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.

Compression Garments (Small and Medium Sizes)

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.

Device Description

The Reprocessed Compression Garment is the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The Reprocessed Compression Garment is compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubinq to individual bladders within the garment. The controller's software delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.

The modified reprocessed compressible garment is for single-patient-use and is available in knee length and thigh length confiqurations.

AI/ML Overview

This is a 510(k) summary for a reprocessed medical device (compression garments), not an AI/ML device. Therefore, the questions about acceptance criteria, study design, expert involvement, and training/test sets for an AI/ML device are not directly applicable.

However, I can extract the relevant information regarding the performance data and the conclusion for this reprocessed device:

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

The document does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance in the manner expected for an AI/ML device. Instead, it indicates:

Acceptance Criteria Type	Reported Device Performance
Functional Characteristics	Demonstrated appropriate functional characteristics through bench top verification.
Manufacturing Process	Includes visual and functional testing of all reprocessed products prior to release.

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

Sample Size: The document mentions "Representative samples of the Reprocessed Compression Garments were tested." It does not specify the exact number of samples.
Data Provenance: Not applicable/not specified. The testing is bench-top verification of reprocessed physical devices.

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 is for a physical reprocessed medical device, not an AI/ML device requiring expert ground truth for output evaluation.

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

Not applicable. This is for a physical reprocessed 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

Not applicable. This is for a physical reprocessed medical device.

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

Not applicable. This is for a physical reprocessed medical device.

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

The "ground truth" here is the expected functional performance of the original (non-reprocessed) compression garment and the established quality standards for medical devices. The performance is assessed via "bench top verification" and "visual and functional testing."

8. The sample size for the training set

Not applicable. This is for a physical reprocessed medical device, not an AI/ML device requiring a training set.

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

Not applicable. This is for a physical reprocessed medical device.

Study Proving Device Meets Acceptance Criteria:

The study described is bench-top verification and functional testing of "Representative samples of the Reprocessed Compression Garments." The purpose of this testing was to demonstrate that the reprocessed garments possess "appropriate functional characteristics" and that the manufacturing process ensures quality through "visual and functional testing of all reprocessed products prior to release."

Conclusion:

Based on this functional testing, Covidien concluded that the modified Reprocessed Compression Garment is substantially equivalent to the existing Reprocessed Compression Garment (K140813). This substantial equivalence implies that the reprocessed device meets the necessary performance and safety standards without requiring the extensive clinical trial data that might be associated with a new or significantly different device.

Summary

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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

August 18, 2016

Covidien Wing Ng Director, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K161105

Trade/Device Name: Reprocessed Compression Garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 11, 2016 Received: July 14, 2016

Dear Wing Ng:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 yours,

M.A. Hillebrand

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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Reprocessed Single-Use Device Models Included in Clearance:

Device Model	Device Name	OriginalManufacturer
9529R	Reprocessed Express Sleeve - Knee LengthMedium	Covidien
9789R	Reprocessed Express Sleeve - Knee LengthLarge	Covidien
9790R	Reprocessed Express Sleeve - Knee Length X-Large	Covidien
9545R	Reprocessed Express Sleeve - Thigh LengthSmall	Covidien
9530R	Reprocessed Express Sleeve - Thigh LengthMedium	Covidien
9780R	Reprocessed Express Sleeve - Thigh LengthLarge	Covidien
74021R	Reprocessed Comfort Sleeve - Knee LengthSmall	Covidien
74022R	Reprocessed Comfort Sleeve - Knee LengthMedium	Covidien
74023R	Reprocessed Comfort Sleeve - Knee LengthLarge	Covidien

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510(k) Number (if known): To Be Determined K161105

Device Name: Reprocessed Compression Garment

Indications for Use:

Compression Garments (Large and X-Large Sizes)

Compression Garments (Small and Medium Sizes)

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)

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Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue vertical stripe and a white square in the center. To the right of the square is the word "COVIDIEN" in blue sans-serif font.

510(K) SUMMARY

1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048

Contact:	Mr. Wing Ng
Title:	Director, Regulatory Affairs
Telephone:	(508) 261 – 6596
Fax:	(508) 261 – 6596
Date Prepared:	April 18, 2016

2. Device:

Trade Names: SCD™ Express Compression Sleeve SCD™ Comfort Compression Sleeve Common Name: Compression Garment Classification Name: Sleeve, Limb, Compressible Regulation Number: 21 CFR 876.5800 Product Code: JOW Classification: Class II

3. Predicate Devices:

Covidien Reprocessed Compression Garments (K140813)

4. Device Description:

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The modified reprocessed compressible garment is for single-patient-use and is available in knee length and thigh length confiqurations.

5. Intended Use:

Compression Garments (Large and X-Large Sizes)

Compression Garments (Small and Medium Sizes)

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. 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 modified Reprocessed Compression Garment is substantially equivalent to the existing Reprocessed Compression Garment (K140813).

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).