adult (23-33cm) |
| | Adult (25-35cm) | Large Adult (31-40cm) |
| | Adult Long (25-35cm) | Thigh (38-50cm) |
| | Large Adult (33-47cm) | |
| | Large Adult Long (33-47cm) | |
| | Adult Thigh (46-66cm) | |
| Repeated inflation | 10,000 inflations | 10,000 inflations |
| | 3,000 hook and loop closures | 3,000 hook and loop closures |
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993 | Comply with ISO 10993 |
| | biocompatibility evaluation | biocompatibility evaluation |

The Unimed Blood Pressure Cuff has the same Intended Use, basic construction, and technology specification as the predicated devices are wrapped the patient's arm or leg and secured by a hook and loop fastener commonly called Velcro. Both devices are available in the same size and range and are intended for the same patient populations.

(1) Material: Although the patient materials for subject device and predicate device are not all the same, but they are all conformed to ISO 10993.

(2) Size: We extend the length of the cuffs in order to accommodate special groups, such as neonates and overweight subjects. Based on the performance testing in this submission, the slight difference on the range of these blood pressure cuffs does not raise any safety or effectiveness issue.

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Image /page/3/Picture/0 description: The image shows a logo with the words "Med Uni" stacked on top of each other. The logo is enclosed in a rounded rectangle with a thick black border. There is a horizontal line separating the two words. The text is in a bold, sans-serif font.

Medical Supplies Inc. Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

# Performance Summary

The Unimed Blood Pressure Cuff has been tested according to the following standards:

- � ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
- � ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing, 2003
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for � irritation and delayed-type hypersensitivity, 2002+A1:2006

# Conclusion

The subject device Unimed Blood Pressure Cuff has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject device is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all capital letters. There is a logo to the left of the text.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

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

Unimed Medical Supplies, Inc. c/o Mr. Clare He Underwriters Laboratories Inc. Electronic Building, Parage Electronic Industrial Park No. 8 Nanyun Er Road, Gangzhou 510663 CHINA

NOV 22 2011

Re: K112544

Trade/Device Name: Unimed Blood Pressure Cuffs: U1883S, U1883D, U1882S, U1882D, U1881S, U1881D, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, U1869S, U1869D, U1889S, U1889D, U1884S, and U1884D (18 models) Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXO Dated: November 4, 2011 Received: November 8, 2011

Dear Mr. He:

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 - Mr. Clare He

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

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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Image /page/6/Picture/0 description: The image is a logo for Med Uni. The logo is in a rounded rectangle shape. The words "Med" and "Uni" are stacked on top of each other in the center of the logo.

Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

#### Section 4 Indications for Use Statement

510(k) Number:

KII2544

Device Name: Unimed Blood Pressure Cuff

# Indications for Use

The Unimed Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR

/OR

Over-The-Counter Use _

(Part 21 CFR 801 Sub part D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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**510(k) Number** K112544

Confidential

Unimed Blood Pressure Cuff - 510(k) Submission

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