RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME

K121145 · Renu Medical, Inc. · JOW · Jun 12, 2012 · Cardiovascular

Device Facts

• Record ID: K121145
• Device Name: RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
• Applicant: Renu Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.

Device Story

ReNu Medical Reprocessed Aircast VenaFlow DVT garments are reprocessed versions of original Aircast VenaFlow compression sleeves. Used in home and institutional settings, these garments function as part of a compression system to prevent deep vein thrombosis and pulmonary embolism. The device consists of inflatable bladders within a sleeve; operation involves pneumatic inflation to provide compression. Reprocessing includes cleaning and functional verification to ensure the device remains substantially equivalent to the original. Healthcare providers or patients use the garments as prescribed. The device provides mechanical compression to the limb, aiding blood flow and reducing DVT risk.

Clinical Evidence

Bench testing only. Testing included 100% verification of bladder integrity via leak testing at 52mmHg and evaluation of Velcro adhesion at that pressure. No clinical data was required or provided.

Technological Characteristics

Compression sleeve with inflatable bladders. Materials, design, and mode of operation are identical to the original Aircast VenaFlow DVT garments. Energy source is pneumatic (external pump system). Reprocessed via validated cleaning and functional testing protocols. No software or electronic components integral to the garment itself.

Indications for Use

Indicated for patients in home and institutional settings for non-invasive prevention of deep vein thrombosis (DVT) and pulmonary embolism.

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

• VenaFlow System 30A Aircast VenaFlow DVT garments (K992454)
• ReNu Medical Reprocessed Compression Sleeves (K031159)

Submission Summary (Full Text)

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# Section 12: 510(k) Summary

JUN 1 2 2012

Submitters Name and Address:

ReNu Medical, Inc. 9800 Evergreen Way Everett, WA 98024 Phone: [phone] Fax: [phone]

FDA Registration Number: 3034520

Contact Person: L. Bruce Pierson Chief Operating Officer

Date Summary Prepared: 02/20/12

Trade or Proprietary Name(s): ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh and Foot DVT garments. (All Sizes)

Common Name: Sleeve, limb, compression

Product Code: JOW

Panel: Cardiovascular 870.5800

Classification: Class II

Equivalent Device(s)

510k# K992454, VenaFlow System 30A Aircast VenaFlow DVT garments. (All Sizes). 510k# K031159 ReNu Medical Reprocessed Compression Sleeves different manufactures, types and sizes.

Device Description: The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)

Indications for Use:

The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.

#### Technological characteristics of the ReNu Medical Reprocessed Aircast VenaFlow DVT garments:

The predicate devices and the ReNu Medical Aircast VenaFlow DVT garments are identical in intended use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance techniques and reprocessing methodology.

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K121145 Pg 2 of 2

#### Summary of Comparison Tests

Bench testing was conducted to ensure that reprocessing did not compromise the performance of the device in a manner that is substantially equivalent to that of the predicate devices.

Bench testing is conducted to demonstrate leak testing of bladders and Velcro adhesion. 100% verification of bladder integrity is performed on the reprocessed Aircast VenaFlow DVT garments by implementing the leak test where the bladders are pressurized to 52mmHg. In addition the Velcro is evaluated to determine Velcro adhesion intact at this pressure.

#### Biocompatibility

Reprocessing does not affect the biocompatibility of the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

JUN 1 2 2012

ReNu Medical, Inc. c/o Mr. Bruce Pierson 9800 Evergreen Way Everett, WA 98204

### Re: K121145

ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh, and Foot DVT. (All Sizes) Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 10, 2012 Received: April 16, 2012

Dear Mr. Pierson:

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). and Cosmeter for (110) was 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 may be subject to additions, 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. Bruce Pierson

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely vours.

cmg. Killam

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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## Section 4: Indications for Use

510(k) Number (if known):

Device Name: ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh and Foot DVT garments. (All Sizes)

Indications for Use:

The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (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)

(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K21145