TOTIM Patient Cushion Immobilization System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Essebi Medical SRL % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 April 30, 2019 ### Re: K190894 Trade/Device Name: TOTIM Patient Cushion Immobilization System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 4, 2019 Received: April 5, 2019 ### Dear Mr. Job: 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 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. 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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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) #### K190894 Device Name TOTIM Patient Cushion Immobilization System Indications for Use (Describe) The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body, head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition, including Computed Tomography (CT), Magnetic Resonance (MR) Imaging, to support treatment planning. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (7/17) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for TOTIM, a company that specializes in immobilization systems in radiotherapy. The logo features a stylized human figure inside of a circle, followed by the text "TOTIM" in a bold, sans-serif font. Below the company name is the tagline "TOTALLY - IMMOBILE" and "immobilization system in radiotherapy" in a smaller font. The logo is simple, modern, and professional, and it effectively communicates the company's focus on immobilization systems. Image /page/3/Picture/1 description: The image shows the CE marking, which is a mandatory conformity marking for certain products sold within the European Economic Area. The text "Direttiva CEE 93/42 Dispositivo Medico Directive EEC 93/42 Medical Device" is present, indicating that the product is a medical device and complies with the European Economic Community directive 93/42. The text "Dispositivo Medico di Classe I Medical Device Class I" is also present, indicating that the product is a Class I medical device. ### Section 5 - 510(k) Summary K190894 # A. Submitter Information | Submitter Name & Address: | ESSEBI MEDICAL SRL<br>Strada Campo del Fiume 84<br>47896 Faetano<br>Repubblica di San Marino | |---------------------------|-------------------------------------------------------------------------------------------------------------| | Contact Person: | Pietro Sordina, President and Chief Executive Officer<br>Telephone: 00378-0549-963858<br>p.sordina@totim.it | | Date Summary Prepared: | January 22, 2019 | | Trade Name: | TOTIM® Patient Cushion Immobilization System | | Common Name: | Patient Cushion | | Classification Names &: | Medical charged-particle radiation therapy system<br>Accelerator, Linear, Medical (892.5050) | | Numbers: | Nuclear Magnetic Resonance Imaging (892.1000) | | Device Class: | Class II | | Review Panels: | Radiology | | Product Codes: | IYE | # B. Predicate Device The proposed device is substantially equivalent to the following predicate device: | Predicate Device | Manufacturer | |-----------------------------------------------------------------------------------------------------------------|--------------| | RediFoam™ two-part positioning foam RediFoam for verifiable<br>repositioning throughout treatment.<br>(K951808) | MEDTEC, Inc. | The purpose of this 510(k) is to 1) release new SRS/SRT/SGRT compatible system, and 2) identify intended use statements for the proposed device. ESSEBI MEDICAL has not submitted any prior submissions for the proposed device. # C. Device Descriptions TOTIM is a fully sealed, polyurethane foam cushion covered with microfiber polyester tissue for patient positioning and immobilization during simulation, planning and radiation treatment. The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for TOTIM, a company that specializes in immobilization systems for radiotherapy. The logo features a stylized human figure inside of a rounded rectangle, with the company name "TOTIM" in large, bold letters to the right. Below the company name, the words "TOTALLY - IMMOBILE" are printed in a smaller font. The phrase "immobilization system in radiotherapy" is printed at the bottom of the logo. Image /page/4/Picture/1 description: The image shows the CE marking, which is a symbol used to indicate that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area. The text next to the CE marking says "Direttiva CEE 93/42 Dispositivo Medico Directive EEC 93/42 Medical Device Dispositivo Medico di Classe I Medical Device Class I". This indicates that the product is a medical device and complies with the European Union's Medical Device Directive 93/42/EEC and is a Class I medical device. Construction Features: Cushion: External Cover Microfiber polyester / PU (fully sealed) - Internal pouch (fully sealed): PE/AL/PET humidity-resistant pouch containing two reagents ready to be mixed. Technical Characteristics: Cushion with external cover in microfiber comfortable and absorbent water repellent non-woven material, washable/easily samitized- temperature controlled exothermic reaction- the short window of time required for solidification allows for the correct modeling of the external cover in microfiber polyester tissue fully sealed. Single-patient /single-use - Latex Free -Radiotransparent - MR safe. Patent Pending: SM P-201700411 IT 102017000098840 UE 18000703.1 8 U.S. 16/117,817 The TOTIM® Patient Cushions Immobilization System device is manufactured of non-magnetic materials. The device is used in a healthcare facility/hospital. The device is intended to be used on adult and pediatric patients. The following model is included in this submission: | Device Family | Part No. | Device Name | |---------------------------------------|------------------|--------------| | Patient Cushion Immobilization System | T3001<br>TTM3001 | TOTIM BODY L | # D. Indications for Use/Intended Use Statements # Indications for Use: TOTIM® Patient Cushion Immobilization System is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body or the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning. System Intended Use: The device is part of a system intended to immobilize, position and reposition patients undergoing radiation therapy including SBRT. # Device- Specific Intended Use: The device maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with noncustomizable supports. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for TOTIM, a company that specializes in immobilization systems for radiotherapy. The logo features a stylized human figure inside of a circle to the left of the company name. Below the company name is the tagline "TOTALLY - IMMOBILE" and the phrase "immobilization system in radiotherapy." Image /page/5/Picture/1 description: The image shows the CE marking, which is a symbol used to indicate that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area. The text next to the CE marking says "Direttiva CEE 93/42 Dispositivo Medico Directive EEC 93/42 Medical Device Dispositivo Medico di Classe I Medical Device Class I". This indicates that the product is a medical device and complies with the European Union's Medical Device Directive 93/42/EEC and is a Class I medical device. # E. Comparison of Technological Characteristics Technological characteristics that have changed between the proposed and predicate device include changes in design and materials and in safety use with cushion fully sealed . The proposed TOTIM Patient Cushion device have been proven to reduce preparation time, especially for difficult set-ups. The TOTIM cushion proposed compared to the predicate product are improving because the polyester microfiber cushion coupled to the internal PU film is a cushion closed fully sealed. Inside the cushion there is a fully sealed pouch with two separate components ready to produce the polyurethane foam. The advantages of having a closed system for both the external bag and the inner pouch allows operators greater safety and easy to use. With Totim we eliminate the risk of the foam out of the outer bag, make the use more practical, less risk and fast because the components are already inside the pouch contained in the fully sealed closed bag. Furthermore, the cushion with respect to the predicate product being made of a microfiber is more comfortable for the patient. The fabric of the cushion coupled with the internal PU film allows perfect adherence to the foam being both polyurethane products obtaining a unique and compact end-product. | # | Feature | Predicate Device<br>( RediFoam™ Two-part<br>positioning foam) | ESSEBI MEDICAL Device<br>(TOTIM® Patient Cushion<br>immobilization system) | |---|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Indications for<br>Use | RediFoam™ - The device is<br>indicated to position and/or<br>immobilize adult. Is indicated to<br>assist in the proper positioning<br>of patients for radiation therapy<br>and radiosurgery simulation. | The device is indicated to position<br>and/or immobilize adult and pediatric<br>patients undergoing radiation therapy<br>of the body or the head, brain, and<br>neck, including Surface Guided<br>Radiation Therapy (SGRT) and<br>electron, photon, and proton<br>treatments. The device is also used<br>during image acquisition, including<br>Computed Tomography (CT)<br>Magnetic Resonance (MR) Imaging,<br>to support treatment planning. | | 2 | Classification | Class II<br>(K951808) | Class II | | 3 | Features | Polyurethane foam<br>immobilization system using<br>open bag. | Polyurethane foam immobilization<br>system using fully sealed bag/cushion.<br>System can be attached to the<br>treatment or simulation couch,<br>extension, or overlay along with other<br>optional positioning and<br>immobilization devices and<br>accessories. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for TOTIM, a company that specializes in immobilization systems for radiotherapy. The logo features a stylized human figure inside a circle, followed by the company name in bold, sans-serif font. Below the company name is the tagline "TOTALLY - IMMOBILE" and the phrase "immobilization system in radiotherapy". Image /page/6/Picture/1 description: The image shows the CE marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The text next to the CE marking includes the phrases "Direttiva CEE 93/42", "Dispositivo Medico", "Directive EEC 93/42", and "Medical Device". Below the CE marking, the text "Dispositivo Medico di Classe I" and "Medical Device Class I" are present, indicating that the product is a Class I medical device. | # | Feature | Predicate Device<br>(RediFoam™ Two-part positioning foam) | ESSEBI MEDICAL Device<br>(TOTIM® Patient Cushion Immobilization System) | |---|------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | 4 | Materials | Bag in Polyethylene film<br><br>2 Bottle Polyurethane:<br>bottle#1– bottle#2 | Cushion: Microfiber polyester / PU fully sealed<br><br>Internal pouch: PE/AL/PET<br><br>Internal pouch fully sealed with 2 pockets: Polyurethane | | 5 | Device Body<br>Contact<br>Category | Unknown | Limited contact duration (<24 hours) for surface devices (skin) | | 6 | Immobilization | Unknown | The cushion system can reproduce the patient position within a treatment cycle: SRS/SRT,SGRT, MRI, ELETRON, PHOTON, PROTON and PROTON treatments | | 7 | Performance | Unknown | SRS/SRT, SGRT, MRI | # F. Non-Clinical Testing Non-clinical testing was completed to confirm that the proposed device is as safe and effective as the predicate device and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness. A scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. The TOTIM device was tested with ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Materials), TOTIM is MR Safe. The devices are intended for limited contact duration (<24 hours) for surface devices (skin). Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5:2009、10993-12: 2012 and ISO 10993-10: 2010. Declaration of Conformity 93/42/CEE Medical Device Class I # G. Conclusion This premarket submission for the TOTIM® Patient Cushion Immobilization System of polyurethane foam to be used in radiotherapy for repeated positioning of the patient has demonstrated substantial equivalence as defined and understood in the Federal Food. Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.