TRIPLEPLAY PRO

K141360 · Wildcat Medical, Inc. · JOW · Jun 12, 2014 · Cardiovascular

Device Facts

• Record ID: K141360
• Device Name: TRIPLEPLAY PRO
• Applicant: Wildcat Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TriplePlay Pro (supplied with a pair of model TP-3333, TP-3636, or TP-3434 "cuffs") is indicated for being an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremeties (simulating muscle contractions). This device can be used to: - Aid in the prevention of DVT; . - Enhance blood circulation; . - Diminish post-operative pain and swelling; ● - Reduce wound healing time; ● - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower . limbs: - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .

Device Story

TriplePlay Pro is a portable, physician-prescribed compressible limb sleeve system. It utilizes pneumatic cuffs (models TP-3333, TP-3636, TP-3434) to apply external compression to extremities. By simulating muscle contractions, the device stimulates blood flow to prevent deep vein thrombosis (DVT), reduce edema, and promote healing of various leg ulcers and chronic venous insufficiency. The system is intended for use in clinical or home settings to manage circulation and post-operative recovery. Healthcare providers prescribe the device to improve patient outcomes through mechanical stimulation of venous return.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable compressible limb sleeve system (Class II, 21 CFR 870.5800). Includes pneumatic cuffs (TP-3333, TP-3636, TP-3434). Operates via mechanical compression to stimulate blood flow.

Indications for Use

Indicated for patients requiring DVT prophylaxis, enhanced blood circulation, reduction of post-operative pain/swelling, wound healing, or treatment of venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema. Also indicated for prophylaxis in individuals expecting prolonged stationary periods.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Image /page/0/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

June 12, 2014

Wildcat Medical. Inc. Mike Bartlett Director Of Product Developement 1638 S. Main Street Tulsa, Oklahoma 74119

Re: K141360

> Trade/Device Name: Tripleplay pro Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve.Limb.Compressible Regulatory Class: Class II Product Code: JOW Dated: May 19, 2014 Received: May 28, 2014

Dear Mike Bartlett,

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

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Page 2 - Mike Bartlett

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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/ReportalProblem/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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

MAFDA

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 STATEMENT

## K141360 510(k) Number (if known):

Device Name: TriplePlay Pro

## Indications_for Use:

TriplePlay Pro (supplied with a pair of model TP-3333, TP-3636, or TP-3434 "cuffs") is indicated for being an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremeties (simulating muscle contractions). This device can be used to:

- Aid in the prevention of DVT; .
- Enhance blood circulation; .
- Diminish post-operative pain and swelling; ●
- Reduce wound healing time; ●
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower . limbs:
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .

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 CDRH, Office of Device Evaluation (ODE)

MADA

Special 510(k) Submission Model TPVT-01P Compressible Limb Sleeve Device Wildcat Medical, Inc.

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