(133 days)
No
The document describes post-processing algorithms based on the physical properties of materials at different energy levels, not AI/ML techniques. There is no mention of training data, models, or AI/ML specific performance metrics.
No.
The device is a post-processing application for CT images, designed to visualize chemical composition and assist radiologists in diagnosis, not to directly treat or provide therapy to patients.
Yes
The device "syngo.CT Dual Energy" is designed to visualize information from CT images, differentiate between the chemical composition of substances (e.g., kidney stones, Gout tophi), and aid in the diagnosis of various conditions by providing detailed insights into body materials. The text explicitly states "Only a well-trained radiologist can make the final diagnosis upon consideration of all available information" for the Kidney Stones feature, implying its role in the diagnostic process.
No
The device is described as a "post-processing application" that operates with CT images. While it is software, it is explicitly designed to work with and process data from CT scanners, which are hardware medical devices. The description focuses on the software's functionality in analyzing and visualizing CT data, not as a standalone software device independent of a hardware component for data acquisition.
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 description clearly states that syngo.CT Dual Energy is a post-processing application that operates on CT images acquired from the human body. It analyzes the attenuation coefficients of different materials within the body based on dual-energy X-ray spectra.
- Input: The input is CT image data, not biological samples.
- Output: The output is enhanced visualization and quantitative evaluation of the chemical composition of materials within the body, presented as images and potentially numerical data, not a diagnostic result derived from a biological sample analysis.
- Intended Use: The intended use is to improve the visualization and evaluation of anatomical regions based on CT scans, aiding a well-trained radiologist in making a diagnosis. While it provides information about the chemical composition of things like kidney stones, the final diagnosis is made by the radiologist considering all available clinical information, not solely based on a test performed on a biological sample.
Therefore, syngo.CT Dual Energy is a medical imaging software application used for post-processing and analysis of CT data, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
- · Monoenergetic 1)
- · Brain Hemorrhage
- · Gout Evaluation 1)
- · Lung Vessels
- · Heart PBV
- · Bone Removal
- · Lung Perfusion
- · Liver VNC 1)
- · Monoenergetic Plus 1)
- · Virtual Unenhanced 1)
- Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones 1) 2)
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format) 1)
- · Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
This functionality supports data from Photon-Counting CT scanners.
-
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.
Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.
Modifications
A listing of device modifications for the software version SOMARIS/8 VB71 is as follows:
In this software version, additional application classes of syngo.CT Dual Energy can be used with Photon Counting Computed Tomography (PCCT) data. These application classes are Gout Evaluation, Liver VNC and Kidney Stones. There is no change in the algorithm itself, but they support the PCCT acquisition mode only.
In addition, this application uses the feature Lung Lobe Segmentation which supports the automatic segmentation of thoracic images based on lung lobes.
There are no relevant changes for the three DE scan modes Dual Source, Twin Beam, and Twin Spiral.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images based on two different X-ray spectra, Photon-Counting CT scanners
Anatomical Site
human body, Brain, Lung, Heart, Liver, Kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
well-trained radiologist
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)
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
Non-clinical tests (integration and functional) were conducted for syngo.CT Dual Energy functionality during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Liver VNC was evaluated on four-phase liver scans from the NAEOTOM Alpha. The virtual non contrast (VNC) images from the three contrast enhanced phases agreed well with the true non contrast images.
The application Kidney Stones was validated on both phantom data and clinical data. In the phantom scans, the size of the stones and the chemical composition computed from PCCT data agreed with the known size and composition of the stones in the phantoms. In clinical data, the performance on PCCT data was similar to the performance on the already approved dual-source dual-energy (DSDE) data.
For Gout, results from PCCT data were directly compared with results from the already approved DSDE scan mode. The volume and the position of Gout tophi were the same for DSDE and PCCT data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2023
Siemens Medical Solutions, USA, Inc. % Monsuru Bello Regulatory Affairs Professional 810 Innovation Dr. KNOXVILLE, TN 37932
Re: K232155
Trade/Device Name: syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 23, 2023 Received: October 23, 2023
Dear Monsuru Bello:
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.
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); 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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232155
Device Name syngo.CT Dual Energy
Indications for Use (Describe)
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
- · Monoenergetic 1)
- · Brain Hemorrhage
- · Gout Evaluation 1)
- · Lung Vessels
- · Heart PBV
- · Bone Removal
- · Lung Perfusion
- · Liver VNC 1)
- · Monoenergetic Plus 1)
- · Virtual Unenhanced 1)
- Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones 1) 2)
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format) 1)
- · Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
This functionality supports data from Photon-Counting CT scanners.
-
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots in a circular pattern.
510(k) Summary
FOR
syngo.CT Dual Energy
I. Identification of the Submitter
Importer/Distributor
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany
Establishment Registration Number 3004977335
Submitter Contact Person:
Submitter Contact Person: Monsuru K Bello Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (202) 856-6099 Email: Monsuru.bello@siemens-healthineers.com
Alternate Contact:
Clayton Ginn Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 Email: clayton.ginn@siemens-healthineers.com
II. Device Name and Classification
| Product Name: | syngo.CT Dual Energy |
|---|---|
| Propriety Trade Name: | syngo.CT Dual Energy |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
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Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
III. Predicate Device
| Predicate Device: | |
|---|---|
| Trade Name: | syngo.CT Dual Energy |
| 510(k) Number: | K212889 |
| Clearance Date: | 03/28/2022 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | IAK |
Reference Device:
| Trade Name: | syngo.CT Extended Functionality |
|---|---|
| 510(k) Number: | K203699 |
| Clearance Date: | 04/30/2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
IV. Device Description
Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.
Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.
Modifications
A listing of device modifications for the software version SOMARIS/8 VB71 is as follows:
In this software version, additional application classes of syngo.CT Dual Energy can be used with Photon Counting Computed Tomography (PCCT) data. These application classes are Gout Evaluation, Liver VNC and Kidney Stones. There is no change in the algorithm itself, but they support the PCCT acquisition mode only.
In addition, this application uses the feature Lung Lobe Segmentation which supports the automatic segmentation of thoracic images based on lung lobes.
There are no relevant changes for the three DE scan modes Dual Source, Twin Beam, and Twin Spiral.
6
Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
V. Indications for Use
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
- Monoenergetic 1) ●
- Brain Hemorrhage
- Gout Evaluation 1)
- Lung Vessels
- Heart PBV
- . Bone Removal
- . Lung Perfusion
- Liver VNC 1)
- . Monoenergetic Plus 1)
- Virtual Unenhanced 1) ●
- Bone Marrow
- Hard Plaques
- Rho/Z
- Kidney Stones 1) 2) ●
- SPR (Stopping Power Ratio)
- SPP (Spectral Post-Processing Format) 1) ●
- . Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
- This functionality supports data from Photon-Counting CT scanners.
-
- Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.
VI. Comparison of Technological Characteristics with the Predicate Device
The differences in this software version SOMARIS/8 VB70 are as follows as compared to the predicate device syngo.CT Dual Energy SOMARIS/8 VB60.
1. Modification: Additional Evaluation of Photon Counting CT Data
In this software version SOMARIS/8 VB71, three application classes Gout Evaluation, Liver VNC and Kidney Stones support the evaluation of Photon CT Counting data. The algorithms /functionality of these application classes remain unchanged as compared to the predicate device syngo.CT Dual Energy, SOMARIS/8 VB60 (K212889, clearance date 03/28/2022).
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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
2. Modification: Lung Lobe Segmentation
This application supports the automatic segmentation of thoracic images based on lung lobes. The lung lobe segmentation feature generates mean values and volume for each lung lobe. The resulting data set contains the slices with the segmentation as overlay and a table with the corresponding volumes. This feature is the same as used in the reference device syngo.CT Extended Functionality, SOMARIS/8/ VB51 (K203699, clearance date 04/30/2021).
In this software version, 8 (EIGHT) application classes support the PCCT mode, while in the previous version, 5 classes supported it. For the applications classes Liver VNC, Gout Evaluation and Kidney Stones the algorithms and functionality have not been changed or modified. The core difference is that these classes support the additional fourth acquisition mode (PCCT).
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
Non-Clinical Testing
This submission contains performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Dual Energy functionality during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Summary of the Evaluation of application classes for Photon Counting Data.
The subject device extends the application classes Liver VNC, Kidney Stones, and Gout Evaluation to Photon-Counting CT data.
Liver VNC was evaluated on four-phase liver scans from the NAEOTOM Alpha. The virtual non contrast (VNC) images from the three contrast enhanced phases agreed well with the true non contrast images.
The application Kidney Stones was validated on both phantom data and clinical data. In the phantom scans, the size of the stones and the chemical composition computed from PCCT data agreed with the known size and composition of the stones in the phantoms. In clinical data, the performance on PCCT data was similar to the performance on the already approved dual-source dual-energy (DSDE) data.
For Gout, results from PCCT data were directly compared with results from the already approved DSDE scan mode. The volume and the position of Gout tophi were the same for DSDE and PCCT data.
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Image /page/8/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
Risk Analysis
The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Siemens hereby certifies that syngo.CT Dual Energy meets the following FDA Recognized Consensus standards listed below:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software –Software Life Cycle
Processes; 62304:2006 (1st Edition) / A1:2016 | 01/14/2019 | AAMI, ANSI, IEC |
| 5-125 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 Third
Edition 2019-12 | 12/23/2019 | ISO |
| 5-117 | General I
(QS/RM) | Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements 15223-1:2016 | 8/21/2017 | ISO |
| 5-129 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2016+AMD1:2020 | 07/06/2020 | ANSI, AAMI, IEC |
Conclusion
syngo.CT Dual Energy has the same intended use and similar indication for use as the predicate device.
The subject device syngo.CT Dual Energy does not have changes in fundamental scientific technology compared to the predicate devices. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device.
For the subject device, syngo.CT Dual Energy, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT Dual Energy to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.