AIRCAST VENAFLOW ELITE SYSTEM

K122499 · Djo, LLC · JOW · Oct 18, 2012 · Cardiovascular

Device Facts

• Record ID: K122499
• Device Name: AIRCAST VENAFLOW ELITE SYSTEM
• Applicant: Djo, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aircast VenaFlow Elite System is an intermittent pneumatic compression device that is intended to apply intermittent application of pressure to a patient's calf, thigh or foot for the purpose of assisting blood in the veins. The Aircast VenaFlow Elite System is a prescription device for use in a clinical setting or in the home.

Device Story

Intermittent pneumatic compression device; applies rapid inflation with graduated sequential compression to calf, thigh, or foot; accelerates venous velocity; enhances fibrinolysis. System includes controller and various cuff types; supports mains or battery operation. Two configurations: Clinical (full range of accessories) and Home (simplified instructions, limited to calf cuffs/tubing). Operated by clinicians or patients; used to assist venous blood flow. Output is mechanical compression; helps prevent DVT. Device provides therapeutic benefit through improved circulation.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including FMEA risk assessment for home use, Human Factors and Usability Study to validate home-use safety, and electrical safety/EMC testing per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Intermittent pneumatic compression system; includes controller and inflatable limb cuffs (calf, thigh, foot). Powered by mains or battery. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Configuration-specific accessories (tubing, cuffs).

Indications for Use

Indicated for prophylaxis of Deep Vein Thrombosis (DVT) in clinical or home settings.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Aircast VenaFlow Elite System (K091700)
• Kendall SCD™ 700 Sequential Compression Controller (K102737)

Submission Summary (Full Text)

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K122499

Traditional 510(k): New Device Aircast VenaFlow Elite System

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## 510(k) Summary

Aircast® VenaFlow® Elite System 510(k) Number K122499

Applicants Name:

· DJO, LLC 1430 Decision Street Vista, Ca 92081

August 15, 2012

Contact Person:

Lorri Trotter Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]

Aircast VenaFlow Elite System

Compressible Limb Sleeve Device

Date Prepared:

Trade Name:

Common/Usual Name:

Classification Name: Sleeve, Limb, Compressible (21 CFR 870.5800, Product Code JOW)

Predicate Device(s):

Device Description:

Aircast VenaFlow Elite System (K091700) Kendall SCD™ 700 Sequential Compression Controller (K102737)

The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis. The Aircast VenaFlow Elite System provides the user with an option of battery operation in addition to operation from the mains power. The Aircast VenaFlow Elite System is easy to use and provides the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.

The Aircast VenaFlow Elite System is available in two configurations. The CLINICAL configuration is for medical

OCT
18
2012

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Traditional 510(k): New Device Aircast VenaFlow Elite System

Image /page/1/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is a sphere with curved lines running across it. The text "DJO" is in a bold, sans-serif font, and the word "GLOBAL" is in a smaller font below it.

facilities and offers the full range of accessories including cuffs, varying tube lengths, optional battery and replacement kits. The HOME configuration is for home use and is provided with simplified patient instructions and offers a specific set of accessories limited to calf cuffs and tubing.

Intended Use: The Aircast VenaFlow Elite System is an intermittent pneumatic compression device that is intended to apply intermittent application of pressure to a patient's calf, thigh or foot for the purpose of assisting blood in the veins. The Aircast VenaFlow Elite System is a prescription device for use in a clinical setting or in the home.

Technological Characteristics: The modified device has the same technological characteristics as compared to predicate device Aircast VenaFlow Elite System (K091700)

Performance Data:

A Failure Modes and Effects Analysis (FMEA) was created to adequately assess the risks related to home use: Known and potential hazards for operation of the Aircast VenaFlow Elite System were evaluated for risk and the severity of the failure effects to the user and probability of occurrence were categorized.

A Human Factors and Usability Study was conducted to validate the usability of the Aircast VenaFlow Elite System in the home environment. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.

The modified device meets Electrical Safety testing according to IEC 60601-1 and Electromagnetic Compatibility according to IEC 60601-1-2.

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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 depiction of an eagle or bird-like figure with three wing-like strokes. 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

OCT 1 8 2012

DJO, LLC c/o Ms. Lorri Trotter 1430 Decision Street Vista CA 92081

Re: K122499

Trade/Device Name: Aircast Venaflow Elite System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: August 15, 2012 Received: August 16, 2012

## Dear Ms. Trotter:

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 - Ms. Lorri Trotter

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 vours.

Cuestillal

Bram D. Zuckerman, MD 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): K122499

Device Name: Aircast VenaFlow Elite System

Indications For Use:

Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.

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)

iM&Kllele

n Sign-Om Division of Cardiovascular Devices

KI 22,499 510(k) Number

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