(82 days)
The function of the BellySTEP™ is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics.
The function of the HeadSTEP™ is for fixation and (re)positioning of the head and neck area of the patient during radiotherapy and diagnostics.
The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy.
The function of the WingSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the iCAST™ thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
BellySTEP™: The BellySTEP™ is made for the positioning of the lower abdomen of a patient. The BellySTEP™ Baseplate enables the use of Inter-changeable inserts. It is made of Polyethylene Foam and covered with artificial leather.
HeadSTEP™: The HeadSTEP™ iFRAME based immobilization system guarantees high precision and facile repositioning in routine cranial as well as head and neck immobilization.
BreastSTEP™: The BreastSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation.
ProSTEP™: The ProSTEP™ was designed to improve the accuracy of the positioning of the hip and the lower extremities.
WingSTEP™: The WingSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation.
iCAST™: The iCAST™ Thermoplastic is a non-sticky low temperature thermoplastic sheet material for the production of immobilization masks (head, head/neck) for patients undergoing radiation therapy treatment.
The provided document is a 510(k) Summary for several IT-V Medizintechnik GmbH positioning devices (BellySTEP™, HeadSTEP™, BreastSTEP™, ProSTEP™, WingSTEP™, and iCAST™). The entire submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is not applicable or cannot be extracted from this type of regulatory submission.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, there are no explicit acceptance criteria or direct device performance metrics reported for the IT-V devices themselves. The "performance" is implicitly deemed equivalent to the predicate devices.
| Device | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| BellySTEP™ | Substantially equivalent in design, construction, function, and intended use to the SINMED Bellyboard System (K060131). | "The BellySTEP™ is substantially equivalent to the SINMED Bellyboard System in design, construction, and function." (pages 0-1) |
| HeadSTEP™ | Substantially equivalent in intended use, construction, and materials to the SINMED Positilt head inclination system (K060131). | "The HeadSTEP™ is designed to position the head and neck of a patient for diagnostics and radiotherapy and reposition it several times. This is exactly the purpose of the Positilt head inclination system." "The same kind of construction and materials are used to reach this." (pages 2-3) |
| BreastSTEP™ | Substantially equivalent in intended use, inclination capability, and arm support fixation to the SINMED Posiboard (K060131). | "The SINMED Posiboard is intended to position patients undergoing irradiation treatment in the breast- and lung area. This is exactly the same purpose of the BreastSTEP™." "The same inclination of the upper body is also possible with the BreastSTEP™." "Arm support fixation is also possible on the BreastSTEP™." (pages 5-6) |
| ProSTEP™ | Substantially equivalent in intended use and technical characteristics for positioning and immobilization to the SINMED Combifix (K060131). | "The SINMED Combifix is intended for positioning and immobilization of pelvis and lower extremities. The ProSTEP™ is a system with which the pelvis and lower extremities are positioned in the same way as with the SINMED Combifix. Both devices are exactly the same in terms of intended use and technical characteristics." (pages 7-8) |
| WingSTEP™ | Substantially equivalent in intended use to position arms above the head for breast and lung area treatments, to the SINMED PET-armsupport (K060131). | "The SINMED PET-armsupport is intended to position patients undergoing irradiation treatment in the breast- and lung area. This is exactly the same purpose of the WingSTEP™." "This positioning of the arms above the head to achieve more space around the breast- and lung area is also the exact intended use of the WingSTEP™." (pages 9-10) |
| iCAST™ | Substantially equivalent in material, intended use, and general characteristics to the ORFIT Raycast Thermoplastics (K991319). | "The product we want to register is exactly the same as registered by ORFIT in 1999. The material, the intended use, etc. have not changed since then." (page 11) |
2. Sample Size Used for the Test Set and Data Provenance:
No test set or associated data provenance (country of origin, retrospective/prospective) is described in this 510(k) Summary. The submission relies on comparison to existing, cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No new test set was created for these devices.
4. Adjudication Method for the Test Set:
Not applicable. No new test set was created.
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. These are medical positioning devices, not AI/software devices that would typically undergo MRMC studies for reader performance improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. These are hardware medical devices, not algorithms.
7. The type of ground truth used:
The ground truth implicitly used is the regulatory clearance of the predicate devices. The claim of substantial equivalence asserts that the new devices do not raise different questions of safety and effectiveness than the predicate devices, which were themselves proven safe and effective.
8. The sample size for the training set:
Not applicable. These are hardware medical devices, not AI/machine learning models that require training sets.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for these devices.
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「JUL 2 1 2008
Section 05
Image /page/0/Picture/2 description: The image shows a logo for IT-Medizintechnik GmbH. The logo consists of the letters "IT" and a stylized "V" shape, all in white, set against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in black.
رن
510(k) SUMMARY IT-V positioning devices
1. BellySTEP™
| IT - V Medizintechnik GmbH | ||
|---|---|---|
| Submitted by | Kranebitterbodenweg 40a | |
| 6020 Innsbruck | ||
| Austria | ||
| Contact person | Markus Völp (C.E.O.) | |
| Phone: +43/664 4009009 | ||
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | BellySTEP™ | |
| Common name | Pelvis and lower extremities immobilization system. | |
| Classification name | Accelerator, Linear, Medical | |
| Class 2 devices, 892.5050 IYE | ||
| Predicate device | Bellyboard system by SINMED BV | |
| Description of the devices | The BellySTEP™ is made for the positioning of the lowerabdomen of a patient. The BellySTEP™ Baseplate enablesthe use of Inter-changeable inserts. It is made ofPolyethylene Foam and covered with artificial leather. | |
| Intended use | Positioning of the lower abdomen of a patient duringradiotherapy and diagnostics. | |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | The BellySTEP™ is substantially equivalent to the SINMEDBellyboard System in design, construction, and function. TheBellySTEP™ is flat and has a similar, generally rectangular-shaped contour, with areas specifically designed for theabdomen, and thighs. The Prone pillow support cushion hasa contoured opening so that the patient may rest his/herhead comfortably in the prone position during treatmentprocess. The inter-changeable inserts are also designed withan open, contoured cut out region. The patient is positionedover the abdominal cushion such that the belly drops into thecut out region during the radiation therapy session. TheBellySTEP™ is constructed in a manner similar to thebellyboard System from SINMED. |
Document #:
510(k) summary.doc
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Image /page/1/Picture/1 description: The image shows a logo for a company called IT-V MEDIZINTECHNIK GMBH. The logo is in a black box with white text. The top line of the logo is the company's initials, IT-V, and the bottom line is the company's full name, MEDIZINTECHNIK GMBH.
| Substantial Equivalence Device | The BellySTEP TM is defined as substantially equivalent (SE)in terms of intended use to the SINMED Bellyboard,manufactured by SINMED BV (Registration number8030455) and cleared by FDA with K060131. |
|---|---|
| -------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| BellySTEPT™ | SINMED bellyboard system | |
|---|---|---|
| Intended use | Positioning of the lower abdomen ofa patient during radiotherapy anddiagnostics. | Positioning of the lower abdomen ofa patient during radiotherapy anddiagnostics. |
| 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 | Made of Polyethylene Foam andcovered with artificial leather. ThePE foam material is commonly usedin radiotherapy. | Carbon fiber sandwich construction. |
| Dimensions | Thick hollow construction with anaperture to place the belly. Flat top-part for positioning the arms andhead. | Thick hollow construction with anaperture to place the belly. Flat top-part for positioning the arms andhead. |
| Design / Shape | Ergonomic design for a comfortableposition and support of the patient. | Ergonomic design for a comfortableposition of the patient. Extra ruler forlaser - alignment along the sides ofthe bellyboard. |
| Possible adjustments | No adjustments possible, only byusing additional cushions like theprone pillow support cushion. | No adjustments possible, only byusing additional cushions like theprone-cushion. |
| Couch fixation | Can be placed at indexed positionon the couch. | Can be placed at indexed positionon the couch, using fixation strips. |
| Accessories | Various Inter-changeable inserts andprone pillow to optimize thepositioning and comfort of thepatient. | Prone cushion for bellyboard toimprove the position on thebellyboard. |
| Compatibility with theenvironment andother devices | This device can be used both incombination with an CT-scanner andan accelerator. | This device can be used both incombination with an CT-scannerand an accelerator. |
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Image /page/2/Picture/1 description: The image shows a logo for a company called IT-V MEDIZINTECHNIK GMBH. The logo consists of the letters IT-V in a bold, sans-serif font. The letters are white on a black background. Below the letters is the company name, MEDIZINTECHNIK GMBH, in a smaller, sans-serif font. The company name is black on a white background.
2. HeadSTEP™
| IT - V Medizintechnik GmbH | ||
|---|---|---|
| Submitted by | Kranebitterbodenweg 40a | |
| 6020 Innsbruck | ||
| Austria | ||
| Contact person | Markus Völp (C.E.O.) | |
| Phone: +43/664 4009009 | ||
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | HeadSTEP™ | |
| Common name | Head and neck immobilization systems | |
| Classification name | Accelerator, Linear, Medical | |
| Class 2 devices, 892.5050 IYE | ||
| Predicate device | Positilt head inclination system by SINMED BV | |
| Description of the devices | The HeadSTEP™ iFRAME based immobilization systemguarantees high precision and facile repositioning in routinecranial as well as head and neck immobilization. | |
| Intended use | Fixation and (re)positioning of the head and neck duringradiotherapy and diagnostics | |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | The HeadSTEP™ is designed to position the head and neck ofa patient for diagnostics and radiotherapy and reposition itseveral times. | |
| This is exactly the purpose of the Positilt head inclinationsystem. The same kind of construction and materials are usedto reach this. Products from both companies are used for thesame kind of radiotherapy treatments. These products fromboth companies are really competitive systems. | ||
| Substantial Equivalence | The HeadSTEP™ is defined as substantially equivalent (SE) interms of intended use to the SINMED Positilt head inclinationsystem, manufactured by SINMED BV (Registration number8030455) and cleared by FDA with K060131. |
| Document #:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 510(k) summary.doc | Version 1 of 2008-03-2811 1800 1100 1100 100 | page 3 of 12 |
|---|---|---|---|
| A |
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Image /page/3/Picture/1 description: The image shows a logo for IT-V Medizintechnik GmbH. The logo consists of the letters "IT-V" in a bold, sans-serif font, with a horizontal line connecting the "T" and the "V". The letters are white and set against a black rectangular background. Below the rectangle, the words "MEDIZINTECHNIK GMBH" are printed in black, also in a sans-serif font.
| HeadSTEP™ | SINMED Positilt | |
|---|---|---|
| Intended use | Fixation and (re) positioning of thehead and neck during radiotherapyand diagnostics. | Fixation and (re) positioning of thehead and neck during radiotherapyand diagnostics. |
| Target population | Radiotherapy patients with tumors inhead and neck area. | Radiotherapy patients with tumors inhead and neck area. |
| Position of thepatient | Lying on a couch in prone or supineposition. Shoulders and head arepositioned by in a certain positionusing accessories for an optimizedtreatment. | Lying on a couch in prone or supineposition. Shoulders and head arepositioned by in a certain positionusing accessories for an optimizedtreatment. |
| Material | Radio-translucent carbon fiberconstruction. The skin contactmaterial carbon fiber is exactly thesame as those used in the predicatedevice. | Carbon fiber and acrylic, polyethylenefoam. |
| Dimensions | Square shaped baseplate whichfollows the patients contours of thehead. | Square shaped baseplate whichfollows the patients contours of thehead. |
| Design / Shape | Flat baseplate on which thethermoplastic mask can be placed.Using a 23-step elevationmechanism, the baseplate can beinclined to change the position of thehead. | Flat baseplate on which thethermoplastic mask and various headsupports can be placed. Using thePositilt or other accessories, thebaseplate can be inclined to changethe position of the head. |
| Possible adjustments | Head can be lifted or inclined byusing the 23-step elevationmechanism, without any wedges. | Head can be lifted or inclined by usingthe blocks and wedges or the Positiltsystem. |
| Couch fixation | The aluminum fixation rails connectsthe baseplate to the couch. Theadjustable aluminum rails can bemounted on the baseplate. Theyallow the baseplate to be lockeddown in the desired position on thesimulator or treatment couch. | The aluminum fixation rails connectsthe baseplate to the couch. Theadjustable aluminum rails can bemounted on all of our baseplates. Theyallow the baseplate to be locked downin the desired position on the simulatoror treatment couch. |
| Accessories | Foam head supports, which canposition the head for an optimizedtreatment.Thermoplastic mask-material whichcan be placed on the baseplate withplastic profiles. | Foam head supports, which canposition the head for an optimizedtreatment.Thermoplastic mask-material whichcan be placed on the baseplate withplastic profiles. |
510(k) summary.doc Document #: Version 1 of 2008-03-28 page 4 of 12
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Image /page/4/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font. The letters IT are white on a black background, while the W is black on a white background. Below the letters is the text "MEDIZINTECHNIK GMBH" in a smaller, sans-serif font.
| Compatibility with the environment and other devices | Can be used on all brands of couches in diagnostic and radiotherapy environment. |
|---|---|
| Can be used on all brands of couches in diagnostic and radiotherapy environment. |
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Image /page/5/Picture/1 description: The image shows a logo with the text "IT-V" in a black rectangle. The letters are white and bold. Below the rectangle, the text "MEDIZINTECHNIK GMBH" is written in a smaller font size. The text is also in black and white.
3. BreastSTEP™
| IT - V Medizintechnik GmbH | |
|---|---|
| Submitted by | Kranebitterbodenweg 40a6020 InnsbruckAustria |
| Contact person | Markus Völp (C.E.O.)Phone: +43/664 4009009 |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | BreastSTEP™ |
| Common name | Breast and thorax immobilization systems |
| Classification name | Accelerator, Linear, MedicalClass 2 devices, 892.5050 IYE |
| Predicate Device | Posiboard by SINMED BV |
| Description of the devices | The BreastSTEP™ enable positioning, repositioning and highcomfort in the routine breast and thorax fixation. |
| Intended use | Positioning of the lung- and thorax area of the patient duringradiotherapy and diagnostics. |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | The SINMED Posiboard is intended to position patientsundergoing irradiation treatment in the breast- and lung area.This is exactly the same purpose of the BreastSTEP™. Thepatient support of the SINMED Posiboard can be inclined forbetter treatment. This same inclination of the upper body isalso possible with the BreastSTEP™. To keep the arms out ofthe treatment area, the arms are placed above the head.Various arm supports can be fixed on the SINMED Posiboard.This arm support fixation is also possible on theBreastSTEP™. The features of the SINMED Posiboard can allbe found on the BreastSTEP™. |
| Substantial Equivalence Device | The BreastSTEP™ is defined as substantially equivalent (SE)in terms of intended use to the SINMED Posiboard,manufactured by SINMED BV (Registration number 8030455)and cleared by FDA with K060131. |
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Thereon LA P Separate Land Callery of Children Comments of |
|---|---|---|
| Document #: | 510(k) summary.doc------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Version 1 of 2008-03-28 |
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page 6 of 12
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Image /page/6/Picture/1 description: The image shows a logo with the text "IT-V MEDIZINTECHNIK GMBH". The letters "IT" are on the left side of the logo, followed by a dash and the letter "V". The text "MEDIZINTECHNIK GMBH" is located below the logo. The logo is enclosed in a rectangular box.
| BreastSTEP™ | SINMED Posiboard | |
|---|---|---|
| Intended use | Positioning of the lung- and thoraxarea of the patient duringradiotherapy and diagnostics. | Positioning of the lung- and thoraxarea of the patient during radiotherapyand diagnostics. |
| Target population | Patients with tumors in breast andthorax. | Patients with tumors in breast andthorax. |
| Position of thepatient | Supine position, can be inclined, witharms above the head. | Supine position, can be inclined, witharms above the head. |
| Material | Carbon fiber sandwich construction,PE Foam, and acrylic. Only non-metal materials are used, like foam,acrylic and carbon fiber sandwich inthe treatment area.The skin contact material carbonfiber is exactly the same as thoseused in the predicate device. | Carbon fiber sandwich construction,PE Foam, and acrylic. Only non-metalmaterials are used, like foam, acrylicand carbon fiber sandwich in thetreatment area. |
| Dimensions | Optimized dimensions (width) to beCT-scanner compatible. | Optimized dimensions (width) to beCT-scanner compatible. |
| Design / Shape | Baseplate, with an aperture forplacing headsupports. Above thehead the arms can be placed byusing various armsupports. | Baseplate, with an aperture for placingheadsupports. Above the head thearms can be placed by using variousarmsupports. |
| Possible adjustments | 0-20 degrees inclination possible. | 0-25 degrees inclination possible. |
| Couch fixation | The BreastSTEP™ is fixed onto thecouch using indexing bars. | The Posiboard is fixed onto the couchwith fixationstrips. |
| Accessories | Various headsupports for acomfortable patient positioning.Various armsupports for patientpositioning. | Various headsupports for acomfortable patient positioning.Various armsupports for patientpositioning. |
| Compatibility with theenvironment andother devices | Due to the chosen construction andmaterials, these products can beused during both diagnostics andradiotherapy. | Due to the chosen construction andmaterials, these products can be usedduring both diagnostics andradiotherapy. |
| Document #: | 510(k) summary.doc. | Version 1 of 2008-03-28------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|---|
| Property of ChildrenNo. of Cattle on 14 |
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Image /page/7/Picture/1 description: The image shows a logo with the text "IT-V" in a bold, sans-serif font. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo and text are contained within a rectangular box.
4. ProSTEP™
| IT - V Medizintechnik GmbH | ||
|---|---|---|
| Submitted by | Kranebitterbodenweg 40a | |
| 6020 Innsbruck | ||
| Austria | ||
| Contact person | Markus Völp (C.E.O.)Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | ProSTEP™ | |
| Common name | Pelvis and lower extremities immobilization systems | |
| Classification name | Accelerator, Linear, MedicalClass 2 devices, 892.5050 IYE | |
| Predicate device | Combifix by SINMED BV | |
| Description of the devices | The ProSTEP™ was designed to improve the accuracy of thepositioning of the hip and the lower extremities. | |
| Intended use | Positioning of hip and lower extremities of a patient forradiotherapy | |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | The SINMED Combifix is intended for positioning andimmobilization of pelvis and lower extremities.The ProSTEP™ is a system with which the pelvis and lowerextremities are positioned in the same way as with theSINMED Combifix. Both devices are exactly the same in termsof intended use and technical characteristics. | |
| Substantial Equivalence Device | The ProSTEP™ is defined as substantially equivalent (SE) interms of intended use to the SINMED Combifix, manufacturedby SINMED BV (Registration number 8030455) and cleared byFDA with K060131. |
| Addresses of the lim an a se a semployer was | |
|---|---|
| Document #: | 510(k) summary.doc |
Version 1 of 2008-03-28
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Image /page/8/Picture/0 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The letters are white against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo and text are enclosed in a rectangular border.
| ProSTEP™ | SINMED Combifix | |
|---|---|---|
| Intended use | Positioning of hip and lowerextremities of a patient forradiotherapy. | Positioning of hip and lowerextremities of a patient forradiotherapy. |
| Target population | Patients undergoing irradiationtreatment in pelvis or lowerextremities. | Patients undergoing irradiationtreatment in pelvis or lowerextremities. |
| Position of thepatient | Supine position. | Supine position. |
| Material | Carbon fiber sandwich constructionor plastic (PE-Foam) devices. | Carbon fiber sandwich construction orplastic (acrylic and PE-Foam) devices. |
| Design | Baseplate on which the hip andlower extremities of the patient canbe positioned by using a KneeSTEPand FeetSTEP system. | Baseplate on which the hip and lowerextremities of the patient can bepositioned by using a Kneefix orFeetfix. |
| Possible adjustments | These devices can be adjusted tooptimize the fit for the patient.Individual adjustment can bereached by changing distances. | These devices can be adjusted tooptimize the fit for the patient.Individual adjustment can be reachedby changing distances. |
| Couch fixation | Baseplate can be positioned on thecouch on indexed positions. | Baseplate can be positioned on thecouch on indexed positions. |
| Accessories | N. a. | Repovac vacuum cushions.Multi Purpose Support Cushion |
| Compatibility with theenvironment andother devices | The ProSTEP™ can be used both inthe diagnostic and treatmentenvironment, due to the materialsand construction chosen. | The Combifix system can be used bothin the diagnostic and treatmentenvironment, due to the materials andconstruction chosen. |
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Image /page/9/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font. The letters are white on a black background. Below the letters is the text "MEDIZINTECHNIK GMBH" in a smaller, sans-serif font. The text is black on a white background.
5. WingSTEP™
.
| IT - V Medizintechnik GmbH | |
|---|---|
| Submitted by | Kranebitterbodenweg 40a |
| 6020 Innsbruck | |
| Austria | |
| Contact person | Markus Völp (C.E.O.) |
| Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | WingSTEPTM |
| Common name | Breast and thorax immobilization systems |
| Classification name | Accelerator, Linear, Medical |
| Class 2 devices, 892.5050 IYE | |
| Predicate Device | PET-armsupport by SINMED BV |
| Description of the devices | The WingSTEPTM enable positioning, repositioning and highcomfort in the routine breast and thorax fixation. |
| Intended use | Positioning of the lung- and thorax area of the patient duringradiotherapy and diagnostics. |
| The SINMED PET-armsupport is intended to position patientsundergoing irradiation treatment in the breast- and lung area.This is exactly the same purpose of the WingSTEPTM. | |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | To keep the arms out of the treatment area the SINMED PET-armsupport place the arms above the head. This positioning ofthe arms above the head to achieve more space around thebreast- and lung area is also the exact intended use of theWingSTEPTM. |
| Substantial Equivalence Device | The WingSTEPTM is defined as substantially equivalent (SE) interms of intended use to the SINMED PET-armsupport,manufactured by SINMED BV (Registration number 8030455)and cleared by FDA with K060131. |
Document #:
510(k) summary.doc
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Image /page/10/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font, with a horizontal line connecting the T and the W. The letters are white on a black background. Below the letters, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font.
| WingSTEP™ | SINMED PET-armsupport | |
|---|---|---|
| Intended use | Positioning of the lung- and thoraxarea of the patient duringradiotherapy and diagnostics. | Positioning of the lung- and thoraxarea of the patient during radiotherapyand diagnostics. |
| Target population | Patients with tumors in breast andthorax. | Patients with tumors in breast andthorax. |
| Position of thepatient | Supine position with arms above thehead. | Supine position with arms above thehead. |
| Material | Acrylic construction, PE foam. Onlynon-metal materials are used, likefoam and acrylic in the treatmentarea. | Acrylic construction, PE foam. Onlynon-metal materials are used, likefoam and acrylic in the treatment area. |
| Dimensions | Optimized dimensions (width) to beCT-scanner compatible. | Optimized dimensions (width) to beCT-scanner compatible. |
| Design / Shape | Baseplate, with an aperture forplacing headsupports. Above thehead the arms can be placed byusing armsupports. | Baseplate, with an aperture for placingheadsupports. Above the head thearms can be placed by usingarmsupports. |
| Possible adjustments | No adjustments possible. | No adjustments possible. |
| Couch fixation | The WingSTEP™ is fixed onto thecouch using indexing bars. | The PET-armsupport is fixed onto thecouch with fixationstrips. |
| Accessories | Various headsupports for acomfortable patient positioning.Armsupports for patient positioning. | Various headsupports for acomfortable patient positioning.Armsupports for patient positioning. |
| Compatibility with theenvironment andother devices | Due to the chosen construction andmaterials, these products can beused during both diagnostics andradiotherapy. | Due to the chosen construction andmaterials, these products can be usedduring both diagnostics andradiotherapy. |
510(k) summary.doc Document #:___
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Image /page/11/Picture/1 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The text is set against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo appears to be for a medical technology company.
6. iCAST™
| IT - V Medizintechnik GmbH | |
|---|---|
| Submitted by | Kranebitterbodenweg 40a |
| 6020 Innsbruck | |
| Austria | |
| Contact person | Markus Völp (C.E.O.) |
| Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | iCAST™ |
| Common name | Thermoplastic immobilization system |
| Classification name | Accelerator, Linear, Medical |
| Class 2 devices, 892.5050 IYE | |
| Predicate Device | Raycast Thermoplastics by ORFIT Industries |
| Description of the devices | The iCAST™ Thermoplastic is a non-sticky low temperaturethermoplastic sheet material for the production ofimmobilization masks (head, head/neck) for patientsundergoing radiation therapy treatment. |
| Intended use | Thermoplastic materials are used to retain and reproduce apatient's position during radiation therapy. |
| Summary of the technologicalcharacteristics of your devicecompared to the predicate device | ORFIT has registered this product in 1999. ORFIT is one of ourdistributors. We want to register this product under our ownname. So the product we want to register is exactly the sameas registered by ORFIT in 1999.The material, the intended use, etc. have not changed sincethen. Therefore a comparison seems to be not necessary. |
| Substantial Equivalence Device | The thermoplastic is defined as substantially equivalent (SE) interms of intended use to the ORFIT Raycast thermoplasticmaterial, manufactured by ORFIT (Registration number9613183) and cleared by FDA with K991319. |
| Document #: | 510 |
|---|---|
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Image /page/12/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2008
Ms. Cornelia Damsky Regulatory Consultant IT V MEDIZINTECHNIK GMBH 56 Westcott Road STAMFORD CT 06902
Re: K081218
Trade/Device Name: IT-V Positioning Devices: BellySTEP™, HeadSTED™, BreastSTEPTM ProSTEP™, WingSTEP™, and iCASTTM
Regulation Number: 21 CFR 892.5050
Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II
Product Code: IYE
Dated: April 11, 2008
Received: May 1, 2008
Dear Ms. Damsky:
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 (PMA), 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.
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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 (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.
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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
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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Image /page/14/Picture/1 description: The image shows a logo with the letters "IT-V" in a bold, sans-serif font. The letters are white and are set against a black background. Below the letters, the words "MEDIZINTECHNIK GMBH" are written in a smaller, sans-serif font. The text is also in black.
Indications for Use
510(k) Number K081218
Device Name:
8 선수 : 2017-02-07
これがある。 **
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IT-V positioning devices:
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- BellySTEP !!!
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- HeadSTEP™
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- BreastSTEP TH
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- ProSTEP ™
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- WingSTEP TM
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- iCAST™
Indications for Use:
- The function of the BellySTEP™ is for positioning of the lower abdomen of a 1. BellySTEP™ patient during radiotherapy and diagnostics.
- The function of the HeadSTEP™ is for fixation and (re)positioning of the head-2. HeadSTEP™ and neck area of the patient during radiotherapy and diagnostics.
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- BreastSTEP™ The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
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- ProSTEP™ The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy.
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- WingSTEP™ The function of the WingSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
- The function of the iCAST™ thermoplastic materials are for use in retaining and 6. ICAST™ reproducing a patient's position during radiation therapy.
Prescription Use: Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hogarth Whe
Page 1 of 1
(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081218
§ 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.