AIR-BAND RADIAL COMPRESSION DEVICE

K122405 · Datascope Corp., Cardiac Assist Division · DXC · Nov 9, 2012 · Cardiovascular

Device Facts

• Record ID: K122405
• Device Name: AIR-BAND RADIAL COMPRESSION DEVICE
• Applicant: Datascope Corp., Cardiac Assist Division
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Device Story

AIR-BAND™ is a sterile, single-use, disposable radial compression device. It consists of a clear medical-grade polyurethane window and bulb, a clear medical-grade PVC flexible tube, and a pressure-sensitive, self-adhesive peel backing. The device is applied to the wrist over the transradial puncture site. A luer valve on the fill tube allows a clinician to connect a luer lock syringe to manually inflate or deflate the bulb with air. The bulb provides localized pressure to the artery to assist in achieving hemostasis. The clear window allows the clinician to visualize the puncture site during the compression process. The device is intended for use in a clinical setting following transradial procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility, pressure equivalence to the TR Band predicate, packaging performance, product stability (shelf life), and sterilization validation.

Technological Characteristics

Materials: medical-grade polyurethane (window/bulb), medical-grade PVC (tube). Form factor: wristband with adhesive backing. Operation: manual inflation/deflation via luer valve and syringe. Connectivity: none. Sterilization: not specified.

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)
• Safeguard® 24cm Pressure Assisted Dressing (K062569)

Submission Summary (Full Text)

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S10(K) Summary

100 million in the state

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and the comments of ,

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Datascope Corp. Premarket Notification Traditional 510(k) AIR-BAND™ Radial Compression Device

| Date: | August 6, 2012 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Datascope Corp.<br>15 Law Drive<br>Fairfield, NJ 07004<br> |
| Contact Person: | Carla S. Cerqueira<br>Regulatory Affairs Specialist II<br>Datascope Corp.<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade name: | AIR-BAND™ Radial Compression Device |
| Common/Usual Name: | Compression Device |
| Classification Name: | 21 CFR 870.4450 Vascular Clamp |
| Predicate Devices: | K070423 TR Band ™<br>K062569 Safeguard® 24cm Pressure Assisted Dressing |
| Device Description: | AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has a<br>clear medical grade polyurethane window and bulb that facilitates visualization of<br>the puncture site, a clear medical grade PVC flexible tube, and a pressure<br>sensitive, self-adhesive peel backing. A luer valve on the end of the fill tube<br>enables a luer lock syringe to be connected to inflate and deflate the bulb with air<br>to provide compression of the transradial puncture site. |
| Intended Use: | The AIR-BAND™ Radial is a compression device to assist hemostasis of the<br>radial artery after a transradial procedure. |
| Design Characteristics: | The AIR-BAND™ has the same intended use and configuration (wristband) as the<br>predicate device, TR Band™ (K070423). The materials used are equivalent and<br>the product design is similar to that of the predicate device Safeguard® 24cm<br>Pressure Assisted Dressing (K062569). The AIR-BAND™ is manually operated<br>(inflated/deflated) like both predicate devices. |
| Performance Data: | Bench top testing was used to demonstrate substantial performance equivalence<br>to the predicate devices. Performance Testing included: |
| | NOV 9 2012<br>• Biocompatibility Testing<br>• Pressure Equivalence to Predicate (TR Band)<br>• Packaging Performance<br>• Product Stability (Shelf Life)<br>• Product Sterilization |

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## Datascope Corp. Premarket Notification Traditional 510(k) AIR-BAND™ Radial Compression Device

·

Summary: The AIR-BAND™ submitted in this 510(k) has essentially the same intended use, design/ technological and performance characteristics as the predicate devices. The results of all testing demonstrate that the AIR-BAND™ Radial Compression Device is as safe, as effective, and performs as well as the predicate devices. .

## ' · ·

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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 features a stylized eagle or bird-like figure with three curved lines forming its body and wings. 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

NOV 9 2012

Datascope Corp., Cardiac Assist Division % Ms. Carla Cerqueira 15 Law Dr. Fairfield, NJ 07004-0011

Re: K122405

Trade/Device Name: Air-band radial compression device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: October 5, 2012 Received: October 9, 2012

Dear Ms. Cerqueira:

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.

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

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Page 2 - Ms. Carla Cerqueira

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,

Matthew G.

Hillebrenner

Bram D. Zuckerman, M.D.

Digitally signed by Matthew G. Hillebrennem
DN:c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300213272,
cn=Matthew G. Hillebrenner
Date: 2012.11.08 16:15:12-05'00

Director

Division of Cardiovascular Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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## Indications For Use

K122405 510(k) Number (if known):

Device Name: AIR-BAND™ Radial Compression Device

Indications For Use:

The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Prescription Use __ X (Part 21 CFR 801 Subpart D) · AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gus Kleber

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number k122405