COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)

K121001 · Novitas Medical, LLC · JOW · Apr 17, 2012 · Cardiovascular

Device Facts

• Record ID: K121001
• Device Name: COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
• Applicant: Novitas Medical, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions: The CMP-001 (Compression Plus) is intended for: - Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains. - Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions - Aids the blood flow back to the heart . - Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications The CMP-002 (DVTmax) is intended for: - Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema - Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains - Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions - Decrease the risk of deep venous thrombosis (DVT) . - Aids the blood flow back to the heart, . - Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

Device Story

Compression System (Models CMP-001, CMP-002) functions as intermittent, sequential pneumatic compression device; intended for home or hospital use by adults. Device applies pneumatic pressure to limbs to aid blood flow, reduce edema, treat vascular/lymphatic insufficiency, and reduce DVT risk (CMP-002). Features optional localized thermal therapy (hot/cold) for post-traumatic/surgical conditions. System aids healing of cutaneous ulcers and reduces compartmental pressures. Operation involves pneumatic inflation/deflation cycles; clinical benefit includes improved circulation and reduced swelling/anticoagulant dependency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intermittent, sequential pneumatic compression system; includes optional thermal therapy component. Designed for adult limb application. Class II device (21 CFR 870.5800).

Indications for Use

Indicated for adult patients requiring intermittent, sequential pneumatic compression for vascular or lymphatic insufficiency (e.g., CVI, lymphedema, venous stasis ulcers), edema reduction (post-op, burns, sprains), and DVT risk reduction (CMP-002). Includes optional localized thermal therapy.

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)

{0}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human figures arranged in a row, with their heads tilted upwards. The figures are connected by a flowing line that represents the department's mission to promote health and well-being.

#### Public Health Service

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

APR 1 7 2012

Novitas Medical, LLC c/o Mr. William J. Sammons Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K121001

Trade/Device Name: Compression System - Models CMP-001 and CMP-002 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW, ILO Dated: March 30, 2012 Received: April 2, 2012

Dear Mr. Sammons:

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

{1}------------------------------------------------

Page 2 - Mr. William J. Sammons

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 (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/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.

M.A. Hollebe

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Section 4

#### Indications for Use Statement

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

## Device Name: Compression System - Models: CMP-001 and CMP-002

Indications for Use: The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:

The CMP-001 (Compression Plus) is intended for:

- Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions
- Aids the blood flow back to the heart .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

The CMP-002 (DVTmax) is intended for:

- Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions
- Decrease the risk of deep venous thrombosis (DVT) .
- Aids the blood flow back to the heart, .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

{3}------------------------------------------------

K121øøi pg 2 of 2

The device is intended for home or hospital use and the target patient population is adults.

Prescription Use _ V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D C)

(21 CFR 801 Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Miller

(Division Sign-Off) Division of Cardiovascular Devices

K121001 510(k) Number_