(11 days)
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.
The submission describes several types of immobilization systems and cushions for radiotherapy and diagnostics:
- Head and shoulder positioning and immobilization systems (Baseplates): Posifix 1,2,4,5,7 head and neck systems, Positilt head inclination system, Posifix Pediatric, Headsupports, Blocks and wedges, Shouldersupport cushion. These are designed to position and reposition the head and neck.
- Head and shoulders immobilization systems (Extensionplates): Posifix-EXT systems, Shoulderretractor, Couchtop Cover. These are intended to position the head and neck outside the couch.
- Lung and thorax immobilization systems: Thorawedge, Posirest, Posiboard, PET-armsupport. These are for positioning the patient for irradiation in the lung and thorax area.
- Pelvis and lower extremities immobilization systems (Bellyboard system): Bellyboard, Prone thorax support cushion for Bellyboard. These are developed to reduce irradiated small bowel volume in gynaecological patients.
- Pelvis and lower extremities immobilization systems: Posifix-12, Multifix, Combifix-system (Baseplate with Kneefix and Feetfix), Multi Purpose Support cushions. These are for positioning of hip and lower extremities.
- Repovac Cushions: Vacuum cushions filled with polystyrene beads that can be made vacuum to follow and keep the contour of a patient for reproducible positioning.
- Posicast immobilization systems: Thermoplastic mask material for patient immobilization.
The provided text is a 510(k) summary for Sinmed Radiotherapy products, including immobilization systems for various body parts and Repovac cushions. The document states that "No comparative investigations are performed" and "No clinical comparative tests are necessary" because the Sinmed devices are stated to be "substantially equivalent" to predicate devices, or in one case, "exactly the same" as a previously registered device. Therefore, it does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices, implying that the acceptance criteria are met by virtue of this equivalence and the known function of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy of immobilization in mm, reproducibility over time, specific clinical outcomes) for the Sinmed devices. The primary "performance" reported is that they are technologically equivalent and function in the same way as the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Similar to predicate device (Fixation and (re)positioning during radiotherapy and diagnostics for various body parts) | Functions for the same purpose as predicate device; "exactly the same" as predicate in one case. |
| Technological Characteristics: Similar materials, design, dimensions, possible adjustments, couch fixation, accessories, and compatibility as predicate devices. | "Same kind of construction and materials are used," "all features can be found." |
| Safety and Effectiveness: Assumed to be safe and effective due to substantial equivalence to predicate devices, which are legally marketed. | No specific safety or effectiveness data beyond material biocompatibility tests (cytotoxicity reports mentioned as enclosed in Chapter 11, but not detailed here). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that "No comparative investigations are performed" and "No clinical comparative tests are necessary." Therefore, there is no test set sample size and no data provenance from a clinical study for performance evaluation. The data provenance mentioned refers to the predicate devices and their existing registrations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no comparative investigation or clinical study with a test set was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no comparative investigation or clinical study with a test set was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The devices are physical immobilization systems, not AI-powered diagnostic tools, so MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the devices are physical immobilization systems, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of this 510(k) submission, is established by substantial equivalence to legally marketed predicate devices. This implies that the predicate devices' established safety and effectiveness, based on their prior clearances and clinical experience, serve as the "ground truth" for what constitutes acceptable performance and safety for similar devices. The document refers to "clinical experience" with both predicate and proposed devices to argue that they "function in the same way."
8. The sample size for the training set
Not applicable, as the devices are physical immobilization systems, not machine learning models requiring training data.
9. How the ground truth for the training set was established
Not applicable, as the devices are physical immobilization systems, not machine learning models.
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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 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 | |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) | |
| Tradename: | -Posifix 1,2,4,5,7 head and neck systems-Positilt head inclination system-Posifix Pediatric-Headsupports-Blocks and wedges-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 anddiagnostics. | |
| Substantial Equivalence Device: | The Sinmed head and neck immobilization systems are defined asSubstantially Equivalent (SE) to the Bionix 3-Way Head immobilizator; 3WayDeLuxe Reusable Frame, manufactured by Bionix Development corporation.Registration number: 1526854) and cleared by FDA with K933613 | |
| Description of the devices: See Sinmedproduct Catalogue 2006 | Page: 48491213 | Product:-Posifix 1,2,4,5,7 head and neck systems-Positilt head inclination system-Posifix Pediatric-Headsupports-Blocks and wedges-Shouldersupport cushion |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | The Sinmed devices indicated above are all designed to position the head-and neck of a patient for diagnostics and radiotherapy and exactly repositionit several times. All these products can be used in combination with eachother to optimize the set-up of a patient. This is exactly the purpose of theBionix 3-Way Head Immobilizator. The same kind of construction andmaterials are used to reach this. Products from both companies are used forthe same kind of radiotherapy treatments. These products from both |
companies are really competitive systems
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Image /page/1/Picture/1 description: The image shows the word "Sinmed" in bold, black letters. The first letter, "S", is enclosed in parentheses. The word is printed in a simple, sans-serif font. The background is white.
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.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.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.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.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.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.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.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.Foam blocks and wedges can be used for a better and more comfortable positioning of the patient.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 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 | |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) | |
| Tradename: | -Posifix-EXT systems-Shoulderretractor-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 anddiagnostics. | |
| Substantial Equivalence Device: | The Sinmed head and neck immobilization systems are defined asSubstantially Equivalent (SE) to the Bionix, Versaboard, Model 7040,manufactured by Bionix Development Corporation, Registration number:1526854) and cleared by FDA with K030051 | |
| Description of the devices: See Sinmedproduct Catalogue 2006 | Page:8355 | Product:Posifix-EXT systemsShoulderretractorCouchtop Cover |
| Summary of the technologicalcharacteristics of your device comparedto the predicate device | The Sinmed Posifix-EXT system, in combination with the Shoulderretractorand the Couchtopcover, can exactly be compared with the BionixVersaboard. These products from both companies are intended to positionthe head- and neck of the patient outside the couch, to optimize thetreatment possibilities. The Bionix baseplate is longer and also supportsthe back and buttocks of the patient. Sinmed has chosen to design ashorter version, and creates this total support by using the couchtop cover.On both systems the mask-material can be placed as well as a choice ofheadsupports for the positioning of the head.In order to further increase the space around the head of the patient, theshoulders should be suppressed. Sinmed uses a separate Shoulderretractor for this, and Bionix uses the relocatable shoulder suppressionsystem which can be integrated in the baseplate.Both systems are placed and locked on the cranial side of the radiotherapytreatment couch. Both systems are specially developed for use duringradiotherapy 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- andneck during radiotherapy, especially IMRT-treatment. | Fixation and (re)positioning of the head- and neckduring diagnostics and radiotherapy.This new board is ideal for IMRT and will solve many ofyour hard to reach angles and maximize your treatmentangles. |
| Target population. | Patient with tumors in head- and neck-area,treated with IMRT-techniques | Patient with tumors in head- and neck-area, treated withIMRT-techniques |
| Special feature inrelation to head andshoulder immob.systems.(baseplates) | These extension plates position the head- andshoulders of the patient outside the couch,which enlarges the radiotherapy treatmentpossibilities. | It extends off the couch for a broad range of treatmentoptions while improving therapy accuracy. |
| Position of thepatient | Shoulderretractor suppresses the shoulders foran optimized treatment. | The optional relocatable shoulder suppression systemallows you to comfortably push down the shoulders forbetter reproducibility. |
| Material | Carbon fiber sandwich construction, PE-foam.The skin contact materials carbon fiber isexactly the same as that used in the predicatedevice. The cytotoxicity test of the carbon fibertop layer we use is enclosed in Chapter 11.The PE-Foam material is commonly used inradiotherapy, the toxicity report is enclosed inChapter 11. | Carbon fiber sandwich construction.. |
| Dimensions | Baseplate supports the head and shoulders ofthe patient. When also using the couchtopcover, the patient support is completely flatfrom head to buttocks. | Baseplate supports the patient from head to buttocks. |
| Design / Shape | Head- and shoulders are supported by thebaseplate and positioned outside the couch. | Head and shoulders are supported by the baseplate. Itextends off the couch for a broad range of treatmentoptions while improving therapy accuracy. |
| Possibleadjustments | No adjustments possible with the baseplate.Adjustments in positioning of the head- andshoulders can be done by using accessorieslike different headsupports or theshoulderretractor. | No adjustments possible with the baseplate.Adjustments in positioning of the head- and shoulderscan be done by using accessories like differentheadsupports or the shoulder suppression system. |
| Couchfixation | Flat baseplate which hooks onto the cranialside of the treatment couch and can be locked.After mounting onto the couch, the constructionis fixed with a locking mechanism. | Baseplate can be placed on the couch and attachedonto the cranial side. |
| Accessories | -Thermoplastic mask-material which can beplaced on the baseplate with fixation profiles.-Various headsupports designed for adedicated treatment can be used on thisbaseplate.-Couchtop Cover to overcome the heightdifference when also using other baseplates. | -Thermoplastic mask-material which can be placed onthe baseplate with plastic profiles.- Headsupports designed for a dedicated treatment canbe used on this baseplate. |
| Compatibility withthe environment andother devices | Three types of which each can be placed on aVarian, 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.
2-16
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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 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 | ||||||||||
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) | ||||||||||
| Tradename: | -Thorawedge-Posirest-Posiboard-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 asSubstantially Equivalent (SE) to the MedTec CARBON FIBER BREASTBOARD, manufactured by MED-TEC,INC. (Registration number:1932738) and cleared by FDA with K974703. | ||||||||||
| Description of the devices: See Sinmedproduct Catalogue 2006 | Page: Product: 27 Thorawedge 26 Posirest 23 Posiboard 29 PET-armsupport | ||||||||||
| Summary of the technologicalcharacteristics of your device comparedto the predicate device | The Medtec Breastboard is a device intended to position patientsundergoing irradiation treatment in the breast- and lung area. This isexactly the same purpose of the Sinmed devices in this group.The patient support of the Medtec Breastboard can be inclined for bettertreatment. This same inclination of the upper body is also possible with theSinmed Posiboard and the Thorawedge.To keep the arms out of the treatment area, arms above the head, variousarmsupports can fixed on the Medtec Breastboard. This fixation ofarmsupports is also possible on the Sinmed Posiboard. This positioning ofthe arms above the head to achieve more space around the breast andlung-area is also the exact intended use of the Sinmed Posirest and PET-armsupport and the Thorawedge system.The features of the Medtec Breastboard can all be found in the SinmedPosiboard. The other three Sinmed lung and thorax immobilizationsystems 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 | MedTecCarbon Fiber Breast Board | |
|---|---|---|
| immobilization systems | ||
| Intended use | Positioning the patient for irradiation in thelung- and thorax area. | Positioning the patient for irradiation in the lung-and thorax area. |
| Targetpopulation. | Patients with tumors in breast and thorax. | Patients with tumors in breast and thorax |
| Position of thepatient | Supine position, can be inclined, with armspositioned above the head | Supine position, can be inclined, with armspositioned above the head |
| Material | Carbon fiber sandwich construction, PE-Foam, and acrylic. Only non-metalmaterials are used, like foam, acrylic andcarbon fiber sandwich in the treatmentarea.The skin contact material carbon fiber isexactly the same as that used in thepredicate device. The cytotoxicity test ofthe carbon fiber top layer we use isenclosed in Chapter 11.The PE-Foam material is commonly usedin radiotherapy, the toxicity report isenclosed in Chapter 11.The acrylic material is the same used in theSinmed head and shoulder positioning andimmobilization systems. (baseplates) andis identical to the material used in thepredicate device Bionix 3-WAY HEADIMMOBILIZER. | Carbon-fiber sandwich, there are no metalcomponents in the vital scanning and treatmentareas making it even more "CT-friendly"; |
| Dimensions | Optimized dimensions (width) to be CT-scanner compatible | Available in both standard and CT-compatiblewidths. |
| Design / Shape | Baseplate, with an aperture for placingvarious headsupports, Above the head thearms can be placed by using variousarmsupports. | Baseplate, with an aperture for placing variousheadsupports, Above the head the arms can beplaced by using various armsupports. |
| Possibleadjustments | 0-25 degrees inclination possible withPosiboard and Thorawedge.0 degrees inclination with Posirest andPET-armsupport. | 0-25 degrees inclination possible. |
| Couchfixation | Posirest, Posiboard, PET-armsupport isfixed onto the couch with fixationstrips. | The Medtec Carbon Fiber Breastboard is fixed ontothe couch using the MedTec fixation rails. |
| Accessories | Various headsupports for a comfortablepatient positioning. Various armsupportsfor patient positioning. | Various headsupports for a comfortable patientpositioning. Various armsupports for patientpositioning. |
| Compatibilitywith theenvironmentand otherdevices | Due to the chosen construction andmaterials, these products can be usedduring both diagnostics and radiotherapy. | Due to the chosen construction and materials,these products can be used during bothdiagnostics 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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Image /page/6/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, less bold font. The text is black against a white background.
Sinmed pelvis and lower extremities immobilization systems (Bellyboard system)
| Date prepared | 23-09-05 |
|---|---|
| Submitter | Sinmed BV |
| Address: | Pasteurstraat 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) |
| Tradename: | BellyboardProne thorax support cushion for Bellyboard |
| Common name: | Pelvis and lower extremities immobilization systems (Bellyboard system) |
| Classification name: | Linear medical accelerator |
| Classification: | Class 2 devices, 892.5050 IYE |
| Intended use: | The Sinmed Bellyboard has been developed in order to reduce theirradiated small bowel volume of gynaecological patients undergoingtreatment in the pelvic region. |
| Substantial Equivalence Device: | The Sinmed Pelvis and lower extremities immobilization systems(Bellyboard) are defined as Substantially Equivalent (SE) to the MedTecBellyboard, manufactured by MedTec. INC.(Registration number: 1932738) and cleared by FDA with K023293. |
| Description of the devices: See Sinmedproduct Catalogue 2006 | Page: 31Product: BellyboardPage: 32Prone thorax support for Bellyboard |
| Summary of the technologicalcharacteristics of your device comparedto the predicate device | The Sinmed Bellyboard is substantially equivalent to the MedTecAdvanced Belly board System in design, construction, and function. TheSinmed BellyBoard is flat and has a similar, generally roundedrectangular-shaped contour, with areas specifically designed for thehead, abdomen, and thighs. The Prone Thorax support cushion has acontoured opening so that the patient may rest his/her head comfortablyin the prone position during the treatment process. The abdominalcushion is also designed with an open, contoured cut out region. Thepatient is positioned over the abdominal cushion such that the belly dropsinto the cut out region during the radiation therapy session. The SinmedBellyBoard is constructed in a manner similar to the Advanced Bellyboard System from Med-Tec. having a hollow thermoformed |
thermoplastic shell.
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Sinmed
Radiotherapy products
| Sinmed Bellyboard system | MedTec Bellyboard | |
|---|---|---|
| Intended use | The Sinmed Bellyboard has beendeveloped in order to reduce theirradiated small bowel volume ofgynaecological patients undergoingtreatment in the pelvic region. | The Intermediate Bellyboard features a standard-sized portal for displacement of the small bowel ofgynecological patients. |
| Target population | Patients with tumors in the lower-abdomen area | Patients with tumors in the lower-abdomen area |
| Position of thepatient | Prone position on this device | Prone position on this device |
| Material | Carbon fiber sandwich shell constructionThe skin contact materials carbon fiber isexactly the same as that used in theearlier described predicate device: BionixVERSABOARD, MODEL 7040. Thecytotoxicity test of the carbon fiber toplayer we use is enclosed in Chapter 11.PE-Foam: The PE-Foam material iscommonly used in radiotherapy, thetoxicity report is enclosed in Chapter 11. | Thermoformed plastic shell with a foam core |
| Dimensions | Thick hollow construction with anaperture to place the belly. Flat top-partfor positioning the arms and head. | Thick hollow construction with an aperture to placethe belly. Flat top-part for positioning the arms andhead. |
| Design / Shape | Ergonomic design for a comfortableposition of the patient. Extra ruler forlaser-alignment along the sides of theBellyboard. | It features ergonomically correct contours forpatient comfort and support, along with millimeterscales for laser alignment. |
| Possibleadjustments | No adjustments possible, only by usingadditional cushions like the prone-cushion. | "Interchangeable belly inserts make this Bellyboardsystem highly versatile and patient- and setup-friendly." |
| Couchfixation | Can be placed at indexed positions onthe couch, using fixation strips. | Indexed Patient Positioning System-compatible,using the MedTec rails |
| Accessories | Prone cushion for Bellyboard to improvethe position on the Bellyboard | Various cushions to optimize the positioning andcomfort of the patient |
| Compatibility withthe environmentand other devices | This device can be used both incombination with a CT-scanner and anaccelerator. | This device can be used both in combination with aCT-scanner and an accelerator. |
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/8/Picture/1 description: The image shows the logo for Sinmed Radiotherapy products. The logo consists of the word "Sinmed" in a bold, sans-serif font, with the "S" stylized to look like a bracket. Below the word "Sinmed" are the words "Radiotherapy products" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to promote Sinmed's products and services in the field of radiotherapy.
Sinmed Pelvis and lower extremities immobilization systems
| Date prepared | 23-09-05 |
|---|---|
| Submitter | Sinmed BV |
| Address: | Pasteurstraat 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) |
| Tradename: | -Posifix-12-Multifix-Combifix-system (Baseplate with Kneefix and Feetfix)-Multi Purpose Support cushions |
| Common name: | Pelvis and lower extremities immobilization systems |
| Classification name: | Linear medical accelerator |
| Classification: | Class 2 devices, 892.5050 IYE |
| Intended use: | Positioning of hip and lower extremities of a patient for radiotherapy. |
| Substantial Equivalence Device: | The Sinmed Pelvis and lower extremities immobilization systems depicted above are defined as Substantially Equivalent (SE) to the Hip Fixation System manufactured by MedTec, INC.(Registration number: 1932738) and cleared by FDA with K950866. |
| Description of the devices: See Sinmed product Catalogue 2006 | Page: Product:36 Posifix-1236 Multifix35 Combifix-system (Baseplate with Kneefix and Feetfix)53 Multi Purpose Support cushions |
| Summary of the technological characteristics of your device compared to the predicate device | All four products: Posifix-12, Multifix, Combifix-system (Baseplate with Kneefix and Feetfix) and the Multi Purpose Support cushions are products for positioning and immobilization of pelvis and lower extremities. These Sinmed products can be used individually or in combination with each other. The Posifix-12 and the Multifix are baseplates which should be used in combination with thermoplastic masks to fix the pelvis and lower extremities properly. The Medtec Hip Fixation system also uses the thermoplastic masks to fix the hips and extremities of the patient. The Sinmed Combifix is a system with which the pelvis and lower extremities are positioned in the same way as with the Medtec HipFix, but cannot be |
fixed with Posicast masks. The Sinmed Multi Purpose Support Cushions are actually important accessories of the Sinmed Multifix. With these cushions, the positioning of the extremities can be optimized and fixed with the thermoplastic mask-material.
Sinmed Premarket Notification Submission 510(k)
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Image /page/9/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, serif font. The word "Sinmed" is the main focus of the image, with the phrase "Radiotherapy products" providing additional context.
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| Sinmed Pelvis and lower extremities | MedTec | |
|---|---|---|
| immobilization systems | Hip Fixation System | |
| Intended use | Positioning of hip and lower extremities of apatient for radiotherapy. | The HipFix system is a popular choice for hip andpelvis immobilization in either the prone or supineposition. |
| Targetpopulation. | Patients undergoing irradiation treatment inpelvis or lower extremities. | Patients undergoing irradiation treatment in pelvisor lower extremities. |
| Position of the | Supine position (Combifix) | Prone or supine position. |
| patient | OrProne and supine position. (Posifix-12, | |
| Multifix and MultiPurpose Support cushions) | ||
| Material | Carbon fiber sandwich or plastic (acrylic andPE-Foam) devices.The skin contact materials carbon fiber isexactly the same as that used in the earlierdescribed predicate device: BionixVERSABOARD, MODEL 7040. Thecytotoxicity test of the carbon fiber top layer | Carbon fiber with plastic |
| we use is enclosed in Chapter 11.PE-Foam: The PE-Foam material iscommonly used in radiotherapy, the toxicityreport is enclosed in Chapter 11.The acrylic material is the same used in theSinmed head and shoulder positioning andimmobilization systems. (baseplates) and isidentical to the material used in the | ||
| predicate device Bionix 3-WAY HEADIMMOBILIZER. | ||
| Design | Baseplate on which the hip and lowerextremities of the patient can be positionedby using an individually shaped mask, orusing a Kneefix- or Feetfix or a MultiPurpose Support Cushion. | Baseplate on which the hip and lower extremities ofthe patient can be positioned by using anindividually shaped mask. Various cushions can beused to improve the patient positioning. |
| Possible | These devices can be adjusted to optimize | These devices can be adjusted to optimize the fit |
| adjustments | the fit for the patient. Individual adjustment | for the patient. Individual adjustment can bereached by changing distances or using individual |
| can be reached by changing distances orusing Posicast masks. | masks. | |
| Couchfixation | Baseplates can be positioned on the couchon indexed positions. | Indexed Patient Positioning System-compatible |
| Accessories | Repovac vacuum cushionsThermoplastic Posicast mask materialMulti Purpose Support Cushion. | Vac-Lok™ vacuum cushionsThermoplastic mask material |
| Compatibilitywith theenvironment andother devices | The -Posifix-12, Multifix, Combifix-systemand Multi Purpose Support cushions can beused both in the diagnostic and treatmentenvironment, due to the materials andconstruction chosen. | The Hip Fixation System can be used both in thediagnostic and treatment environment, due to thematerials and construction chosen. |
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 substantial equivations are performed, but from clinical experience is known that both products function in the same way.
.
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Image /page/10/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. The "S" in "Sinmed" is stylized with a curved line above it. Below the word "Sinmed", the words "Radiotherapy products" are written in a smaller, sans-serif font. There is a line separating the two phrases.
Sinmed Repovac Cushions
| Date prepared | 23-09-05 |
|---|---|
| Submitter | Sinmed BV |
| Address: | Pasteurstraat 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) |
| Tradename: | Repovac cushions |
| Common name: | Repovac cushions |
| Classification name: | Linear medical accelerator |
| Classification: | Class 2 devices, 892.5050 IYE |
| Intended use: | Repovac vacuum cushions provide a comfortable, accurate andreproducible patient position throughout the total course of a radiationtherapy treatment. |
| Substantial Equivalence Device: | The Sinmed Repovac cushions depicted above are defined asSubstantially Equivalent (SE) to the Vac-Loc immobilization systemmanufactured by Med-Tec INC. (Registration number: 1932738) andcleared by FDA with K935300. |
| Description of the devices: See Sinmedproduct Catalogue 2006 | Page: 45Product: Repovac cushions |
| Summary of the technologicalcharacteristics of your device compared tothe predicate device | Sinmed Repovac cushions, are plastic bags, filled with polystyrenebeads and can be made vacuum to follow and keep the contour of apatient. This vacuumbag can be used during the total treatment toachieve an identical patient set-up every time.This is exactly the intended use and functioning of the MedTec vacuumcushions. Differences can be found in shape, color and top layer |
material.
:
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Sinmed
Radiotherapy products
| Sinmed Repovac cushions | MedTecVac-Lok Immobilization System | |
|---|---|---|
| Intended use | Repovac vacuum cushions provide acomfortable, accurate and reproduciblepatient position throughout the total course ofa radiation therapy treatment. | When a complete vacuum is drawn through thequick-release valve, the cushion becomes a rigidand comfortable mold, offering accuratereproducibility throughout the course of simulationand treatment. |
| Targetpopulation. | Radiotherapy patients, all kinds of treatments | Radiotherapy patients, all kinds of treatments |
| Position of thepatient | The cushion forms a rigid mould of the patientby a vacuum that is drawn following thepatient's contours. The quick-release valveand the airtight polyurethane bag allow themould to maintain its shape over a longperiod of time. This ensures a reproduciblepatient sel-up through imaging, simulationand treatment of the patient. | While semi-deflated, the cushion is easily moldedaround a patient's anatomical contours. When acomplete vacuum is drawn through the quick-release valve, the cushion becomes a rigid andcomfortable mould, offering accuratereproducibility throughout the course of simulationand treatment. |
| Material | Polyurethane sheets with Polystyrenemicropellets. The skin contact materials areexactly the same as those used in thepredicate device. | A rugged clear urethane and an extra-durablenylon-reinforced blue urethane material thatresists punctures. Rugged, radiotranslucentcushions are filled with tiny polystyrene beads. |
| Dimensions | Different dimensions available, square or aspecial shape for a special purpose. | Different dimensions available, square or aspecial shape for a special purpose. |
| Design / Shape | Various dimensions and shapes available forvarious purposes. | Various dimensions and shapes available forvarious purposes. |
| Possibleadjustments | Cushion follows the individual contours of thepatients. | Cushion follows the individual contours of thepatients. |
| CouchfixationAccessories | Cushions cannot be fixed onto the couch.Vacuum pump, both manual and electrical"Moulding guides" to facilitate moulding of thecushion | Cushions cannot be fixed onto the couch.Electrical Vacuum pump"Helping hands" to facilitate moulding of thecushion |
| Compatibilitywith theenvironmentand otherdevices | Some Vacuumcushions are speciallydesigned for use on Sinmed positioningdevices to improve the positioning andcomfort of the patient. | Some Vacuumcushions are specially designed foruse on Medtec positioning devices to improve thecomfort and positioning of the patient. |
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/12/Picture/1 description: The image shows the word "Sinmed" in bold, black letters. Below the word 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 context about the company or product.
Sinmed Posicast immobilization systems
| Date prepared | 23-09-05 |
|---|---|
| Submitter | Sinmed BV |
| Address: | Pasteurstraat 62811 DX ReeuwijkPhone: 0031-182-394495Fax: 0031-182-395014 |
| Contact person: | Caroline de Keijzer (Quality Manager)Leo de Mooy (Technical Director) |
| Tradename: | Posicast |
| Common name: | Posicast immobilization systems |
| Classification name: | Linear medical accelerator |
| Classification: | Class 2 devices, 892.5050 IYE |
| Intended use: | Immobilization of a patient by using a thermoplastic mask. |
| Substantial Equivalence Device: | The Sinmed POSICAST IMMOBILIZATION SYSTEM depicted above is defined asSubstantially Equivalent (SE) to the Posicast Immobilization SYSTEM registered byHuestis Machine Corporation.(Registration number: 1219183) and cleared by FDA with K926187. The following tablecompares the Sinmed POSICAST IMMOBILIZATION SYSTEM and the predicate device.Huestis has registered this product when they were our representative in 1992. Thedistribution of Sinmed Posicast will be through another American company. Therefore wewant to register this product under our own name. So the product we want to register isexactly the same as the material Huestis has registered in 1992. |
| Description of the devices: See Sinmed product Catalogue 2006 | Page: 14-21 Product: Posicast |
| Summary of the technological | The 510(k) for Posicast has been approved by the FDA in 1994 (K926187). The material, |
characteristics of your device compared to the predicate device
intended use etc. have not changed since then. Therefore a comparison seems to be not necessary.
| Sinmed POSICAST IMMOBILIZATION SYSTEM | Huestis Posicast Immobilization SYSTEM | |
|---|---|---|
| Intended use | Exactly the same | Exactly the same |
| Target population. | " | " |
| Position of thepatient | " | " |
| MaterialDimensionsDesign / ShapePossibleadjustments | " | " |
| Couchfixation | " | " |
| AccessoriesCompatibility withthe environmentand other devices | " | " |
Brief discussion of the nonclinical tests submitted
Both the Sinmed Posicast immobilization system and the Huestis Posicast Immobilization SYSTEM are exactly the same. Therefore no clinical comparative tests are necessary.
Sinmed Premarket Notification Submission 510(k)
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Image /page/13/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized symbol in the center. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The symbol in the center appears to be a stylized representation of a human figure or a bird, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
Sinmed Holding Internation B.V. % Ms. Patricia L. Murphy Eastern Regional Manager, Medical Certification KEMA Quality B.V. US Medical Operations 4377 County Line Road CHALFONT PA 18914
Re: K060737
Trade/Device Name: Sinmed Immobilization Systems (Head and Shoulder, Lung and Thorax, Pelvis and Lower Extremities, and Posicast) and Sinmed Repovac Cushions Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 16, 2006 Received: March 20, 2006
Dear Ms. Murphy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (08) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): -
Device Name:
- ·Posifix 1,2,4,5,7 -head and neck systems 1 -Posititt head inclination system -Posifix Pediatric
- Headsupports
- -Blocks and wedges
- Shouldersupport cushion
- -Posifix-EXT systems
- 2 -Shoulderretractor
- -Couchtop cover
- ਤੇ -Thorawedge
- -Posirest
- -Posiboard
- ·PET-armsupport
- -Bellyboard प
- -Prone thorax support cushion for Bellyboard
5 -Posifix-12 -Multifix -Combifix-system (Baseplate with Kneefix and Feetfix) -Multi Purpose Support cushion -Reporac cushions
- હ 7 -Posicast
Indications For Use:
- roution and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 1
- Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 2
- Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. 3
- Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. 4
- Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. 5
- Fixation and (re)positioning of the patient during radiotherapy and diagnostics. 6
- Fixation and (re)positioning of the patient during radiotherapy and diegnostics. 7
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
510(k) Sinmed (8030455) IYE-Positioning devices
Nancy C Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060737
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.