MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra

K142515 · Siemens Medical Solutions USA, Inc. · LNH · Oct 8, 2014 · Radiology

Device Facts

• Record ID: K142515
• Device Name: MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Your MAGNETOM MR system [Aera/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis. Your MAGNETOM MR system [Aera/Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Device Story

MAGNETOM Combi Suite Neurosurgery is an optional hardware package for MAGNETOM Aera and Skyra MR systems; enables patient transfer between OR table and MR scanner via Combi Dockable Table. Facilitates intraoperative imaging during neurosurgical procedures. System inputs include MR signals processed into transverse, sagittal, coronal, and oblique cross-sectional images/spectra. Operated by clinical staff in hospital/neurosurgical environments. Output consists of diagnostic images/spectra interpreted by physicians to assist in diagnosis and surgical guidance. Benefits include seamless patient transport and real-time intraoperative imaging capabilities without requiring patient repositioning between separate OR and MR tables.

Clinical Evidence

Bench testing only. Includes biocompatibility (EN ISO 10993-1: cytotoxicity, skin irritation, sensitization), electrical safety (IEC 60601-1), and software verification/validation. Performance testing covered MR imaging, spectroscopy, static magnetic field strength, acoustic noise, dB/dt, and RF heating. No clinical data presented.

Technological Characteristics

MR diagnostic device; hardware includes Combi Dockable Table, interface boxes, transfer boards, and NORAS2 head holder. Complies with IEC 60601-1 (electrical safety) and ISO 14971 (risk management). Software version syngo MR D13A/D13C. No active electrical circuits in dockable table requiring EMC testing per IEC 60601-2-33.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities, including intraoperative imaging during neurosurgical procedures. Contraindications include patients with non-MR-safe implants or devices.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• MAGNETOM Artis Combi Suite for MAGNETOM systems Aera and Skyra (K140253)

Reference Devices

• NORAS2 head holder (K133506)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2014

Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K142515

Trade/Device Name: MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Systems Aera and Skyra Regulation Number: 21 CFR 892.1000

Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 5, 2014 Received: September 8, 2014

Dear Mr. Fields:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
for

Janine M. Morris 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) K142515

#### Device Name

"MAGNETOM Combi Suite Neurosurgery" for the MAGNETOM systems Aera and Skyra

#### Indications for Use (Describe)

Your MAGNETOM MR system [Aera/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

Your MAGNETOM MR system [Aera/Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

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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### Section 5 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

## l General Information

| Establishment | Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany<br>Registration Number: 3002808157<br><br>SIEMENS SHENZHEN MAGNETIC RESONANCE<br>LTD.<br>Siemens MRI Center<br>Hi-Tech Industrial park (middle)<br>Gaoxin C. Ave., 2nd<br>Shenzhen 518057, P.R. CHINA<br>Registration Number: 3004754211 |
| Contact Person | Cordell L. Fields, Esq.<br>Regulatory Affairs Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

### Classification and Device Name

| Trade name: | MAGNETOM Combi Suite Neurosurgery for the<br>MAGNETOM systems Aera and Skyra. |
|-----------------------|-------------------------------------------------------------------------------|
| Classification Name: | Regulation Description:<br>- Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |

MAGNETOM Combi Suite Neurosurgery for the MAGNETOM systems Aera/Skyra

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Device Class:

Product Code:

## II Safety and Effectiveness Information Supporting Substantial Equivalence

ll

LNH

### Device Description

MAGNETOM Combi Suite Neurosurgery is the marketing name for an optional package for the MAGNETOM systems Aera and Skyra that includes the modified Combi Dockable Table for use with standalone OR tables (Operation Room) in a clinical workflow. The market name, MAGNETOM Combi Suite Neurosurgery, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow. MAGNETOM Combi Suite Neurosurgery enables the user to move a patient via the Combi Dockable Table from the OR table to the MR and vice versa in order to acquire intraoperative images.

The intended use of the MAGNETOM Aera, MAGNETOM Skyra, and the supported OR-Tables remains unchanged.

The MAGNETOM Combi Suite Neurosurgery will only be available for MAGNETOM systems Aera and Skyra and will be available as an option to newly manufactured scanners; existing scanners can be upgraded with this sales bundle. The sales bundles include new hardware for the MAGNETOM systems Aera and Skyra.

### Summary of new features for MAGNETOM Combi Suite Neurosurgery:

### Software

No software changes have been made with respect to the predicate device MAGNETOM Artis Combi Suite with K140253 cleared on March 20, 2014.

### Hardware

Maquet Package

- . Combi Dockable Table
- Interface Box
- NORAS2 head holder ●

² The NORAS head holder is a medical device in its own right and was cleared under K133506 on August 6, 2014 and is not subject to this 510(k) submission

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### Trumpf Package (TruSystem 7500)

- . Combi Dockable Table
- . Interface Box
- Transfer Board
- Support cushion for Transfer Board ●
- NORAS2 head holder
- Floor dock o

### Substantial Equivalence

The sales bundle MAGNETOM Combi Suite Neurosurgery for the MAGNETOM systems Aera and Skyra is substantially equivalent to the following current legally marketed device (Table 1):

| Table 1: | Predicate device for MAGNETOM Combi Suite Neurosurgery for the<br>MAGNETOM systems Aera and Skyra |
|----------|---------------------------------------------------------------------------------------------------|
|----------|---------------------------------------------------------------------------------------------------|

| Predicate Device<br>Name | FDA Clearance<br>Number / Date | Manufacturer | Manufacturer,<br>Product Code | Claim Substantial<br>Equivalence to |
|----------------------------------------------------------------------------|---------------------------------------|--------------|-------------------------------|-------------------------------------------------------------------------|
| MAGNETOM Artis<br>Combi Suite for<br>MAGNETOM<br>systems Aera and<br>Skyra | K140253,<br>cleared March<br>20, 2014 | Siemens AG | LNH | MAGNETOM Artis<br>Combi Suite for<br>MAGNETOM systems<br>Aera and Skyra |

This predicate has not been subject to any recalls.

### Safety and Effectiveness

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

Risk Management is ensured via a Risk Analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA. Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.

The MAGNETOM systems Aera and Skyra with sales bundle MAGNETOM Combi Suite Neurosurgery conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

### Indications for Use

The MAGNETOM MR [Aera/Skyra] system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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The MAGNETOM MR system [Aera/Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-safe biopsy needles.

### Comparison of Technological Characteristics with the Predicate Device & Conclusion as to Substantial Equivalence

MAGNETOM Aera/Skyra with software syngo MR D13A as well as MAGNETOM Skyra with software syngo MR D13C combined with MAGNETOM Combi Suite Neurosurgery has the same intended use and the same technical characteristics as the predicate device (Table 1: Predicate device for MAGNETOM Combi Suite Neurosurgery for the MAGNETOM systems Aera and Skyra with respect to the magnetic resonance features and functionalities. The differences between the subject device and the predicate device. which include the aforementioned hardware, provide the MAGNETOM systems Aera and Skyra with additional capabilities by allowing the user to transfer a patient via the Combi Dockable Table from the OR table to the MR and vice versa in order to acquire intraoperative images.

There are no new issues of safety or effectiveness introduced with the MAGNETOM Combi Suite Neurosurgery. The basic functionality of MAGNETOM Combi Suite Neurosurgery remains the same to the predicate device (Table 1: Predicate Neurosurgery for the MAGNETOM systems Aera and Skyra). However with this package, the MAGNETOM CombiSuite can now also be used within a Neurosurgery workflow / environment.

Therefore, Siemens believes that the subject devices, MAGNETOM Combi Suite Neurosurgery, are substantially equivalent to the predicate device, MAGNETOM Artis Combi Suite (Table 1).

### III Performance Data

The following performance data is being provided in support of the substantial equivalence:

### Biocompatibility Testing

The biocompatibility evaluation for MAGNETOM Combi Suite Neurosurgery was conducted in accordance with EN ISO 10993-1. The testing included the following tests:

- · Cytotoxicity
- Skin Irritation .
- o Sensitization

### Electrical safety and electromagnetic compatibility (EMC)

The MAGNETOM Combi Suite Neurosurgery does not contain active electrical circuits that require electromagnetic compatibility testing when not connected to the MR System.

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In addition, within particular standard IEC 60601-2-33, chapter 202.6.101 the components of the MR system located inside the controlled area, are excluded from the requirements given in IEC60601-1-2: 2007, thus the Combi Dockable Table, even when energized via the MR System, does not need to be tested for electromagnetic compatibility.

For electrical safety the system complies to the IEC 60601-1.

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.

### Bench and Acoustic Testing

- . MR Imaqing
- . Spectroscopy
- Safetv
- Static Magnetic Field Strength O
- Acoustic noise level o
- dB/dt O
- RF Heating o

## IV Conclusions

The submitted data support the safety of the device. The hardware and software verification and validation demonstrate that the MAGNETOM CombiSuite Neurosurgery device performs as specified.