(9 days)
Not Found
No
The document describes standard image processing and reconstruction techniques for PET/CT systems and does not mention AI, ML, or related concepts.
No.
The device is used for imaging and aids in diagnosis, but it does not directly treat or alleviate a condition, which is the primary function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states: "The device output can aid to diagnosis when used by a qualified physician." This explicitly indicates its role in aiding diagnosis.
No
The device description explicitly lists multiple hardware components including a CT gantry, PET gantry, patient handling system, and x-ray generator. While it includes a software workstation for processing and display, it is an integrated system with significant hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SceptreP3 system is described as producing cross-sectional images of the human body using PET and CT technologies. It measures the distribution of radiopharmaceuticals and uses x-ray transmission to create images and attenuation maps.
- Lack of Sample Analysis: The description focuses on imaging the body directly, not on analyzing samples taken from the body.
The device is clearly an in vivo imaging system, designed to visualize structures and processes within the living body.
N/A
Intended Use / Indications for Use
The SceptreP3 system is intended to be used:
-
- to produce cross-sectional images of the human body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
-
- to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles,
-
- to create attenuation maps from the x-ray data to correct the PET images, and
-
- 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.
Product codes
90 KPS, JAK
Device Description
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 |
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.
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.
Mentions image processing
The system processes, displays, and stores the reconstructed images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Positron Emission Tomography (PET)
Anatomical Site
Human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040902, K003241, K023768, K021314
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
KOHL4NS
SEP 1 7 2004
HITACHI
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel.: 330.425.1313 Fax: 330.425.1410
510(k) Summary
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 425-1410 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | June 11, 2004 |
Device Name
| Device Name: | Computed tomography x-ray system, Emission computed
tomography system |
|-------------------------|------------------------------------------------------------------------------|
| Trade/Proprietary Name: | SceptreP3 |
| Common Name: | Computed Tomography X-ray System, Emission
computed tomography system |
| Classification Name: | System, X-Ray, Tomography, Computed
System, Tomography, Emission Computed |
| Classification Number: | Sec. 892.1750
Sec. 892.1200 |
Predicate Devices
| Predicate Devices: | Hitachi Medical | K040902 | |
|---|---|---|---|
| ECAT EMERGE PET | CTI PET Systems | K003241 | |
| PET/CT Patient Handling | |||
| System (PHS) | CTI PET Systems | K023768 | |
| Sceptre-VS (AVIA) | |||
| Workstation | Hitachi Medical | K021314 |
1
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.
2
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,
-
- to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles,
-
- to create attenuation maps from the x-ray data to correct the PET images, and
-
- 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.
3
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.
4
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (800) 638-2041 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
5
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K042428 |
| Device Name: | SceptreP3 PET/CT System |
Indications for Use:
The SceptreP3 system is intended to be used:
-
- 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
Prescription Use $\checkmark$
OR
Over-the-Counter Use