(27 days)
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
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.
Acceptance Criteria and Study Details for BodyFIX System
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K013391) | Reported Device Performance (BodyFIX System K121530) |
|---|---|---|
| Transversal plane CT localization error x,y | Not explicitly stated, implied to be comparable to predicate's performance | Mean 0.5 ±0.7 mm |
| Longitudinal plane localization error z | Not explicitly stated, implied to be comparable to predicate's performance | Range 0.3 - 2.0 mm |
| Linac set-up error | Not explicitly stated, implied to be comparable to predicate's performance | 1.0 mm approx |
Note: The provided document primarily focuses on establishing substantial equivalence to a predicate device (BodyFIX K013391). The "Acceptance Criteria" column above is derived from the predicate device's characteristics as a benchmark for the new device. Specific quantitative acceptance criteria for the new device's performance are not detailed in the provided text as separate, predefined thresholds for "passing" a study, but rather a comparison to the predicate's reported performance. The study described shows the new device's performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, given the device's manufacturer (Medical Intelligence Medizintechnik GmbH in Schwabmuenchen, Germany), it is likely that any testing involved German facilities, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.
4. Adjudication Method
The provided document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding human readers improving with or without AI assistance, as the device is a physical patient positioning and immobilization system, not an AI software.
6. Standalone (Algorithm Only) Performance Study
The provided document does not describe a standalone (algorithm only) performance study. The BodyFIX System is a physical medical device for patient positioning and immobilization, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance metrics (localization and set-up errors) appears to be derived from direct measurements of the device's accuracy in a controlled or simulated environment, as indicated by "Transversal plane CT localisation error x,y" and "Longitudinal plane localisation error z" and "Linac set-up error." This suggests a technical or engineering validation rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic accuracy.
8. Sample Size for the Training Set
The provided document does not mention or specify a sample size for a training set. This is expected as the BodyFIX System is a physical device, not an AI or machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for a training set is not applicable here.
{0}------------------------------------------------
Traditional 510(k) 510(k) Summary
JUN 2 0 2012
BodyFIX System
-
Applicant
-
- Address
-
- Contact Person
-
- Preparation Date
-
- Device Submitted
-
- Proprietary Name
-
- Common Name
-
- Classification Name
-
- Substantial Equivalence
-
- Device Description
-
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.
{1}------------------------------------------------
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 withhard foam core | |
| Stereotactic fiducial built into frame | Yes | |
| Weight | 77 kg (approx) | 39 kg (approx) |
| Noise | 60dB (A) | |
| Operation Mode | Continuous (unattendedrunning) | |
| 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 suppressingdiaphragmatic movement | Plastic fixation sheet andstabilising cushion | Plastic fixation sheet andstabilising cushion |
| Fixation | Vacuum cushion and plasticfixation sheet | Vacuum cushion and plasticfixation sheet |
| Imaging studies | CT and/or MRI for treatmentplanning | |
| Clinical Applications | Patient positioning andimmobilisation, thoracic,abdominal, pelvic, arm and legtherapeutic targets | |
| Transversal plane CT localisationerror x,y | Mean 0.5 ±0.7 mm | |
| Longitudinal plane localisationerror 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 EnvironmentGuidelines | The unit or system solely usesHF-energy for its internalfunction. Therefore its HFemissions are very low, and | The unit or system solely usesHF-energy for its internalfunction. Therefore its HFemissions are very low, and |
510(k) Summary
.
{2}------------------------------------------------
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
{4}------------------------------------------------
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
Page 1 of 1
§ 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.