Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

Device Description

Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information required to describe the acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states:

"The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles."
"Testing included: bioburden testing; biocompatibility testing (cytotoxicity, irritation, sensitization); cleaning process validation; equipment qualification; and visual inspection."

While these are types of tests performed, the document does not provide:

A table of acceptance criteria and reported device performance: It lists types of tests but not specific criteria (e.g., "bioburden must be < X CFU/device") or the quantitative results from these tests.
Sample size used for the test set and data provenance: No details on how many devices were tested or where the devices/data originated.
Number of experts used to establish the ground truth and their qualifications: This type of information is typically not relevant for reprocessing validation studies, which focus on objective physical, chemical, and biological measures.
Adjudication method: Not applicable for the types of tests described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is a reprocessing validation, not an AI or diagnostic imaging study.
Standalone performance: While the tests are for the device itself (standalone), there are no specific performance metrics like sensitivity/specificity often seen in diagnostic device studies.
Type of ground truth used: Not applicable in the context of bioburden or biocompatibility tests. The "ground truth" would be established by validated analytical methods.
Sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document is primarily a regulatory filing to demonstrate substantial equivalence to a predicate device, focusing on the safety and effectiveness of the reprocessing method. It does not elaborate on the specific methodologies or detailed results of the performance testing in a way that would satisfy the comprehensive request.

Summary

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September 3, 2021

Surgical Instrument Service and Savings (dba Medline ReNewal) Richard Wynkoop VP Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K143166

Trade/Device Name: Medline ReNewal Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW

Dear Richard Wynkoop:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 16, 2015. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Nicole Gillette, OHT2: Office of Cardiovascular Devices, 240 - 402 - 6630, Nicole.Gillette@fda.hhs.gov.

Sincerely.

Nicole M. Gillette -S

Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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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

Surgical Instrument Service and Savings (dba Medline Renewal) Richard Wynkoop VP Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K143166

Trade/Device Name: Medline Renewal Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 15, 2014 Received: December 17, 2014

Dear Richard Wynkoop,

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

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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 (OS) 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. Willemen

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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Indications for Use

510(k) Number (if known) K143166

Device Name

Medline ReNewal Reprocessed Compression Limb Sleeves

Indications for Use (Describe)

Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the text is the Medline logo, which features the word "MEDLINE" in blue with a stylized blue symbol.

Special 510(K) Medline ReNewal Reprocessed Compression Limb Sleeves

7.0 510(k) Summary

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Names	Brandi PanteleonRichard D. WynkoopDirector, Regulatory AffairsVP, QA/RAP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.comE: rwynkoop@medline.com
Date Prepared	January 15, 2014
Device Names	Proprietary Name: Medline ReNewal Reprocessed Compression LimbSleevesCommon Name:, Compression Limb Sleeves
Classification	Sleeve, limb, compressible§ 870.5800Class IIProduct Code: JOW
PredicateDevice	K012658 - Surgical Instrument Service and Savings, Inc. ReprocessedCompression Limb Sleeves
DeviceDescription	Medline ReNewal Reprocessed Compression Limb Sleeves are used with apump system to apply sequential compression to the lower limbs (leg andfoot). They are made of a variety of materials and come in various sizes.They are originally manufactured as single use devices.
Indications forUse	Medline ReNewal Reprocessed Compression Limb Sleeves are designedto be used with a pump system to apply sequential compression to thelower limbs to prevent deep vein thrombosis.
TechnologicalCharacteristics	The technological characteristics of the devices are identical to thepredicate devices. There has been no change to the fundamental scientifictechnology of the devices.
PerformanceTesting	The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices after the specifiednumber of reprocessing cycles. Testing included:• bioburden testing;• biocompatibility testing (cytotoxicity, irritation, sensitization);• cleaning process validation;• equipment qualification; and• visual inspection.

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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.

Conclusion	Based on the information provided, the modified Medline ReNewal Reprocessed Compression Limb Sleeves are substantially equivalent to the predicate device.
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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).