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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the TOTIM Patient Cushion Immobilization System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data for new acceptance criteria. Therefore, a comprehensive description of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in clinical trial reports or performance studies for novel devices, is not present in this document.

However, based on the information provided, we can infer some aspects related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary, specific numerical acceptance criteria for performance metrics (like accuracy of immobilization) are not explicitly stated as they would be for a novel device. Instead, the performance is primarily demonstrated through the equivalence to the predicate device and the results of non-clinical testing.

Feature	Implicit Acceptance Criteria (Inferred)	Reported Device Performance (from text)
Material Safety	Biocompatibility comparable to predicate and relevant standards.	Biocompatibility testing completed for patient-contacting materials in accordance with ISO 10993-5:2009, 10993-12:2012, and ISO 10993-10:2010. Device intended for limited contact duration (<24 hours) for surface devices (skin).
MR Compatibility	No significant MR image artifacts or safety concerns (RF heating, magnetically induced torque, magnetically induced displacement force).	TOTIM device tested with ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Materials). Result: TOTIM is MR Safe. A scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force.
Immobilization	Ability to position and immobilize patients for radiation therapy with reproducibility, comparable to or improved over the predicate device.	"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." "The cushion system can reproduce the patient position within a treatment cycle: SRS/SRT, SGRT, MRI, ELETRON, PHOTON, PROTON and PROTON treatments." "The proposed TOTIM Patient Cushion device have been proven to reduce preparation time, especially for difficult set-ups."
User Safety	Reduced risk for operators during preparation and use.	"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."
Patient Comfort	Comparable or improved patient comfort compared to the predicate device.	"Furthermore, the cushion with respect to the predicate product being made of a microfiber is more comfortable for the patient."
Radiotransparency	Must be radiotransparent to allow for imaging during treatment planning and verification.	"Radiotransparent" (listed under Technical Characteristics)
Sterilization	Single-patient/single-use.	"Single-patient /single-use" (listed under Technical Characteristics)
Latex-free	Must be latex-free.	"Latex Free" (listed under Technical Characteristics)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical performance data involving patients, as this is a 510(k) submission primarily relying on non-clinical testing and substantial equivalence.

For Biocompatibility testing: The sample size would refer to the materials tested, not human subjects. The provenance would be the materials themselves.
For MR compatibility testing (ASTM F2119-07): The sample size refers to the device and materials tested, not patients.

There is no mention of prospective or retrospective patient data for performance evaluation in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

This information is not provided because the submission relies on non-clinical testing and substantial equivalence. No ground truth in the sense of expert consensus on patient diagnostic or treatment outcomes is established for a "test set" from patient data.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of a human-reviewed "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The device is a physical patient immobilization system, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical patient immobilization system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests involved objective measurements and standards:

Biocompatibility: Demonstrated by testing against ISO standards (ISO 10993-5, -10, -12), where the "ground truth" is compliance with these established safety benchmarks.
MR Safety: Established by testing against ASTM F2119-07, where the "ground truth" is the quantitative measurement of artifacts and evaluation of safety against defined criteria.
Material properties (Radiotransparency, Latex-free, Single-use): "Ground truth" is based on material specifications and manufacturing processes.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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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. 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

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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

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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)

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)

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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 SRLStrada Campo del Fiume 8447896 FaetanoRepubblica di San Marino
Contact Person:	Pietro Sordina, President and Chief Executive OfficerTelephone: 00378-0549-963858p.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 systemAccelerator, 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 verifiablerepositioning throughout treatment.(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

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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	T3001TTM3001	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.

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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( RediFoam™ Two-partpositioning foam)	ESSEBI MEDICAL Device(TOTIM® Patient Cushionimmobilization system)
1	Indications forUse	RediFoam™ - The device isindicated to position and/orimmobilize adult. Is indicated toassist in the proper positioningof patients for radiation therapyand radiosurgery simulation.	The device is indicated to positionand/or immobilize adult and pediatricpatients undergoing radiation therapyof the body or the head, brain, andneck, including Surface GuidedRadiation Therapy (SGRT) andelectron, photon, and protontreatments. The device is also usedduring image acquisition, includingComputed Tomography (CT)Magnetic Resonance (MR) Imaging,to support treatment planning.
2	Classification	Class II(K951808)	Class II
3	Features	Polyurethane foamimmobilization system usingopen bag.	Polyurethane foam immobilizationsystem using fully sealed bag/cushion.System can be attached to thetreatment or simulation couch,extension, or overlay along with otheroptional positioning andimmobilization devices andaccessories.

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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(RediFoam™ Two-part positioning foam)	ESSEBI MEDICAL Device(TOTIM® Patient Cushion Immobilization System)
4	Materials	Bag in Polyethylene film2 Bottle Polyurethane:bottle#1– bottle#2	Cushion: Microfiber polyester / PU fully sealedInternal pouch: PE/AL/PETInternal pouch fully sealed with 2 pockets: Polyurethane
5	Device BodyContactCategory	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.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.