(186 days)
No
The description focuses on standard image processing and comparison techniques for patient registration, without mentioning AI or ML algorithms.
No.
This device is described as an X-ray Imaging System intended for patient setup and localization prior to proton treatment, which is a diagnostic and positioning tool, not a therapeutic one itself.
No
The device is described as a "patient setup and localization tool" used to acquire and process images for patient positioning corrections prior to treatment, not for diagnosing a medical condition.
No
The device description explicitly states that the software product is a sub-system of the McLaren Proton Treatment System and integrates with hardware components such as the X-ray generator & tube assembly, amorphous silicon flat-panel detector, and electro-mechanical controls.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described X-ray Imaging System is used for patient setup and localization using imaging acquired directly from the patient's body (in vivo imaging). It compares these images to pre-treatment planning data to adjust the patient's position for radiation therapy.
- No Sample Analysis: The system does not analyze biological samples taken from the patient.
Therefore, its function falls outside the scope of in vitro diagnostics. It is a medical device used for image-guided patient positioning in the context of radiation therapy.
N/A
Intended Use / Indications for Use
The X-ray Imaging System is intended to be used as a patient setup and localization tool that is capable of processing orthogonal or CBCT images acquired at the start of the treatment. The images will be compared against Digitally Reconstructed Radiographs or CTs that were used to define the treatment plan. The comparison will generate position correction vectors if required and provide them to the McLaren Proton Treatment position corrections prior to treatment.
Product codes
LHN
Device Description
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System (K160063). The software product described by this document is considered a sub-system of the McLaren Proton Treatment System.
The software product integrates with the following components of the McLaren Proton Treatment System:
- . X-ray generator & tube assembly
- Amorphous silicon flat-panel detector
- . Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient
The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient's position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and Digitally Reconstructed Radiographs or CTs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Orthogonal images, CBCT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation technician
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)
The device underwent full design testing that included unit integration, verification, and validation testing to ensure all design requirements and risk measures were properly implemented and effective. Imaging performance and radiography and cone beam CT was assessed using standard measurement tools and phantoms and passed all tests. Additional testing was conducted to establish data for predicate comparison.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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K181498
5 510(K) SUMMARY
5.1 510(k) Owner Information
| Submittal Date: | 04-JUNE-2018 |
|---|---|
| Company Name: | EhmetDx, LLC |
| Street Address: | 47801 W Anchor Ct. |
| City, St, Zip: | Plymouth, MI 48170 |
| Country: | USA |
| Phone: | +1 (614) 905-7161 |
| Fax: | +1 (734) 738-1975 |
| Contact: | Daniel Schoettlin |
| Contact Title: | Director of Quality and Regulatory Affairs |
5.2 Device Information
| Trade Name: | X-ray Imaging System for the McLaren Proton Therapy System |
|---|---|
| Common Name: | X-ray Imaging System, XIS |
| Classification Name: | Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code LHN) |
5.3 Predicate Device
EhmetDx, LLC is claiming the X-ray Imaging System is substantially equivalent to the device listed in Table 5-1 Predicate Device. The predicate device was chosen based on the fact they have similar intended uses, principles of operation and are comparable in terms of identified performance and technological characteristics.
| Device | 510(k)
Number | Indication for Use |
|---------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IBA I₂C | K132847 | I₂C is used with a charged particle or photon radiation therapy
system for localization of the patient position with respect to
the therapy equipment and to provide correction feedback to
the radiation therapy system |
Table 5-1 Predicate Device
5.4 Device Description
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System (K160063). The software product described by this document is considered a sub-system of the McLaren Proton Treatment System.
The software product integrates with the following components of the McLaren Proton Treatment System:
- . X-ray generator & tube assembly
1
- Amorphous silicon flat-panel detector
- . Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient
The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient's position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and Digitally Reconstructed Radiographs or CTs.
5.5 Intended Use
The X-ray Imaging System is intended to be used as a patient setup and localization tool that is capable of processing orthogonal or CBCT images acquired at the start of the treatment. The images will be compared against Digitally Reconstructed Radiographs or CTs that were used to define the treatment plan. The comparison will generate position correction vectors if required and provide them to the McLaren Proton Treatment System for patient position corrections prior to treatment.
5.6 Technological Characteristics
There are several differences from the IBA I₂C and EhmetDx XIS devices. We do not foresee any of these differences materially impacting the safety or effectiveness of the X-ray Imaging System for the McLaren Proton Treatment System relative to patient setup and localization devices currently in commerce.
-
- Similar to the predicate device, the XIS provides the following imaging and registration characteristics:
- a. Acquisition of 2D, 2D stereoscopic and 3D images
- b. 3D images generation by acquiring images while imaging hardware is rotated around the desired volume. The acquired images are then reconstructed using broadly used algorithms to create a 3D volume.
- ﻥ Registration capabilities for 2D2D, 2D3D, and 3D3D for position localization and correction vector generation
- Data coordination with external 30 party systems for data pushes and pulls in d. conformance with DICOM standards.
-
- While the IBA I2C is a fully integrated hardware and software platforms, the EhmetDx XIS is a software platform. As a software platform the XIS is designed for exclusive integration with the McLaren Proton Treatment System. A major design feature of the McLaren Proton Treatment System is its modular approach to subsystem integration. This modular design allows the McLaren Proton Treatment System to update aspects as technology and products improve over time. The XIS will introduce CBCT localization capabilities to the already approved orthogonal capabilities.
2
- Title: X-ray Imaging System 510(k) Submission
-
- The X-ray Imaging System for the McLaren Proton Treatment System interfaces with a Varian 4030CB 40cm × 30cm image receptor whereas the IBA I2C uses the Thales Pixium 43cm × 43cm imaging detector. Both detectors have been used for radiography and CBCT. The major difference is the larger size of the Thales detector can provide a larger axial field-of-view (FOV). However, the site of treatment is well known in advance and the irradiated field-of-view from the imager should be minimized as much as practical to reduce radiation dose. In addition, the larger cone angles associated with the increased axial FOV will result in more severe incomplete data artifacts for these circular orbit systems. The larger image receptor, while a nice feature, does not offer much practical advantage over the use of the Varian 4030CB.
-
- While IBA system offer integrated registration software, the X-ray Imaging System for the McLaren Proton Treatment System generates DICOM output files that are then used by the 3rd party 510(k) approved MIM registration software to determine the appropriate correction vector for patient setup. MIM Software, Inc. is primarily a medical software company and has the advantage that it can devote (and has devoted) significant effort to ensuring that the registration interface works seamlessly and accurately. Presently the MIM 4.1 registration software is listed under 510(k) K001276 and K071964.
| Features and Characteristics | EhmetDx
XIS | IBA I2C
(K132847) |
|------------------------------------------------------------------------|----------------|----------------------|
| Indications for Use | | |
| Verification of patient setup and
positioning | ✓ | ✓ |
| Used with charged-particle radiation
therapy system | ✓ | ✓ |
| Used with photon radiation therapy system | ✓ | ✓ |
| Image Acquisition | | |
| kV imaging with large-area flat-panel | ✓ | ✓ |
| Stereoscopic radiographs | ✓ | ✓ |
| Conebeam CT | ✓ | ✓ |
| Flexible use of different x-ray tubes and
imaging panels | ✓ | ✓ |
| Image matching (with 3rd party MIM software - 510(k) K001276, K071964) | | |
| Registration using anatomical landmarks | ✓ | ✓ |
| Registration using fiducial landmarks | ✓ | ✓ |
| Registration using CBCT with planning CT | ✓ | ✓ |
5.6.1 Features and Characteristics
EH ETDX
3
Title: X-ray Imaging System 510(k) Submission
| Features and Characteristics | EhmetDx
XIS | IBA I₂C
(K132847) |
|----------------------------------------------------------------------|----------------|----------------------|
| Registration using radiographs with DRRs
created from planning CT | ✓ | ✓ |
| 2D2D (5 DOF registration) | ✓ | ✓ |
| 2D3D (6 DOF registration) | ✓ | ✓ |
| Interface with 3rd party applications | | |
| DICOM exchange of clinical and imaging
data | ✓ | ✓ |
| Transfer of patient position correction
vector | ✓ | ✓ |
5.6.2 Technical and Performance Specifications Comparison
| Technical and Performance Specifications | EhmetDx
XIS | IBA I2C
(K132847) |
|----------------------------------------------------------------------------------------|-----------------|----------------------|
| Specifications defined through integration with the McLaren Proton
Treatment System | | |
| X-ray generator operating range
(radiographic) | 40–150 kVp | 40–150 kVp |
| Flat panel imaging receptor manufacturer | 40–150 kVp | 60–125 kVp |
| Used with photon radiation therapy
system | Varian | Thales |
| Flat panel pixel size | 194 μm | 148 μm |
| Flat panel pixel detector dimensions | 40×30 cm | 43×43 cm |
| Active imaging area | 39.7×29.8
cm | 42.0×42.5 cm |
| Flat panel pixel array size | 2048×1536 | 2874×2840 |
| X-ray Imaging System Specifications | | |
| CBCT distance accuracy | ≤1% | 1% |
| CBCT spatial resolution | ≥5 lp/cm | ≥5 lp/cm |
| CBCT low-contrast resolution | 15mm@1% | 15mm@1% |
| CBCT CT number accuracy | ±40 HU | ±40 HU |
| CBCT CT number uniformity | ±40 HU | ±40 HU |
5.7 Non-clinical Testing
The device underwent full design testing that included unit integration, verification, and validation testing to ensure all design requirements and risk measures were properly implemented and effective. Imaging performance and radiography and cone beam CT was assessed using standard measurement tools and phantoms and passed all tests. Additional testing was conducted to establish data for predicate comparison.
4
5.8 Clinical Testing
EhmetDx did not perform clinical testing for the X-ray Imaging System and no clinical data was collected during device validation activity and substantial equivalence testing.
5.9 Testing Conclusion
The testing performed and their results confirmed the system performed as designed, has similar performance characteristics as the predicate device, and is safe and effective for patient use.
5
Image /page/5/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
December 10, 2018
EhmetDx, LLC % Mr. Daniel Schoettlin Director of Ouality and Regulatory Affairs 47801 W Anchor Ct PLYMOUTH MI 48170
Re: K181498
Trade/Device Name: X-ray Imaging System for the McLaren Proton Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: LHN Dated: November 5, 2018 Received: November 5, 2018
Dear Mr. Schoettlin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
6
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181498
Device Name
X-ray Imaging System for the McLaren Proton Treatement System
Indications for Use (Describe)
The X-ray Imaging System is intended to be used as a patient setup and localization tool that is capable of processing orthogonal or CBCT images acquired at the start of the treatment. The images will be compared against Digitally Reconstructed Radiographs or CTs that were used to define the treatment plan. The comparison will generate position correction vectors if required and provide them to the McLaren Proton Treatment position corrections prior to treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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