(27 days)
No
The device description and intended use focus on mechanical components for patient positioning and immobilization, with no mention of AI or ML capabilities. The performance metrics relate to localization error, not algorithmic performance.
No.
The device is used to position and immobilize patients during radiotherapy and other medical procedures, but it does not directly treat or diagnose a disease.
No
The device is described as a patient positioning and immobilization device used for stereotactic diagnostic localization and radiotherapy. While it mentions "diagnostic localization," its primary function is positioning and immobilization for various treatments, and it doesn't perform diagnostic analysis itself.
No
The device description clearly lists multiple hardware components including a vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for patient positioning and immobilization during medical procedures like radiotherapy, radiosurgery, and surgery. This is a therapeutic or procedural support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly outlines a system for physically positioning and immobilizing a patient. It involves vacuum cushions, pumps, and baseplates. These are physical components used externally on the patient.
- No Mention of Diagnostic Testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Input Imaging Modality: While it uses imaging (CT/MRI) for treatment planning, the device itself is not performing the imaging or interpreting the images for diagnostic purposes. It's used in conjunction with the imaging for positioning.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended to be used by radiologists and surgeons for the following:
. Patient positioning and immobilization
- Stereotactic diagnostic localization .
- Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets
Product codes
IYE
Device Description
The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate.
The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump.
- 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and/or MRI for treatment planning
Anatomical Site
thoracic, abdominal, pelvic, arm and leg therapeutic targets
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and surgeons
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Traditional 510(k) 510(k) Summary
JUN 2 0 2012
BodyFIX System
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Applicant
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- Address
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- Contact Person
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- Preparation Date
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- Device Submitted
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- Proprietary Name
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- Common Name
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- Substantial Equivalence
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- Device Description
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BodyFIX 510(k) Summary
Medical Intelligence Medizintechnik GmbH Robert-Bosch-Straße 8 Schwabmuenchen 86830 Germany Michael Wolff, +49 (0) 8232 9692 701 April 19th, 2012 / June 13th, 2012
BodyFIX System
BodyFIX
BodyFIX
Accelerator, Linear, Medical
The BodyFIX System is substantially equivalent in terms of intended use to the following currently marketed device: BodyFIX (K013391).
The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate.
The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump.
- 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.
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Traditional 510(k) 510(k) Summary
BodyFIX System .
:
| Dimensions | 600 x 988 x 510 (approx) | 580 x 410 x 355 (approx) |
|---|---|---|
| Construction Material | Carbon fibre sandwich with | |
| hard foam core | ||
| Stereotactic fiducial built into frame | Yes | |
| Weight | 77 kg (approx) | 39 kg (approx) |
| Noise | 60dB (A) | |
| Operation Mode | Continuous (unattended | |
| running) | ||
| Power | 1000 VA (max) | 1100 VA |
| Voltage | 100; 110; 120; 230; 240; V AC | |
| Current | 8 A (max) | |
| Fuses | T8 A/250 V AC | |
| Metohod of suppressing | ||
| diaphragmatic movement | Plastic fixation sheet and | |
| stabilising cushion | Plastic fixation sheet and | |
| stabilising cushion | ||
| Fixation | Vacuum cushion and plastic | |
| fixation sheet | Vacuum cushion and plastic | |
| fixation sheet | ||
| Imaging studies | CT and/or MRI for treatment | |
| planning | ||
| Clinical Applications | Patient positioning and | |
| immobilisation, thoracic, | ||
| abdominal, pelvic, arm and leg | ||
| therapeutic targets | ||
| Transversal plane CT localisation | ||
| error x,y | Mean 0.5 ±0.7 mm | |
| Longitudinal plane localisation | ||
| error z | Range 0.3 - 2.0 mm | |
| Linac set-up error | 1.0 mm approx | |
| Anterior Body Form | ||
| (immobilisation) | Yes | Yes |
| Posterior Body Form | ||
| (immobilisation) | Yes | Yes |
| Treatment Modality | Photon linear accelerator | Photon linear accelerator |
| Immobilisation | Non-invasive | Non-invasive |
| HF Emissions (CISPR 11) | Class B | Class B |
| Electromagnetic Environment | ||
| Guidelines | The unit or system solely uses | |
| HF-energy for its internal | ||
| function. Therefore its HF | ||
| emissions are very low, and | The unit or system solely uses | |
| HF-energy for its internal | ||
| function. Therefore its HF | ||
| emissions are very low, and |
510(k) Summary
.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Wolff Regulatory Affairs Manager Medical Intelligence Medizintechnik GMBH Robert-Bosch-Strabe 8 SCHWABMUNCHEN 86830 GERMANY
JUN 2 0 2012
Re: K121530
Trade/Device Name: BodyFIX® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 4, 2012 Received: May 24, 2012
Dear Mr. Wolff:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: BodyFIX® System
Indications for Use: .
This product is intended to be used by radiologists and surgeons for the following:
. Patient positioning and immobilization
- Stereotactic diagnostic localization .
- Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mull D. Oth
Division of Rediological Devices stic Device Evaluation and Office of In Vitro Diagno
K1A21530
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