MODIFICATION TO: ECAT LSO PET/CT SCANNER

K013504 · Cti Pet Systems, Inc. · KPS · Oct 31, 2001 · Radiology

Device Facts

• Record ID: K013504
• Device Name: MODIFICATION TO: ECAT LSO PET/CT SCANNER
• Applicant: Cti Pet Systems, Inc.
• Product Code: KPS · Radiology
• Decision Date: Oct 31, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Indications for Use

The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce 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. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

Device Story

Combined PET/CT scanner; utilizes LSO crystal block detectors for PET and Siemens SOMATOM EMOTION CT component for X-ray transmission data. Inputs: positron-emitting radiopharmaceuticals (PET) and X-ray transmission data (CT). Transforms inputs via computer reconstruction to produce cross-sectional images; CT data provides attenuation correction maps for PET. Used in clinical settings by trained healthcare professionals. Output: fused PET/CT images providing anatomical and metabolic information. Benefits: enables precise anatomical localization of metabolic activity; facilitates noise-free attenuation correction; supports standard diagnostic protocols.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and bench-level design specifications.

Technological Characteristics

Dual-modality imaging system; PET component uses 144 LSO crystal block detectors; CT component uses Siemens SOMATOM EMOTION (single or dual-slice) X-ray scanner. System includes gantry, patient handling system, and computational workstations. Connectivity supports integrated PET/CT image fusion and attenuation correction. Software performs computer reconstruction of transmission data.

Indications for Use

Indicated for humans requiring metabolic/physiologic imaging via injected positron-emitting radiopharmaceuticals and cross-sectional X-ray imaging. Used by trained healthcare professionals for whole-body oncology and diagnostic imaging.

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

• ECAT PET/CT (K002715)

Reference Devices

• Siemens SOMATOM EMOTION (K002713)
• CPS ECAT ACCEL PET (K002584)
• Siemens SOMATOM EMOTION MS (K991764)

Submission Summary (Full Text)

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K01 3504
Page 1 of 2

### 510(k) SUMMARY

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

## Identification of Submitter

Submitter:

Telephone No: Fax No: Date of preparation:

#### Identification of the Product

Device Proprietary Name: Common Name:

Classification Name:

William Skremsky CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932 [phone] [phone] October 8, 2001

ECAT LSO PET/CT Scanner Combination Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) Emission Computed Tomography System per 21 CFR 892.1200

# Marketed Device to Which Equivalence is Claimed

| Device | Manufacturer | 510(k) Number |
|-------------|-----------------------|---------------|
| ECAT PET/CT | CTI PET Systems (CPS) | K002715 |

#### Device Description and Comparison

Device Description and Comparison emission tomography (PET) and X-ay computed The BCAT LSO FETICT is a combined position is a modified version of the ECAT PET/CT
tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT P (K002715) and will utilize the same CT component from the Siemens SOMATOM Project 10 (1002713) and will unite the same CT Component from PET component that uses 288 BGO EMOTION (CT) Scanner. Thowever, in place of and Lee configured with the CPS ECAT ACCEL PET
crystal block detectors, the ECAT LSO PET/CT will be configured with the Cliences S (K002584) using 144 LSO crystal block detectors, in combination with the Siemens Somation of the (KUU2384) using 144 LSO crystal block accessions and the PET transmission sources are not As with the predicale system, 2D I ET acquisition data is acquired only in 3D and PET
included in the modified ECAT LSO PET/CT. PET employees and externill be attenuation correction map data is obtained from the CT. The PET and CT components will be attenuation correction map cata is obusined from the original ECAT PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system.

The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational The ECAT LSO I ETCT gainly stractare, pail remain essentially the same as the ECAT PET/CT system (ACS 3), workslations to accommodate the different PET detectors. In addition, the ECAT with only imilor modifications to acconmisear. ITT will also be offered with either the Siemens.
LSO PET/CT as well as the HR+ based ECAT PET/CT will also be offered of MC LSO FETCT as well as the First based inthe dual slice Duo version, SOMATON EMOTION MS
single slice EMOTION CT (K991764) or the dual slice interest of X reverse of X rev single silce EMOTION Of the system. The EMOTION MS CT with two rows of X-ray (KU030T+), for the CT component of the System. The Execue of otherwise affect performance of the ECAT LSO PET/CT.

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510(k) Summary ECAT LSO PET/CT Scanner p. 2

K013504
Page 2 of 2

The ECAT LSO PET/CT scanner is intended for use primarily as a clinical, whole-body oncology machine with mid-range spiral CT performance and fast patient-throughput clinical PET performance. The CT component will also enhance PET scans by allowing fast, essentially noise-free attenuation correction for PET studies, and by providing precise anatomical reference through fused PET and CT images. In addition, the ECAT LSO PET/CT will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on the PET/CT system.

#### Indications for Use

The CPS/Siemens ECAT PET/CT system is a combined positron emission tomography (PET) and Xray computed tomography (CT) scanner. The PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected position emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce 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.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 7001

Mr. William Skremsky Senior Regulatory Affairs Specialist CTI, Inc. 810 Innovation Drive KNOXVILLE TENNESSEE 37932 Re: K013504 Trade/Device Name: Modification to: ECAT LSO PET/CT Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system

Regulatory Class: II Product Code: 90 KPS Dated: October 18, 2001 Received: October 22, 2001

Dear Mr. Skremsky:

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 (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. Brogdon

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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510(k) Number (if known):

Device Name: ECAT LSO PET/CT Scanner

Indications for Use:

The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce 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.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient. }

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-The-Counter Use ______ |
|----------------------|----------------------------------------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | | |
| | <div> <span style="text-decoration: overline;">Nancy Brogdon</span> </div> | | (Optional Format 1-2-96) |
| (Division Sign-Off) | | | |
| | Division of Reproductive, Abdominal, | | |
| | and Radiological Devices | | |
| 510(k) Number | <div> <span style="text-decoration: overline;">K013504</span> </div> | | |