CTU676 DEVICE

K073013 · Compression Technologies Unlimited, Inc. · JOW · Nov 21, 2007 · Cardiovascular

Device Facts

• Record ID: K073013
• Device Name: CTU676 DEVICE
• Applicant: Compression Technologies Unlimited, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The CTU676 is a prescriptive device that includes continuous enhanced circulation therapy of the lower limbs. The CTU676 is intended for use in the following: - Enhancing blood circulation - Reducing wound-healing time. - Preventing Deep Vein Thrombosis (DVT). - Diminishing post-operative pain and swelling - Treatment and assistance in healing: stasis dermatitis - Venous stasis ulcers; arterial and diabetic ulcers - Treatment of Chronic venous insufficiency - Reducing edema

Device Story

CTU676 is an air-inflatable compression system for lower limbs; consists of air pump, cycle control valve, and microprocessor-controlled circuit board. System uses disposable single-cell garments connected via PVC tubing. Microprocessor monitors pressure via feedback sensor; adjusts voltage to air pump to maintain preset 52 mmHg pressure. Cycle: sequential inflation/deflation over ~85 seconds; holds pressure for 3 seconds, releases for 1 minute. Operated by patient or staff via ON/OFF switch; includes visual/audible alarms for pressure, battery, and system failures. Used in clinical or home settings to enhance circulation, prevent DVT, and aid wound healing. Healthcare providers use output to manage venous/arterial conditions; patient benefits from improved circulation and reduced edema.

Clinical Evidence

Bench testing only. Non-clinical design verification and validation included mechanical performance evaluations and simulated use tests. Testing confirmed electrical and ultrasonic safety, electromagnetic compatibility, and component compatibility. Validation on healthy volunteers confirmed performance of the new cuff and software modifications.

Technological Characteristics

High-impact ABS plastic housing; NiMH rechargeable batteries. Sensing via pressure sensor feedback circuit. Actuation via air pump and cycle control valve. Dimensions: 6ft tubing. Connectivity: standalone. Software: microprocessor-based pressure control. Sterilization: not specified.

Indications for Use

Indicated for patients requiring enhanced lower limb circulation therapy to prevent DVT, reduce edema, manage post-operative pain/swelling, and assist in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, diabetic ulcers, and chronic venous insufficiency. Prescriptive use only.

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

• TravelAir™
• DVTcare™ CA5
• WizAir™

Submission Summary (Full Text)

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### Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

#### 1. Contact Person

Doug Hale Compression Technologies Unlimited Inc. Lansing, Mi. 48917 [e-mail] Order Line: 517-420-8204 Fax: [phone] NOV 2 ] 2007

#### 2. General Information Compression Technologies Unlimited Inc. Name: CTU676 Devices Trade Name: Classification Name: Compressible Limb Sleeve This device is classified by the Division of Cardiovascular Classification: Devices into Class II, (21 CFR 870.5800)

### 3. Device Description and Predicate Device Information

The CTU676 devices are used for different forms of compression therapy. The system is an air inflatable garment that is controlled by an electrical air pump. The air pump controls the garment so chambers inflate and deflate sequentially over a period of ~ 85 seconds. Patient or staff operated controls with visual and / or audible alarms for low pressure, high pressure, low battery, and system failures.

The controls use a power on/off switch on the side of the unit. On the front of the unit are fault indicators. The preset to 52 mmHg. The power on light will flash and stay illuminated when the unit is operating. The charging light will illuminate when batteries are charging.

### Principle of Operation

The CTU676 is designed to provide airflow to the garment for the purpose of controlling garment patient interface pressure. The CTU676 is provided with circuity to sense the pressure in the garment and maintain the selected level of CTU676 output, by increasing or decreasing the effective voltage applied to the air pump.

The CTU676 main components are an air pump, cycle control valve assembly and the pump controller circuit board, which also controls the alarm system.

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The output of the pump is sent through 1 or 2 PVC clear tubes that are connected to either 1209 calf garment or the 1205 full leg garment. The cycle control valve controls the airflow to both of the garments simultaneously until preset pressure is reached then holds for 3 seconds and releases for 1 minute.

### Component Description

#### Garment

The garment is composed of a single air cell. It is connected to the pump by a single tube that is integral to the garment. This terminates in a female connector, which attaches to a male connector on the right hand side of the pump, which allows air to flow to each of the garments. The garment sleeve is disposable and intended for use with one patient only. The garments are disposable and for single use only.

### CTU676 outer casing

The CTU676 outer case is made out of a high impact ABS plastic housing that contains a pump unit, microprocessor pressure control circuit board, an air control valve, and rechargeable NiMH batteries. Controls are kept to a minimum, comprising of an ON/OFF switch located on the right side of the unit. The output of the CTU676 is sent along a 6ft long tube to the garments. The heart of the system is the microprocessor controller circuit board. This automatically controls the voltage to the air pump thus allowing sufficient airflow to maintain the preset pressure using a pressure sensor feedback circuit. This circuit also contains Audible & Visual alarms.

#### 4. Intended Use

The CTU676 is a prescriptive device that includes continuous enhanced circulation therapy of the lower limbs. The CTU676 is intended for use in the following:

- . Enhancing blood circulation
- Reducing wound-healing time. �
- Preventing Deep Vein Thrombosis (DVT). .
- . Diminishing post-operative pain and swelling
- Treatment and assistance in healing: stasis dermatitis ●
- Venous stasis ulcers; arterial and diabetic ulcers .
- . Treatment of Chronic venous insufficiency

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- . Reducing edema
#### 5. Substantial Equivalence Comparison

The CTU Inc. devices are substantially equivalent to the following devices with respect to intended use, design, materials and construction:

- TravelAir™ .
- DVTcare™ CA5 .
- WizAir™ .

The CTU676 System is substantially equivalent in all aspects, e.g., technical characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available predicate devices. The CTU676 System includes an additional cuff for the Foot and Booster cuff for faster inflation of the cell. The pressure profile of the new cuff is similar to Wiz Air System; however, the additional cuff and software modification were verified through bench testing and validation that was performed on healthy volunteers. Testing results showed that the CTU676 performed according to its specifications in operated in a safe and effective manner.

### 6. Summary of Studies

The function and performance of the CTU676 Systems have been evaluated through non-clinical design verification and validation tests. Testing included mechanical performance evaluations and simulated use tests. The results of the CTU676 System performance evaluations demonstrate that the CTU676 System device design is well suited for its intended use.

CTU Inc. completed mechanical performance evaluations to verify that the CTU676 systems meet the defined design specifications and conform to the safety and performance of the product and to support the compatibility of the internal components. Test results support the electrical and ultrasonic safety, electromagnetic compatibility, and performance of the CTU676 for its intended use.

### 7. Conclusion (statement of equivalence)

The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the CTU676 Device.

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

NOV 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Compression Technologies Unlimited, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K073013

CTU676 Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 24, 2007 Received: October 25, 2007

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Mark Job

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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 Statement

Page 1 of 1

510(k) Number: Pending

Device Name: CTU676 devices

Indications for use:

The CTU676 is a prescriptive device that includes continuous enhanced circulation therapy of the lower limbs. The CTU676 is intended for use in the following:

- Enhancing blood circulation .
- Reducing wound-healing time.
- Preventing Deep Vein Thrombosis (DVT). �
- Diminishing post-operative pain and swelling .
- Treatment and assistance in healing: stasis dermatitis ◆
- . Venous stasis ulcers; arterial and diabetic ulcers
- Treatment of Chronic venous insufficiency .
- Reducing edema .

Prescription Use X (per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

| Concurrence of CORH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------|
| (Division Sign-Off) Division of Cardiovascular Devices | May 8, 2007 |
| 510(k) Number | k073013 |