VENODYNE V810

K110358 · Microtek Medical, Inc. · JOW · May 5, 2011 · Cardiovascular

Device Facts

• Record ID: K110358
• Device Name: VENODYNE V810
• Applicant: Microtek Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: May 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venodyne DVT Advantage 810 venous compression system is an instrument designed to reduce the incidence of venous thromboembolism by preventing the lower limbs or feet aiding the blood flow back toward the heart to help prevent DVT (Deep Vein Thrombosis) in Patients at risk.

Device Story

The Venodyne DVT Advantage 810 is a microprocessor-controlled pneumatic pump system. It connects to single-chamber leg or foot garments. The device operates by intermittently inflating and deflating these garments to a preset pressure, compressing the limb or foot to assist venous blood return toward the heart. It is intended for use in clinical settings to reduce the incidence of venous thromboembolism in at-risk patients. Healthcare providers operate the system, which manages compression cycles and includes alarm modes and battery operation. The device provides mechanical prophylaxis against DVT.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing confirmed performance of controller features, compression cycle operation, alarm modes, and battery operations. Electrical safety and electromagnetic compatibility testing performed per UL 60601-1, CAN/CSA standards, EN 55011:2007, FCC part 18, and EN 60601-1-2:2007.

Technological Characteristics

Microprocessor-controlled pneumatic pump; single-chamber leg/foot garments. Standards: UL 60601-1, CAN/CSA C22.2 601 series, EN 55011:2007, FCC part 18, EN 60601-1-2:2007. Features include battery operation and alarm modes.

Indications for Use

Indicated for patients at risk of Deep Vein Thrombosis (DVT) to aid blood flow back toward the heart by compressing lower limbs or feet.

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

• SCD Express Portable Compression System, Tyco Healthcare/Kendall (K040511)
• Venodyne Model 610, Microtek Medical, Inc. (K001802)
• Venodyne DVT Advantage Plus 710, Microtek Medical, Inc. (K011318)

Submission Summary (Full Text)

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#### 510(k) Summary -- K110358

#### Submitter Information:

Microtek Medical, Inc. 602 Lehmberg Road Columbus, Mississippi 39702

| Contact person: | Amy Fowler |
|-------------------------|------------------------------------------------------------------|
| Contact address: | Ecolab Inc. EUC 9 370 Wabasha Street North St. Paul, MN 55102 |
| Contact e-mail address: | [e-mail] |
| Office telephone: | 651-293-2237 |
| Fax: | 651-225-3122 |

Date Prepared: April 14, 2011

### Device Name:

Proprietary name: Microtek Medical, Inc. Venodyne DVT Advantage, 810 Compression System

Common name: Compressible Limb Sleeve Pump

Classification name: Compressible Limb Sleeve Pump, 21 CFR 870.5800

#### Predicate Devices:

- K040511 SCD Express Portable Compression System, Tyco Healthcare/Kendall
- Venodyne Model 610, Microtek Medical, Inc. K001802

Venodyne DVT Advantage Plus 710, Microtek Medical, Inc. K011318

#### Description of Device:

The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower

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limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.

#### Intended Use:

The Venodyne DVT Advantage 810 venous compression system is an instrument designed to reduce the incidence of venous thromboembolism by preventing the lower limbs or feet aiding the blood flow back toward the heart to help prevent DVT (Deep Vein Thrombosis) in Patients at risk.

## Technological Characteristics:

Testing was performed on the proposed Venodyne DVT Advantage 810 compression system to confirm substantial equivalence to the predicate device(s). Testing included Electrical Safety testing according to UL 60601-1, CAN/CSAC22.2 601 .- M90, CAN/CSA C22.2 601.1S1-94, and CAN/CSA C22.2 601.1B-98, Radio Disturbance according to EN 55011:2007, Radio Noise Emissions according to FCC part 18 and Electromagnetic Compatibility according to EN 60601-1-2:2007. In addition Verification and Validation testing was performed on general controller features, compression cycle operation, alarm modes, and battery operations. Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

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

Microtek Medical, Inc. c/o Mr. Tom Bonner Vice President, Regulatory Affairs 602 Lehmberg Road Columbus, MS 39702

MAY - 5 2011

Re: K110358

Trade/Device Name: Venodyne V810 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: April 18, 2011 Received: April 20, 2011

Dear Mr. Bonner:

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.

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Page 2 - Mr. Tom Bonner

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/ResourcesforYou/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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# Indications for Use

510(k) Number (if known):

K110358

Device Name:

Venodyne DVT Advantage Model 810

Indications For Use:

The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Vein Thrombosis) in patients at risk.

X 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 &DRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off) Division of Cardio 510(k) Number

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