SOMATOM Edge Plus

K173607 · Siemens Medical Solutions USA, Inc. · JAK · Mar 21, 2018 · Radiology

Device Facts

• Record ID: K173607
• Device Name: SOMATOM Edge Plus
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Mar 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations .* * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Enql J Med 2011;365:395-409) and subsequent literature, for further information.

Device Story

Multi-slice X-Ray Computed Tomography (CT) scanner; generates cross-sectional images via computer reconstruction of X-ray transmission data. System components: 78 cm bore gantry, patient handling system, power distribution cabinet, image management system. Used in neurology, oncology, cardiology, trauma, emergency, and interventional radiology. Operated by trained healthcare professionals. Input: X-ray transmission data from axial/spiral planes. Output: DICOM-compliant cross-sectional images for physician diagnosis, radiotherapy planning, and simulation. Features include iterative reconstruction (SAFIRE, ADMIRE, iMAR), tin filter technology, and FAST 3D camera. Benefits: improved workflow, patient positioning, and diagnostic aid.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per documented procedures, design reviews, and test plans. Dosimetry and imaging performance evaluations met predetermined acceptance values. No clinical trials were performed for this submission.

Technological Characteristics

Multi-slice CT scanner; 64 rows, 128 slices/rotation. 78 cm bore; Straton MX Sigma tube (20-800 mA, 70-140 kV). Stellar Infinity detector. Iterative reconstruction (SAFIRE, ADMIRE, iMAR). Tin filter technology. Connectivity: DICOM. Standards: IEC 60601-1, IEC 60601-2-44, NEMA XR 25/28, ISO 14971.

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT for diagnosis, treatment preparation, and radiation therapy planning. Includes low-dose lung cancer screening for high-risk populations as defined by professional medical societies.

Regulatory Classification

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.

Predicate Devices

• SOMATOM Definition Edge (K152036)

Reference Devices

• SOMATOM Drive (K161196)
• SOMATOM Confidence (K162302)

Submission Summary (Full Text)

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March 21, 2018

Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Ms. Alaine Medio Regulatory Affairs Projects Manager 810 Innovation Drive KNOXVILLE TN 37934

Re: K173607

Trade/Device Name: SOMATOM Edge Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 19, 2018 Received: February 20, 2018

Dear Ms. Medio:

We have reviewed vour 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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert 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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DEPARIMENTÉOI音制:公告AGIHANDHUMANISERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

#### 510(k) Number (if known)

K173607

Device Name

#### SOMATOM Edge Plus

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

#### The images delivered by the system can be used by a trained physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

#### This CT system can be used for low dose lung cancer screening in high risk populations .*

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011;365:395-409) and subsequent literature, for further information.

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#

s required by 21 CFR Part 807.87(h)

## ldentification of the Submitter

| Importer / Distributor: | Siemens Medical Solutions USA, Inc.<br>40 Liberty Boulevard<br>Malvern, PA 19355<br>Establishment Registration Number: 2240869 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Siemens Healthcare GmbH<br>Siemensstraße 1<br>D-91301 Forchheim, Germany<br>Establishment Registration Number: 3004977335 |
| Submitter / Contact Person: | M. Alaine Medio, RAC<br>PET and PCS Regulatory Projects Manager<br>Siemens Medical Solutions USA, Inc.<br>810 Innovation Drive<br>Knoxville, TN 37932<br>[e-mail] |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | November 20, 2017 |
| Identification of the product | |
| Device Proprietary Name: | SOMATOM Edge Plus |
| Common Name: | Computed Tomography (CT) System |
| Classification Name: | Computed Tomography X-Ray System per 21 CFR<br>892.1750 |
| Product Code: | 90 JAK |
| Classification Panel: | Radiology |
| Device Class: | Class II |

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## Marketed Devices to which Equivalence is claimed

Predicate:

| Device Proprietary Name: | SOMATOM Definition Edge |
|--------------------------|----------------------------------------------------------------------------------------|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | 90 JAK |
| Device Class: | Class II |
| 510(k) Number: | K152036 |
| Recall Information: | This predicate device has not been the subject of any<br>design related recalls. |
| Reference Devices: | |
| Device Name: | SOMATOM Drive<br>SOMATOM Confidence |
| 510(k) Numbers: | K161196 (SOMATOM Drive)<br>K162302 (SOMATOM Confidence) |
| Recall Information: | These reference predicates have not been the subject of<br>any design related recalls. |

## Device Description:

The SOMATOM Edge Plus systems are multi-slice X-Ray Computed Tomography scanners.

The device produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

These systems are intended to be utilized by appropriately trained health care professionals. Typical uses of the systems include neurology, oncology and cardiology in standard practice as well as in trauma or emergency situations. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and simulation, as well as during interventional radiology procedures.

Each SOMATOM Edge Plus consists of a 78 cm bore size qantry (including mechanical and electrical components), a patient handling system (PHS) that moves the patient into and out of the gantry during the scans (various beds can be paired with this system), a Power Distribution Cabinet (PDC) and an Image Management System (comprised of various computers).

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The SOMATOM Edge Plus software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The SOMATOM Edge Plus is based on the commercially available SOMATOM Definition Edge system (K152036). The software (VB10) has been updated to incorporate additional features as well as provide updates for workflow and anomaly corrections as compared to the predicate device. Key changes compared to the primary predicate include:

- . Updated X-Ray Tube
- . Tin Filter Technology
- Touch Panel Controls
- lmprovements to patient positioning ●
- Updated computers due to obsolescence ●
- Updates to software to add improved features and functionality
- Inclusion of the features available on other SOMATOM CT systems such as O SOMATOM Drive (K161196) and SOMATOM Confidence (K162302)
- HD FoV Improvements o
- CARE and FAST feature improvements O
- kV and Filter Independent CaScore o

The SOMATOM Edge Plus consists of the following key specifications:

| Feature | SOMATOM Edge Plus<br>Subject Device |
|------------------------------------|----------------------------------------|
| Patient Port Diameter | 78 cm |
| Tilt | +/- 30 degrees |
| Scan times Full Scan | 0.28, 0.33, 0.5, 1.0 s |
| # Ranges / protocol | 33 |
| Sliding Gantry Travel Range | 12 m |
| Max Scan Range | 2000 mm |
| Tube Assembly | Straton MX Sigma |
| Tube current | 20 - 800 mA |
| Tube Voltages | 70, 80, 90, 100, 110, 120, 130, 140 kV |
| DMS Technology | Stellar Infinity |
| Number of Rows | 64 |
| Max number of slices /<br>rotation | 128 |
| FAST 3D Camera | Yes |
| Touch Panel Controls | YES |
| Iterative Reconstruction | SAFIRE, ADMIRE, iMAR |
| Tin Filter Technology | Yes |

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## Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diaqnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Enql J Med 2011;365:395-409) and subsequent literature, for further information.

## Performance Testinq / Safety and Effectiveness:

Siemens adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards. Siemens claims compliance with the following product standards for the SOMATOM Edge Plus:

- IEC 60601-1: 2005+ A1:2012
- IEC 60601-1-2: 2014 ●
- IEC 60601-1-3: 2013 ●
- IEC 60601-1-6:2010 +A1:2013 ●
- . IEC 60601-2-44: 2009 + A1:2012 + A2:2016
- IEC 62366-1:2015 ●
- IEC 61223-2-6:2006
- . IEC 61223-3-5:2004
- NEMA XR 25-2010
- NEMA XR 28-2013
- NEMA PS3.1-3.20

Additionally, the SOMATOM Edge Plus has been developed in accordance with the requirements of the following standards:

- IEC 62304:2006 +A1:2015
- ISO 14971:2012 (ISO 14971:2007) .

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

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Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.

Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The SOMATOM Edge Plus software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the SOMATOM Edge Plus and external devices.

Verification, Validation and Performance testing for the SOMATOM Edge Plus, including the dosimetry and imaging performance evaluation, were conducted during product development. Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing. Performance testing met the predetermined acceptance values.

The successful verification and validation testing demonstrates that the SOMATOM Edge Plus functions as intended and that performance is comparable to the predicate devices.

#### Statement regarding Substantial Equivalence:

There have been no changes implemented in the SOMATOM Edge Plus as compared to the predicate devices that impact either the fundamental scientific technology or the intended use. The SOMATOM Edqe Plus, as described in this Premarket Notification, is substantially equivalent to the currently commercially available predicate devices.