(82 days)
Not Found
No
The device description and intended use focus solely on physical positioning and immobilization devices for radiotherapy and diagnostics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The devices are for patient positioning and immobilization during radiotherapy and diagnostics, not for directly treating a disease or condition.
No
The devices are primarily intended for patient positioning, fixation, and repositioning during radiotherapy and diagnostics. While "diagnostics" is mentioned, the core function described for all devices (BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, iCAST) is patient immobilization to facilitate accurate delivery of radiation therapy, not to actively diagnose a medical condition.
No
The device description clearly outlines physical components made of materials like Polyethylene Foam and artificial leather, as well as thermoplastic sheets. These are hardware components, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of all these devices is for positioning, fixation, and repositioning of patients during radiotherapy and diagnostics. This is a physical function related to patient setup and immobilization for medical procedures.
- Device Description: The descriptions detail physical devices made of materials like polyethylene foam, artificial leather, and thermoplastic sheets, designed to support and hold parts of the body.
- Lack of IVD Characteristics: IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with biological specimens or the generation of diagnostic information from such specimens.
These devices fall under the category of medical devices used in a clinical setting, specifically for supporting and positioning patients during procedures like radiotherapy and imaging. They are not designed to analyze biological samples or provide diagnostic information in the way an IVD does.
N/A
Intended Use / Indications for Use
- The function of the BellySTEPTM is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics.
- The function of the HeadSTEPTM is for fixation and (re)positioning of the head and neck area of the patient during radiotherapy and diagnostics.
- The function of the BreastSTEPTM is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
- The function of the ProSTEPTM is for positioning of hip and lower extremities of a patient for radiotherapy.
- The function of the WingSTEPTM is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
- The function of the iCASTTM thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
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 WingSTEPTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
BellySTEP™: lower abdomen
HeadSTEP™: head and neck
BreastSTEP™: lung- and thorax area
ProSTEP™: hip and lower extremities
WingSTEP™: lung- and thorax area
iCAST™: head, head/neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
BellySTEP™: can be used both in combination with an CT-scanner and an accelerator.
HeadSTEP™: Can be used on all brands of couches in diagnostic and radiotherapy environment.
BreastSTEP™: can be used during both diagnostics and radiotherapy.
ProSTEP™: can be used both in the diagnostic and treatment environment, due to the materials and construction chosen.
WingSTEP™: can be used during both diagnostics and radiotherapy.
iCAST™: Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
「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 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. | ||
| Intended use | Positioning of the lower abdomen of a patient during | |
| radiotherapy and diagnostics. | ||
| Summary of the technological | ||
| characteristics of your device | ||
| compared to the predicate device | The BellySTEP™ is substantially equivalent to the SINMED | |
| Bellyboard System in design, construction, and function. The | ||
| BellySTEP™ is flat and has a similar, generally rectangular- | ||
| shaped contour, with areas specifically designed for the | ||
| abdomen, and thighs. The Prone pillow support cushion has | ||
| a contoured opening so that the patient may rest his/her | ||
| head comfortably in the prone position during treatment | ||
| process. The inter-changeable inserts are also designed with | ||
| an open, contoured cut out region. The patient is positioned | ||
| over the abdominal cushion such that the belly drops into the | ||
| cut out region during the radiation therapy session. The | ||
| BellySTEP™ is constructed in a manner similar to the | ||
| bellyboard System from SINMED. |
Document #:
510(k) summary.doc
1
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 number
8030455) and cleared by FDA with K060131. |
| -------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| BellySTEPT™ | SINMED bellyboard system | |
|---|---|---|
| Intended use | Positioning of the lower abdomen of | |
| a patient during radiotherapy and | ||
| diagnostics. | Positioning of the lower abdomen of | |
| a patient during radiotherapy and | ||
| diagnostics. | ||
| Target population | Patients with tumors in the lower- | |
| abdomen area. | Patients with tumors in the lower- | |
| abdomen area. | ||
| Position of the | ||
| patient | Prone position on this device. | Prone position on this device. |
| Material | Made of Polyethylene Foam and | |
| covered with artificial leather. The | ||
| PE foam material is commonly used | ||
| in radiotherapy. | Carbon fiber sandwich construction. | |
| Dimensions | Thick hollow construction with an | |
| aperture to place the belly. Flat top- | ||
| part for positioning the arms and | ||
| head. | Thick hollow construction with an | |
| aperture to place the belly. Flat top- | ||
| part for positioning the arms and | ||
| head. | ||
| Design / Shape | Ergonomic design for a comfortable | |
| position and support of the patient. | Ergonomic design for a comfortable | |
| position of the patient. Extra ruler for | ||
| laser - alignment along the sides of | ||
| the bellyboard. | ||
| Possible adjustments | No adjustments possible, only by | |
| using additional cushions like the | ||
| prone pillow support cushion. | No adjustments possible, only by | |
| using additional cushions like the | ||
| prone-cushion. | ||
| Couch fixation | Can be placed at indexed position | |
| on the couch. | Can be placed at indexed position | |
| on the couch, using fixation strips. | ||
| Accessories | Various Inter-changeable inserts and | |
| prone pillow to optimize the | ||
| positioning and comfort of the | ||
| patient. | Prone cushion for bellyboard to | |
| improve the position on the | ||
| bellyboard. | ||
| Compatibility with the | ||
| environment and | ||
| other devices | This device can be used both in | |
| combination with an CT-scanner and | ||
| an accelerator. | This device can be used both in | |
| combination with an CT-scanner | ||
| and an accelerator. |
2
Image /page/2/Picture/1 description: The image shows a logo for a company called IT-V MEDIZINTECHNIK GMBH. The logo consists of the letters IT-V in a bold, sans-serif font. The letters are white on a black background. Below the letters is the company name, MEDIZINTECHNIK GMBH, in a smaller, sans-serif font. The company name is black on a white background.
2. HeadSTEP™
| IT - V Medizintechnik GmbH | ||
|---|---|---|
| Submitted by | Kranebitterbodenweg 40a | |
| 6020 Innsbruck | ||
| Austria | ||
| Contact person | Markus Völp (C.E.O.) | |
| Phone: +43/664 4009009 | ||
| Preparation Date | Feb. 11, 2008 | |
| Trade Name | HeadSTEP™ | |
| Common name | Head and neck immobilization systems | |
| Classification name | Accelerator, Linear, Medical | |
| Class 2 devices, 892.5050 IYE | ||
| Predicate device | Positilt head inclination system by SINMED BV | |
| Description of the devices | The HeadSTEP™ iFRAME based immobilization system | |
| guarantees high precision and facile repositioning in routine | ||
| cranial as well as head and neck immobilization. | ||
| Intended use | Fixation and (re)positioning of the head and neck during | |
| radiotherapy and diagnostics | ||
| Summary of the technological | ||
| characteristics of your device | ||
| compared to the predicate device | 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. Products from both companies are used for the | ||
| same kind of radiotherapy treatments. These products from | ||
| both companies are really competitive systems. | ||
| Substantial Equivalence | The HeadSTEP™ is defined as substantially equivalent (SE) in | |
| terms of intended use to the SINMED Positilt head inclination | ||
| system, manufactured by SINMED BV (Registration number |
- and cleared by FDA with K060131. | |
| Document #:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 510(k) summary.doc | Version 1 of 2008-03-28
11 1800 1100 1100 100 | page 3 of 12 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------|--------------|
| | | A | |
3
Image /page/3/Picture/1 description: The image shows a logo for IT-V Medizintechnik GmbH. The logo consists of the letters "IT-V" in a bold, sans-serif font, with a horizontal line connecting the "T" and the "V". The letters are white and set against a black rectangular background. Below the rectangle, the words "MEDIZINTECHNIK GMBH" are printed in black, also in a sans-serif font.
| HeadSTEP™ | SINMED Positilt | |
|---|---|---|
| Intended use | Fixation and (re) positioning of the | |
| 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. | 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. | ||
| Material | Radio-translucent carbon fiber | |
| construction. The skin contact | ||
| material carbon fiber is exactly the | ||
| same as those used in the predicate | ||
| device. | Carbon fiber and acrylic, polyethylene | |
| foam. | ||
| Dimensions | Square shaped baseplate which | |
| follows the patients contours of the | ||
| head. | Square shaped baseplate which | |
| follows the patients contours of the | ||
| head. | ||
| Design / Shape | Flat baseplate on which the | |
| thermoplastic mask can be placed. | ||
| Using a 23-step elevation | ||
| mechanism, the baseplate can be | ||
| inclined to change the position of the | ||
| head. | Flat baseplate on which the | |
| thermoplastic mask and various head | ||
| supports can be placed. Using the | ||
| Positilt or other accessories, the | ||
| baseplate can be inclined to change | ||
| the position of the head. | ||
| Possible adjustments | Head can be lifted or inclined by | |
| using the 23-step elevation | ||
| mechanism, without any wedges. | Head can be lifted or inclined by using | |
| the blocks and wedges or the Positilt | ||
| system. | ||
| Couch fixation | The aluminum fixation rails connects | |
| the baseplate to the couch. The | ||
| adjustable aluminum rails can be | ||
| mounted on the baseplate. They | ||
| allow the baseplate to be locked | ||
| down in the desired position on the | ||
| simulator or treatment couch. | The aluminum fixation rails connects | |
| the baseplate to the couch. The | ||
| adjustable aluminum 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. | ||
| Accessories | Foam head supports, which can | |
| position the head for an optimized | ||
| treatment. | ||
| Thermoplastic mask-material which | ||
| can be placed on the baseplate with | ||
| plastic profiles. | Foam head supports, which can | |
| position the head for an optimized | ||
| treatment. | ||
| Thermoplastic mask-material which | ||
| can be placed on the baseplate with | ||
| plastic 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. |
5
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 40a |
| 6020 Innsbruck | |
| Austria | |
| 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, Medical |
| Class 2 devices, 892.5050 IYE | |
| Predicate Device | Posiboard by SINMED BV |
| Description of the devices | The BreastSTEP™ enable positioning, repositioning and high |
| comfort in the routine breast and thorax fixation. | |
| Intended use | Positioning of the lung- and thorax area of the patient during |
| radiotherapy and diagnostics. | |
| Summary of the technological | |
| characteristics of your device | |
| compared to the predicate device | 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 | |
| patient support of the SINMED Posiboard can be inclined for | |
| better treatment. This same inclination of the upper body is | |
| also possible with the BreastSTEP™. To keep the arms out of | |
| the 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 the | |
| BreastSTEP™. The features of the SINMED Posiboard can all | |
| be 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. |
:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Thereon LA P Separate Land Callery of Children Comments of |
|---|---|---|
| Document #: | 510(k) summary.doc | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Version 1 of 2008-03-28 | |
ﺴﯿﺴﯿﺴﯿﺖ ﺳﯿﻤﻪ ﺑﺮﺍﯼ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ ﺍﺳﺖ.
page 6 of 12
6
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 thorax | |
| area of the patient during | ||
| radiotherapy and diagnostics. | Positioning of the lung- and thorax | |
| area of the patient during radiotherapy | ||
| and diagnostics. | ||
| Target population | Patients with tumors in breast and | |
| thorax. | Patients with tumors in breast and | |
| thorax. | ||
| Position of the | ||
| patient | Supine position, can be inclined, with | |
| arms above the head. | Supine position, can be inclined, with | |
| arms 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 in | ||
| the treatment area. | ||
| The skin contact material carbon | ||
| fiber is exactly the same as those | ||
| used in the predicate device. | Carbon fiber sandwich construction, | |
| PE Foam, and acrylic. Only non-metal | ||
| materials are used, like foam, acrylic | ||
| and carbon fiber sandwich in the | ||
| treatment area. | ||
| Dimensions | Optimized dimensions (width) to be | |
| CT-scanner compatible. | Optimized dimensions (width) to be | |
| CT-scanner compatible. | ||
| Design / Shape | Baseplate, with an aperture for | |
| placing headsupports. Above the | ||
| head the arms can be placed by | ||
| using various armsupports. | Baseplate, with an aperture for placing | |
| headsupports. Above the head the | ||
| arms can be placed by using various | ||
| armsupports. | ||
| Possible adjustments | 0-20 degrees inclination possible. | 0-25 degrees inclination possible. |
| Couch fixation | The BreastSTEP™ is fixed onto the | |
| couch using indexing bars. | The Posiboard is fixed onto the couch | |
| with fixationstrips. | ||
| Accessories | Various headsupports for a | |
| comfortable patient positioning. | ||
| Various armsupports for patient | ||
| positioning. | Various headsupports for a | |
| comfortable patient positioning. | ||
| Various armsupports for patient | ||
| positioning. | ||
| Compatibility with the | ||
| environment and | ||
| other devices | Due to the chosen construction and | |
| materials, these products can be | ||
| used during both diagnostics and | ||
| radiotherapy. | Due to the chosen construction and | |
| materials, these products can be used | ||
| during both diagnostics and | ||
| radiotherapy. |
| Document #: | 510(k) summary.doc. | Version 1 of 2008-03-28
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Property of Children
No. of Cattle on 14 | |
7
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, Medical | |
| Class 2 devices, 892.5050 IYE | ||
| Predicate device | Combifix by SINMED BV | |
| Description of the devices | The ProSTEP™ was designed to improve the accuracy of the | |
| positioning of the hip and the lower extremities. | ||
| Intended use | Positioning of hip and lower extremities of a patient for | |
| radiotherapy | ||
| Summary of the technological | ||
| characteristics of your device | ||
| compared to the predicate device | 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. | ||
| Substantial Equivalence Device | The ProSTEP™ is defined as substantially equivalent (SE) in | |
| terms of intended use to the SINMED Combifix, manufactured | ||
| by SINMED BV (Registration number 8030455) and cleared by | ||
| FDA with K060131. |
| Addresses of the lim an a se a semployer was | |
|---|---|
| Document #: | 510(k) summary.doc |
Version 1 of 2008-03-28
8
Image /page/8/Picture/0 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The letters are white against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo and text are enclosed in a rectangular border.
| ProSTEP™ | SINMED Combifix | |
|---|---|---|
| Intended use | Positioning of hip and lower | |
| extremities of a patient for | ||
| radiotherapy. | Positioning of hip and lower | |
| extremities of a patient for | ||
| radiotherapy. | ||
| Target population | Patients undergoing irradiation | |
| treatment in pelvis or lower | ||
| extremities. | Patients undergoing irradiation | |
| treatment in pelvis or lower | ||
| extremities. | ||
| Position of the | ||
| patient | Supine position. | Supine position. |
| Material | Carbon fiber sandwich construction | |
| or plastic (PE-Foam) devices. | Carbon fiber sandwich construction or | |
| plastic (acrylic and PE-Foam) devices. | ||
| Design | Baseplate on which the hip and | |
| lower extremities of the patient can | ||
| be positioned by using a KneeSTEP | ||
| and FeetSTEP system. | Baseplate on which the hip and lower | |
| extremities of the patient can be | ||
| positioned by using a Kneefix or | ||
| Feetfix. | ||
| Possible adjustments | These devices can be adjusted to | |
| optimize the fit for the patient. | ||
| Individual adjustment can be | ||
| reached by changing distances. | These devices can be adjusted to | |
| optimize the fit for the patient. | ||
| Individual adjustment can be reached | ||
| by changing distances. | ||
| Couch fixation | Baseplate can be positioned on the | |
| couch on indexed positions. | Baseplate can be positioned on the | |
| couch on indexed positions. | ||
| Accessories | N. a. | Repovac vacuum cushions. |
| Multi Purpose Support Cushion | ||
| Compatibility with the | ||
| environment and | ||
| other devices | The ProSTEP™ can be used both in | |
| the diagnostic and treatment | ||
| environment, due to the materials | ||
| and construction chosen. | The Combifix system can be used both | |
| in the diagnostic and treatment | ||
| environment, due to the materials and | ||
| construction chosen. |
9
Image /page/9/Picture/1 description: The image shows a logo for IT-W Medizintechnik GmbH. The logo consists of the letters IT-W in a bold, sans-serif font. The letters are white on a black background. Below the letters is the text "MEDIZINTECHNIK GMBH" in a smaller, sans-serif font. The text is black on a white background.
5. WingSTEP™
.
| IT - V Medizintechnik GmbH | |
|---|---|
| Submitted by | Kranebitterbodenweg 40a |
| 6020 Innsbruck | |
| Austria | |
| Contact person | Markus Völp (C.E.O.) |
| Phone: +43/664 4009009 | |
| Preparation Date | Feb. 11, 2008 |
| Trade Name | WingSTEPTM |
| Common name | Breast and thorax immobilization systems |
| Classification name | Accelerator, Linear, Medical |
| Class 2 devices, 892.5050 IYE | |
| Predicate Device | PET-armsupport by SINMED BV |
| Description of the devices | The WingSTEPTM enable positioning, repositioning and high |
| comfort in the routine breast and thorax fixation. | |
| Intended use | Positioning of the lung- and thorax area of the patient during |
| radiotherapy and diagnostics. | |
| 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 WingSTEPTM. | |
| Summary of the technological | |
| characteristics of your device | |
| compared 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 of | |
| the arms above the head to achieve more space around the | |
| breast- and lung area is also the exact intended use of the | |
| WingSTEPTM. | |
| Substantial Equivalence Device | The WingSTEPTM is defined as substantially equivalent (SE) in |
| terms 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 thorax | |
| area of the patient during | ||
| radiotherapy and diagnostics. | Positioning of the lung- and thorax | |
| area of the patient during radiotherapy | ||
| and diagnostics. | ||
| Target population | Patients with tumors in breast and | |
| thorax. | Patients with tumors in breast and | |
| thorax. | ||
| Position of the | ||
| patient | Supine position with arms above the | |
| head. | Supine position with arms above the | |
| head. | ||
| Material | Acrylic construction, PE foam. Only | |
| non-metal materials are used, like | ||
| foam and acrylic in the treatment | ||
| area. | Acrylic construction, PE foam. Only | |
| non-metal materials are used, like | ||
| foam and acrylic in the treatment area. | ||
| Dimensions | Optimized dimensions (width) to be | |
| CT-scanner compatible. | Optimized dimensions (width) to be | |
| CT-scanner compatible. | ||
| Design / Shape | Baseplate, with an aperture for | |
| placing headsupports. Above the | ||
| head the arms can be placed by | ||
| using armsupports. | Baseplate, with an aperture for placing | |
| headsupports. Above the head the | ||
| arms can be placed by using | ||
| armsupports. | ||
| Possible adjustments | No adjustments possible. | No adjustments possible. |
| Couch fixation | The WingSTEP™ is fixed onto the | |
| couch using indexing bars. | The PET-armsupport is fixed onto the | |
| couch with fixationstrips. | ||
| Accessories | Various headsupports for a | |
| comfortable patient positioning. | ||
| Armsupports for patient positioning. | Various headsupports for a | |
| comfortable patient positioning. | ||
| Armsupports for patient positioning. | ||
| Compatibility with the | ||
| environment and | ||
| other devices | Due to the chosen construction and | |
| materials, these products can be | ||
| used during both diagnostics and | ||
| radiotherapy. | Due to the chosen construction and | |
| materials, these products can be used | ||
| during both diagnostics and | ||
| radiotherapy. |
510(k) summary.doc Document #:___
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Image /page/11/Picture/1 description: The image shows a logo with the text "IT-W" in a bold, sans-serif font. The text is set against a black background. Below the logo, the words "MEDIZINTECHNIK GMBH" are printed in a smaller, sans-serif font. The logo appears to be for a medical technology company.
6. iCAST™
| IT - V Medizintechnik GmbH | |
|---|---|
| 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 temperature |
| thermoplastic sheet material for the production of | |
| immobilization masks (head, head/neck) for patients | |
| undergoing radiation therapy treatment. | |
| Intended use | Thermoplastic materials are used to retain and reproduce a |
| patient's position during radiation therapy. | |
| Summary of the technological | |
| characteristics of your device | |
| compared to the predicate device | ORFIT has registered this product in 1999. ORFIT is one of our |
| distributors. We want to register this product under our own | |
| name. So 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. Therefore a comparison seems to be not necessary. | |
| Substantial Equivalence Device | The thermoplastic is defined as substantially equivalent (SE) in |
| terms of intended use to the ORFIT Raycast thermoplastic | |
| material, manufactured by ORFIT (Registration number |
- and cleared by FDA with K991319. |
| Document #: | 510 |
|---|---|
| ------------- | ----- |
. '
.
Version 1 of 2008-03-28
)(k) summary.doc
:
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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.
13
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。 **
.
IT-V positioning devices:
-
- BellySTEP !!!
-
- HeadSTEP™
-
- BreastSTEP TH
-
- ProSTEP ™
-
- WingSTEP TM
-
- 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.
-
- BreastSTEP™ The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
-
- ProSTEP™ The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy.
-
- 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