The Kendall SCD Compression System is designed to increase venous blood flow in the at risk patient, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.

Device Description

The proposed devices, Sequential Compression Comfort Sleeves, are the compressible limb sleeve component of a pneumatic compression system for applying pressure to a patient's leg for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Sequential Compression Comfort Sleeves are compatible with the SCD Express Controller (K040511), SCD Response Controller (K992079) and SCD Sequel Controller (K942664), collectively referred to as SCD Controllers. SCD Controllers provide air to the sleeves through tubing connected to each bladder of the sleeve delivering an intermittent, sequentially gradient pneumatic pressure to the limb. The controller system monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system within the controllers.

The proposed single-patient-use, disposable sleeves are available in knee, thigh and thigh Tear-Away styles. The Tear-Away function allows the clinician to convert the patient from a thigh length sleeve to a knee length sleeve without changing to a new sleeve. TThe sleeve connects to a controller via a 3-lumen tubing set. The tubing set connects to the sleeve via a low-profile connector that can be disengaged to allow for patient ambulation without sleeve removal.

AI/ML Overview

The provided text describes the Kendall SCD Sequential Compression Comfort Sleeves (K100306), which are compressible limb sleeves designed to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria for AI performance.

Therefore, the requested information elements related to AI performance, ground truth, expert consensus, and sample sizes for training/test sets are not applicable or cannot be extracted from the provided text. The document describes a traditional medical device submission, not an AI/ML device submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "There are no FDA performance standards established and required for the proposed device." Instead, it refers to general standards and product verification/validation testing. The acceptance criteria for the sleeves themselves would revolve around their functional and material properties, rather than diagnostic accuracy metrics typically seen with AI.

Acceptance Criteria (Inferred from "Product Testing" and "Product Comparison")	Reported Device Performance
Biocompatibility: Materials are safe for patient contact.	Compliance with ISO 10993-1.
Packaging Integrity/Durability: Withstands shipping and handling.	Compliance with ISTA 2A (Preshipment Testing Procedures).
Functional Equivalence: Delivers intermittent, sequentially gradient pneumatic pressure effectively.	Demonstrated through product verification and validation testing, including hemodynamic testing on healthy human subjects, showing identical function and mode of operation to predicate devices.
Material Construction: Comfort, durability, and ability to form bladders.	Constructed of four layers (two PVC layers, polyester mesh, wickable polyester fabric) forming a "pillowcase" around bladders, with tubing welded inside, described as making the sleeves "more comfortable" than predicate devices.
Compatibility: Works with specified controllers.	Designed to be used with SCD Express Controller (K040511), SCD Response Controller (K992079), and SCD Sequel Controller (K942664).
Intended Use Equivalence: Prevents DVT and PE in at-risk patients.	Identical intended use to predicate devices and supported by extensive clinical literature on IPC devices.
Safety and Effectiveness: No major risks, acceptable risk/benefit ratio.	Extensive published clinical literature on IPC devices confirms safety and performance, with no major risks identified.

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

Test Set Sample Size: The document mentions "hemodynamic testing on healthy human subjects." However, the specific number of subjects is not provided.
Data Provenance: The hemodynamic testing was on "healthy human subjects." The country of origin is not specified. The submission primarily relies on a review of "published and unpublished clinical literature" regarding IPC devices, which would have diverse international provenance and be retrospective in nature for the published literature.

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

This is not applicable for this type of device submission. The "ground truth" for a pneumatic compression sleeve is its physical function and physiological effect (blood flow increase), not a diagnostic label requiring expert consensus. The "experts" involved would be engineers for functional testing and clinicians/researchers for physiological assessment, but their number and specific qualifications for establishing a "ground truth" in the AI sense are not detailed.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving multiple human readers for image or data interpretation. This submission concerns a physical medical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not an AI-powered device.

7. The Type of Ground Truth Used

For the device itself, the "ground truth" is its functional performance (e.g., pressure delivery, material integrity) as measured by engineering tests and its physiological effect (increased venous blood flow) as measured in hemodynamic studies. For the claim of DVT/PE prevention, the "ground truth" is established by the extensive body of clinical literature on IPC devices, demonstrating their effectiveness in preventing these outcomes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set for machine learning models.

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

Not applicable. See point 8.

Summary

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510(k) Summary

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

Kendall, a Division of Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048 Date Prepared: 29 January 2010

MAY - 4 2010

Contact Person 1.

Mia Proli Manager, Regulatory Affairs (508) 261-8037

2. Name of Medical Device

Classification Name: Sleeve, Limb, Compressible Kendall SCD™ Sequential Compression Comfort Sleeves Proprietary Name:

3. Identification of Legally Marketed Device

The proposed devices, Sequential Comfort Sleeves, are identical in intended use, function and mode of operation to the SCD Express System Sleeves (K040511); SCD Express Tear-Away Sleeves (K040649) and SCD Large/X-Large Knee and Thigh Sleeves (K051805).

4. Device Description

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K100306: Kendall SCD Sequential Compression Comfort Sleeves

ട. Device Intended Use

6. Product Comparison

The proposed devices, Sequential Comfort Sleeves, are identical in intended use, function and mode of operation to the SCD Express System Sleeves (K040511): SCD Express Tear-Away Sleeves (K040649) and SCD Large/X-Large Knee and Thigh Sleeves (K051805).

The predicate SCD Sleeves are constructed of two layers of non-woven polyester laminated to a thin film of PVC that are welded together to form bladders. Tubes are attached to the bladders via rigid PVC inlet ports which are welded to the laminate material. To make the sleeves more comfortable, the proposed Comfort Sleeves will be constructed of four layers; two lavers of non-laminated PVC welded together to form bladders with covers made from both a polyester mesh fabric and a wickable polyester fabric, which form a "pillowcase" around the bladders. In this design, the tubing will be welded into the bladders, beneath the sleeves, without the use of an inlet port.

7. Product Testing

There are no FDA performance standards established and required for the proposed device. However, the standards listed in the table below have been reviewed and applied in whole or in part as deemed appropriate during design, development, and manufacture of the proposed device:

StandardNumber	Standard Title	Version
ISO 10993-1	Biological Evaluation of Medical Devices Part 1: Evaluation andTesting	2003
ISTA 2A	ISTA Preshipment Testing Procedures - Combination Tests forPackaged Products	2008

Product verification and validation testing as detailed in this 510(k) submission was used to demonstrate equivalence of the proposed device. Such testing included basic functional and performance tests, along with hemodynamic testing on healthy human subjects.

Intermittent pneumatic compression systems (IPC), such as the Kendall SCD Compression System, have been used clinically by healthcare professionals for over twenty years. A review of published and unpublished clinical literature identifies no major risks associated with these devices. Extensive published clinical experience with these devices confirms an acceptable risk/benefit ratio and provides substantial clinical evidence to support the following conclusions:

1. Sufficient clinical literature and data exist to demonstrate the safety and performance of IPC devices.
1. The objectives of the clinical review were met by an analysis of all relevant aspects of safety and performance reported in scientific literature and no gaps of information are present.
1. All of the published reports examined for the clinical review are from recognized scientific, peer-reviewed journals and address the indications of the devices.

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K100306: Kendall SCD Sequential Compression Comfort Sleeves

The literature reveals little variation in the clinical indications for the use of the devices 4. under review.
1. The literature and the narrative review provide critical evaluation of the hazards and risks and appropriate safety measures for the devices with respect to patients, medical staff, and third parties.
1. The patient/study populations reported in the literature, the medical purpose, indications for use, and types of diseases reported are those intended for the devices.
1. The literature reviewed addresses the technology, critical performance, design, current state of the art and principles of use and features of the devices as well as competing products and technology.
1. No references are identified which indicate the presence of risks inherent to the design.
1. The claims made in the device labelling are substantiated by the published clinical data.

8. Conclusion

・

Product verification and validation testing and a review of clinical literature demonstrate that Kendall Sequential Compression Comfort Sleeves are as safe, as effective and perform as well as the predicate devices.

Sequential Compression Comfort Sleeves are substantially equivalent to the predicate devices in the following areas:

Both the proposed and predicate devices are intended to be used with the SCD Express . Controller (K040511), SCD Response Controller (K992079) and SCD Sequel Controller (K942664).
When connected to a compression system, both the proposed and predicated devices . are compressible limb sleeves designed to increase blood flow by applying pressure to a patient's limb for the prevention of deep vein thrombosis and pulmonary embolism.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design. The bird's head and neck are formed by the silhouettes of three faces, suggesting a connection between health, humanity, and government services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Covidien c/o Mia Proli Manager, Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048

MAY - 4 2010

Re: K100306

Kendall SCDTM Sequential Compression Comfort Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 29, 2010 Received: February 3, 2010

Dear Ms. Proli:

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.

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

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Page 2 - Ms. Mia Proli

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/CDRHOffices/ucm115809.html 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Dina R. Vihmer

Bram D. Zuckerman, M.D.
Director

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K100306

Device Name: Sequential Compression Comfort Sleeves

Indications for Use: The Kendall SCD Compression System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.

Prescription Use _ X

OR ·

Over-The-Counter Use (Per 21 CFR 801.109)

Please Do Not Write Below This Line - Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dma R. V. Lumer

(Division Sign-Off) (Division Sign Sign Sin, Devices

510(k) Number صكصلاحصاليك ك

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).