The Kendall SCDTM 700 Sequential Compression System (hereby referenced as "Kendall SCDTM 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 Kendall SCDTM 700 Series is a prescription device for use in a clinical setting or in the home.

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 SCDTM 700 Series Compression System with Leg Sleeves is indicated for:

Deep vein thrombosis and pulmonary embolism prophylaxis. .
The use of the Kendall SCDTM 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 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).

AI/ML Overview

The Kendall SCD™ 700 Sequential Compression Controller is an intermittent pneumatic compression device intended for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for circulation enhancement, edema management, extremity pain, leg ulcers, and venous stasis/insufficiency when used with appropriate garments.

Here's an analysis of the acceptance criteria and study data:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Risks related to home user operation are adequately assessed and deemed acceptable.	A Use Failure Modes and Effects Analysis (UFMEA) was conducted to assess risks for home users. The output of the UFMEA identified the need for validation testing. A Human Factors and Usability Study was conducted, which substantiates the acceptability of the risks identified during the risk assessment activities. (Specific quantitative metrics for "acceptability" are not provided in this summary, but the study's conclusion indicates the criteria were met.)
Electrical safety in accordance with IEC 60601-1 and UL60601-1.	Electrical Safety testing was conducted according to IEC 60601-1 and UL60601-1. (The summary states it "were conducted," implying compliance, though no specific results like pass/fail are provided).
Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2.	Electromagnetic Compatibility testing was conducted according to IEC 60601-1-2. (The summary states it "were conducted," implying compliance, though no specific results like pass/fail are provided).
Device maintains similar technological characteristics and intended use as the predicate device (Kendall SCD™ 700 Sequential Compression Controller, K102737).	The modified device has the "same technological characteristics as compared to the predicate device." The intended use is also consistent with the predicate. (This is a qualitative acceptance criterion based on comparison to the predicate, and the submission asserts it is met).

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size for the Human Factors and Usability Study.
- Data Provenance: Not specified in the provided summary. The study validated usability "in the home environment," suggesting a prospective nature with real or simulated users.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the summary. The Human Factors and Usability Study likely involved participants representative of the intended user population (e.g., patients, caregivers), and observational/interview data, rather than expert-established ground truth in the medical diagnostic sense.
Adjudication Method for the Test Set:
- This information is not provided as the validation was a Human Factors and Usability Study addressing risk, not a diagnostic accuracy study requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not conducted as the device is a therapeutic compression device, not an imaging or diagnostic device requiring human reader interpretation in the context of AI. The performance data focuses on safety, usability, and technical standards.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this device is an active medical device that requires human interaction (application of garments, operation of controls). Its "performance" is tied to its mechanical function, safety, and usability, not an AI algorithm performing a standalone task. The studies performed (UFMEA, Human Factors, Electrical Safety, EMC) are all relevant to the device's integrated function and human interaction.
The Type of Ground Truth Used:
- For the Human Factors and Usability Study, the "ground truth" would be related to user performance, errors, task completion rates, and subjective feedback indicating safe and effective operation in a home environment. This is derived from observed user interaction and qualitative/quantitative data collected during the study, rather than a clinical ground truth like pathology for diagnosis.
- For Electrical Safety and EMC testing, "ground truth" is adherence to the specified international standards (IEC 60601-1, UL 60601-1, IEC 60601-1-2).
The Sample Size for the Training Set:
- This device is not an AI/ML device that requires a "training set." The development process would have involved engineering design, iterative testing, and risk analysis, not a data-driven training of an algorithm.
How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K120944

510(k) Summary of Safety and Effectiveness

MAY 3 1 2012

SUBMITTER:	Covidien15 Hampshire StMansfield, MA 02048Tel. No.: (508) 452-1659
CONTACT PERSON:	Jennifer SullivanSr. Regulatory Affairs Specialist
DATE PREPARED:	March 28, 2012
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 SCDTM 700 Sequential Compression Controller (K102737)
DEVICE DESCRIPTION:	The Kendall SCDTM 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 SCDTM 700 Sequential Compression System (herebyreferenced as "Kendall SCDTM 700 Series") is designed to applyintermittent pneumatic compression to increase venous blood flow inat-risk patients in order to help prevent deep vein thrombosis andpulmonary embolism. The Kendall SCDTM 700 Series is aprescription device for use in a clinical setting or in the home.
TECHNOLOGICALCHARACTERISTICS:	The modified device has the same technologicalcharacteristics as compared to the predicate device.
PERFORMANCE DATA:	A Use Failure Modes and Effects Analysis (UFMEA) was created toadequately assess the risks related to the home user. Known andpotential hazards for operation of the Kendall SCDTM 700 Seriessystem were evaluated for risk and the severity of the failure effectsto the patient and servicing personnel and probability of occurrencewere categorized. The output of the UFMEA identified the need toconduct validation testing.A Human Factors and Usability Study was conducted to validateusability of the Kendall SCDTM 700 Series system in the homeenvironment. The result of the Human Factors and Usability Studysubstantiates the acceptability of the risks identified during the riskassessment activities.In addition, Electrical Safety testing according to IEC 60601-1 andUL60601-1 and Electromagnetic Compatibility according to IEC60601-1-2 were conducted.

{1}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

MAY 3 1 2012

Covidien c/o Ms. Jennifer Sullivan Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfiled. MA 02048

Re: K120944

Trade/Device Name: Kendall SCD™ 700 Sequential Compression Controller Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW Dated: March 28, 2012 Received: March 29, 2012

Dear Ms. Sullivan:

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

{2}------------------------------------------------

Page 2 - Ms. Jennifer Sullivan

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.

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,

Bram D. Zuckerman, M.D.

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

Enclosure

{3}------------------------------------------------

Indications For Use

510(k) Number (if known):

Kendall SCD™ 700 Sequential Compression Controller Device Name:

K120944

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 Kendall SCD™ 700 Series is a prescription device for use in a clinical setting or in the home.

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
510(k) Number	K120944

Covidien 510(k) Premarket Notification

Page 16 TMTrademark

KI20944

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).