(13 days)
Not Found
No
The description focuses on mechanical and firmware modifications to a patient handling system, with no mention of AI or ML for image analysis, control, or other functions.
No.
The device is a patient handling system used to support and move a patient through a PET/CT scanner during image acquisition, which is a diagnostic process, not a therapeutic one.
Yes
The device is a component of a PET/CT scanner system, which is explicitly stated to acquire "PET and CT diagnostic image data." The "ECAT PET/CT scanners are 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 crosssectional images of the body by computer reconstruction of x-ray transmission data." These functions are directly related to diagnosis.
No
The device description explicitly states the modification consists of "two added footswitches and revised PHS controller firmware," indicating the inclusion of hardware components (footswitches) in addition to software (firmware).
Based on the provided text, the 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 PET/CT Patient Handling System is a mechanical component used to support and move a patient during imaging procedures. It does not perform any tests on biological samples.
- Intended Use: The intended use describes the system's role in acquiring diagnostic image data from the patient in vivo (within the living body), not in vitro (outside the living body).
The device is a component of an imaging system used for diagnostic purposes, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
The PET/CT Patient Handling System (PHS) is a system component of CPS ECAT PET/CT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic image data are being acquired from the patient.
The ECAT PET/CT scanners are 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 these systems 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.)
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The subject device is the patient handling system (PHS) or patient bed that is used with the currently marketed CPS ECAT PET/CT scanners. The ECAT PET/CT, ECAT LSO PET/CT and ECAT LSO PET/CT 16 systems are combined position tomography (PET) and X-ray computed tomography (CT) scanners. These three dual modality PET/CT tomographs all utilize the same basic patient handling system (PHS) to support and move the patient through the patient port in the scanner gantry. Currently, vertical positioning of the patient on the bed of these PET/CT scanners is only possible when the PHS bed is fully retracted out of the patient port.
The proposed modification for the PHS used on these three PET/CT scanners, which consists of two added footswitches and revised PHS controller firmware, will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
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 modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 2 5 2002
510(k) SUMMARY
[As required by 21 CFR 807.87(h)]
Identification of Submitter Submitter:
Contact Person:
Telephone No: Fax No: Date of preparation:
CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932. William Skremsky Senior Regulatory Affairs Specialist (865) 218-2522 (865) 218-3000 November 8, 2002
Identification of the Product
Device Proprietary Name: Common Name: Classification Name:
PET/CT Patient Handling System (PHS) Patient Bed Emission Computed Tomography System per 21 CFR 892.1200
Marketed Devices to Which Equivalence is Claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| PHS for ECAT PET/CT | CTI PET Systems (CPS) | K002715 |
| PHS for ECAT LSO PET/CT | CTI PET Systems (CPS) | K013504 |
| PHS for ECAT LSO PET/CT 16 | CTI PET Systems (CPS) | K023518 |
Device Description and Comparison to the Unmodified Device
The subject device is the patient handling system (PHS) or patient bed that is used with the currently marketed CPS ECAT PET/CT scanners. The ECAT PET/CT, ECAT LSO PET/CT and ECAT LSO PET/CT 16 systems are combined position tomography (PET) and X-ray computed tomography (CT) scanners. These three dual modality PET/CT tomographs all utilize the same basic patient handling system (PHS) to support and move the patient through the patient port in the scanner gantry. Currently, vertical positioning of the patient on the bed of these PET/CT scanners is only possible when the PHS bed is fully retracted out of the patient port.
The proposed modification for the PHS used on these three PET/CT scanners, which consists of two added footswitches and revised PHS controller firmware, will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port.
Intended Use
The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic studies are performed on the patient.
1
510(k) Summary ECAT LSO PET/CT Scanner p. 2
Safety and Effectiveness
The PET/CT Patient Positioning System, with the proposed modification for the patient positioning enhancement described in this 510(k), 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 and UL 187, the X-Ray Equipment Standard for Safety. The modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements.
Substantial Equivalence Determination
In the opinion of CPS, the PET/CT Patient Positioning System, incorporating the described patient positioning enhancement modification, utilizes the same scientific technology as the unmodified version and raises no new questions with regard to its safety and effectiveness. Therefore, we believe the modified Patient Positioning System is substantially equivalent to the unmodified version with respect to design, material and composition, energy source, and safety characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2002
Mr. William Skremsky Senior Regulatory Affairs Specialist CTI, Inc. 810 Innovation Drive KNOXVILLE TN 37932
Re: K023768
Trade/Device Name: PET/CT Patient Handling System (PHS) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II
Product Code: 90 KPS Dated: November 8, 2002 Received: November 12, 2002
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.
3
Page 2
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 | (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 Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
Page / of /
510(k) Number (if known):
Device Name: PET/CT Patient Handling System (PHS)
Indications for Use:
The PET/CT Patient Handling System (PHS) is a system component of CPS ECAT PET/CT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic image data are being acquired from the patient.
The ECAT PET/CT scanners are 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 crosssectional 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 these systems 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)
David G. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OF
Over-The-Counter Use