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.. .

Device Description

The Kendall SCD™ 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).

AI/ML Overview

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Outcome
Electric Safety	Compliance with IEC 60601-1 and UL60601-1	Testing performed according to specified standards.	Passed
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 and EN55011	Testing performed according to specified standards.	Passed
Enclosure Protection	Compliance with IEC 60529	Testing performed according to specified standards.	Passed
General Controller Features	Verification and Validation of features to match predicate device.	Design Verification and Validation testing performed.	Substantially Equivalent
Compression Cycle Operation	Verification and Validation of compression parameters and function to match predicate device.	Design Verification and Validation testing performed.	Substantially Equivalent
Controller Alarm and Test Modes	Verification and Validation of alarm and test mode functionality to match predicate device.	Design Verification and Validation testing performed.	Substantially Equivalent
Battery Operations	Verification and Validation of battery performance and functionality to match predicate device.	Design Verification and Validation testing performed.	Substantially Equivalent
Biocompatibility	All components comprised of materials in accordance with ISO Standard 10993-1.	Statement of compliance with ISO Standard 10993-1.	Compliant
Intended Use	Device's intended use matches predicate device: intermittent pneumatic compression for DVT and PE prevention.	Device is identical to predicate device in terms of intended use.	Identical
Mode of Function	Device's mode of function matches predicate device.	Device is identical to predicate device in terms of mode of function.	Identical

Note: The reported device performance indicates that the Kendall SCD™ 700 Controller met all specified criteria, demonstrating substantial equivalence to the predicate device (Kendall SCD Express™ Portable Compression System, K040511).

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size for the individual tests (Electric Safety, Electromagnetic Compatibility, Enclosure Protection, Design Verification and Validation testing). It only states that "Testing was performed" for each category.

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be prospective as they involved performance testing on the proposed Kendall SCD 700 Controller to compare it to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The 510(k) summary does not mention using experts to establish ground truth for the performance testing. The evaluation primarily relies on engineering and technical standards compliance (IEC, UL, EN, ISO) and functional verification against a predicate device.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method. Given the nature of the testing (compliance with standards and functional verification), adjudication by multiple external reviewers is typically not applicable in the same way it would be for a clinical trial evaluating diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this submission. The device is a physical medical device (sequential compression controller), not an AI-powered diagnostic tool.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a hardware system, not an algorithm. The "performance data" refers to the device's physical and functional attributes, not algorithmic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Kendall SCD™ 700 Sequential Compression Controller relies on:

Engineering and Safety Standards: Compliance with established international and national standards such as IEC 60601-1, UL60601-1, IEC 60601-1-2, EN55011, and IEC 60529.
Predicate Device Performance: The functional behavior (General Controller Features, Compression Cycle Operation, Controller Alarm and Test Modes, Battery Operations) of the legally marketed predicate device (Kendall SCD Express™ Portable Compression System, K040511) serves as the benchmark for substantial equivalence.
Biocompatibility Standards: Compliance with ISO Standard 10993-1 for materials.

No "expert consensus," "pathology," or "outcomes data" in a clinical diagnostic sense was used as ground truth for this device's engineering performance evaluation.

8. The Sample Size for the Training Set

This question is not applicable to the Kendall SCD™ 700 Sequential Compression Controller. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

Summary

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510(k) Summary of Safety and Effectiveness

SUBMITTER:	Covidien15 Hampshire StMansfield, MA 02048 06856Tel. No.: (508) 261-6325	K102737
		OCT 19 2010
CONTACT PERSON:	Melody BiSr. 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)(K040511)
DEVICE DESCRIPTION:	The Kendall SCD™ 700 Sequential Compression controller is anintermittent pneumatic compression device for applying sequential,gradient pressure to a patient's limbs for the prevention of DVT andPE. The controller delivers air though the tubing sets to the pair ofdisposable garments (one for each limb).
INTENDED USE:	The Kendall SCD 700 Sequential Compression Controller is designedto apply intermittent pneumatic compression to increase venous bloodflow in at-risk patients in order to help prevent deep vein thrombosisand pulmonary embolism.
TECHNOLOGICALCHARACTERISTICS:	The proposed Kendall SCD 700 Controller is identical to thepredicate device in terms of its intended use and mode of function. Thedevice will now be offered with improved features and robustness
MATERIALS:	All components of the SCDTM 700 Sequential Compression System arecomprised of materials which are in accordance with ISO Standard10993-1.
PERFORMANCE DATA:	Testing was performed on the proposed Kendall SCD 700 Controller tocompare it to the predicate device. Testing included Electric Safetytesting according to IEC 60601-1 and UL60601-1, ElectromagneticCompatibility according to IEC 60601-1-2 and EN55011 andEnclosure Protection testing according to IEC 60529. In additionDesign Verification and Validation testing was performed on GeneralController Features, Compression Cycle Operation, Controller Alarmand Test Modes and Battery Operations. Results from the testingdemonstrate that the modified device is substantially equivalent to thelegally 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 (800) 638-2041 or (301) 796-7100 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 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)

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

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

(Division Sign-Off)

Division of Cardiovascular Devices

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

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).