Who is the manufacturer of Proton Positioing and Immobilization Devices?

Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap filed the 510(k) submission for Proton Positioing and Immobilization Devices (K180021).

What is the FDA product code for Proton Positioing and Immobilization Devices?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Proton Positioing and Immobilization Devices?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Proton Positioing and Immobilization Devices?

Carbon Fiber Conformal Couch Top (K973842).

Who can help prepare an FDA 510(k) submission like Proton Positioing and Immobilization Devices?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Proton Positioing and Immobilization Devices

K180021 · Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap · IYE · Jun 29, 2018 · Radiology

Device Facts

Record ID	K180021
Device Name	Proton Positioing and Immobilization Devices
Applicant	Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
Product Code	IYE · Radiology
Decision Date	Jun 29, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	Pediatric

Intended Use

General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok-Bars, Extensions, Cushions, and Accessories. Head, Neck, and Shoulder Devices: The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions. Support Garments: The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. Breast Positioning Devices: The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

Device Story

Device family includes positioning/immobilization aids: couch tops, overlays, extensions, thermoplastic masks, cushions, support garments, and breast boards. Used in radiation oncology (IMPT, IMRT, PBPT, IGRT, VMAT, SRS, SRT, SBRT) and diagnostic imaging (CT, MR). Operated by radiation oncology therapists, medical physicists, and oncologists. Devices provide mechanical support and immobilization to ensure reproducible patient positioning during simulation, planning, and treatment delivery. Some devices (AccuForm cushions) use chemical activation to mold to patient anatomy; others (thermoplastic masks) are softened in heated water. Output is physical patient stabilization. Benefits include improved treatment accuracy, reduced healthy tissue exposure, and patient comfort. Used in healthcare facilities.

Clinical Evidence

No clinical data. Bench testing only. Performance testing confirmed that devices used in the proton beam path do not perturb or impact the beam in a way that cannot be accounted for in treatment planning. Risk analysis confirms safety for pediatric/adolescent use.

Technological Characteristics

Mechanical, non-powered, static devices. Materials include carbon fiber, thermoplastic, nylon, and polystyrene beads. Limited skin contact (<24 hours). Non-sterile. MR-safe as labeled. No software or electronics.

Indications for Use

Indicated for adult and pediatric/adolescent patients undergoing radiation therapy (electron, photon, proton) and image acquisition for treatment planning. Specific anatomical regions include head, brain, neck, spine, breast, and chest. Support garments and breast positioning devices are contraindicated for patients under 12 years of age.

Regulatory Classification

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.

Predicate Devices

Carbon Fiber Conformal Couch Top (K973842)

Reference Devices

Uni-Frame Head Immobilization System (K933227)
MRI Patient Positioning Devices (K080072)
Sinmed Positioning Devices (K060737)
Moldcare Head & Neck Cushion (K982624)
Vac-Lok Immobilization System (K935300)
Chabner XRT Garments (K121284)
Carbon Fiber Breast Board (K974703)

Related Devices

K142420 — Patient Positioning Devices · Macromedics BV · Mar 27, 2015
K213439 — FlexBoardTM, EagleBoardTM, BreastBoard SXTM · Macromedics BV · Jun 24, 2022
K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set · Macromedics BV · Mar 19, 2025
K991319 — RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS · Orfit Industries · Sep 21, 1999
K060737 — SINMED POSITIONING DEVICES · Sinmed BV · Mar 31, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radi % Ms. Alena Newgren Regulatory Specialist 140 1 8th Street SE ORANGE CITY IOWA 51041 June 29, 2018 # Re: K180021 Trade/Device Name: Proton Positioning and Immobilization Devices Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 22, 2017 Received: January 3, 2018 Dear Ms. Alena: 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 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); {1}------------------------------------------------ # Page 2 - Ms. Alena Newgren 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 medical devices and radiation-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. Michael D.'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180021 #### Device Name General Positioning Devices; Head, Neck, and Shoulders Devices; Support Garments; Breast Positioning Devices #### Indications for Use (Describe) General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices: Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions. Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. Type of Use (Select one or both, as applicable) | <input checked="true" 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font, also in blue. The logo is clean and modern, and the use of blue gives it a professional and trustworthy feel. # 510(k) Summary # A. Submitter Information | | Submitter Name & Address: MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radiotherapy" 1401 8th St. SE Orange City, IA 51041 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Alena Newgren, Regulatory Specialist Telephone: 712-737-8688, Fax: 877-613-6300 regulatory@civcort.com | | Date Summary Prepared: | June 13, 2018 | | Trade Name: | Proton Positioning and Immobilization Solutions | | Common Name: | Head, Neck and Shoulders Devices General Positioning Devices Support Garments Breast Positioning Devices | | Classification Names & | Medical charged-particle radiation therapy system (892.5050) | | Numbers: | System, Nuclear Magnetic Resonance Imaging (892.1000) | | Device Class: | Class II | | Review Panels: | Radiology | | Product Codes: | IYE, LNH | # B. Predicate Devices The subject devices are substantially equivalent to the predicate devices in the following 510(k)s: | Predicate Device: | Manufacturer | |-----------------------------------------------|--------------| | K973842: Carbon Fiber Conformal Couch Top | MEDTEC, Inc. | | Reference Devices: | | | K933227: Uni-Frame Head Immobilization System | | | K080072: MRI Patient Positioning Devices | | | K060737: Sinmed Positioning Devices | | | K982624: Moldcare Head & Neck Cushion | | | K935300: Vac-Lok Immobilization System | | | K121284: Chabner XRT Garments | | | K974703: Carbon Fiber Breast Board | | The purpose of this 510(k) is to modify the intended use/indications for use for the subject devices including specification of proton treatment and pediatric/adolescent use. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. ### D. Device Descriptions This submission does not include in-vitro diagnostic devices. The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment. The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable. The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable. The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable. The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable. The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment. The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints. Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static. Detailed device specific descriptions are located in Section 11. The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable. The following models are included in this submission: ### www.civcort.com {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in large, bold letters. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, thinner font. ## Table A. Head, Neck, and Shoulders Devices. | Device Family | Part No. | Device Name | Reference 510(k) | |-----------------------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Overlay | MTPT210002 | Type-S™ Overlay (Reusable non-sterile overlay with thermoplastic frame for use with Hitachi proton system) | K933227 | | Overlay | MTMRHNTYPES | Type-S™ Overlay (Reusable non-sterile Type-S™ overlay with strap) | K080072 | | Thermoplastic Mask | MTAPUDMP | Disposable non-sterile head only FirmFit™ Thermoplastic (2.3mm) | K060737 | | Thermoplastic Mask | MTAPSDMP | Disposable non-sterile head neck, and shoulder FirmFit™ Thermoplastic (2.3mm) | | | Thermoplastic Mask | MTAPUDMPSG | Disposable non-sterile head only open face FirmFit™ Thermoplastic (2.3mm) | | | Extension | MTPT210001 | Type-S™ Extension (Reusable non-sterile head extension for use with Hitachi proton system) | K933227 | | Extension | MTIL6665 | Type-S Extension (Reusable non-sterile extension for use with Universal Couchtop Long Extension) | K973842 | | Extension | MTIL6668 | SRS Posifix Extension (Reusable non-sterile SRS compatible extension for use with Universal Couchtop Long Extension) | K973842 | | Cushion | MTACL1520 | AccuForm™ Cushion (15 x 20 cm) | | | Cushion | MTACL2035 | AccuForm™ Cushion (20 x 35 cm) chamfered | | | Cushion | MTACL2035HF | AccuForm™ Cushion (20 x 35 cm) chamfered, half fill | | | Cushion | MTACL2045 | AccuForm™ Cushion (20 x 45 cm) | K982624 and | | Cushion | MTACL4060 | AccuForm™ Cushion (40 x 60 cm) | K080072 | | Cushion | MTACL6060 | AccuForm™ Cushion (60 x 60 cm) | | | Cushion | MTACL14242 | AccuForm™ Cushion (20 x 25 cm) | | | Cushion | MTACLTYPES1 | AccuForm™ Cushion (Types-S) | | | Couchtop & Lok-Bar | MTIL6720 | IPPS™ Couchtop (Reusable non-sterile one piece couchtop with Lok-Bar) | | | | MTIL6740 | Universal Couchtop (Reusable non-sterile couchtop with Lok- Bar, rectangular extension, and storage rack) | K973842 | | Extension | MTIL6660 | Rectangular Extension (Reusable non-sterile rectangular extension for use with Universal Couchtop Long Extension) | K973842 | | Accessories (Hand Grips) | MTIL662501 | Patient Hand Grip (Reusable non-sterile SBRT Body Pro- Lok™ hand grip (right) for use with Universal Couchtop) | K973842 | | | MTIL662502 | Patient Hand Grip (Reusable non-sterile SBRT Body Pro- Lok™ hand grip (left) for use with Universal Couchtop) | | | Cushion (Vac-Lok) | MTVLG35FC | Vac-Lok ™ Cushion (Reusable, non-sterile, 70 x 100 cm, 35L, nylon bag with indexing safe for use in 1.5T and 3.0T MR environments) | K080072 K935300 | | Cushion (Combifix) | 151004 | Combifix™ (Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix cushion, and Kneefix™ cushion) | K060737 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in large, bold letters. A blue circle is above the V in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, thinner font. # Table B. General Positioning Devices. ### www.civcort.com {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. The logo is clean and modern, and the blue color gives it a sense of trust and reliability. ## Table C. Support Garments | Support Garments (Brassiere) | CRTBRA01 | Chabner XRT® Radiation Bra, Size 1 | | |------------------------------------|----------|------------------------------------|---------| | | CRTBRA02 | Chabner XRT® Radiation Bra, Size 2 | | | | CRTBRA03 | Chabner XRT® Radiation Bra, Size 3 | | | | CRTBRA04 | Chabner XRT® Radiation Bra, Size 4 | | | | CRTBRA05 | Chabner XRT® Radiation Bra, Size 5 | | | | CRTBRA06 | Chabner XRT® Radiation Bra, Size 6 | K121284 | | | CRTBRA07 | Chabner XRT® Radiation Bra, Size 7 | | | | CRTBRA08 | Chabner XRT® Radiation Bra, Size 8 | | | | CRTBRA09 | Chabner XRT® Radiation Bra, Size 9 | | | | CRTEXT01 | Bra Extender | | ## Table D. Breast Positioning Devices | Breastboard | MTM400 | C-Qual™ (Reusable non-sterile breastboard with head support and Monarch™ Overhead Arm Positioner) | K080072 | |-------------|--------|---------------------------------------------------------------------------------------------------|---------| |-------------|--------|---------------------------------------------------------------------------------------------------|---------| # E. Indications for Use/Intended Use Statements ### General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok-Bars, Extensions, Cushions, and Accessories. The following are other positioning devices: ### Head, Neck, and Shoulder Devices: The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions. ### www.civcort.com {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in large, rounded letters. Above the "V" is a small, light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. ### Support Garments: The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. #### Breast Positioning Devices: The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. ### F. Comparison of Technological Characteristics This 510(k) is being submitted only to add the Proton Intended Use and pediatric/adolescent use for these previously cleared devices. | MTPT210002 | Type-S TM Overlay | | | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component/ Parameter | Proposed Device | Predicate Device | Reference Device | | 510k | K180021 | K973842 | K933227 | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | The intended use of this device is to immobilize the head during radiation therapy. | | Design Features | The Type-S Overlay is placed on top of the treatment table via Lok-Bar and allows for attachments of head or head, neck, and shoulders thermoplastic masks. The Overlay also allows a headrest to be used. The | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The baseplate sets on the treatment table and allows for attachments of head or head, neck, and shoulders thermoplastic masks. The baseplate also allows a headrest to be used. The baseplate is fitted with two registration pins that index to | ## Head, Neck, and Shoulders Devices ### www.civcort.com {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The word "CIVCO" is in large, bold, blue letters, with a light blue circle above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. | | Overlay has holes that correspond to thermoplastic mask attachment pins. | | corresponding holes in the thermoplastic frame to give precision repositioning. Four swivel clamps allow quick lock down and removal of the thermoplastic frame. | |------------------------------------|--------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principle of Operation | Mechanical devices without the use of software or electronics. | | | | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | | | | Sterility | N/A Devices are non-sterile | | | | MTPT210001 | Type-S™ Extension | | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component/ Parameter | Proposed Device | Predicate Device | Reference Device | | 510k | K180021 | K973842 | K933227 | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | The intended use of this device is to immobilize the head during radiation therapy. | | Design Features | The device attaches to the end of the treatment table via a cantilever lock and pin mechanism. The Extensions allows for the placement of a headrest and has corresponding holes for thermoplastic mask attachment of head only or head, neck, and shoulders. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The baseplate sets on the treatment table and allows for attachments of head or head, neck, and shoulders thermoplastic masks. The baseplate also allows a headrest to be used. The baseplate is fitted with two registration pins that index to corresponding holes in the thermoplastic frame to give precision repositioning. Four swivel clamps allow quick lock down and removal of the thermoplastic frame. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A light blue circle is above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. | Principle of Operation | Mechanical devices without the use of software or electronics. | |------------------------------------|------------------------------------------------------------------| | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | | Sterility | N/A Devices are non-sterile | | MTMRHNTYPES | Type-ST™ Overlay | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component/ Parameter | Proposed Device | Predicate Device | Reference Device | | 510k | K180021 | K973842 | K080072 | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI. | | Design Features | The Overlay is attached to the treatment couch top via Lok-Bar and secured by a Velcro strap. The overlay is contoured to follow the anatomy of the head, neck, and shoulder region by a 'S' shape. The Overlay contains holes for thermoplastic mask to attach to in either head only or head, neck, and shoulder style. A headrest can be placed on the Overlay for patient positioning and comfort. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The device is attached to the treatment pedestal via Lok-Bar and allows attachment of other positioning and immobilization devices or to be used stand-alone. The device allows a headrest to be added and thermoplastic masks to be attached. | | Principle of Operation | Mechanical devices without the use of software or electronics. | | | | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | | | | Sterility | N/A Devices are non-sterile | | | Corporate Office | 2301 Jones Boulevard | Coralville, IA 52241 | USA | office +1 (319) 248.6757 | info@civcort.com Global Sales Office | 1401 8º Street SE | Orange City, IA 51041 | USA | office +1 (712) 737.8688 | fax +1 (877) 613.6300 510(k) Summary – Page 8 {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a stylized font. Above the V is a light blue circle. Below the logo is the word "Radiotherapy" in a smaller, sans-serif font. | MTAPUDMP Component/ Parameter | Disposable non-sterile head only FirmFit™ Thermoplastic | Proposed Device | Predicate Device | Reference Device | Reference Device | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | 510k | K180021 | K973842 | K080072 | K060737 | | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI. | Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. | | | Design Features | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. The SnapFrame style allows the user to pull the sides down first and then connect the top portion with the sides to make a continuous U- shaped frame. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | | | Principle of Operation | Mechanical devices without the use of software or electronics. | Mechanical devices without the use of | Mechanical devices without the use of software or electronics | Mechanical devices without the use of software or electronics | | | | | software or electronics. | | | | | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | Limited contact duration (<24 hours) for surface devices (skin). | Limited contact duration (<24 hours) for surface devices (skin). | Limited contact duration (<24 hours) for surface devices (skin). | | | Sterility | N/A Devices are non- sterile | N/A Devices are non-sterile | N/A Devices are non- sterile | N/A Devices are non- sterile | | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and consists of the word "CIVCO" in a sans-serif font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller sans-serif font, also in blue. | MTAPSDMP | Disposable non-sterile head neck, and shoulder FirmFit™ Thermoplastic | | | | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component/ Parameter | Proposed Device | Predicate Device | Reference Device | Reference Device | | 510k | K180021 | K973842 | K080072 | K060737 | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. | Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. | | Design Features | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. The SnapFrame style allows the user to pull the | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font, also in blue. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel. | | sides down first and then connect the top portion with the sides to make a continuous U- shaped frame. | | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------|--|--| | Principle of Operation | Mechanical devices without the use of software or electronics. | | | | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | | | | Sterility | N/A Devices are non-sterile | | | | MTAPUDMPSG | Disposable non-sterile head only open face FirmFit™ Thermoplastic | | | | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component/ Parameter | Proposed Device | Predicate Device | Reference Device | Reference Device | | 510k | K180021 | K973842 | K982624 | K060737 | | Intended Use/ Indications for Use | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. | Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. | | Design Features | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms the mask around the patient's head and locks the | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then | Thermoplastic Masks are composed of a frame, mask, and push pins. The thermoplastic mask is submerged in heated water to soften. Once removed from the water, the user quickly dries off the water and then forms | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "I" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. | | pins into pinholes of the Couchtop, Extension, or Overlay. The SnapFrame style allows the user to pull the sides down first and then connect the top portion with the sides to make a continuous U-shaped frame. | forms the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | the mask around the patient's head and locks the pins into pinholes of the Couchtop, Extension, or Overlay. | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Principle of Operation | Mechanical devices without the use of software or electronics. | | | | Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | | | | Sterility | N/A Devices are non-sterile | | | | MTIL6665 | Type-S Extension | Predicate Device | |-…