SCEPTREP3 PET/CT

K042428 · Hitachi Medical Systems America, Inc. · KPS · Sep 17, 2004 · Radiology

Device Facts

• Record ID: K042428
• Device Name: SCEPTREP3 PET/CT
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: KPS · Radiology
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SceptreP3 system is intended to be used: 1) to produce cross-sectional images of the human body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area, 2) to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles, 3) to create attenuation maps from the x-ray data to correct the PET images, and 4) to combine (co-register) the CT and PET images after reconstruction to produce images with both anatomical and physiological data. The system processes, displays, and stores the reconstructed images. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Story

SceptreP3 integrates a multi-slice CT scanner, a PET scanner, a patient handling system, and an AVIA workstation; combines PET emission data and CT transmission data to produce cross-sectional images. CT subsystem uses third-generation slip-ring technology with a high-frequency generator and solid-state detectors; PET subsystem uses partial-ring LSO detector technology. Workstation initiates data acquisition, processes images, creates attenuation correction maps from CT data, and performs image fusion for anatomical/physiological display. Used in clinical settings by physicians/technicians. Output provides diagnostic aid through fused anatomical and physiological visualization; benefits patients by enabling simultaneous assessment of metabolic and structural information.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and performance comparison to predicate devices, confirming that the integrated system maintains the performance characteristics of its individual, previously cleared subsystems.

Technological Characteristics

Integrated PET/CT system. CT: 3rd-gen slip-ring, high-frequency generator, solid-state detectors (4-slice). PET: Partial-ring LSO detectors. Workstation: PC-based, Windows OS, DICOM compliant. Connectivity: Networked for image storage/archiving. Sterilization: N/A (imaging equipment).

Indications for Use

Indicated for use in patients requiring cross-sectional imaging of the human body for the measurement of positron-emitting radiopharmaceutical distribution and x-ray transmission imaging. Used by qualified physicians for diagnostic aid.

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

• Hitachi Medical (K040902)
• ECAT EMERGE PET (K003241)
• PET/CT Patient Handling System (PHS) (K023768)
• Sceptre-VS (AVIA) Workstation (K021314)

Submission Summary (Full Text)

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

KOHL4NS

SEP 1 7 2004

# HITACHI

#### HITACHI MEDICAL SYSTEMS AMERICA, INC.

1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel.: [phone] Fax: [phone]

# 510(k) Summary

### Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: [phone]<br>fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | June 11, 2004 |

### Device Name

| Device Name: | Computed tomography x-ray system, Emission computed<br>tomography system |
|-------------------------|------------------------------------------------------------------------------|
| Trade/Proprietary Name: | SceptreP3 |
| Common Name: | Computed Tomography X-ray System, Emission<br>computed tomography system |
| Classification Name: | System, X-Ray, Tomography, Computed<br>System, Tomography, Emission Computed |
| Classification Number: | Sec. 892.1750<br>Sec. 892.1200 |

### Predicate Devices

| Predicate Devices: | | Hitachi Medical | K040902 |
|--------------------|-----------------------------------------|-----------------|---------|
| | ECAT EMERGE PET | CTI PET Systems | K003241 |
| | PET/CT Patient Handling<br>System (PHS) | CTI PET Systems | K023768 |
| | Sceptre-VS (AVIA)<br>Workstation | Hitachi Medical | K021314 |

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### Device Description

#### Introduction

The SceptreP3 combines the technologies of a multi-slice x-ray computed tomography system, rne Socker 3 comments on computed tomography scanner, and a DICOM compliant image workstation into an integrated system that uses the PET and CT data to produce cross-sectional images of the body at various angles.

The system is made up of 4 discrete sub-systems that are independently marketed under unique 510(k) clearances. The sub-system models are:

| Sub-System | Model | Manufacturer | 510(k) |
|---------------|--------------------------------------|-----------------------|---------|
| CT | Presto | Hitachi Medical | K040902 |
| PET | ECAT ART-LSO PET System | CTI PET Systems (CPS) | K003241 |
| Workstation | Sceptre-VS (AVIA) | Hitachi Medical | K021314 |
| Patient Table | PET/CT Patient Handling System (PHS) | CTI PET Systems (CPS) | K023768 |

#### Scientific Concepts

The CT sub-system uses "third generation" CT technology, where the x-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 4 slices of data simultaneously. The x-ray sub-system features a high frequency generator, x-ray tube, and collimation system that produces a fan beam x-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the x-ray tube/detector (opinal) boat ates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system.

The PET sub-system uses partial ring LSO detector technology, where the detectors rotate around the patient and collect emission data from the injected radiopharmaceutical.

The computer workstation (AVIA™) initiates data acquisition and processes the resultant images. The images are stored, printed, and archived as required. CT data is used to create attenuation correction maps for the PET images as well as for standard CT image display. The workstation is also capable of fusing CT and PET images into one display to show both anatomical and physiological data. The workstation is based on current PC technology using the Windows™ operating system.

#### Physical and Performance Characteristics

The SceptreP3 system consisting of a CT gantry, a PET gantry, operator's workstation, patient handling system (table), high-frequency x-ray generator, and accessories. The system performance is identical to the predicate devices.

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#### Performance Comparison

Because the SceptreP3 simply combines freestanding CT and PET systems, its performance mirrors the predicate devices. There are no fundamental performance changes to the CT and PET sub-systems, nor the image workstation. The only change allows the workstation to the control PET data collection, request motion of the PHS and to automatically receive the image data from the CT and PET sub-systems.

The evaluation results of the SceptreP3 are comparable to the predicate devices and support our conclusion that the Sceptre PET/CT system is substantially equivalent.

# Device Intended Use

The SceptreP3 system is intended to be used:

- l ) to produce cross-sectional images of the human body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
- 2) to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles,
- 3) to create attenuation maps from the x-ray data to correct the PET images, and
- 4) to combine (co-register) the CT and PET images after reconstruction to produce images with both anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can provide an aid to diagnosis when used by a qualified physician.

# Device Technological Characteristics

The CT and PET sub-system are functionally identical to their predicate devices. Physically, the SceptreP3 combines the two gantries under one cover and uses a new patient table, called a Patient Handling System (PHS). The PHS is identical to the predicate PHS device.

The operation of the system is virtually identical to the predicates because the operating software on the CT and PET subsystems is largely unchanged. The key differences are the ability to initiate PET data collection and control the PHS from the AVIA workstation. This necessitated minor changes to the CT and PET sub-systems to allow them to accept commands from the A VIA. The PHS design allows the table pallet to extend through the CT aperture into the PET aperture. Gantry controls provide the same features as the CT predicate, but the control layout was modified to accommodate the new covers.

Despite these differences, the SceptreP3 system is technologically equivalent in concept, function, and performance to the predicate devices.

### Conclusions

The SceptreP3 system has been developed and validated according to applicable standards. Testing has proven that the system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

#### SEP 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hitachi Medical Systems America, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

#### Re: K042428

Trade/Device Name: SceptreP3 PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

. II

Regulatory Class: II Product Code: 90 KPS and JAK Dated: September 7, 2004 Received: September 8, 2004

Dear Mr. Lehtonen:

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 for ass station 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 sadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogh manone of your device of your device of your device to a legally premarket notincation. The PDF anishing sites on 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 If you desire specific acrise as your he 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compliance at (201) 22th Part 807.97) you may obtain. Other general by releveloc to promative includious (et the Act may be obtained from the Division of Small mormation on your responsional and Consumer Assistance at its toll-free number [phone] or 14andraorerors, International address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Broughton

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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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K042428 |
| Device Name: | SceptreP3 PET/CT System |

Indications for Use:

The SceptreP3 system is intended to be used:

- 1) to produce cross-sectional images of the hunan body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
- tadiopliatinaccunears within the things a suy produced by x-ray transmission from the same axial plane 2) taken at different angles,
- taken at different angles,
to create attenuation maps from the x-ray data to correct the PET images, and 3)
- to creat anchuation maps from the A tay images after reconstruction to produce images with both 4) anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can aid to diagnosis when used by a qualified physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Layson

(Division Sign-Off) Division of Reproductive, and Radiological Dev 510(k) Number

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Over-the-Counter Use