KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

K102737 · Covidien, LLC · JOW · Oct 19, 2010 · Cardiovascular

Device Facts

• Record ID: K102737
• Device Name: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
• Applicant: Covidien, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 700 Series") is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

Device Story

Intermittent pneumatic compression device; delivers air via tubing to disposable leg sleeves or foot cuffs. Controller applies sequential, gradient pressure to limbs to increase venous blood flow. Operates by compressing limbs to enhance venous movement; measures limb refill time after compression cycle to determine timing of next cycle. Used in clinical settings for at-risk patients; operated by healthcare providers. Output is mechanical compression; assists in preventing DVT and PE; aids circulation and edema management.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electrical safety, electromagnetic compatibility, enclosure protection, and design verification/validation of controller features, compression cycle operation, alarms, and battery performance.

Technological Characteristics

Intermittent pneumatic compression controller. Materials comply with ISO 10993-1. Features include sequential gradient pressure delivery and automated limb refill time measurement. Electrical safety per IEC 60601-1/UL60601-1; EMC per IEC 60601-1-2/EN55011; enclosure protection per IEC 60529.

Indications for Use

Indicated for DVT and PE prophylaxis in at-risk patients. Leg sleeves indicated for DVT/PE prophylaxis. Foot cuffs indicated for circulation enhancement, DVT prophylaxis, acute/chronic edema, extremity pain from trauma/surgery, leg ulcers, and venous stasis/insufficiency.

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

• Kendall SCD Express™ Portable Compression System (PCS) (K040511)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien<br>15 Hampshire St<br>Mansfield, MA 02048 06856<br>Tel. No.: [phone] | K102737 |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | OCT 19 2010 |
| CONTACT PERSON: | Melody Bi<br>Sr. Specialist, Regulatory Affairs | |
| DATE PREPARED: | Sept 17, 2010 | |
| TRADE/PROPRIETARY NAME: Kendall SCD™ 700 Sequential Compression Controller | | |
| COMMON/USUAL NAME: | Compressible Limb Sleeve Device | |
| CLASSIFICATION NAME: | Sleeve, Limb, Compressible | |
| PREDICATE DEVICE(S): | Kendall SCD Express™ Portable Compression System (PCS)<br>(K040511) | |
| DEVICE DESCRIPTION: | The Kendall SCD™ 700 Sequential Compression controller is an<br>intermittent pneumatic compression device for applying sequential,<br>gradient pressure to a patient's limbs for the prevention of DVT and<br>PE. The controller delivers air though the tubing sets to the pair of<br>disposable garments (one for each limb). | |
| INTENDED USE: | The Kendall SCD 700 Sequential Compression Controller is designed<br>to apply intermittent pneumatic compression to increase venous blood<br>flow in at-risk patients in order to help prevent deep vein thrombosis<br>and pulmonary embolism. | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The proposed Kendall SCD 700 Controller is identical to the<br>predicate device in terms of its intended use and mode of function. The<br>device will now be offered with improved features and robustness | |
| MATERIALS: | All components of the SCDTM 700 Sequential Compression System are<br>comprised of materials which are in accordance with ISO Standard<br>10993-1. | |
| PERFORMANCE DATA: | Testing was performed on the proposed Kendall SCD 700 Controller to<br>compare it to the predicate device. Testing included Electric Safety<br>testing according to IEC 60601-1 and UL60601-1, Electromagnetic<br>Compatibility according to IEC 60601-1-2 and EN55011 and<br>Enclosure Protection testing according to IEC 60529. In addition<br>Design Verification and Validation testing was performed on General<br>Controller Features, Compression Cycle Operation, Controller Alarm<br>and Test Modes and Battery Operations. Results from the testing<br>demonstrate that the modified device is substantially equivalent to the<br>legally marketed predicate device. | |

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Covidien LLC c/o Melody Bi Ph.D. Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

OCT 1 9 2010

Re: K102737

> Kendall SCD™ 700 Sequential Compression Controller Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 17, 2010 Received: September 22, 2010

Dear Dr. Bi:

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.

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Page 2 - Melody Bi Ph.D.

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/CDRH/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 yours,

ram 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

# OCT 1 9 2010

K102137 510(k) Number (if known):

Kendall SCD™ 700 Sequential Compression Controller Device Name:

Indications For Use:

The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 700 Series") is designed to apply intermittent pneumatic compression 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 singlepatient 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 cycle has reached set pressure, 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 Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:

- Deep vein thrombosis and pulmonary embolism prophylaxis. .
The use of the Kendall SCD 700 Series Compression System with Foot Cuffs is indicated for:

- Circulation enhancement. .
- Deep vein thrombosis prophylaxis. .
- Edema Acute. .
- Edema Chronic. .
- Extremity pain incident to trauma or surgery. .
- . Leg Ulcers.
- Venous stasis / venous insufficiency.. .

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

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

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Concurrence of/CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

| Covidien 510(k) Premarket Notification | 6102737 |
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| Page 19 | ^TM Trademark |