SINMED POSITIONING DEVICES

K060737 · Sinmed BV · IYE · Mar 31, 2006 · Radiology

Device Facts

• Record ID: K060737
• Device Name: SINMED POSITIONING DEVICES
• Applicant: Sinmed BV
• Product Code: IYE · Radiology
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. Fixation and (re)positioning of the patient during radiotherapy and diagnostics. Fixation and (re)positioning of the patient during radiotherapy and diagnostics.

Device Story

Sinmed immobilization systems consist of various baseplates, cushions, and thermoplastic masks used to secure patients in specific positions (prone, supine) during radiotherapy and diagnostic imaging. Baseplates (carbon fiber/acrylic) attach to treatment couches via rails; thermoplastic masks and foam supports (PE-foam) are used to immobilize specific body regions. Repovac vacuum cushions (polyurethane bags with polystyrene beads) create rigid molds of patient contours. Devices are used in clinical radiotherapy/diagnostic environments by healthcare professionals to ensure reproducible patient setup, improving treatment accuracy and patient comfort. No automated processing or software is involved.

Clinical Evidence

No clinical data or comparative investigations were performed. Substantial equivalence is based on design, material, and functional similarity to legally marketed predicate devices and established clinical experience.

Technological Characteristics

Materials: Carbon fiber sandwich, acrylic, PE-foam, polyurethane, polystyrene beads. Principle: Mechanical immobilization via baseplates, thermoplastic masks, and vacuum-formed cushions. Energy: None (passive). Form factor: Modular baseplates, cushions, and masks. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for radiotherapy and diagnostic patients requiring immobilization and positioning of the head, neck, thorax, lung, abdomen, pelvis, or lower extremities. Contraindications not specified.

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

• Bionix 3-Way Head immobilizator (K933613)
• Bionix Versaboard, Model 7040 (K030051)
• MedTec Carbon Fiber Breast Board (K974703)
• MedTec Bellyboard (K023293)
• MedTec Hip Fixation System (K950866)
• Med-Tec Vac-Loc immobilization system (K935300)
• Huestis Posicast Immobilization System (K926187)

Submission Summary (Full Text)

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K060737

# MAR 3 1 2006

510(k) summary, IYE- positioning devices

Image /page/0/Picture/3 description: The image shows the word "Sinmed" in bold, black letters. Below the word "Sinmed" are the words "Radiotherapy products" in a smaller font. The word "Sinmed" appears to be a company name or brand, and the words "Radiotherapy products" indicate the type of products the company offers.

Sinmed head and shoulder positioning and immobilization systems. (Baseplates)

| Date prepared | 23-09-05 | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Sinmed BV | |
| Address: | Pasteurstraat 6<br>2811 DX Reeuwijk<br>Phone: [phone]<br>Fax: [phone] | |
| Contact person: | Caroline de Keijzer (Quality Manager)<br>Leo de Mooy (Technical Director) | |
| Tradename: | -Posifix 1,2,4,5,7 head and neck systems<br>-Positilt head inclination system<br>-Posifix Pediatric<br>-Headsupports<br>-Blocks and wedges<br>-Shouldersupport cushion | |
| Common name: | Head and shoulders immobilization systems. | |
| Classification name: | Linear medical accelerator | |
| Classification: | Class 2 devices, 892.5050 IYE | |
| Intended use: | Fixation and (re)positioning of the head- and neck during radiotherapy and<br>diagnostics. | |
| Substantial Equivalence Device: | The Sinmed head and neck immobilization systems are defined as<br>Substantially Equivalent (SE) to the Bionix 3-Way Head immobilizator; 3Way<br>DeLuxe Reusable Frame, manufactured by Bionix Development corporation.<br>Registration number: 1526854) and cleared by FDA with K933613 | |
| Description of the devices: See Sinmed<br>product Catalogue 2006 | Page: 4<br>8<br>4<br>9<br>12<br>13 | Product:<br>-Posifix 1,2,4,5,7 head and neck systems<br>-Positilt head inclination system<br>-Posifix Pediatric<br>-Headsupports<br>-Blocks and wedges<br>-Shouldersupport cushion |
| Summary of the technological<br>characteristics of your device<br>compared to the predicate device | The Sinmed devices indicated above are all designed to position the head-<br>and neck of a patient for diagnostics and radiotherapy and exactly reposition<br>it several times. All these products can be used in combination with each<br>other to optimize the set-up of a patient. This is exactly the purpose of the<br>Bionix 3-Way Head Immobilizator. The same kind of construction and<br>materials are used to reach this. Products from both companies are used for<br>the same kind of radiotherapy treatments. These products from both | |

companies are really competitive systems

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Radiotherapy products

| | Sinmed head and neck immobilization baseplates | Bionix 3-WAY HEAD IMMOBILIZER |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Fixation and (re)positioning of the head- and neck during radiotherapy and diagnostics | Fixation and (re)positioning of the head and neck during radiotherapy and diagnostics |
| Target population. | Radiotherapy patients with tumors in head- and neck area. | Radiotherapy patients with tumors in head- and neck area. |
| Position of the patient | Lying on a couch in prone or supine position.<br>Shoulders and head are positioned by in a certain position using accessories for an optimized treatment. | When you're treating tumors in the head and neck region, accurate, reproducible positioning is essential. Our 3-Way Immobilizer works on prone, supine and lateral positioned patients. |
| Material | Carbon fiber and acrylic, polyethylene foam.<br>The skin contact materials carbon fiber and acrylic are exactly the same as those used in the predicate device. The cytotoxicity test of the carbon fiber top layer we use is enclosed in Chapter 11.<br>The PE-Foam material is commonly used in radiotherapy, the toxicity report is enclosed in Chapter 11. | Carbon fiber and acrylic version baseplates |
| Dimensions | Square shaped baseplate which follows the patients contours of head (Posifix -4, -5, -7, Positilt) or head and shoulders (Posifix-1 and - 2 and - Pediatric). | Square shaped baseplate which follows the patients contours of the head. |
| Design / Shape | Flat baseplate on which the thermoplastic mask and various headsupports can be placed.<br>Using the Positilt or other accessories, the baseplate can be inclined to change the position of the head. | Flat baseplate on which the thermoplastic mask and various headsupports can be placed. The baseplate can be inclined to change the position of the head. |
| Possible adjustments | Head can be lifted or inclined by using the blocks and wedges or the Positilt system. | Head can be tilted or inclined by using the 3-way head immobilizator. |
| Couchfixation | The Aluminium fixationrails connects the baseplate to the couch.<br>The adjustable aluminium rails can be mounted on all of our baseplates. They allow the baseplate to be locked down in the desired position on the simulator or treatment couch.<br>Depending on the type of couch, one can choose from several mounting brackets. | The SecureFit bar connects the baseplate to the couch. Our SecureFit bar was designed to index our immobilization devices to the Exact™ Couch for increased accuracy. |
| Accessories | Foam headsupports, blocks and wedges, which can position the head for an optimized treatment. Foam Shouldersupport cushion for a better and more comfortable positioning of the patient.<br>Thermoplastic mask-material which can be placed on the baseplate with plastic profiles. | Headsupports designed for a dedicated treatment can be used on these baseplates.<br>Foam blocks and wedges can be used for a better and more comfortable positioning of the patient.<br>Thermoplastic mask-material which can be placed on the baseplate with plastic profiles. |
| Compatibility with the environment and other devices | Can be used on all brands of couches in diagnostic and radiotherapy environment. | Can be used on an Exact™ couch in diagnostic and radiotherapy environment. |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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Image /page/2/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. Below the word "Sinmed" is the phrase "Radiotherapy products" in a smaller, lighter font. The word "Sinmed" is the main focus of the image, with the phrase below providing additional context.

## Sinmed head and shoulders immobilization systems. (Extensionplates)

| Date prepared | 23-09-05 | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Submitter | Sinmed BV | |
| Address: | Pasteurstraat 6<br>2811 DX Reeuwijk<br>Phone: [phone]<br>Fax: [phone] | |
| Contact person: | Caroline de Keijzer (Quality Manager)<br>Leo de Mooy (Technical Director) | |
| Tradename: | -Posifix-EXT systems<br>-Shoulderretractor<br>-Couchtop Cover | |
| Common name: | Head and shoulders immobilization systems | |
| Classification name: | Linear medical accelerator | |
| Classification: | Class 2 devices, 892.5050 IYE | |
| Intended use: | Fixation and (re)positioning of the head- and neck during radiotherapy and<br>diagnostics. | |
| Substantial Equivalence Device: | The Sinmed head and neck immobilization systems are defined as<br>Substantially Equivalent (SE) to the Bionix, Versaboard, Model 7040,<br>manufactured by Bionix Development Corporation, Registration number:<br>1526854) and cleared by FDA with K030051 | |
| Description of the devices: See Sinmed<br>product Catalogue 2006 | Page:<br>8<br>35<br>5 | Product:<br>Posifix-EXT systems<br>Shoulderretractor<br>Couchtop Cover |
| Summary of the technological<br>characteristics of your device compared<br>to the predicate device | The Sinmed Posifix-EXT system, in combination with the Shoulderretractor<br>and the Couchtopcover, can exactly be compared with the Bionix<br>Versaboard. These products from both companies are intended to position<br>the head- and neck of the patient outside the couch, to optimize the<br>treatment possibilities. The Bionix baseplate is longer and also supports<br>the back and buttocks of the patient. Sinmed has chosen to design a<br>shorter version, and creates this total support by using the couchtop cover.<br>On both systems the mask-material can be placed as well as a choice of<br>headsupports for the positioning of the head.<br>In order to further increase the space around the head of the patient, the<br>shoulders should be suppressed. Sinmed uses a separate Shoulder<br>retractor for this, and Bionix uses the relocatable shoulder suppression<br>system which can be integrated in the baseplate.<br>Both systems are placed and locked on the cranial side of the radiotherapy<br>treatment couch. Both systems are specially developed for use during<br>radiotherapy treatment, and not during diagnostics. | |

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Image /page/3/Picture/1 description: The image shows the word "Sinmed" in bold, black font. The letters are closely spaced together, creating a compact and easily readable word. The font appears to be sans-serif, giving it a modern and clean look. The word is likely a brand name or a company name.

Radiotherapy products

| | Sinmed head and neck immobilization | Bionix |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | baseplates (Extensionplate) | VERSABOARD, MODEL 7040 |
| | | |
| Intended use | Fixation and (re)positioning of the head- and<br>neck during radiotherapy, especially IMRT-<br>treatment. | Fixation and (re)positioning of the head- and neck<br>during diagnostics and radiotherapy.<br>This new board is ideal for IMRT and will solve many of<br>your hard to reach angles and maximize your treatment<br>angles. |
| Target population. | Patient with tumors in head- and neck-area,<br>treated with IMRT-techniques | Patient with tumors in head- and neck-area, treated with<br>IMRT-techniques |
| Special feature in<br>relation to head and<br>shoulder immob.<br>systems.(baseplates) | These extension plates position the head- and<br>shoulders of the patient outside the couch,<br>which enlarges the radiotherapy treatment<br>possibilities. | It extends off the couch for a broad range of treatment<br>options while improving therapy accuracy. |
| Position of the<br>patient | Shoulderretractor suppresses the shoulders for<br>an optimized treatment. | The optional relocatable shoulder suppression system<br>allows you to comfortably push down the shoulders for<br>better reproducibility. |
| Material | Carbon fiber sandwich construction, PE-foam.<br>The skin contact materials carbon fiber is<br>exactly the same as that used in the predicate<br>device. The cytotoxicity test of the carbon fiber<br>top layer we use is enclosed in Chapter 11.<br>The PE-Foam material is commonly used in<br>radiotherapy, the toxicity report is enclosed in<br>Chapter 11. | Carbon fiber sandwich construction.. |
| Dimensions | Baseplate supports the head and shoulders of<br>the patient. When also using the couchtop<br>cover, the patient support is completely flat<br>from head to buttocks. | Baseplate supports the patient from head to buttocks. |
| Design / Shape | Head- and shoulders are supported by the<br>baseplate and positioned outside the couch. | Head and shoulders are supported by the baseplate. It<br>extends off the couch for a broad range of treatment<br>options while improving therapy accuracy. |
| Possible<br>adjustments | No adjustments possible with the baseplate.<br>Adjustments in positioning of the head- and<br>shoulders can be done by using accessories<br>like different headsupports or the<br>shoulderretractor. | No adjustments possible with the baseplate.<br>Adjustments in positioning of the head- and shoulders<br>can be done by using accessories like different<br>headsupports or the shoulder suppression system. |
| Couchfixation | Flat baseplate which hooks onto the cranial<br>side of the treatment couch and can be locked.<br>After mounting onto the couch, the construction<br>is fixed with a locking mechanism. | Baseplate can be placed on the couch and attached<br>onto the cranial side. |
| Accessories | -Thermoplastic mask-material which can be<br>placed on the baseplate with fixation profiles.<br>-Various headsupports designed for a<br>dedicated treatment can be used on this<br>baseplate.<br>-Couchtop Cover to overcome the height<br>difference when also using other baseplates. | -Thermoplastic mask-material which can be placed on<br>the baseplate with plastic profiles.<br>- Headsupports designed for a dedicated treatment can<br>be used on this baseplate. |
| Compatibility with<br>the environment and<br>other devices | Three types of which each can be placed on a<br>Varian, Siemens or Elekta couch. | Can be placed on a Varian couch |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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Image /page/4/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. Below the word "Sinmed" is the phrase "Radiotherapy products" in a smaller, regular font. The word "Sinmed" appears to be the name of a company or brand, and the phrase "Radiotherapy products" indicates the type of products that the company offers.

## Sinmed lung and thorax immobilization systems

| Date prepared | 23-09-05 | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Submitter | Sinmed BV | | | | | | | | | | |
| Address: | Pasteurstraat 6<br>2811 DX Reeuwijk<br>Phone: [phone]<br>Fax: [phone] | | | | | | | | | | |
| Contact person: | Caroline de Keijzer (Quality Manager)<br>Leo de Mooy (Technical Director) | | | | | | | | | | |
| Tradename: | -Thorawedge<br>-Posirest<br>-Posiboard<br>-PET-armsupport | | | | | | | | | | |
| Common name: | Lung and thorax immobilization systems | | | | | | | | | | |
| Classification name: | Linear medical accelerator | | | | | | | | | | |
| Classification: | Class 2 devices, 892.5050 IYE | | | | | | | | | | |
| Intended use: | Positioning the patient for irradiation in the lung- and thorax area. | | | | | | | | | | |
| Substantial Equivalence Device: | The Sinmed Lung and thorax immobilization systems are defined as<br>Substantially Equivalent (SE) to the MedTec CARBON FIBER BREAST<br>BOARD, manufactured by MED-TEC,INC. (Registration number:<br>1932738) and cleared by FDA with K974703. | | | | | | | | | | |
| Description of the devices: See Sinmed<br>product Catalogue 2006 | Page: Product: 27 Thorawedge 26 Posirest 23 Posiboard 29 PET-armsupport | | | | | | | | | | |
| Summary of the technological<br>characteristics of your device compared<br>to the predicate device | The Medtec Breastboard is a device intended to position patients<br>undergoing irradiation treatment in the breast- and lung area. This is<br>exactly the same purpose of the Sinmed devices in this group.<br>The patient support of the Medtec Breastboard can be inclined for better<br>treatment. This same inclination of the upper body is also possible with the<br>Sinmed Posiboard and the Thorawedge.<br>To keep the arms out of the treatment area, arms above the head, various<br>armsupports can fixed on the Medtec Breastboard. This fixation of<br>armsupports is also possible on the Sinmed Posiboard. This positioning of<br>the arms above the head to achieve more space around the breast and<br>lung-area is also the exact intended use of the Sinmed Posirest and PET-<br>armsupport and the Thorawedge system.<br>The features of the Medtec Breastboard can all be found in the Sinmed<br>Posiboard. The other three Sinmed lung and thorax immobilization<br>systems are less complicated devices with the same purpose, each with | | | | | | | | | | |

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Image /page/5/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.

Radiotherapy products

| | Sinmed Lung and thorax | MedTec<br>Carbon Fiber Breast Board |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | immobilization systems | |
| Intended use | Positioning the patient for irradiation in the<br>lung- and thorax area. | Positioning the patient for irradiation in the lung-<br>and thorax area. |
| Target<br>population. | Patients with tumors in breast and thorax. | Patients with tumors in breast and thorax |
| Position of the<br>patient | Supine position, can be inclined, with arms<br>positioned above the head | Supine position, can be inclined, with arms<br>positioned above the head |
| Material | Carbon fiber sandwich construction, PE-<br>Foam, and acrylic. Only non-metal<br>materials are used, like foam, acrylic and<br>carbon fiber sandwich in the treatment<br>area.<br>The skin contact material carbon fiber is<br>exactly the same as that used in the<br>predicate device. The cytotoxicity test of<br>the carbon fiber top layer we use is<br>enclosed in Chapter 11.<br>The PE-Foam material is commonly used<br>in radiotherapy, the toxicity report is<br>enclosed in Chapter 11.<br>The acrylic material is the same used in the<br>Sinmed head and shoulder positioning and<br>immobilization systems. (baseplates) and<br>is identical to the material used in the<br>predicate device Bionix 3-WAY HEAD<br>IMMOBILIZER. | Carbon-fiber sandwich, there are no metal<br>components in the vital scanning and treatment<br>areas making it even more "CT-friendly"; |
| Dimensions | Optimized dimensions (width) to be CT-<br>scanner compatible | Available in both standard and CT-compatible<br>widths. |
| Design / Shape | Baseplate, with an aperture for placing<br>various headsupports, Above the head the<br>arms can be placed by using various<br>armsupports. | Baseplate, with an aperture for placing various<br>headsupports, Above the head the arms can be<br>placed by using various armsupports. |
| Possible<br>adjustments | 0-25 degrees inclination possible with<br>Posiboard and Thorawedge.<br>0 degrees inclination with Posirest and<br>PET-armsupport. | 0-25 degrees inclination possible. |
| Couchfixation | Posirest, Posiboard, PET-armsupport is<br>fixed onto the couch with fixationstrips. | The Medtec Carbon Fiber Breastboard is fixed onto<br>the couch using the MedTec fixation rails. |
| Accessories | Various headsupports for a comfortable<br>patient positioning. Various armsupports<br>for patient positioning. | Various headsupports for a comfortable patient<br>positioning. Various armsupports for patient<br>positioning. |
| Compatibility<br>with the<br>environment<br>and other<br>devices | Due to the chosen construction and<br>materials, these products can be used<br>during both diagnostics and radiotherapy. | Due to the chosen construction and materials,<br>these products can be used during both<br>diagnostics and radiotherapy. |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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### Sinmed pelvis and lower extremities immobilization systems (Bellyboard system)

| Date prepared | 23-09-05 |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Sinmed BV |
| Address: | Pasteurstraat 6<br>2811 DX Reeuwijk<br>Phone: [phone]<br>Fax: [phone]…