E.CAM COMPUTER / E.SOFT WORKSTATION

K023190 · Siemens Medical Solutions USA, Inc. · LLZ · Oct 24, 2002 · Radiology

Device Facts

• Record ID: K023190
• Device Name: E.CAM COMPUTER / E.SOFT WORKSTATION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: - Planar Imaging - Whole body imaging - Tomographic imaging (SPECT) for non positron emitter - Positron imaging by coincidence - Positron imaging without coincidence up to 588 keV - Display and process nuclear medicine, PET and CT images

Device Story

E.CAM Computer/e.soft Workstation serves as the primary interface for Siemens E.CAM Gamma cameras and a processing/review platform for nuclear medicine and PET/CT images. Input data includes radionuclide distribution signals from Gamma cameras and external image data (NM, PET, CT) via DICOM/TCP/IP. The device performs image reconstruction, including Flash 3D OSEM modeling, attenuation correction using CT images, and PET quantification. Operated by clinicians in clinical settings, the system facilitates image review, processing, and storage. Output consists of processed diagnostic images and quantitative data, aiding healthcare providers in clinical decision-making regarding radionuclide distribution. HIPAA support is integrated for patient data privacy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design control activities, including Failure Modes and Effects Analysis (FEMA) and comparison of technological characteristics to predicate devices.

Technological Characteristics

Nuclear medicine imaging workstation; supports SPECT, PET, and CT image processing. Features Flash 3D OSEM reconstruction algorithm and CT-based attenuation correction. Connectivity via TCP/IP and DICOM for integration with PACS, HIS/RIS, and imaging modalities. Software-based platform for image acquisition, review, and quantification.

Indications for Use

Indicated for patients requiring nuclear medicine imaging, including planar, whole body, and SPECT imaging, as well as PET imaging (coincidence and non-coincidence). Used for the detection and imaging of radionuclide distribution in the body or organs.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• E.CAM Computer (K992731)
• ICON Computer System (K903315B)
• ADAC Pegasys (K892358)
• Hawkeye Option for Dual-Headed Variable Angle Gamma Camera (K991841)
• ECAT PET SCANNER (K002715)

Submission Summary (Full Text)

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KO23190

## OCT 2 4 2002

# 510(k) SUMMARY

## [As required by 21 CFR 807.87(h)]

#### Identification of Submitter

Corresponding Official: Establishment:

Establishment Registration Number: Telephone Number: Fax Number: E-mail Address: Date of preparation:

Richard S. Demke Siemens Medical Solutions USA, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195 1423253 (Owner / Operator Number: 9010023) [phone] [phone] [e-mail]

#### Identification of the Product

Device Proprietary Name: Classification Name:

Common Name: Product code: Class:

E.CAM Computer / e.soft Workstation Emission computed tomography system per 21 CFR 892.12000 2050 Nuclear Medicine Imaging system 90年 Class II

#### Models

- E.SOFT A Acquisition Review & Processing E.SOFT P E.SOFT V Review E.SOFT AP Acquisition, Review & Processing
#### Identification of Legally Marketed Equivalent Devices

| Device | Manufacturer | 510(k) Number |
|-------------------------------------------------------------------|-------------------------------------|---------------|
| E.CAM Computer | Siemens Medical Solutions USA, Inc. | K992731 |
| ICON Computer System | Siemens Medical Solutions USA, Inc. | K903315B |
| ADAC Pegasys | Phillips Medical Systems | K892358 |
| Hawkeye Option for Dual-<br>Headed Variable Angle<br>Gamma Camera | EL GEMS Ltd./ GE Medical | K991841 |
| ECAT PET SCANNER | CTI PET Systems, Inc. | K002715 |

000009

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### Page 2

### Device Description

E.CAM Computer / e.soft Workstation provides primary user interface for acquiring images from the Siemens E.CAM family of nuclear medicine Gamma cameras, as well as a collection of clinical applications for processing and review of images from any nuclear medicine and/or positron emission imaging systems. E.SOFT relies on standard networking and image transfer protocols (TCP/IP and DICOM) for connection to/from other devices, including NM, PET and CT imaging stations, image review/storage (PACS) stations, hardcopy devices, external archive devices and HIS/RIS (Hospital information/Radiological Information Systems).

### Description of Change or Modification

E.CAM Computer / e.soft Workstation is to be modified to provide attenuation correction with computed tomography images (CT), improved reconstruction with Flash 3D OSEM modeling, PET quantification activity and HIPAA (patient privacy) support.

### Intended Use of Device

E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques:

- . Planar Imaging
- Whole body imaging .
- Tomographic imaging (SPECT) for non positron emitter 、
- Positron imaging by coincidence .
- Positron imaging without coincidence up to 588 keV .
- Display and process nuclear medicine, PET and CT images .

### Device Comparison

Attenuation correction is performed by all SPECT vendors, including e.soft with an emission source. Attenuation correction with computed tomography images (CT) is currently performed by GE Medical Systems (K991841). Most SPECT devices support OSEM Reconstruction. E.soft will provide improved processing with Flash 3D OSEM Reconstruction. Pet quantification activity streamlines the use of PET data by combining new & existing pet related displays & processing the data in a single protocol (or activity). The concerns of patient data security, access & privacy are accomplished by supporting the HIPAA directives.

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### Summary of Design Control Activities

The risk analysis method used to assess the impact of the modifications was based on a Failure Modes and Effects Analysis (FEMA). This analysis built upon the previous risk analysis and incorporated the software modifications indicated in this submission.

### Substantial Equivalence

The modified E.CAM Computer / e.soft Workstation has the following similarities to the product which previously received 510(k) clearance:

- 트 have the same indicated use,
- 내 use the same operating principle,
- . incorporate the same basic product design

In summary, the E.CAM Computer described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2002

Re: K023190

Mr. Richard S. Demke Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 2501 North Barrington Road HOFFMAN ESTATES IL 60195-5203

Trade/Device Name: E.CAM Computer/e.soft Workstation Emission Tomography System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 26, 2002 Received: September 25, 2002

Dear Mr. Demke:

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 (sec 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); 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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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|------------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx . | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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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# Indication for Use Statement

510(k) Number
(if known)

K023190

Device Name:

E.CAM Computer / e.soft Workstation, Emission Tomography System
(Computer)

Indications For Use: E.CAM Computer / e.soft Workstation is a Gamma Camera computer for
nuclear medicine used to detect or image the distribution of
radionuclides in the body or organ, using the following techniques:
- Planar Imaging
- Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter
- Positron imaging by coincidence
- Positron imaging without coincidence up to 588 keV
- Display and process nuclear medicine, PET and CT images

#### (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use

(Optional Format 1-2-96)

David G. Seymour

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __

000007