MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE

{0}------------------------------------------------ # 510(k) Summary In accordance with 21 CFR Part 807.92, this summary is submitted by: Midwest Midwestern Reprocessing Center, LLC. 3995 Fashion Square Blvd. Suite 11 Saginaw, MI 48603 Phone: (989) 583-4623 Fax: (989) 583-4633 1. Contact Person Date Prepared: May 10, 2010 Jerome James Consultant Phone: (205) 314-3920 Fax: (205) 314-3959 Email: jerry.james@hygia.net 2. Name of Device Classification Name: Sleeve, Limb, Compressible Classification Product Code: JOW Common Name: Compressible Limb Sleeve Device Trade or Proprietary Name: Midwestern Reprocessing Center Reprocessed Sleeves/Foot Cuffs 3. Predicate Devices Corresponding compression sleeves / foot cuffs legally marketed by the follow original equipment manufacturers under the following 510(k)s: | K992454 | Aircast Sleeves / Foot Cuffs - Aircast, Inc. | |------------------|--------------------------------------------------------------------------| | K974318 | ALP® DVT Sleeves - Healthcare Service and Supply | | K040511, K040649 | Kendall SCD Express® Sleeves / Foot Cuffs - Tyco<br>Healthcare / Kendall | | K953648 | Novamedix ImPad® - Novamedix, Ltd. | | K890938 | SCD™ Sleeves - Kendall Healthcare | Corresponding reprocessed compression sleeves legally marketed by Hygia Health Services under the following 510(k)s: . AUG 2 7 2010 K101330 Pg1082 {1}------------------------------------------------ K101330 pg 2 of 2 | K053575 | Reprocessed Aircast Sleeves / Foot Cuffs | |---------|----------------------------------------------------------| | K053575 | Reprocessed ALP® DVT Sleeves | | K053575 | Reprocessed Kendall SCD Express® Sleeves / Foot<br>Cuffs | | K021509 | Reprocessed Novamedix ImPad® | | K012417 | Reprocessed Kendall SCD™ Sleeves | #### 4. · Device Description The Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller. 5. Device Intended Use The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable. #### 6. Technological Characteristics The Midwestern Reprocessing Center reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics. The overall designs, materials, energy sources, modes of operation, and performance characteristics are no different than the original devices. 7. Performance Data Functional Testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective. #### 8. Conclusion Based on the assessment of functional testing, cleaning validation, and biocompatibility testing performed. Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed sleeves/foot cuffs are substantially equivalent to the predicate devices. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Midwest Reprocessing Center c/o Mr. Jerome James Regulatory Consultant 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603 AUG 2 7 2010 Re: K101330 Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves Midwest Reprocessing Center Reprocessed Novamedix ImPad® Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: May 11, 2010 Received: May 12, 2010 Dear Mr. James: 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. {3}------------------------------------------------ #### Page 2 - Mr. Jerome James 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 of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Barry D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 510(k) Number (if known): K101330 Device Name: Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs Indications For Use: The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. Prescription Use (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) (Dwision/Sign-Off) Division of Cardiovas 510(k) Number K101330 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ {5}------------------------------------------------ 510(k) Number (if known): K101330 Device Name: Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve Indications For Use: The Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency. 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) {6}------------------------------------------------ 510(k) Number (if known): K101330 Device Name: Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs Indications For Use: The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. Prescription Use (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) {7}------------------------------------------------ 510(k) Number (if known): K101330 Device Name: Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves Indications For Use: The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis. Prescription Use (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) {8}------------------------------------------------ 510(k) Number (if known): K101330 Device Name: Midwest Reprocessing Center Reprocessed Novamedix ImPad® Indications For Use: The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: - o Prevent deep vein thrombosis - 0 Reduce wound healing time - Treat and assist healing of venous leg ulcers O - o Reduce edema caused by venous insufficiency in the lower extremities Prescription Use × (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) {9}------------------------------------------------ Page A - Mr. Jerome James ### K101330 Applicant: Midwest Reprocessing Center 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603 Consultant: Jerome James, Senior Consultant Ph: (205)314-3920 x114 Fax: (205)314-3959 Email: jerry.james@hygia.net Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve Device Name: Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs > Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves Midwest Reprocessing Center Reprocessed Novamedix ImPad® | Manufacturer | 510(k) | Models | |---------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Aircast Inc. | K992454 | 3010, 3010-5, 3010-PL, 3012, 3012-5, 3012-PL, 3015, 3015-5, 3015-PL, 3016, 3016-5, 3016-PL | | Healthcare Services and<br>Supply<br>(Currie Medical ALP®<br>DVT Sleeves) | K974318 | ALP-1, ALP-2, ALP-2XL, ALP-3, ALP-3(S), ALP-4, PVA-1, PVA-2 | | Kendall & Kendall SCD<br>Sleeves & Express<br>Sleeves/Foot Cuffs<br>(Tyco Healthcare) | K890938,<br>K040511,<br>K040649 | 5065, 5075, 5107, 5329, 5330, 5345, 5480, 5489, 5897, 5898, 5329-M, 5489-M, 5330-M, 5345-M, 5480-M, 9529, 9789, 9530, 9545, 9780, 5046, 5048, 5057, 5059 | | Novamedix ImPad<br>(Novamedix) | K953648 | | ### Indications for Use (IFU) - 1. The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. {10}------------------------------------------------ KI01330 Page & - Mr. Jerome James > The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. - 2. The Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency. - 3. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are used in the treatment of venous legfoot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. - 4. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis. - 5. The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: - Prevent deep vein thrombosis o - o Reduce wound healing time - Treat and assist healing of venous leg ulcers o - Reduce edema caused by venous insufficiency in the lower extremities o {11}------------------------------------------------ Page 3 - Mr. Jerome James ### K101330 Applicant: Midwest Reprocessing Center 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603 Consultant: Jerome James, Senior Consultant Ph: (205)314-3920 x114 Fax: (205)314-3959 Email: jerry.james@hygia.net Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve Device Name: Midwest Reprocessing Center Reprocessed Venodyne Sleeves Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves Midwest Reprocessing Center Reprocessed Nutech® Combo Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeves Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap | Manufacturer | 510(k) | Models | | |------------------|---------------------------------|-----------------------------------|------------------------------------| | Venodyne Sleeves | K011318,<br>K001802,<br>K930526 | V3012, V3014, V3022, V3026, V6010 | | | | CTC VasoPress | K061967,<br>K061814,<br>K000147 | VP 501M, VP 501L, VP 530M, VP 530L | | | | Huntleigh<br>Healthcare Inc. | K881632 | | Nutech | | | K981311,<br>K944567 | #### Indications for Use (IFU) - The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous 1. leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a noninvasive therapeutic method for prevention of deep vein thrombosis. - 2. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. {12}------------------------------------------------ ### Page 4 - Mr. Jerome James The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. - 3. The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a noninvasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency. - 4. The Midwest Reprocessing Center Reprocessed Nutech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: - Prevent deep vein thrombosis O' - o Reduce wound healing time - o Treat and assist healing of venous leg ulcers - O Reduce edema caused by venous insufficiency in the lower extremities - 5. The Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to: - o Prevent deep vein thrombosis - Reduce wound healing time o - ಂ Treat and assist healing of venous leg ulcers - Reduce edema caused by venous insufficiency in the lower extremities 0 - 6. The Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: - o Deep vein thrombosis - o Reduce wound healing time - Treat and assist healing of venous leg ulcers ಂ - o Reduce edema caused by venous insufficiency in the lower extremities - o Decrease compartmental pressures - 7. The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency. - 8. The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: - o Deep vein thrombosis - o Reduce wound healing time - 0 Treat and assist healing of venous leg ulcers - Reduce edema caused by venous insufficiency in the lower extremities O - Decrease compartmental pressures 0 (K101330)