(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.
§ 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.