The Reprocessed Kendall SCD™ Express Foot Cuff is a single patient use garment that connects to an intermittent pneumatic controller via a tubing set to deliver a set amount of pressure to the foot in order to promote blood flow.

AI/ML Overview

The provided document, K163055, describes the reprocessing of the Kendall SCD Express Foot Cuff. Since this is a reprocessed device and not a new diagnostic or prognostic tool, the acceptance criteria and study information typically sought for AI-powered devices or novel medical technologies are not directly applicable in the same way.

However, I can extract the information relevant to the reprocessing validation and present it in a format that aligns with your request where possible.

Acceptance Criteria and Device Performance for Reprocessed Kendall SCD™ Express Foot Cuff

This document describes the validation of a reprocessed medical device, the Kendall SCD™ Express Foot Cuff, not a novel diagnostic AI system. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Acceptance Criteria (from context)	Reported Device Performance (from context)
Functional Integrity	Hook and Loop Simulated Use	Not explicitly quantified, but implied to maintain functionality over simulated use.	Tested to demonstrate appropriate functional characteristics.
	Leak Testing	Not explicitly quantified, but implied to prevent leaks.	Tested to demonstrate appropriate functional characteristics.
	System Compatibility	Compatibility with intermittent pneumatic controller.	Tested to demonstrate appropriate functional characteristics.
Biocompatibility	Biological Safety	Meet ISO 10993-1 requirements.	Biocompatibility testing conducted in accordance with ISO 10993-1.
Cleaning Validation	Effectiveness of Cleaning Process	Meet AAMI TIR 30:2011 requirements.	Cleaning process validated in accordance with AAMI TIR 30:2011 requirements.
Manufacturing Quality	Visual Inspection	Free from visible defects.	Visual and functional testing of all reprocessed products prior to release.
	Functional Testing	Operates as intended.	Visual and functional testing of all reprocessed products prior to release.

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

Sample Size: Not explicitly stated for each test. The document mentions "Representative samples of the reprocessed foot cuffs were tested."
Data Provenance: The testing appears to be prospective benchtop validation conducted by Covidien. The country of origin for the data is implicitly the United States, given the FDA submission.

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

This type of information is generally not applicable for a Class II reprocessed medical device's benchtop validation. "Ground truth" in the context of device reprocessing refers to adherence to established engineering, biocompatibility, and sterilization standards, rather than expert interpretation of clinical data. The validation relies on objective measurements against these standards.

4. Adjudication Method for the Test Set

Not applicable. The validation involves objective measurements and adherence to specified performance standards rather than expert adjudication of qualitative outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is for evaluating diagnostic performance with human readers, which is not relevant for the reprocessing of a limb sleeve.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this reprocessing validation is based on established industry standards and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, AAMI TIR 30:2011 for cleaning validation) and the design and performance specifications of the original predicate device. Benchtop tests measure against these objective standards.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" here refers to the development of the reprocessing procedures, which would involve process development and validation, not data-driven machine learning.

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

Not applicable, as no training set in the AI sense was used. The "ground truth" for developing the reprocessing protocols would be based on scientific principles of cleaning, disinfection/sterilization, material integrity, and functionality, developed through engineering and scientific experts to ensure that the reprocessed device performs identically to the new device and meets all safety requirements.

Summary

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

December 23, 2016

Covidien Jennifer Sullivan Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K163055

Trade/Device Name: Reprocessed Kendall SCD Express Foot Cuff Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 31, 2016 Received: November 1, 2016

Dear Jennifer 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 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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

M.A. Hillemann

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Model	Device Name	OriginalManufacturer
5897R	Reprocessed Kendall SCDTM Express Foot Cuff – Regular	Covidien
5898R	Reprocessed Kendall SCDTM Express Foot Cuff – Large	Covidien

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510(k) Number (if known): K163055

Device Name:

Reprocessed Kendall SCD™ Express Foot Cuff

Indications for Use:

The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and 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 o

Prescription Use: X AND/OR Over-the-Counter Use: (Part 21 CFR 801 Subpart D) (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)

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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a lighter blue cross shape inside, followed by the word "COVIDIEN" in a bold, dark blue font. The logo is simple and modern, with a focus on the company name.

510(k) SUMMARY

1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048

Contact: Jennifer Sullivan Title: Regulatory Affairs Manager Telephone: (508) 452-1659 Fax: (508) 452-1659 Email: jennifer.sullivan@medtronic.com Date Prepared: October 31, 2016

2. Device:

Trade Name:	Reprocessed Kendall SCD™ Express Foot Cuff
Classification Name:	Sleeve, Limb, Compressible
Regulation Number:	21 CFR 870.5800
Product Code(s):	JOW
Classification:	Class 2

3. Predicate Devices:

Kendall SCD™ Express Foot Cuff, K040511

4. Device Description:

5. Intended use: The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and 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 .

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6. Technological Characteristics:

The Reprocessed Kendall SCD™ Express Foot Cuffs are identical to the predicate device in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.

7. Performance Data:

Representative samples of the reprocessed foot cuffs were tested to demonstrate appropriate functional characteristics through bench top verification. Testing included; hook and loop simulated use, leak testing and system compatibility. Biocompatibility testing was conducted in accordance with ISO 10993-1. The cleaning process was validated in accordance with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.

8. Conclusion:

Based on functional testing, Covidien has demonstrated that the Reprocessed Kendall SCD™ Express Foot Cuffs are substantially equivalent to the predicate device as described in this premarket notification.

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).