SCENIUM 1.1

K061545 · Siemens Molecular Imaging, Ltd. · KPS · Jun 30, 2006 · Radiology

Device Facts

• Record ID: K061545
• Device Name: SCENIUM 1.1
• Applicant: Siemens Molecular Imaging, Ltd.
• Product Code: KPS · Radiology
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. The software is deployed via medical imaging workstations and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.

Device Story

Scenium 1.1 is post-processing software for medical imaging workstations; it does not control scanner hardware. Input consists of PET and SPECT brain scan image data. Software provides workflows specific to drug and disease combinations; performs automated analysis by quantifying mean pixel values within standard regions of interest (ROIs). Output is visualized rendered images and numerical data for clinician review. Clinicians use this information to facilitate comparison with existing scans and assess pathologies. Benefits include standardized quantification to support clinical decision-making in brain imaging.

Clinical Evidence

No clinical data provided. The submission relies on substantial equivalence to legally marketed predicate devices and compliance with quality system regulations (21 CFR 820) and risk management standards (BS EN ISO 14971:2001).

Technological Characteristics

Post-processing software for medical imaging workstations. Features include visualization, rendering, and automated quantification of mean pixel values in standard ROIs. Compliant with 21 CFR 892.1200 (Emission computed tomography system) and 21 CFR 892.2050 (PACS). Designed under 21 CFR 820 and BS EN ISO 14971:2001 risk management standards.

Indications for Use

Indicated for clinicians to aid in assessment and quantification of pathologies in human brain PET and SPECT scans.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Scenium (K042863)
• Syntermed NeuroQ™ (K041022)
• Segami NeuroGam™ on Mirage™ (K043441)

Submission Summary (Full Text)

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# SIEMENS

### 510(k) SUMMARY as required by 21 CFR Part 807.87(h)

Kobir 45

JUN 30 2006

#### Company Contact Details

| Submitter's Name and Address | Siemens Molecular Imaging Ltd |
|------------------------------------|---------------------------------|
| Level 1, 23-38 Hythe Bridge Street | |
| Oxford OX1 2EP | |
| United Kingdom | |
| Establishment registration number: | 3003493157 |
| Contact Name in UK: | Mark Evans |
| Contact Title: | Managing Director |
| Contact E-mail Address: | [e-mail] |
| Telephone Number: | 44-1865-265-500 |
| Fax Number: | 44-1865-265-501 |
| Date of Submission: | 31.05.2006 |

### Contact Details in the US:

| Contact Name: | Frank Pokrop |
|------------------|-----------------------------------------------------------------------------------------|
| Contact Title: | Senior Manager Regulatory Affairs |
| Contact Address: | Siemens Molecular Imaging Group<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60195 |

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[e-mail] Contact E-mail Address: Telephone Number: [phone] Fax Number: [phone]

#### ldentification of the product

| Device Proprietary Name: | Scenium 1.1 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Emission computed tomography system, Product<br>Code 90KPS<br>Picture archiving and communications system,<br>Product Code LLZ |
| Classification Name: | Class II: Sec 21 CFR 892.1200 and CFR 892.2050 |

#### Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|-----------------------------|---------------------------------------------------------------|---------------|
| Scenium | Siemens Molecular Imaging Ltd (formerly Mirada Solutions Ltd) | K042863 |
| Syntermed NeuroQ™ | Syntermed Inc | K041022 |
| Segami NeuroGam™ on Mirage™ | Segami Corporation | K043441 |

#### Device Description:

Scenium 1.1 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.

The software is post processing and does not control the scanning features of the system.

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# SIEMENS

#### Indications for Use:

K061545

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workstations and is orqanized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.

#### Technological characteristics

The software is similar in uses and applications to those the predicate devices. Both the device and predicates are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.

#### Safety and effectiveness concerns:

The device is designed and manufactured under Quality system requlations as outlined in 21 CFR § 820. All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 892.1200 and Picture archiving and communications system CFR 892.2050 have been met, and additionally the software is in compliance with the requirements of BS EN ISO 14971:2001 - Medical Devices -Application of risk management to medical devices.

#### Substantial Equivalence:

Based on the above considerations, Siemens Molecular Imaging Ltd believes that the Scenium 1.1 software is substantially equivalent to the chosen predicate devices. The device and the predicate devices are all post-processing and provide similar features of visualization and numerical data.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 3 0 2006

Siemens Molecular Imaging Ltd. % Mr. Frank Pokrop Senior Manager Regulatory Affairs Siemens Molecular Imaging Group 2501 N. Barrington Road HOFFMAN ESTATES IL 60195

Re: K061545

Trade/Device Name: Scenium 1.1 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: KPS and LLZ Dated: May 31, 2006 Received: June 5, 2006

#### Dear Mr. Pokrop:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The years 1906-2006 are at the top of the seal. There are three stars below the word "Centennial". The text "Protecting and Promoting Public Health" is below the logo.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.fda.gov/cdrl/industry/support/index.html.

Sincerely vours,

Nancy Chrogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SIEMENS

### Indications for Use

510(k) Number (if known):

K 061545

Device Name: Scenium 1.1

Indications for Use:

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workstations and is organized as a series of workflows which are specific to use with particular drug and discase combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.

Prescription Use
(Part 21 CFR 801 Subpart D) ✓

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 Device Evaluation (ODE)

Nancy Burger

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061545