510(k) Summary of Safety and Effectiveness

SUBMITTER: Covidien
15 Hampshire St O 7
Mansfield, MA 02048 06856 OC 1 9 2010
Tel. No.: (508) 261-6325

CONTACT PERSON: Melody Bi

Sr. Specialist, Regulatory Affairs

DATE PREPARED: Sept 17, 201 0

TRADE/PROPRIETARY NAME: Kendall SCDTM 700 Sequential Compression Controller

COMMON/USUAL NAME: Compressible Limb Sleeve Device

CLASSIFICATION NAME: Sleeve, Limb, Compressible

PREDICATE DEVICE(S): Kendall SCD Express TM Portable Compression System (PCS)

(K04051 1)
DEVICE DESCRIPTION: The Kendall SCDTM 700 Sequential Compression controller is an
intermittent pneumatic compression device for applying sequential,
gradient pressure to a patient's limbs for the prevention of DVT and
PE. The controller delivers air though the tubing sets to the pair of
disposable garments (one for each limb).

INTENDED USE: The Kendall SCD 700 Sequential Compression Controller 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.

TECHNOLOGICAL The proposed Kendall SCD 700 Controller is identical to the

CHARACTERISTICS: predicate device in terms of its intended use and mode of fuinction. Thle
device will now be offered with improved features and robustness

MATERIALS: All components of the SCDTm 700 Sequential Compression System are
comprised of materials which are in accordance with ISO Standard
10993-I.

PERFORMANCE DATA: Testing was performed on the proposed Kendall SCD 700 Controller to
compare it to the predicate device. Testing included Electric Safety
testing according to IEC 60601-1 and UL60601-1, Electromagnetic
Compatibility according to IEC 60601-1-2 and EN55011I and
Enclosure Protection testing according to IEC 60529. In addition
Design Verification and Validation testing was performed on General
Controller Features, Compression Cycle Operation, Controller Alarm
and Test Modes and Battery Operations. Results from the testing
demonstrate that the modified device is substantially equivalent to the
legally marketed predicate device.
 4
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

~~~~~~~~~~~~~~~~~~~~~~~~~~Food
and Drug Admninistration
10903 New l-Jarmpshite Avenuec
Documient Control Rtoomn -W066-G609
silver Spring, 101 20993-0002

Covidien LLC
d/o Melody Bi Ph.D. OCT .19 2010
Senior Regulatory Affairs Specialist
15 Hampshire Street
Mansfield, MA 02048

Re: K.102737
Kendall SCDTm 700 Sequential Compression Controller
Regulation Number: 21 CFR 870.5800
Regulation Name: Compressible Limb Sleeve
Regulatory Class: Class 1I (two)
Product Code: JOW
Dated: September 17, 2010
Received: September 22, 2010

Dear Dr. Bi:

We have reviewed your Section 5 10(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 LI (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 Fede~ral Regis~ter.
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.fdai.Rov/AbouiFDA/CentersOffices/CDRH/CDRHOffices/uicmi I15809.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.g4ov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI-' 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
(800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/defaul1t.htmi.

Si cerel urs,

rmD. ckrman, M.D.

Director
Division Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 Kendall SCD"" 700 Sequential Compression System

Indications For Use

OCT 192010
5 10(k) Number (if known): K, ~ 37
Device Name: Kendall SCDIm 100 Sequential Compression Controller

Indications For Use:

The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SC!) 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 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
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.

Trhe 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 (or:
* 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 AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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