Intended use for following codes: 9529(R), 9530(R), 9545(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

Intended use for following codes: 9780(R), 9789(R), 9790(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device 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.

Device Description

The Reprocessed Compression Garments are the compressible limb sleeve component of a pneumatic compression system intended to apply pressure to a patient's leg to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The Reprocessed Compression Garments are compatible with the OEM pneumatic compression controller. The controller provides air to the sleeves through tubing connected to each bladder of the sleeve for the purposes of delivering pneumatic pressure to the limb. The controller software monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system.

The proposed reprocessed device is for single-patient-use and will be available in knee and thigh configurations.

AI/ML Overview

The provided document is a 510(k) summary for the Covidien Reprocessed Compression Garments. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this submission does not contain the type of acceptance criteria, study details, and performance metrics typically found for a medical device that uses an AI/ML algorithm or requires clinical performance evaluation against a specific ground truth.

This 510(k) is for a reprocessed medical device (compression garments) that is compared to its original predicate device based on functional equivalence, material equivalence, and cleaning validation. The performance data focuses on benchtop verification and process validation rather than human reader studies, AI algorithm performance, or ground truth-based evaluation.

Therefore, many of the requested categories in your prompt are not applicable to the information provided in this 510(k) summary. I will answer the applicable questions based on the text.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance	Comments
Functional Characteristics	Demonstrated through benchtop verification and process validation.	This likely includes pressure delivery, leak testing, and reliability. Specific values are not provided.
Visual Inspection	Performed to validate the cleaning process and prior to release.	Indicates a quality control step. Specific criteria or defect rates are not provided.
Leak Testing	Performed as part of functional characteristics testing.	No specific pass/fail criteria or performance metrics provided.
Reliability Testing	Performed as part of functional characteristics testing.	No specific duration, cycles, or failure rates provided.
Biocompatibility	Performance data used to demonstrate device function.	No specific tests, results, or standards cited (beyond implied AAMI TIR 30:2011 for cleaning).
Cleaning Process Validation	Performed in line with AAMI TIR 30:2011 requirements.	This standard is for the "compatibility of materials with sterilization methods and the effects of reprocessing on medical devices." Implies successful validation against this standard. specific results are NOT reported in this document

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for performance testing (e.g., number of garments tested). The document says "Representative samples of the Reprocessed Compression Garments were tested."
Data Provenance: Not specified. The testing was conducted by Covidien, a US-based company, so it's likely internal testing.
Retrospective or Prospective: Not applicable; this was benchtop and process validation, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a reprocessed physical device, not an AI/ML diagnostic tool requiring expert-established ground truth from images or patient data. The "ground truth" here is the original predicate device's specifications and the ability of the reprocessed device to meet those.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process like that used for diagnostic studies was mentioned or implied.

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference standard for this submission is the performance and specifications of the original (predicate) compression garments and relevant engineering/material standards (e.g., AAMI TIR 30:2011 for cleaning). The reprocessed device is deemed substantially equivalent if it meets these established functional and safety criteria.

8. The sample size for the training set

Not applicable. This device does not involve an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not involve an AI/ML algorithm.

Summary

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

JUL 15 2014

COVIDIEN

K140813

TRADITIONAL 510(K) SUMMARY

1. 510(k) Owner:

Applicant:

Telephone: Fax:

Covidien 15 Hampshire Street Mansfield, MA 02048 (508) 452 - 4135 (508) 452 - 1640

Contact: Title: Date Prepared: Daniel Campion Director Regulatory Affairs 3/28/2014

2. Device:

Trade Name:
Classification Name:
Regulation Number:
Product Code(s):
Classification:

Covidien Reprocessed Compression Garments Sleeve, Limb Compressible 21 CFR 870.5800 JOW Class II

3. Predicate Device:

The Reprocessed Compression Garments are substantially equivalent in intended use and operation to the predicate Compression Garments (K051805 and K781357).

4. Device Description:

The proposed reprocessed device is for single-patient-use and will be available in knee and thigh configurations.

5. Intended Use:

Intended use for following codes: 9529(R), 9530(R), 9545(R),

The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

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

Intended use for following codes: 9780(R), 9789(R), 9790(R),

The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device 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.

6. Technological Characteristics:

The Reprocessed Compression Garments 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 Compression Garments were tested to demonstrate appropriate functional characteristics through bench top verification and process validation. Visual inspection, leak testing, reliability testing and biocompatibility performance data were used to demonstrate the device function. Testing was performed to validate the cleaning process in line 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 the performance and cleaning results Covidien concludes that the Reprocessed Compression Garments are safe, effective, and substantially equivalent to the predicate device as described in this premarket notification submission

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 15, 2014

Covidien Mr. Daniel Campion Director Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048 US

Re: K140813

Trade/Device Name: Reprocessed Kendall SCD Express Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: June 18, 2014 Received: June 20, 2014

Dear Mr. Campion:

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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Page 2 - Mr. Daniel Campion

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours.

MA Zilleben

for

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

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K140813

Device Name: Covidien Reprocessed Compression Garments

Indications for Use:

Intended use for following codes: 9780(R), 9789(R), 9790(R),

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

M.A. Hillemann

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).