Medline Hemo-Force DVT Compression Sleeve

K170415 · Medline Industries, Inc. · JOW · Sep 8, 2017 · Cardiovascular

Device Facts

• Record ID: K170415
• Device Name: Medline Hemo-Force DVT Compression Sleeve
• Applicant: Medline Industries, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medline Hemo-Force DVT compression sleeve is recommended for use in patients for whom external compression therapy is indicated to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Device Story

Medline Hemo-Force DVT Compression Sleeve is a pneumatic compression garment designed to increase venous blood flow. It functions as an accessory to a compatible DVT compression pump system. The sleeve is applied to the patient's limb; the pump inflates the sleeve chambers to provide external compression. This mechanical action promotes blood circulation, reducing the risk of deep vein thrombosis. Used in clinical or home settings under prescription. The device is a passive component; it does not contain internal electronics or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design and intended use characteristics.

Technological Characteristics

Pneumatic compression sleeve; consists of flexible fabric/bladder construction; connects to external pneumatic pump via tubing; non-sterile; no electronic components; no software.

Indications for Use

Indicated for patients requiring external compression therapy to increase venous blood flow for the prevention of deep vein thrombosis (DVT).

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.

Submission Summary (Full Text)

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Public Health Service

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

September 8, 2017

Medline Industries, Inc. Matt Clausen Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093

Re: K170415

Trade/Device Name: Medline Hemo-Force DVT Compression Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 4, 2017 Received: August 7, 2017

Dear Matt Clausen:

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 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 of medical device

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Nicole G. Ibrahim -S

for 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) K170415

Device Name

Medline Hemo-Force DVT Compression Sleeve

## Indications for Use (Describe)

The Medline Hemo-Force DVT compression sleeve is recommended for use in patients for whom external compression therapy is indicated to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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