myAblation Guide (VC10A)
Device Facts
| Record ID | K253264 |
|---|---|
| Device Name | myAblation Guide (VC10A) |
| Applicant | Siemens Healthcare GmbH |
| Product Code | QTZ · Radiology |
| Decision Date | Jun 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
Device Story
Software application for percutaneous ablation planning; operates on standalone workstations or integrated into Siemens CT scanners. Inputs include CT, MR, CBCT, and PET/CT images. Features include multimodality viewing, MPR, VRT, and manual/semi-automatic registration. Provides tools for contouring ablation targets and ablated areas; virtual ablation needle path planning; and safety margin visualization. Operated by interventional radiologists and technologists. Output is visual planning data and needle path coordinates exported in DICOM SSO format. Clinicians review outputs to guide procedure preparation; device does not trigger ablation or provide diagnostic/predictive results. Benefits include improved procedural planning and visualization of target/ablation zones.
Clinical Evidence
No clinical studies were performed. Evidence consists of bench testing and retrospective internal studies. Lung lesion segmentation (81 patients, 83 solid/80 subsolid lesions) achieved Dice 0.74/0.70 and sensitivity 0.98/0.95. Renal lesion segmentation (45 patients) achieved Dice 0.62 and sensitivity 0.97. Renal ablation zone segmentation (18 zones) achieved Dice 0.58 and sensitivity 0.92.
Technological Characteristics
Software-based medical image management and processing system. Supports CT, MRI, CBCT, PET/CT. Algorithms: non-AI region growing (lung) and random walker (renal). Connectivity: DICOM, standalone or integrated with Siemens syngo CT systems. Platform: Windows 10, syngo.via VC10A. Software lifecycle per IEC 62304.
Indications for Use
Indicated for physicians to assist in the preparation and performance of percutaneous ablative procedures for soft tissue lesions. Not for neurological or cardiac applications. Not for pediatric patients (as defined by 21 CFR 814.3(s)).
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- myAblation Guide (K240796)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 16, 2026
Siemens Healthcare GmbH
% Lynn Allman
Senior Director, Regulatory Affairs
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, California 94304
Re: K253264
Trade/Device Name: myAblation Guide (VC10A)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QTZ
Dated: May 18, 2026
Received: May 18, 2026
Dear Lynn Allman:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb, Ph.D.
Assistant Director, Imaging Software Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253264 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| myAblation Guide (VC10A) | | |
| Please provide your Indications for Use below. | | ? |
| MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success. myAblation Guide is not intended for use in neurological or cardiac applications and is not intended for pediatric patients (pediatric patients according to US Law 21 CFR 814.3(s)). | | |
| Please select the types of uses (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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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
## **510(k) Summary**
### **myAblation Guide (Version VC10A)**
*The following information is provided as required by 21 CFR 807.92*
#### **I. Submitter, Manufacturer, and Importer/Distributor Information:**
Name and Address: Varian Medical Systems Inc.
3100 Hansen Way, Palo Alto CA 94304
Contact Name: Lynn Allman, Senior Director Regulatory Affairs
E-mail: submissions.support@varian.com
Phone Number: (650) 424-5369
Date Prepared: September 17, 2025
Manufacturer Name: Siemens Healthcare GmbH
Mfg. Address: Henkestr. 127
91052 Erlangen
Germany
Importer/Distributor Name and Address: Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Importer/Distributor Establishment
Registration Number: 2240869
#### **II. Device Information:**
Proprietary Name: myAblation Guide (VC10A)
Common/ Usual Name: System, Image Processing, Radiological
Classification Name: Medical image management and processing system
Classification Panel: Radiology
Regulation Number: §892.2050 Medical image management and processing system
Product Code: QTZ
#### **III. Predicate Device:**
myAblation Guide (K240796)
This predicate has not been subject to a design-related recall.
#### **IV. Subject Device Description:**
myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation.
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**---
The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility.
The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT.
The application includes means and functionalities to support in:
- • Multimodality viewing and contouring of anatomical, functional, and multi-parametric images such as CT, CBCT, PET/CT, MRI
- • Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
- • Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- • Algorithmically supported contouring of targets and ablated tissue in the liver, kidney and lung (target only) on contrast-enhanced CT images
- • Manual and semi-automatic registration using rigid and deformable registration
- • Expansion of created contour structures to visualize a safety margin
- • Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data
- • Export of virtual needle paths in the Dicom SSO format
- • Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities
- • Supports multimodality image fusion
- • Supports user's procedure flow via a task stepper
Thermal ablation cannot be triggered from myAblation Guide.
# **V. Intended Use Statement/Indications for Use Statement:**
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities.
The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation.
The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users.
The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
# **Contraindications:**
myAblation Guide is not intended for use in neurological or cardiac applications and is not intended for pediatric patients (pediatric patients according to US Law 21 CFR 814.3(s)).
# **VI. Substantial Equivalence Discussion:**
The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence.
**Table 1: Comparison of Technological Characteristics between subject and predicate devices**
| Feature And/or Specification Of New/Modified Device | Predicate Device 510(K) ID #K240796 myAblation Guide (VB80A) | Subject Device myAblation Guide (VC10A) | Analysis/Differences |
| --- | --- | --- | --- |
| *Intended Use / Indications for Use* | MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success. | MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success. | Same as predicate |
| *Intended Users* | Physicians | Physicians | Same as predicate |
| *Intended patient population* | The patient demographic chosen by interventional radiologists to undergo ablation treatment | The patient demographic chosen by physicians to undergo percutaneous ablation treatment | Same as predicate |
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
| | (including patient with soft tissue lesions). | (including patient with soft tissue lesions). | |
| --- | --- | --- | --- |
| *US product code* | QTZ (21 CFR 892.2050) | QTZ (21 CFR 892.2050) | Same as predicate |
| *Operating Environment* | Operating Room and the hospital healthcare environment | The application can be used on a standalone workstation, a server-client solution and on CT systems manufactured by Siemens Healthineers with software level Somaris 10 or higher. These items are generally located within a hospital, radiology center, or outpatient clinic environment. If application is used during an interventional procedure, in addition to planning, the application resides in the control room of the imaging modality. | Same as predicate – details were added here to give further clarity on where the application may be accessed from in the healthcare setting. |
| *Operating System / Platform* | Microsoft Windows 10, syngo.via VB80, syngo.via View&Go VA50A & VA55A, syngo.CT VB10 | Microsoft Windows 10, syngo.via VC10A, syngo.via View&Go VA60A, syngo.CT VB20A | Substantially equivalent Verification and validation of software updates to maintain support for the listed operating platforms do not raise significantly different concerns about safety or effectiveness. |
| *Supported modalities* | CT, MRI, CBCT, as well as PET/CT | CT, MRI, CBCT, as well as PET/CT | Same as predicate |
| *(Semi-)Automatic Structure Segmentation* | Yes, for liver | Yes, for liver, lung and kidney | Substantially equivalent – this is a modification to add to the existing library of segmentation algorithms. Verification and validation of these structure segmentation algorithms do not raise significantly different concerns of safety or effectiveness. |
| *Target Structure Margin Indication* | Yes | Yes | Same as predicate |
| *Simulation of Virtual Needle Path (Virtual Ablation Probe Planning)* | Yes | Yes | Same as predicate |
| *3D Visualization of segmented structures, including Ablated Area* | Yes | Yes | Same as predicate |
| *Data export to SHS myNeedle Guide on Siemens Healthineers syngo CT systems* | Yes | Yes | Same as predicate |
| *Image registration: Overlay of Virtual Ablation Probe and Achieved Ablation Probe Position* | Yes | Yes | Same as predicate |
| *Image registration: Overlay of planned and achieved ablation* | Yes | Yes | Same as predicate |
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
| *zone in 2D/3D for visual Evaluation of Ablation Result* | | | |
| --- | --- | --- | --- |
| *(Semi-)Automatic Segmentation of Ablated Areas* | Yes, for liver | Yes, for liver and kidney | Substantially equivalent – this is a modification to add to the existing library of segmentation algorithms. Verification and validation of these segmentation algorithms do not raise significantly different concerns of safety or effectiveness. |
| *Quantitative Evaluation of Ablation Result* | No | No | Same as predicate |
| *Qualitative representation of target structure and margin to ablation zone* | No | Yes | Substantially equivalent – this is a new feature in the subject device version. Verification and validation of these algorithms do not raise significantly different concerns of safety or effectiveness. |
| *Visualization of organs-at-risk* | No | No | Same as predicate |
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
## VII. Performance Data:
### 1. Non-clinical Testing:
myAblation Guide underwent non-clinical testing to demonstrate the design and performance of the devices meet the established design criteria and are substantial equivalent to the predicate devices. The subject device successfully completed functional, usability, and other software-related design testing.
Semi-automatic segmentation algorithms:
#### Lung lesion segmentation:
A retrospective internal study was conducted to evaluate the semi-automatic lung lesion segmentation algorithm, including 81 patients with solid lung lesions and 78 patients with subsolid lung lesions. Ground truth data was created by a board-certified radiation oncologist by performing manual slice-by-slice delineation of lesion volumes.
The semi-automatic lung module segmentation algorithm integrated into myAblation Guide software is a non-AI algorithm based on a region growing implementation that segments lesions based on seed points and iterative adding of neighboring image pixels, of which intensity values are sufficiently similar to the region, until no more neighbors meet the criterion. Depending on the lesion type, the user can select the type of lung lesion to be segmented (solid and subsolid).
The performance of the semi-automatic lung lesion segmentation algorithm has been evaluated in an internal test. This internal analysis included a total of 81 patients with a total of 83 solid lesions and 78 patients with 80 subsolid lesions.
| Metric | Solid lesion | Subsolid lesion |
| --- | --- | --- |
| **Dice / True Positive Lesion** | 0.74 | 0.7 |
| **Sensitivity** | 0.98 | 0.95 |
For solid lesion types comprising 83 lesions, the Dice is 0.74 with a sensitivity of 0.98. For subsolid lesion types comprising 80 lesions, the Dice is 0.7 with a sensitivity of 0.95.
#### Renal lesion segmentation:
The clinical performance testing of the semi-automatic renal lesion and renal ablation zone segmentation has been evaluated in a retrospective internal study. A total of 45 patients have been assessed. The evaluated cases comprise renal lesions and ablation zones.
This algorithm is based on a random walker implementation that assigns image labels by calculating probabilities that a random walk from each pixel reaches a predefined seed region.
The performance of this algorithm has been tested in an internal test. This internal analysis of the renal lesion segmentation included a total of 45 patients with 45 lesions and 18 ablation zones. We used two metrics to quantify the segmentation quality. The first metric, the DICE
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**
coefficient, is used as a measure for evaluating segmentation quality. It quantifies the spatial overlap between the predicted segmentation and the reference ground truth, with higher values indicating better agreement.
Sensitivity is referred to as: “Sensitivity = TP / (TP + FN)” with true positive (TP) defined as Intersection over Union (IoU) ≥ 0.1 and false negative (FN) as IoU < 0.1. Correspondingly, a sensitivity of 0.97 means that, statistically, 97 out of 100 lesion have been segmented and fulfil the requirement of IoU < 0.1.
The DICE for all renal lesion types is 0.62 with a sensitivity of 0.97, as outlined in the following table:
| Metric | All Lesion Types |
| --- | --- |
| **Dice / True Positive Lesion** | 0.62 |
| **Sensitivity** | 0.97 |
The ablation zone algorithm analysis involved a total of 45 patients with 18 available ablation zones. The DICE for renal ablation zones is 0.58 and the overall sensitivity with 0.92, as outlined the following table:
| Metric | Ablation Zone |
| --- | --- |
| **Dice / True Positive Renal Ablation Zone** | 0.58 |
| **Sensitivity** | 0.92 |
## 2. Clinical Testing (N/A):
No clinical studies were carried out for the subject device, and therefore, no such clinical data is provided within this submission.
## 3. Software, Cybersecurity, and Interoperability
Software verification was conducted in accordance with IEC 62304 – “Medical device software - Software life cycle processes” and FDA guidance “Content of Premarket Submissions for Device Software Functions.
Cybersecurity and Interoperability requirements were assessed per FDA guidance’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices, Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices”.
Cybersecurity considerations related to the subject device are included within this submission. Siemens Healthineers conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
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**SIEMENS**
**Healthineers**
myAblation Guide (Version VC10A) Traditional 510(k) Submission – **K253264**---
# **VIII. Conclusion:**
Performance tests were conducted to test the functionality of the device. These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.
Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.
The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction. The manufacturer believes that the subject device is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
# **Assessment on Substantial Equivalence:**
The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that myAblation Guide is as safe, as effective, and performs as well as the predicate device. In summary, the manufacturer is of the opinion that myAblation Guide does not introduce any new significant potential safety risks and is similar to the predicate device.
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