SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. February 16, 2021 Smisson-Cartledge Biomedical LLC Julie Stephens Correspondent 111 Laurel Ridge Drive Alpharetta, Georgia 30004 Re: K052055 Trade/Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LGZ, FRN, FPA Dear Julie Stephens: 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 10, 2017. Specifically, FDA is updating this SE Letter because FDA has identified an additional product code to more clearly categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (301) 796-6294, Alan.Stevens@fda.hhs.gov. Sincerely, Alan M. Stevens -S3 CAPT Alan Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1}------------------------------------------------ Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines. JAN 1 0 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Smisson-Cartledge Biomedical, LLC C/O Ms. Julie Stephens Consultant for Smisson-Cartledge Biomedical, LLC Regulatory Resources Group. Incorporated 111 Laurel Ridge Drive Alpharetta, Georgia 30004 Re: K052055 Trade/Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, FRN Dated: October 18, 2006 Received: October 19, 2006 Dear Ms. Stephens: This letter corrects our substantially equivalent letter of October 26, 2006. 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 {2}------------------------------------------------ Page 2 - Ms. Julie Stephens CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (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 Parts 801 and 809] ), 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" (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 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, # Erin I. Keith -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K052055 Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System Indications For Use: Full range from slow feed to rapid, high flow infusion of: - crystalloid, colloid, or blood product, including packed red blood cells, as volume . replacement for patients suffering from blood loss due to trauma or surgery - warmed fluid to rewarm patients after surgery or for hypothermia . warmed fluid for irrigation in urology procedures . Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 {4}------------------------------------------------ ## Exhibit J - 510(k) SUMMARY This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92. | Submitted By: | Smisson-Cartledge Biomedical LLC<br>502 Mulberry Street, Second Floor<br>Macon, GA 31201<br>Phone: (478) 744-9992 | |---------------|-------------------------------------------------------------------------------------------------------------------| |---------------|-------------------------------------------------------------------------------------------------------------------| Contact Person: Julie Stephens, President/Consultant Regulatory Resources Group, Inc. 510(k) Number: K052055 Date Prepared: July 26, 2005 Device Name and Classification: | Trade/Proprietary Name: | Smisson-Cartledge TIS-1200 Thermal Infusion System | |-------------------------|----------------------------------------------------| | Common Name: | Infusion Pump | | Classification Name: | Infusion Pump | | Product Code: | LGZ: FRN: FPA | ## Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778. K032674. K992672. K983975. K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 ## Device Description: The Smisson-Cartledge TIS-1200 Thermal Infusion System is a portable tabletop or polemount device intended for use in the ambulance, medical helicopter, hospital emergency room and operating room environments. (See Exhibits A and B for photographs and drawings) The system consists of an infusion device and a compatible single-use sterilized disposable set with supply lines capable of interfacing with intravenous (IV) bags or optional-use cardiotomy equipment. It also includes a footswitch to allow hands-free user-controlled stopping and starting of fluid delivery. The Smisson-Cartledge TIS-1200 Thermal Infusion System is a volumetric pump capable of continuous infusion (up to approximately 100 L at a rate of from 10 mL per hour to 1200 mL per minute) and discrete bolus delivery. When the system is set to Bolus mode, the user can select a predetermined delivery volume and a default or adjustable rate and deliver a fixed bolus of up to 1 L. When connected to alternating current (AC) power, the Smisson-Cartledge TIS-1200 Thermal Infusion System can deliver fluids at body temperature in certain modes. It can also be set to run on battery power with heating capabilities disabled to allow transport of the patient. A lithium-ion battery pack provides power backup. The unit (infusion pump) and Large Volume Reservoir Holder are provided non sterile. The Disposable Cassette Kit and Large Volume Reservoir are provided sterile, non-pyrogenic and are single-use only. They are sterilized by Ethylene Oxide (EO) sterilization method. {5}------------------------------------------------ ## Exhibit J - 510(k) SUMMARY ## Indications for Use: Full range from slow feed to rapid, high flow infusion of crystalloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. Full range from slow feed to rapid, high flow infusion of warmed fluid to rewarm patients after surgery or for hypothermia. Full range from slow feed to rapid, high flow infusion of warmed fluid for irrigation in urology procedures. ## Similarities and Differences to the Predicate Devices: ## Similarities The Smisson-Cartledge TIS-1200 Thermal Infusion System has the same basic mechanical characteristics to infuse and warm liquid products into a patient as the predicate devices, and the indications for use are the Belmont predicate device. ## Differences The Smisson-Cartledge TIS-1200 Thermal Infusion System utilizes different materials from the predicate devices; however, the materials are biocompatible. ## Summary of Testing: The Smisson-Cartledge TIS-1200 Thermal Infusion System has the same indications for use, principles of operation, and mechanical characteristics as the predicate devices that were previously cleared for market under a 510(k). These conclusions were verified in performance / bench testing as summarized within the 510(k). The Smisson-Cartledge TIS-1200 Thermal Infusion System device differs only in its materials used. All biocompatibility testing, as required, complies with ISO-10993 "Biological Evaluation of Medical Devices".