Patient Positioning Devices

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 27, 2015 MacroMedics BV % Ms.Caroline de Keijzer Quality Manager Kouwe Hoek 18 2741 PX Waddinxveen THE NETHERLANDS Re: K142420 Trade/Device Name: Patient Positioning Devices Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: II Product Code: IYE, LNH Dated: February 20, 2015 Received: February 23, 2015 Dear Ms. de Keijzer: 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara for Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 2.5-Indications for Use DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K142420 Device Name Patient Positioning Devices Indications for Use (Describe) Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:inline-block"><img alt="Checked" src="checkbox_checked.png"/></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block"><img alt="Unchecked" src="checkbox_unchecked.png"/></div> Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller font. # 510(k) Summary of safety and effectiveness (As required by 21 CFR 807.92) | Applicant: | MacroMedics BV | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Kouwe Hoek 18, 2741PX, Waddinxveen,<br>The Netherlands | | Phone:<br>Fax: | 0031-(0)182 389777<br>0031-(0)182 389778 | | Contact person: | Caroline de Keijzer, Quality and Regulatory Manager | | Prepare date: | June 13, 2014 | | Establishment Registration<br>Number: | 10046168 | | FDA Type: | Traditional 510(k) | | Common name: | -Head and neck positioning systems.<br>-Lung and thorax positioning systems<br>-Pelvic and lower extremities positioning systems<br>-SBRT systems<br>-Thermoplastic positioning systems | | Trade / Proprietary name: | Patient Positioning Devices | | Classification: | Class 2 devices, 892.5050, IYE, LNH | | Review panels: | Radiology | | Performance standards: | No applicable performance standards have been issued<br>under section 514 of the Food, Drug and Cosmetic act. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for "macromedics". The logo consists of a blue circle with a stylized "m" inside it, followed by the word "macromedics" in blue. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller blue font. #### Head and neck positioning systems (1/2) ExaFix-5 ExaFix-5A ExaTilt ExaFix-IMRT baseplate ExaFix-IMRT baseplate MR MaxSupport 1,2,3,4,5,6,7 Block low, Block high Wedge 7, 5, 10, 15 MaxSupport 25,35,45 #### Intended use / Indications for use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. #### Device description: Baseplates and headsupports which are designed to position the head and neck and on which thermoplastic masks can be attached to fix the head and neck of the patient. Baseplates can be positioned on the couch using CouchStrips. The ExaFix-IMRT baseplates are attached onto the couches and extent the head of the patient from the couch at the cranial side. Various accessories offered for specific patient head and neck set-ups. The different headsupports are designed for different head positions. Different blocks are available for lifting the head, wedges and ExaTilt to incline the head. For the Exafix-5 baseplate an acrylic alternative (Exafix-5a) is available for identical head- and neck positioning in the MR environment. For the IMRT baseplates a glassfiber alternative (Exafix IMRT baseplate MR) is available for identical head- and neck positioning in MR environment. The MR safe devices have a 3Pin slot on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. | MacroMedics devices | Predicate devices: | 510(k) number: | |--------------------------------------------------------------------|--------------------------|---------------------------------| | ExaFix-5 | Sinmed Posifix-2 | K060737 (IYE) | | ExaFix-5A | Sinmed Posifix-1 | K060737 (IYE) | | | | K093738 (LNH, reference device) | | ExaTilt | Sinmed Positilt | K060737 (IYE) | | ExaFix-IMRT baseplate | Sinmed IMRT baseplate | K060737 (IYE) | | ExaFix-IMRT baseplate MR | Sinmed IMRT baseplate | K060737 (IYE) | | | | K093738 (LNH, reference device) | | MaxSupport 1,2,3,4,5,6,7 | Sinmed headsupports | K060737 (IYE) | | | | K093738 (LNH, reference device) | | Block low, Block high<br>Wedge 7, 5, 10, 15<br>MaxSupport 25,35,45 | Sinmed Blocks and wedges | K060737 (IYE) | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for "macromedics", a company that provides solutions in radiotherapy. The logo consists of a stylized letter "m" inside a circle on the left, followed by the company name in a sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller font size. #### Head and neck positioning systems (2/2) #### Comparision of technological characteristics: The designs of the MacroMedics and predicate head and neck positioning systems are equivalent in shape, construction materials and functionality. Both the Sinmed devices and the MacroMedics devices are made out of carbon fiber, PE foam and acrylic. MacroMedics uses glass fiber for the MR safe alternative of the carbon fiber IMRT baseplates. The Sinmed headsupports are made out of PE foam, the MacroMedics headsupports have a PU-foam alternative. Both the biocompatibility and the MR safety of these new materials have been described in this 510(k). #### Substantial equivalence summary: MacroMedics claims the proposed head and neck positioning systems to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment. MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials. Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics. #### Conclusions: {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is a logo for "macromedics". The logo features a stylized letter "m" inside a circle on the left side. To the right of the symbol is the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. #### Lung and thorax positioning systems (1/2) BreastBoard LX ThoraxSupport ThoraxSupport MR #### Intended use / Indications for use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. #### Device description: The BreastBoard LX and ThoraxSupports are devices which position the breast and lung area of a patient. The arms are placed above the head and a headsupport can be placed into the baseplate. The backsupport of the BreastBoard LX can be tilted, to tilt the upperpart of the patient´s body for other treatment possibilities. The ThoraxSupport does not have this tilting possibility. Various accessories are provided for positioning of the arms or the thorax. For the ThoraxSupport a glassfiber MR alternative (Thoraxsupport MR) is available for identical lung and thorax positioning in MR environment. The MR safe device has a 3Pin slot on the bottomside and is compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. | MacroMedics Devices | Predicate devices: | 510(k) number: | |---------------------|--------------------|--------------------------------------------------| | BreastBoard LX | Sinmed Posiboard | K060737 (IYE) | | ThoraxSupport | Sinmed Posirest | K060737 (IYE) | | ThoraxSupport MR | Sinmed Posirest | K060737 (IYE)<br>K093738 (LNH, reference device) | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for Macromedcis. The logo features a blue circle with a stylized "m" inside of it. To the right of the circle is the word "macromedics" in a sans-serif font, also in blue. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller, lighter blue font. #### Lung- and thorax positioning systems (2/2) #### Comparision of technological characteristics: The designs of the MacroMedics and predicate lung and thorax positioning systems are equivalent in shape, construction, materials and functionality. Both the Sinmed devices and the MacroMedics devices are made out of carbon fiber with components of plastic, aluminium and foam. MacroMedics uses glass fiber for the MR safe alternative of the ThoraxSupport. Both the biocompatibility and the MR safety of these new materials have been described in this 510(k). #### Substantial equivalence summary: MacroMedics claims the proposed lung and thorax positioning systems to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment. MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials. Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics. #### Conclusions: {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Macromedics. On the left is a blue circle with a stylized "m" inside. To the right of the circle is the word "macromedics" in a sans-serif font, also in blue. Below the word "macromedics" are the words "SOLUTIONS IN RADIOTHERAPY" in a smaller, sans-serif font. #### Pelvic and lower extremities positioning systems (1/2) Pelvic Prone Board Pelvic Prone Board MR LEPS #### Intended use / Indications for use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. #### Device description: Baseplates which are designed to position the pelvic or (lower) extremities of a patient. The Pelvic Prone Board positions the patient in prone position with the arms in cranial direction, belly is placed in an aperture. The shape of the pelvic prone board moves the small bowel and reduces the irradiated small bowel volume while treating the lower abdomen. The LEPS position the legs on a KneeSupport which can be tilted and the feet are positioned in a FeetSupport. Both baseplates can be positioned on the couch using fixation rails. For the Pelvic Prone Board a glassfiber MR alternative (Pelvic Prone Board MR) is available for identical positioning in MR environment. The LEPS is a MR safe device. The MR safe devices have 3Pin slots on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe device is not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. | MacroMedics Devices | Predicate | 510(k) number: | |-----------------------|-------------------|--------------------------------------------------------| | Pelvic Prone Board | Sinmed Bellyboard | K060737 (IYE) | | Pelvic Prone Board MR | Sinmed Bellyboard | K060737 (IYE)<br>K121545 (LNH & IYE, reference device) | | LEPS | Sinmed Combifix | K060737(IYE)<br>K093738 (LNH, reference device) | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a circular icon with a stylized "m" inside, followed by the company name "macromedics" in a sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in smaller letters. #### Pelvic and lower extremities positioning systems (2/2) #### Comparision of technological characteristics: The designs of the MacroMedics and predicate pelvic and lower extremities positioning systems are equivalent in shape, construction, materials and functionality. Both the Sinmed devices and the MacroMedics devices are made out of carbon fiber with components of plastic and foam. MacroMedics uses glass fiber for the MR safe alternative of the Pelvic Prone Board. Both the biocompatibility and the MR safety of this different material have been described in this 510(k). #### Substantial equivalence summary: MacroMedics claims the pelvic and lower extremities positioning systems to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment. MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials. Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics. #### Conclusions: {10}------------------------------------------------ Image /page/10/Picture/1 description: The image is a logo for "macromedics". The logo features a stylized letter "m" enclosed in a circle on the left side. To the right of the symbol is the word "macromedics" in a sans-serif font. Below the company name is the text "SOLUTIONS IN RADIOTHERAPY". ## SBRT systems (1/2) SBRT EAMIS SBRT EAMIS Lite SBRT OmniBoard (UATB) SBRT MultiBoard (UTB) SBRT MultiFrame (UTF) VacuumCushions CouchStrips #### Intended use / Indications for use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. #### Device description: The SBRT systems (Stereotactic Body Radiation Therapy Systems) are devices which can position various bodyparts of the patient. The MacroMedics SBRT systems are carbon fiber baseplates over which various plastic bridges can be placed with attached accessories to position the patient's body. The SBRT OmniBoard does have an inclination possibility of the upper body. The accessories are identical, but the baseboards are different, each baseboard has slightly different features for customer preferences. The patient set-up is similar on all boards, supine position with the arms mainly positioned above the patient's head. Bottom, knees and feet positioned in indexed positions. Vacuumcushions are used for positioning by moulding the cushion around the patients and then take the air out with a vacuumpump. The contrashape of the patient stays in the cushion during the treatment. CouchStrips are strips which connect the patient positioning device onto the couch at indexed positions. Depending on the indexing system of the couch, width of the couch, preference in transverse adjustability and required MR safety different types are available. The SBRT carbon fiber baseplates are MR unsafe and have a 2Pin CouchStrip slot. They are not compatible with the 3Pin MR CouchStrip, which prevents the use in the wrong environment. The CouchStrips for MR are made out of MR safe materials and have 3pins. MR unsafe devices have a 2Pin CouchStrip slot on the bottomside and are not compatible with this 3Pin MR CouchStrip. The Vacuumcushions are MR safe. | MacroMedics Devices | Predicate devices: | 510(k) number: | |-----------------------|-------------------------|--------------------------------------------------| | SBRT EAMIS | CIVCO Body Pro Lok | K111340 (LNH & IYE) | | SBRT OmniBoard (UATB) | CIVCO Body Pro Lok | K111340 (LNH & IYE) | | SBRT MultiBoard (UTB) | CIVCO Body Pro Lok | K111340 (LNH & IYE) | | SBRT MultiFrame (UTF) | CIVCO Body Pro Lok | K111340 (LNH & IYE) | | SBRT EAMIS Lite | CIVCO Rails-Only System | K111340 (LNH & IYE) | | CouchStrips | CIVCO LokBar | K111340 (LNH & IYE) | | VacuumCushions | Sinmed Repovac Cushions | K060737 (IYE)<br>K093738 (LNH, reference device) | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for "macromedics". The logo consists of a circular icon with a stylized "m" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font size. The logo is in a light blue color. ## SBRT systems (2/2) #### Comparision of technological characteristics: The designs of the MacroMedics and predicate SBRT positioning systems are equivalent in construction, accessories, materials and functionality. Both the predicate and the MacroMedics SBRT devices are made out of carbon fiber baseplates with bridges of plastic which clamp on the sides of the baseplates, foam head- knee and FeetSupports can be placed at indexed positions. MacroMedics and Sinmed vacuum cushions are both constructed with a small polystyrene bullets in a nylon bag and a valve for creating vacuum. MacroMedics CouchStrips and the CIVCO LokBars have similar designs, almost identical dimensions and materials. MacroMedics added a carbon fiber alternative for its good mechanical and dosimetric properties. #### Substantial equivalence summary: MacroMedics claims the proposed SBRT systems to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment. MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials. Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics. #### Conclusions: {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Macromedics. The logo consists of a circular icon with a stylized "M" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the tagline "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The logo is primarily in a light blue color. ## Thermoplastic positioning systems (1/2) Thermoplastics various sizes and profiles DSPS & SSPS thermoplastic masks DSPS & SSPS cradles #### Intended use / Indications for use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. #### Device description: MacroMedics thermoplastic masks are developed in order to position the individual patient. The thermoplastic masks are placed in a waterbath of about 70 degrees where they become flexible. After drying and cooling, they make a perfect contramould of the bodypart which needs to be positioned. Plastic profiles attach the mask onto the baseplate. Masks and profiles are available in many different shapes, in order to fit on different baseplates and bodyparts. DSPS offers a possibility to create a thermoplastic mask for both occipital- and facial areas for extra accurate positioning. Both masks are attached onto the DSPS cradle, and the DSPS cradle is attached onto the baseplate. MacroMedics thermoplastic masks with plastic profiles are MR safe. | MacroMedics devices Predicate devices: | | 510(k) number: | |-------------------------------------------|-------------------------|---------------------------------| | Thermoplastics various sizes | Sinmed Posicast | K060737 (IYE) | | and profiles | immobilization system | K093738 (LNH, reference device) | | DSPS & SSPS thermoplastic | CIVCO head | K080072 (IYE) | | masks | immobilization plastics | K093738 (LNH, reference device) | {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for "macromedics". The logo consists of a circular icon with a stylized "m" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. ## Thermoplastic positioning systems (2/2) #### Comparision of technological characteristics: The designs of the MacroMedics and predicate systems are equivalent in construction, design, materials and functionality. Both the predicate and the MacroMedics masks are made out of thermoplastics which are cut in shape and glued or welded into plastic injection moulded profiles. Both thermoplastic masks become soft in warm water and make a contrashape of the patient and are connected onto a baseplate, where they become a rigid patient positioning device after cooling. The DSPS cradle is made out of a carbon fiber construction and can be positioned on the baseplate. With the DSPS both a facial and occipital contrashape can be moulded and fixed. The predicate Medtec and CIVCO devices provide a similar occipital moulding possibility. #### Substantial equivalence summary: MacroMedics claims the proposed thermoplastic positioning systems to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment. MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, product handling, patient positioning and used materials. Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics. #### Conclusions: