Plexus SCD110 Sequential Compression Device Sleeve

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 22, 2019 Midway Medical, LLC. Jim Tobin Vice President of Business Development 3004 Gill Street Bloomington, Illinois 61704 Re: K190975 Trade/Device Name: Plexus SCD110 Sequential Compression Device Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 3, 2019 Received: April 15, 2019 Dear Jim Tobin: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190975 Device Name Plexus SCD110 Sequential Compression Device Sleeve Indications for Use (Describe) The Plexus SCD 110 DVT Sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {3}------------------------------------------------ # 510(k) Summary # Summary Preparation Date: April 3, 2019 # Revision: July 15, 2019 # Submitter / 510(k) Sponsor Midway Medical, LLC. 3004 Gill Street Bloomington, IL 61704 ## Contact Person Jim Tobin Vice President of Business Development Phone: 484-695-6209 Email: jim@midway-medical.com ## Device Name Device Name: Disposable Sequential Compression Device (SCD) Sleeve Proprietary Trade Name: Plexus SCD110 Sequential Compression Device Sleeve Common Name: Compressible Limb Sleeve ## Product Classification Product Classification: Compressible Limb Sleeve, 21 CFR 870.5800 Product Code: JOW Device Class: II ## Primary Predicate Device: | Product | Manufacturer | 510(k) Number | |-------------------------|------------------------|---------------| | Cirona 6200 DVT Sleeves | Devon Medical Products | K141578 | ## Reference Devices: | Product | Manufacturer | 510(k) Number | |--------------------------------|---------------------------------|---------------| | Excel Flowtron DVT Garments | Arjo Huntleigh | K133119 | | Aircast VenoFlow Elite Sleeves | DJO, LLC | K122499 | | Venodyne Advantage Sleeves | Ecolab, Inc. (Microtek Medical) | K110358 | | VasoPress Compression Sleeve | Compression Therapy Concepts | K101915 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the words "MIDWAY MEDICAL" stacked on top of each other. The words are in a bold, sans-serif font and are colored in blue. To the left of the words are two vertical gray bars. 510(k) Summary #### Device Description The Plexus SCD110 Sequential Compression Device is a non-sterile sequential compression sleeve intended to be used with commercially-available compression pumps*. The device is used to prevent the onset of deep vein thrombosis (DVT) by stimulating blood flow and increasing venous flow velocity. The device consists of a pair of soft pressure garment sleeves with an internal air bladder. Each package of Plexus SCD110 has two compression sleeves – one for the right calf and one for the left calf. The Plexus SCD110 is a single-bladder sleeve that provides a preset pattern of intermittent pressure to the deep vein in the lower leg. To use the device, the garment sleeve is wrapped around a patient's calf. The compression sleeve is connected to a commercially available DVT compression pump intended to be used with single-chamber air bladder sleeves. The connector of the sleeve is designed such that it will not connect to a pump intended for multi-chamber sleeves. When the compression pump is turned on, air flows from the air pump into the air bladder inside the compression sleeve, providing pneumatic pressure on the calf muscle and veins underneath. Once the compression pump reaches an air pressure of 40 mmHg), a relief valve is triggered within the DVT pump to let air escape from the sleeve and reduces the pressure within the system. With the relief valve opened, the compression sleeve completely deflates and allows blood to re-enter the deep veins of the patient during this cycle. After a pre-set deflation period (~50-second cycle), the relief valve will close and the air pump will start pumping again to 40 mmHg. This cycle of inflation of the air bladder will continue until the compression pump device is turned off. The Plexus SCD110 sleeve is made of a soft, lightweight, non-woven foam-felt material with a singlechamber bladder made of polyvinyl chloride (PVC). The Plexus SCD sleeve is intended to be compatible with single-chamber DVT pump systems only and the connectors will not allow the sleeve to be attached to any other compression systems (i.e. multi-chamber DVT systems, lymphedema compression systems) * All testing was completed using the following DVT compressions pumps: Cirona™ 6200 (Devon Medical), Flowtron® Excel (ArjoHuntleigh), VenaFlow® Elite System (DJO Global/Aircast), VasoPress® Compression Therapy Pumps (Zimmer Biomet / Compression Therapy Concepts), and Venodyne Advantage (EcoLab Inc. / Microtek Medical, Inc.) #### Device Indications for Use: The Plexus DVT sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for Midway Medical. The logo is composed of two lines of text. The first line says "MIDWAY" and the second line says "MEDICAL". The text is in a sans-serif font and is blue. To the left of the text is a gray vertical bar. # 510(k) Summary #### Contraindications: The Plexus DVT sleeves are contraindicated for use by patients with the following conditions: - Severe atherosclerosis or other ischemic vascular diseases - Suspected or known acute deep vein thrombosis - Severe congestive cardiac failure - Existing pulmonary edema - Existing pulmonary embolisms - Extreme deformity of the limbs - Any local skin or tissue condition in which the garments would interfere including gangrene, untreated or infected wounds, recent skin graft, and/or dermatitis - Known presence of malignancy in the legs - Limb infections, including cellulitis, that have not received antibiotic coverage - Presence of lymphangiosarcoma - In situations where increased lymph and blood flow is undesirable #### Technical Characteristics The technological characteristics of the Plexus are substantially equivalent to the sleeves of the predicate and other single-chamber reference devices. The overall design, materials, mode of operation, and performance characteristics are substantially equivalent to the predicate and reference devices. #### Perfomance Data To validate that the Plexus DVT sleeve meets the intended specifications, a number of non-clinical tests were conducted by a third-party test facility. #### Biocompatibility Tests | Standards and Regulations Applied | Results | Equivalence to Predicate Devices* | |--------------------------------------------|---------|-----------------------------------| | ISO10993-5:2009 In-Vitro Cytotoxicity | Passed | Equivalent | | ISO10993-10:2010 Intracutaneous Reactivity | Passed | Equivalent | | ISO10993-10: 2010 Skin Sensitization | Passed | Equivalent | {6}------------------------------------------------ ## Comparative and Compatibility Performance Tests | Test | Results | Equivalence to Predicate Devices* | |------------------------|---------|-----------------------------------| | Sleeve Burst Test | Passed | Equivalent | | Pressure Accuracy Test | Passed | Equivalent | | Pull Force Test | Passed | Equivalent | The biocompatibility testing and functional testing confirm that the Plexus DVT sleeves perform as intended and are substantially equivalent to the proposed predicate device. No new or additional risks are presented with the Plexus DVT sleeves. * All testing was completed using the following DVT compressions pumps: Cirona™ 6200 (Devon Medical), Flowtron® Excel (ArjoHuntleigh), VenaFlow® Elite System (DJO Global/Aircast), VasoPress® Compression Therapy Pumps (Zimmer Biomet / Compression Therapy Concepts), and Venodyne Advantage (EcoLab Inc. / Microtek Medical, Inc.) ## Conclusion Based on the assessment of the functional testing and biocompatibility testing performed, the Plexus DVT sleeve is substantially equivalent to the predicate device in material content, function and indications for use. As such, these sleeves can be concluded to be as safe and effective as the predicate devices.