IM BAND

K113600 · Synexmed(Shenzhen)Company Limited · DXC · Feb 8, 2012 · Cardiovascular

Device Facts

• Record ID: K113600
• Device Name: IM BAND
• Applicant: Synexmed(Shenzhen)Company Limited
• Product Code: DXC · Cardiovascular
• Decision Date: Feb 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IM Band TM Adjustable Arterial Compression Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Device Story

IM Band is an adjustable arterial compression band; used to assist hemostasis of radial artery post-transradial procedure. Device features an inflatable balloon; transparent material allows visual monitoring of hemostasis site. Clinician adjusts band or turncap to apply pressure to puncture site; balloon conforms to skin surface. Soft, adjustable wrist band design enhances patient comfort. Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Performance testing demonstrated safety and effectiveness.

Technological Characteristics

Adjustable arterial compression band; inflatable balloon mechanism; transparent balloon material; adjustable wrist strap; manual turncap pressure adjustment.

Indications for Use

Indicated for patients requiring hemostasis of the radial artery following a transradial procedure.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• TR Band (K070423)

Submission Summary (Full Text)

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K11 3600

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### 510 (k) summary

FEB - 8 2012

#### 5. 1 Submitter

Synexmed (Shenzhen) company limited B-11/F,ZTY Building, Taohua Road, Futian Free Trade Zone Shenzhen, 518038, China Tel: [phone] Establishment Registration Number: 3008388400

Official contact: Mr. Yongwei Chien, CEO Tel: [phone] ext 808 Fax: [phone] E-mail: [e-mail]

#### 5.2 Device

| Trade name: | IM Band |
|----------------------|-------------------------|
| Classification Name: | Clamp, vascular |
| Classification: | Class II |
| Common Name: | Artery Compression Band |
| Regulation Number: | 870.4450 |

#### 5.3 Predicate Device

The predicate devices used to determine substantial equivalence for the TR Band by the Terumo Medical Corporation (#K070423)

#### 5.4 Device Description

The IM Band TM Adjustable Arterial Compression Band is intended to be used to oppress the vascular puncture in order to stop the bleeding by the inflation of a balloon. Transparent balloon material allows clear monitoring of the hemostasis time. Oppressing inside the balloon can be adapt to the skin surface for better contact. Bleeding can be stopped by simply adjusting the band or turncap according to doctor's instruction. Soft and adjustable wrist band enhances patient comfort.

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Kii 3600

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### 5.5 Intended Use

The IM Band TM Adjustable Arterial Compression Band is a compression device to assist hemostasis of the radial artery after a transradial procedure..

## 5.6 Comparison of Characteristics

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, and sterilization are identical or substantially equivalent to the currently marketed predicate devices.

### 5.7 Performance Data

The results of the performance testing demonstrated the safety and effectiveness of the IM Band TM Adjustable Arterial Compression Band

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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 or bird symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Synexmed (Shenzhen Company, Ltd. % Mr. Yongwei Chien, CEO B-11/F, ZTY Building Taohua Road, Futian Free Trade Zone Shenzhen, 518038, China

FEB - 8 2012

Re: K113600

Trade/Device Name: IM Band™ Adjustable Arterial Compression Band Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: November 30, 2011 Received: December 05, 2011

Dear Mr. Chien:

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

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Page 2 - Mr. Yongwei Chien, CEO

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,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K113600

Device Name:_IM Band ™

Indications For Use:

The IM Band ™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Prescription Use × (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use (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)

Neil REDsle formkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 113600