ECAT HRRT

K040933 · Cti Pet Systems, Inc. · KPS · Jun 7, 2004 · Radiology

Device Facts

• Record ID: K040933
• Device Name: ECAT HRRT
• Applicant: Cti Pet Systems, Inc.
• Product Code: KPS · Radiology
• Decision Date: Jun 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

Device Story

ECAT HRRT is a PET scanner utilizing flat panel detector heads with LSO/LYSO crystal technology in an octagonal arrangement. Device captures positron-emitting radiopharmaceutical distribution in human subjects; data processed by an Intel-based acquisition computer and RAID system. System includes an optional Patient Handling System (PHS) designed for the specific gantry bore. Operated by trained healthcare professionals in clinical settings. Output consists of reconstructed PET images and sinograms used by clinicians to assess metabolic and physiologic functions. Device leverages technology from ECAT ACCEL and E.CAM LSO 311 systems; software is an updated version of Standard ECAT (7.x) modified for higher resolution data sets and clinician-controlled reconstruction parameters. Benefits include improved imaging resolution for diagnostic assessment.

Clinical Evidence

Bench testing only. System performance tested by manufacturer against predetermined PET performance specifications and IEC 60601-1 safety standards. No clinical trial data provided.

Technological Characteristics

Octagonal gantry with eight flat panel detector heads; LSO/LYSO scintillation crystals; Intel-based acquisition PC with RAID storage; fibre channel connectivity; software-based image reconstruction; complies with IEC 60601-1.

Indications for Use

Indicated for use by trained healthcare professionals to image and measure the distribution of injected positron-emitting radiopharmaceuticals in humans to determine metabolic and physiologic functions. Prescription use only.

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 ACCEL (K962797)
• E.CAM LSO 311 (K981027)

Reference Devices

• ECAT ACCEL (K002584)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) SUMMARY

[As required by 21 CFR 807.87(b)]

K040933

Identification of Submitter Submitter:

Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932 [phone] [phone] May 7, 2004

Telephone No: Fax No: Date of preparation:

#### Identification of the Product

Device Proprietary Name: Common Name: Classification Name:

## ECAT HRRT

Positron Emission Tomography (PET) Scanner Emission Computed Tomography System per 21 CFR 892.1200

## Marketed Devices to Which Equivalence is Claimed

| Device | Manufacturer | 510(k) Number |
|---------------|-----------------------|---------------|
| ECAT ACCEL | CTI PET Systems (CPS) | K962797 |
| E.CAM LSO 311 | CTI PET Systems (CPS) | K981027 |

## Device Description

The CTI PET Systems ECAT HRRT is a new positron emission tomography (PET) scanner system. The ECAT HRRT PET scanners utilize flat panel detector heads, combined LSO (Lutetium Oxyortho-Silicate) / LYSO (Lutetium Yttrium Oxyortho-Silicate) crystal detector technology. The HRRT consists of eight detector panels in an octagonal arrangement completely encircling the bore of the Gantry.

A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry.

The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk.

Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.

{1}------------------------------------------------

# 510(k) Summary ECAT HRRT PET Scanner p. 2

#### Indications for Use

The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

## Comparison with Predicate Devices

The ECAT HRRT PET scanner leverages much of the already proven technology, as well as many components and features of currently produced CPS PET tomographic systems. The 360 degree field of view (FOV) detector geometry surrounding the patient port is similar to that of the CPS ECAT ACCEL PET scanner (K002584). The flat panel detectors, LSO/LYSO combined crystal detector technology, and coincidence point source transmission scanning design concepts were borrowed from the E.CAM LSO 311 PET/SPECT system (K981027). The patient handling system (PHS) offered as an option with ECAT HRRT scanner is similar to the PHS used on the CPS ECAT ACCEL. The Advanced Computational System (ACS), used to store and process acquired PET data into sinograms, as well as the reconstruction computer, control console, and the ECAT software are updated versions of those components used in the ECAT ACCEL scanner.

#### Safety and Effectiveness

The CPS ECAT HRRT system has been designed to comply with applicable industry safety standards for this type of medical equipment including the international standard IEC 60601-1, General Requirements for the Safety Electrical Medical Equipment. Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications.

## Substantial Equivalence Determination

In the opinion of CPS, the ECAT HRRT PET scanner utilizes the same scientific technology as the predicate ECAT ACCEL and E.CAM LSO 311 PET/SPECT systems and raises no new questions with regard to its safety and effectiveness. Therefore, we believe the ECAT HRRT is substantially equivalent to those tomographic systems with respect to design, material and composition, energy source, and radiation safety characteristics.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Ms. M. Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI PET Systems, Inc. CPS Innovations 810 Innovation Drive KNOXVILLE TN 37932

Re: K040933 Trade/Device Name: ECAT HRRT PET Scanner Regulatory Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Medio:

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 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.

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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)

I ms letter will and in your to began finding of substantial equivalence of your device to a legally premanted noticated 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 11 you acon office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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

Page 2

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: ECAT HRRT PET Scanner

Indications for Use:

CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by CFS ECA I position cimission comography (2017) (2017) 11:50 PM asure the distribution of appropriately transo neanth care professionals to the purpose of determining mychou position entiting siologic functions within the human body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Sarglon (Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number Page