BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
Device Facts
| Record ID | K081218 |
|---|---|
| Device Name | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST |
| Applicant | It-V Medizintechnik, GmbH |
| Product Code | IYE · Radiology |
| Decision Date | Jul 21, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
Indications for Use
The function of the BellySTEP™ is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics. The function of the HeadSTEP™ is for fixation and (re)positioning of the head and neck area of the patient during radiotherapy and diagnostics. The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy. The function of the WingSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the iCAST™ thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
Device Story
IT-V positioning devices (BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, iCAST) are patient immobilization systems used in radiotherapy and diagnostic environments. Devices consist of baseplates, cushions, and thermoplastic materials designed to secure specific body regions (abdomen, head/neck, thorax, hip/extremities) to ensure accurate, reproducible patient positioning during treatment. Operated by clinical staff in radiotherapy departments; devices are placed on treatment or CT-scanner couches. Some models feature inclination mechanisms or interchangeable inserts to optimize patient comfort and alignment. iCAST is a low-temperature thermoplastic sheet material molded to the patient to create custom immobilization masks. These devices facilitate precise radiation delivery by minimizing patient movement, potentially improving treatment accuracy and patient outcomes.
Clinical Evidence
No clinical data provided; bench testing only. Substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.
Technological Characteristics
Devices utilize radio-translucent materials including carbon fiber sandwich construction, polyethylene foam, acrylic, and thermoplastic sheets. Systems are mechanical, non-powered, and designed for compatibility with CT-scanners and linear accelerators. Fixation is achieved via indexing bars or strips on standard treatment couches. iCAST is a low-temperature thermoplastic material.
Indications for Use
Indicated for patient positioning and immobilization during radiotherapy and diagnostic procedures. BellySTEP: lower abdomen. HeadSTEP: head and neck. BreastSTEP/WingSTEP: lung and thorax. ProSTEP: hip and lower extremities. iCAST: thermoplastic material for patient immobilization. Target populations include patients with tumors in the respective anatomical regions.
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
- Bellyboard system by SINMED BV (K060131)
- Positilt head inclination system by SINMED BV (K060131)
- Posiboard by SINMED BV (K060131)
- Combifix by SINMED BV (K060131)
- PET-armsupport by SINMED BV (K060131)
- Raycast Thermoplastics by ORFIT Industries (K991319)
Submission Summary (Full Text)
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「JUL 2 1 2008
Section 05
Image /page/0/Picture/2 description: The image shows a logo for IT-Medizintechnik GmbH. The logo consists of the letters "IT" and a stylized "V" shape, all in white, set against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in black.
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### 510(k) SUMMARY IT-V positioning devices
#### 1. BellySTEP™
| | IT - V Medizintechnik GmbH | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by | Kranebitterbodenweg 40a | |
| | 6020 Innsbruck | |
| | Austria | |
| Contact person | Markus Völp (C.E.O.) | |
| | Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | BellySTEP™ | |
| Common name | Pelvis and lower extremities immobilization system. | |
| Classification name | Accelerator, Linear, Medical | |
| | Class 2 devices, 892.5050 IYE | |
| Predicate device | Bellyboard system by SINMED BV | |
| Description of the devices | The BellySTEP™ is made for the positioning of the lower<br>abdomen of a patient. The BellySTEP™ Baseplate enables<br>the use of Inter-changeable inserts. It is made of<br>Polyethylene Foam and covered with artificial leather. | |
| Intended use | Positioning of the lower abdomen of a patient during<br>radiotherapy and diagnostics. | |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | The BellySTEP™ is substantially equivalent to the SINMED<br>Bellyboard System in design, construction, and function. The<br>BellySTEP™ is flat and has a similar, generally rectangular-<br>shaped contour, with areas specifically designed for the<br>abdomen, and thighs. The Prone pillow support cushion has<br>a contoured opening so that the patient may rest his/her<br>head comfortably in the prone position during treatment<br>process. The inter-changeable inserts are also designed with<br>an open, contoured cut out region. The patient is positioned<br>over the abdominal cushion such that the belly drops into the<br>cut out region during the radiation therapy session. The<br>BellySTEP™ is constructed in a manner similar to the<br>bellyboard System from SINMED. | |
Document #:
510(k) summary.doc
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Image /page/1/Picture/1 description: The image shows a logo for a company called IT-V MEDIZINTECHNIK GMBH. The logo is in a black box with white text. The top line of the logo is the company's initials, IT-V, and the bottom line is the company's full name, MEDIZINTECHNIK GMBH.
| Substantial Equivalence Device | The BellySTEP TM is defined as substantially equivalent (SE)<br>in terms of intended use to the SINMED Bellyboard,<br>manufactured by SINMED BV (Registration number<br>8030455) and cleared by FDA with K060131. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BellySTEPT™ | SINMED bellyboard system |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Positioning of the lower abdomen of<br>a patient during radiotherapy and<br>diagnostics. | Positioning of the lower abdomen of<br>a patient during radiotherapy and<br>diagnostics. |
| Target population | Patients with tumors in the lower-<br>abdomen area. | Patients with tumors in the lower-<br>abdomen area. |
| Position of the<br>patient | Prone position on this device. | Prone position on this device. |
| Material | Made of Polyethylene Foam and<br>covered with artificial leather. The<br>PE foam material is commonly used<br>in radiotherapy. | Carbon fiber sandwich construction. |
| Dimensions | Thick hollow construction with an<br>aperture to place the belly. Flat top-<br>part for positioning the arms and<br>head. | Thick hollow construction with an<br>aperture to place the belly. Flat top-<br>part for positioning the arms and<br>head. |
| Design / Shape | Ergonomic design for a comfortable<br>position and support of the patient. | Ergonomic design for a comfortable<br>position of the patient. Extra ruler for<br>laser - alignment along the sides of<br>the bellyboard. |
| Possible adjustments | No adjustments possible, only by<br>using additional cushions like the<br>prone pillow support cushion. | No adjustments possible, only by<br>using additional cushions like the<br>prone-cushion. |
| Couch fixation | Can be placed at indexed position<br>on the couch. | Can be placed at indexed position<br>on the couch, using fixation strips. |
| Accessories | Various Inter-changeable inserts and<br>prone pillow to optimize the<br>positioning and comfort of the<br>patient. | Prone cushion for bellyboard to<br>improve the position on the<br>bellyboard. |
| Compatibility with the<br>environment and<br>other devices | This device can be used both in<br>combination with an CT-scanner and<br>an accelerator. | This device can be used both in<br>combination with an CT-scanner<br>and an accelerator. |
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Image /page/2/Picture/1 description: The image shows a logo for a company called IT-V MEDIZINTECHNIK GMBH. The logo consists of the letters IT-V in a bold, sans-serif font. The letters are white on a black background. Below the letters is the company name, MEDIZINTECHNIK GMBH, in a smaller, sans-serif font. The company name is black on a white background.
#### 2. HeadSTEP™
| | IT - V Medizintechnik GmbH | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by | Kranebitterbodenweg 40a | |
| | 6020 Innsbruck | |
| | Austria | |
| Contact person | Markus Völp (C.E.O.) | |
| | Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | HeadSTEP™ | |
| Common name | Head and neck immobilization systems | |
| Classification name | Accelerator, Linear, Medical | |
| | Class 2 devices, 892.5050 IYE | |
| Predicate device | Positilt head inclination system by SINMED BV | |
| Description of the devices | The HeadSTEP™ iFRAME based immobilization system<br>guarantees high precision and facile repositioning in routine<br>cranial as well as head and neck immobilization. | |
| Intended use | Fixation and (re)positioning of the head and neck during<br>radiotherapy and diagnostics | |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | The HeadSTEP™ is designed to position the head and neck of<br>a patient for diagnostics and radiotherapy and reposition it<br>several times. | |
| | This is exactly the purpose of the Positilt head inclination<br>system. The same kind of construction and materials are used<br>to reach this. Products from both companies are used for the<br>same kind of radiotherapy treatments. These products from<br>both companies are really competitive systems. | |
| Substantial Equivalence | The HeadSTEP™ is defined as substantially equivalent (SE) in<br>terms of intended use to the SINMED Positilt head inclination<br>system, manufactured by SINMED BV (Registration number<br>8030455) and cleared by FDA with K060131. | |
| Document #:<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 510(k) summary.doc | Version 1 of 2008-03-28<br>11 1800 1100 1100 100 | page 3 of 12 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------|--------------|
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Image /page/3/Picture/1 description: The image shows a logo for IT-V Medizintechnik GmbH. The logo consists of the letters "IT-V" in a bold, sans-serif font, with a horizontal line connecting the "T" and the "V". The letters are white and set against a black rectangular background. Below the rectangle, the words "MEDIZINTECHNIK GMBH" are printed in black, also in a sans-serif font.
| | HeadSTEP™ | SINMED Positilt |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Fixation and (re) positioning of the<br>head and neck during radiotherapy<br>and diagnostics. | Fixation and (re) positioning of the<br>head and neck during radiotherapy<br>and diagnostics. |
| Target population | Radiotherapy patients with tumors in<br>head and neck area. | Radiotherapy patients with tumors in<br>head and neck area. |
| Position of the<br>patient | Lying on a couch in prone or supine<br>position. Shoulders and head are<br>positioned by in a certain position<br>using accessories for an optimized<br>treatment. | Lying on a couch in prone or supine<br>position. Shoulders and head are<br>positioned by in a certain position<br>using accessories for an optimized<br>treatment. |
| Material | Radio-translucent carbon fiber<br>construction. The skin contact<br>material carbon fiber is exactly the<br>same as those used in the predicate<br>device. | Carbon fiber and acrylic, polyethylene<br>foam. |
| Dimensions | Square shaped baseplate which<br>follows the patients contours of the<br>head. | Square shaped baseplate which<br>follows the patients contours of the<br>head. |
| Design / Shape | Flat baseplate on which the<br>thermoplastic mask can be placed.<br>Using a 23-step elevation<br>mechanism, the baseplate can be<br>inclined to change the position of the<br>head. | Flat baseplate on which the<br>thermoplastic mask and various head<br>supports can be placed. Using the<br>Positilt or other accessories, the<br>baseplate can be inclined to change<br>the position of the head. |
| Possible adjustments | Head can be lifted or inclined by<br>using the 23-step elevation<br>mechanism, without any wedges. | Head can be lifted or inclined by using<br>the blocks and wedges or the Positilt<br>system. |
| Couch fixation | The aluminum fixation rails connects<br>the baseplate to the couch. The<br>adjustable aluminum rails can be<br>mounted on the baseplate. They<br>allow the baseplate to be locked<br>down in the desired position on the<br>simulator or treatment couch. | The aluminum fixation rails connects<br>the baseplate to the couch. The<br>adjustable aluminum rails can be<br>mounted on all of our baseplates. They<br>allow the baseplate to be locked down<br>in the desired position on the simulator<br>or treatment couch. |
| Accessories | Foam head supports, which can<br>position the head for an optimized<br>treatment.<br>Thermoplastic mask-material which<br>can be placed on the baseplate with<br>plastic profiles. | Foam head supports, which can<br>position the head for an optimized<br>treatment.<br>Thermoplastic mask-material which<br>can be placed on the baseplate with<br>plastic profiles. |
510(k) summary.doc Document #: Version 1 of 2008-03-28 page 4 of 12
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| Compatibility with the environment and other devices | Can be used on all brands of couches in diagnostic and radiotherapy environment. |
|------------------------------------------------------|----------------------------------------------------------------------------------|
| | Can be used on all brands of couches in diagnostic and radiotherapy environment. |
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#### 3. BreastSTEP™
| | IT - V Medizintechnik GmbH |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Kranebitterbodenweg 40a<br>6020 Innsbruck<br>Austria |
| Contact person | Markus Völp (C.E.O.)<br>Phone: +43/664 4009009 |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | BreastSTEP™ |
| Common name | Breast and thorax immobilization systems |
| Classification name | Accelerator, Linear, Medical<br>Class 2 devices, 892.5050 IYE |
| Predicate Device | Posiboard by SINMED BV |
| Description of the devices | The BreastSTEP™ enable positioning, repositioning and high<br>comfort in the routine breast and thorax fixation. |
| Intended use | Positioning of the lung- and thorax area of the patient during<br>radiotherapy and diagnostics. |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | The SINMED Posiboard is intended to position patients<br>undergoing irradiation treatment in the breast- and lung area.<br>This is exactly the same purpose of the BreastSTEP™. The<br>patient support of the SINMED Posiboard can be inclined for<br>better treatment. This same inclination of the upper body is<br>also possible with the BreastSTEP™. To keep the arms out of<br>the treatment area, the arms are placed above the head.<br>Various arm supports can be fixed on the SINMED Posiboard.<br>This arm support fixation is also possible on the<br>BreastSTEP™. The features of the SINMED Posiboard can all<br>be found on the BreastSTEP™. |
| Substantial Equivalence Device | The BreastSTEP™ is defined as substantially equivalent (SE)<br>in terms of intended use to the SINMED Posiboard,<br>manufactured by SINMED BV (Registration number 8030455)<br>and cleared by FDA with K060131. |
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| Document #: | 510(k) summary.doc<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Version 1 of 2008-03-28 |
| | | |
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| | BreastSTEP™ | SINMED Posiboard |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Positioning of the lung- and thorax<br>area of the patient during<br>radiotherapy and diagnostics. | Positioning of the lung- and thorax<br>area of the patient during radiotherapy<br>and diagnostics. |
| Target population | Patients with tumors in breast and<br>thorax. | Patients with tumors in breast and<br>thorax. |
| Position of the<br>patient | Supine position, can be inclined, with<br>arms above the head. | Supine position, can be inclined, with<br>arms above the head. |
| Material | Carbon fiber sandwich construction,<br>PE Foam, and acrylic. Only non-<br>metal materials are used, like foam,<br>acrylic and carbon fiber sandwich in<br>the treatment area.<br>The skin contact material carbon<br>fiber is exactly the same as those<br>used in the predicate device. | Carbon fiber sandwich construction,<br>PE Foam, and acrylic. Only non-metal<br>materials are used, like foam, acrylic<br>and carbon fiber sandwich in the<br>treatment area. |
| Dimensions | Optimized dimensions (width) to be<br>CT-scanner compatible. | Optimized dimensions (width) to be<br>CT-scanner compatible. |
| Design / Shape | Baseplate, with an aperture for<br>placing headsupports. Above the<br>head the arms can be placed by<br>using various armsupports. | Baseplate, with an aperture for placing<br>headsupports. Above the head the<br>arms can be placed by using various<br>armsupports. |
| Possible adjustments | 0-20 degrees inclination possible. | 0-25 degrees inclination possible. |
| Couch fixation | The BreastSTEP™ is fixed onto the<br>couch using indexing bars. | The Posiboard is fixed onto the couch<br>with fixationstrips. |
| Accessories | Various headsupports for a<br>comfortable patient positioning.<br>Various armsupports for patient<br>positioning. | Various headsupports for a<br>comfortable patient positioning.<br>Various armsupports for patient<br>positioning. |
| Compatibility with the<br>environment and<br>other devices | Due to the chosen construction and<br>materials, these products can be<br>used during both diagnostics and<br>radiotherapy. | Due to the chosen construction and<br>materials, these products can be used<br>during both diagnostics and<br>radiotherapy. |
| Document #: | 510(k) summary.doc. | Version 1 of 2008-03-28<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Property of Children<br>No. of Cattle on 14 | |
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#### 4. ProSTEP™
| | IT - V Medizintechnik GmbH | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by | Kranebitterbodenweg 40a | |
| | 6020 Innsbruck | |
| | Austria | |
| Contact person | Markus Völp (C.E.O.)<br>Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | ProSTEP™ | |
| Common name | Pelvis and lower extremities immobilization systems | |
| Classification name | Accelerator, Linear, Medical<br>Class 2 devices, 892.5050 IYE | |
| Predicate device | Combifix by SINMED BV | |
| Description of the devices | The ProSTEP™ was designed to improve the accuracy of the<br>positioning of the hip and the lower extremities. | |
| Intended use | Positioning of hip and lower extremities of a patient for<br>radiotherapy | |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | The SINMED Combifix is intended for positioning and<br>immobilization of pelvis and lower extremities.<br>The ProSTEP™ is a system with which the pelvis and lower<br>extremities are positioned in the same way as with the<br>SINMED Combifix. Both devices are exactly the same in terms<br>of intended use and technical characteristics. | |
| Substantial Equivalence Device | The ProSTEP™ is defined as substantially equivalent (SE) in<br>terms of intended use to the SINMED Combifix, manufactured<br>by SINMED BV (Registration number 8030455) and cleared by<br>FDA with K060131. | |
| | Addresses of the lim an a se a semployer was |
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| Document #: | 510(k) summary.doc |
| | |
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Image /page/8/Picture/0 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The letters are white against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo and text are enclosed in a rectangular border.
| | ProSTEP™ | SINMED Combifix |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Positioning of hip and lower<br>extremities of a patient for<br>radiotherapy. | Positioning of hip and lower<br>extremities of a patient for<br>radiotherapy. |
| Target population | Patients undergoing irradiation<br>treatment in pelvis or lower<br>extremities. | Patients undergoing irradiation<br>treatment in pelvis or lower<br>extremities. |
| Position of the<br>patient | Supine position. | Supine position. |
| Material | Carbon fiber sandwich construction<br>or plastic (PE-Foam) devices. | Carbon fiber sandwich construction or<br>plastic (acrylic and PE-Foam) devices. |
| Design | Baseplate on which the hip and<br>lower extremities of the patient can<br>be positioned by using a KneeSTEP<br>and FeetSTEP system. | Baseplate on which the hip and lower<br>extremities of the patient can be<br>positioned by using a Kneefix or<br>Feetfix. |
| Possible adjustments | These devices can be adjusted to<br>optimize the fit for the patient.<br>Individual adjustment can be<br>reached by changing distances. | These devices can be adjusted to<br>optimize the fit for the patient.<br>Individual adjustment can be reached<br>by changing distances. |
| Couch fixation | Baseplate can be positioned on the<br>couch on indexed positions. | Baseplate can be positioned on the<br>couch on indexed positions. |
| Accessories | N. a. | Repovac vacuum cushions.<br>Multi Purpose Support Cushion |
| Compatibility with the<br>environment and<br>other devices | The ProSTEP™ can be used both in<br>the diagnostic and treatment<br>environment, due to the materials<br>and construction chosen. | The Combifix system can be used both<br>in the diagnostic and treatment<br>environment, due to the materials and<br>construction chosen. |
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Image /page/9/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font. The letters are white on a black background. Below the letters is the text "MEDIZINTECHNIK GMBH" in a smaller, sans-serif font. The text is black on a white background.
#### 5. WingSTEP™
.
| | IT - V Medizintechnik GmbH |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Kranebitterbodenweg 40a |
| | 6020 Innsbruck |
| | Austria |
| Contact person | Markus Völp (C.E.O.) |
| | Phone: +43/664 4009009 |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | WingSTEPTM |
| Common name | Breast and thorax immobilization systems |
| Classification name | Accelerator, Linear, Medical |
| | Class 2 devices, 892.5050 IYE |
| Predicate Device | PET-armsupport by SINMED BV |
| Description of the devices | The WingSTEPTM enable positioning, repositioning and high<br>comfort in the routine breast and thorax fixation. |
| Intended use | Positioning of the lung- and thorax area of the patient during<br>radiotherapy and diagnostics. |
| | The SINMED PET-armsupport is intended to position patients<br>undergoing irradiation treatment in the breast- and lung area.<br>This is exactly the same purpose of the WingSTEPTM. |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | To keep the arms out of the treatment area the SINMED PET-<br>armsupport place the arms above the head. This positioning of<br>the arms above the head to achieve more space around the<br>breast- and lung area is also the exact intended use of the<br>WingSTEPTM. |
| Substantial Equivalence Device | The WingSTEPTM is defined as substantially equivalent (SE) in<br>terms of intended use to the SINMED PET-armsupport,<br>manufactured by SINMED BV (Registration number 8030455)<br>and cleared by FDA with K060131. |
Document #:
510(k) summary.doc
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Image /page/10/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font, with a horizontal line connecting the T and the W. The letters are white on a black background. Below the letters, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font.
| | WingSTEP™ | SINMED PET-armsupport |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended use | Positioning of the lung- and thorax<br>area of the patient during<br>radiotherapy and diagnostics. | Positioning of the lung- and thorax<br>area of the patient during radiotherapy<br>and diagnostics. |
| Target population | Patients with tumors in breast and<br>thorax. | Patients with tumors in breast and<br>thorax. |
| Position of the<br>patient | Supine position with arms above the<br>head. | Supine position with arms above the<br>head. |
| Material | Acrylic construction, PE foam. Only<br>non-metal materials are used, like<br>foam and acrylic in the treatment<br>area. | Acrylic construction, PE foam. Only<br>non-metal materials are used, like<br>foam and acrylic in the treatment area. |
| Dimensions | Optimized dimensions (width) to be<br>CT-scanner compatible. | Optimized dimensions (width) to be<br>CT-scanner compatible. |
| Design / Shape | Baseplate, with an aperture for<br>placing headsupports. Above the<br>head the arms can be placed by<br>using armsupports. | Baseplate, with an aperture for placing<br>headsupports. Above the head the<br>arms can be placed by using<br>armsupports. |
| Possible adjustments | No adjustments possible. | No adjustments possible. |
| Couch fixation | The WingSTEP™ is fixed onto the<br>couch using indexing bars. | The PET-armsupport is fixed onto the<br>couch with fixationstrips. |
| Accessories | Various headsupports for a<br>comfortable patient positioning.<br>Armsupports for patient positioning. | Various headsupports for a<br>comfortable patient positioning.<br>Armsupports for patient positioning. |
| Compatibility with the<br>environment and<br>other devices | Due to the chosen construction and<br>materials, these products can be<br>used during both diagnostics and<br>radiotherapy. | Due to the chosen construction and<br>materials, these products can be used<br>during both diagnostics and<br>radiotherapy. |
510(k) summary.doc Document #:___
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Image /page/11/Picture/1 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The text is set against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo appears to be for a medical technology company.
#### 6. iCAST™
| | IT - V Medizintechnik GmbH |
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| Submitted by | Kranebitterbodenweg 40a…
