SWIP

K131241 · Philips Medical Systems Nederland B.V. · LNH · Aug 30, 2013 · Radiology

Device Facts

• Record ID: K131241
• Device Name: SWIP
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LNH · Radiology
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information. SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

Device Story

SWIp (Susceptibility Weighted Imaging with Phase enhancement) is a software option for Philips Achieva and Ingenia 1.5T/3.0T MR systems. It processes 3D FFE (Fast Field Echo) multiecho MR signals to generate high-resolution magnitude and phase images. The algorithm unwraps phase images to create Susceptibility Weighted Phase (SW-P) images, which are then combined with magnitude images to produce Susceptibility Weighted Magnitude (SW-M) images. These outputs highlight tissues with susceptibility differences, such as venous blood (hypo-intense) and mineral deposits. Operated by radiologists in clinical settings, the device integrates into existing MR workflows via ExamCard selection. The enhanced contrast aids radiologists in diagnosing neurological pathologies by visualizing cerebral venous vasculature and mineral deposits. It provides no hardware changes, running on the existing system's reconstructor computer.

Clinical Evidence

Clinical validation was performed to confirm that the SWIp software meets clinical user needs on Achieva and Ingenia 1.5T and 3T systems. The validation (DHF176223) confirmed that all clinical user needs were passed. No specific sensitivity, specificity, or AUC metrics were reported; the evidence relies on successful validation of clinical workflow and image utility for the intended diagnostic applications.

Technological Characteristics

Software-only feature for existing MR systems. Operates on HP Z400/Z420 reconstructor computers (3.6 GHz, 16-32 GB RAM, Windows 7 64-bit). Utilizes 3D FFE pulse sequences for data acquisition. Reconstruction involves phase unwrapping and magnitude/phase image combination. Connectivity is internal to the MR system; no external network connection. No off-the-shelf software used for the feature itself. Complies with cleared parameter limits of the host MR system (K110151).

Indications for Use

Indicated for magnetic resonance imaging of the brain in patients requiring assessment of neurological pathologies, specifically for enhancing contrast of tissues with susceptibility differences such as deoxygenated blood or mineral deposits (e.g., calcium).

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

• ACHIEVA R4 1.5T and ACHIEVA R4 3.OT (aka Ingenia) (K110151)
• Discovery MR450 (K083147)
• MAGNETOM Trio a Tim System (K050200)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the text "K131241 Page 1 of 4" in a handwritten font. The text is smaller than the word "PHILIPS" and is located in the upper right corner of the image.

## Philips Medical Systems Nederland B.V.

## 510(k) Summary

# SWIp

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| I. | General Information<br>21 CFR 807.92 (a)(1), (2) | | |
|----|--------------------------------------------------|----------------------------------------------------------------------------------------------|-------------|
| | Company Name: | Philips Medical Systems Nederland B.V. | |
| | Address: | Veenpluis 4-6<br>5684 PC Best<br>The Netherlands | AUG 30 2013 |
| | Registration No.: | 3003768277 | |
| | Contact Person: | Susan Quick<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| | Prepared (date): | 2013 April 29 | |
| | Trade Name of Device: | SWIp | |
| | Classification: | Class II | |
| | Regulatory Section: | Magnetic Resonance Diagnostic Device.<br>892.1000 | |
| | Product Code: | 90LNH | |

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## 21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:

| 1. Predicate Device: | ACHIEVA R4 1.5T and ACHIEVA R4 3.OT (aka Ingenia) |
|----------------------|---------------------------------------------------|
| Manufacturer: | Philips Healthcare |
| Predicate Device k#: | K110151 |
| 2. Predicate Device: | Discovery MR450 |
| Manufacturer: | GE Healthcare |
| Predicate Device k#: | K083147 |
| 3. Predicate Device: | MAGNETOM Trio a Tim System |
| Manufacturer: | Siemens Medical Solutions |
| Predicate Device k#: | K050200 |

## 21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification :

### Summary of functions of the device and its major components

SWIp (Susceptibility Weighted Imaging with Phase enhancement) exploits the susceptibility differences between tissues. It is based on a 3D FFE acquisition, multiecho compatible, generating high resolution magnitude and phase images.

Phase images are unwrapped to create Susceptibility Weighted Phase (SW-P) images highlighting phase changes due to local susceptibility differences. The magnitude images and SW-P information are combined to generate Susceptibility Weighted Magnitude (SW-M) images with enhanced susceptibility contrast. SW-M images show de-oxygenated blood, such as veins, as hypo-intense signals.

The feature requires:

- Specific parameter settings for the 3D FFE sequence, within cleared parameter . limits, to acquire the MR signals
- A new calculation function to generate SW-M and SW-P images. This function uses . a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
- · The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform.

## 21 CFR 807.92(a)(5); Intended Use

SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in

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combination with other clinical information. SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

### 21 CFR 807.92(a)(6): Technological Characteristics:

The main functional units in the software are:

- Methods (acquisition of MR signals by means of MR pulse sequences)
- Reconstruction (transforming the MR signals to images)
- Patient Administration {storing of the images in the database and providing access}
- Viewing (display of images)

The technical impact of the feature SWIp comprises:

- Methods: modify an existing sequence to acquire the data required for SWIp, within the cleared limits provided by the basic MR system.
- Reconstruction: add a new calculation function that generates the new output images SW-M and SW-P.
- Patient Administration and Viewing: enable storage and display of the new output images with appropriate labels (SW-M and SW-P).

No off-the-shelf software is used for the feature SWIp. The off-the-shelf software used in the basic MR system for the Ingenia and Achieva 1.5T and 3.0T MR systems machine is cleared by K110151.

SWIn is not designed to be connected to an external network.

### Hardware platform description

SWIp does not require any change of the hardware platform. The main extension introduced by SWIp, the new reconstruction algorithm, runs on the Reconstructor computer.

Computer characteristics:

- Manufacturer: HP; Model: Z400 or Z420; Processor clock: 3.6 GHz; RAM: 16-. 32 GB RAM: Processors: 1-2 x quad core
- Operating system: Windows 7, 64 bits .

The SWIp algorithm does not add specific requirements to the Ingenia and Achieva 1.5T and 3.0T. MR systems machine as cleared by K110151.

### Workflow

The only new element for the operator of the SWIp-feature in this clinical routine workflow is:

- 1. Protocol selection: The operator selects an ExamCard with SWIp protocols
- 2. Planscan phase: Optionally the operator may want to change the predefined selection of output image-types

All other steps are not changed. The generated image types can be viewed, postprocessed, printed and archived as any other image type.

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K131241
d or Page 4 of 4

## 21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced o relied on in this premarket notification:

The non-clinical tests that are included in the submission are as follows

- · DHF176222 Verification Test Report
The conclusion from testing the device is:

All the tests performed for SWIp were successful. While using SWIp, the system didn't crash or hang-up. Workflow was smooth and no problems occurred.

### 21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:

The clinical user needs are tested as part of the validation.

- DHF176223 Validation Test Report .
The conclusion from testing the device is:

The clinical validation of SWIp has completed successfully. All clinical user needs are passed for Achieva and Ingenia. 1.5T and 3T systems.

## 21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section:

The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.

The SWip software does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers SWIp to be substantially equivalent to the above mentioned predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of the HHS symbol, which is a stylized representation of a human form, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that resemble a person with outstretched arms. The text is in all caps and is relatively small compared to the symbol.

Public Health Service

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

August 30, 2013

Philips Medical Systems Nederland B.V. % Ms Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44143

Re: K131241

Trade/Device Name: SWIp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 30, 2013 Received: July 31, 2013

Dear Ms. Quick:

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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Page 2-Ms. Quick

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industrv/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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## Indication for use

510(k) Number (if known):

#### SWIp Software option for ACHIEVA 1.5T and 3.0T, INGENIA 1.5T and Device Name: 3.0T MR Systems

Indication For Use:

SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presentibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

Prescription Use メ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED]

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Michael D. O'Hara.

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K131241