SCD EXPRESS PORTABLE COMPRESSION SYSTEM

K040511 · Tyco Healthcare/Kendall · JOW · Jun 28, 2004 · Cardiovascular

Device Facts

• Record ID: K040511
• Device Name: SCD EXPRESS PORTABLE COMPRESSION SYSTEM
• Applicant: Tyco Healthcare/Kendall
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCD Express" system is designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

Device Story

SCD Express™ Portable Compression System (PCS) is an intermittent pneumatic compression device for DVT prophylaxis. System comprises a controller, tubing sets, and single-patient use garments (leg sleeves or foot cuffs). Controller applies sequential, gradient pressure to limbs; measures limb refill time to optimize compression intervals. Designed for hospital use; portable, battery-powered, compact, and quiet. Enables continuous prophylaxis throughout patient risk period. Supports mixed configurations (e.g., foot cuff on one limb, sleeve on other). Healthcare providers use system to enhance venous blood flow; output is mechanical compression. Benefits include reduced risk of DVT and pulmonary embolism, and management of edema, venous stasis, and extremity pain.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 and FDA memorandum G95-1.

Technological Characteristics

Intermittent pneumatic compression system. Components: controller, tubing, disposable leg sleeves (up to 3 bladders) or single-bladder foot garments. Energy source: battery/AC power. Features: sequential gradient compression, limb refill time measurement. Biocompatibility: meets ISO 10993-1 standards.

Indications for Use

Indicated for patients at risk of deep vein thrombosis and pulmonary embolism for circulation enhancement, acute/chronic edema, extremity pain incident to trauma or surgery, leg ulcers, and venous stasis/insufficiency. Used for leg and foot compression.

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

• SCD Response™ Compression System (K992079)
• Novamedix AVImpad (K953648)

Submission Summary (Full Text)

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# 510(k) Summary

# JUN 2 8 2004

# SCD Express™ Portable Compression System (PCS)

In accordance with section 513(1) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Tvco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: February 26, 2004

# Contact Person 1.

Bridget Gardner Manager, Regulatory Affairs (508)-261-6384

# 2. Name of Medical Device

| Classification Name: | Sleeve, Limb, Compressible |
|-----------------------|------------------------------------------------|
| Common or Usual Name: | Compressible Limb Sleeve Device |
| Trade Name: | SCD Express™ Portable Compression System (PCS) |

# 3. Identification of Legally Marketed Device

The proposed SCD Express" Controller and Foot Cuff are substantially equivalent in intended use, function and mode of operation to the currently marketed SCD Response™ Compression System (K992079) and Novamedix AVImpad (K953648).

# 4 . Device Description

The SCD Express™ Controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of Deep Vein Thrombosis (DVT). This new SCD Express™ system has the potential to provide uninterrupted DVT prophylaxis as it is used throughout the hospital, and it can be worn and used continuously by the patient during the entire period of risk.

The SCD Express" system has been designed to be more compact, quieter, lightweight, and offer battery power. Additional features also include the ability to provide sequential, gradient compression to each limb individually and the flexibility to provide compression to various sleeves consisting of up to three bladders each.

The SCD Express™ Controller will also have the potential to be used as a compression foot device. A new feature for an SCD-based system, the SCD Express™ Foot Cuff will provide DVT prophylaxis in situations that allow for a wrap only on the foot due to obstacles on the leg (e.g., surgery). In addition, the product has been designed to have the capability of providing high pressure, compression to a foot garment. In this configuration, the SCD Express™ system would still include the controller and a pair of tubing sets, but a pair of single patient use, single bladder disposable foot garments would be used in place of the aforementioned sleeves. The SCD Express " system will also allow for mixed configurations where a foot garment could be used on one limb while a sleeve was used on the other.

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# റ Device Intended Use

The SCD Express" system is designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

Indications for use:

- · Circulation Enhancement
- · Deep Vein Thrombosis Prophylaxis
- Edema Acute
- Edema Chronic
- · Extremity Pain Incident to Trauma or Surgery
- · Leg Ulcers
- · Venous Stasis / Venous Insufficiency

# 6. Product Comparison

The SCD Express™ Controller and the SCD Response™ Compression System (K992079) as well as the SCD Express™ PCS Foot Cuff to the Novamedix AVImpad (K953648) are substantially equivalent in intended use, function and mode of operation.

#### 7. Nonclinical Testing

Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract, wavy lines, resembling a stylized human form. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2004

Tyco Heathcare/Kendall c/o Ms. Bridget Gardner Manager, Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048

Re: K040511

Kendall SCD Express™ Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 26, 2004 Received: February 27, 2004

Dear Ms. Gardner:

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 for ass surver 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 r ou may, therefore, while 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 rr your de rice 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, I'DA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Bridget Gardner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Drivinsion that your device complies with other requirements of the Act that I DI Hab made a and regulations administered by other Federal agencies. You must or any I ederal station and 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 form in the qualis) 37800 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation on to begin marketing your device as described in your Section 510(k) This letter will and in yours of substantial equivalence of your device to a legally prematics notification "cresults 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 If you usee office of Compliance at [phone]. Additionally, for questions on the vromotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (2017) 971 1057. Theo, pressent 807.97) you may obtain. Other general information on your presponsibilities under the Act may be obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dvina D. Vochner

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): K040511

Device Name: Kendall SCD Express™ Compression System

Indications For Use:

The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.

The use of the SCD EXPRESS Compression System with Foot Cuffs is also indicated for: (a) circulation enhancement, (b) edema -- acute, (c) edema -- chronic, (d) extremity pain incident to trauma or surgery, (e) leg ulcers, and (f) venous stasis /venous insufficiency.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunia P. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K04051