Medline ReNewal Reprocessed Compression Limb Sleeves

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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 {1}------------------------------------------------ #### 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ### 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Names | Brandi Panteleon<br>Richard D. Wynkoop<br>Director, Regulatory Affairs<br>VP, QA/RA<br>P: 541-923-3310<br>F: 541-923-3375<br>E: bpanteleon@medline.com<br>E: rwynkoop@medline.com | | Date Prepared | January 15, 2014 | | Device Names | Proprietary Name: Medline ReNewal Reprocessed Compression Limb<br>Sleeves<br>Common Name:, Compression Limb Sleeves | | Classification | Sleeve, limb, compressible<br>§ 870.5800<br>Class II<br>Product Code: JOW | | Predicate<br>Device | K012658 - Surgical Instrument Service and Savings, Inc. Reprocessed<br>Compression Limb Sleeves | | Device<br>Description | Medline ReNewal Reprocessed Compression Limb Sleeves are used with a<br>pump system to apply sequential compression to the lower limbs (leg and<br>foot). They are made of a variety of materials and come in various sizes.<br>They are originally manufactured as single use devices. | | Indications for<br>Use | Medline ReNewal Reprocessed Compression Limb Sleeves are designed<br>to be used with a pump system to apply sequential compression to the<br>lower limbs to prevent deep vein thrombosis. | | Technological<br>Characteristics | The technological characteristics of the devices are identical to the<br>predicate devices. There has been no change to the fundamental scientific<br>technology of the devices. | | Performance<br>Testing | The functional characteristics of the proposed devices have been evaluated<br>and found to be equivalent to the predicate devices after the specified<br>number of reprocessing cycles. Testing included:<br>• bioburden testing;<br>• biocompatibility testing (cytotoxicity, irritation, sensitization);<br>• cleaning process validation;<br>• equipment qualification; and<br>• visual inspection. | {5}------------------------------------------------ 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. | <b>Conclusion</b> | Based on the information provided, the modified Medline ReNewal Reprocessed Compression Limb Sleeves are substantially equivalent to the predicate device. | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|