(77 days)
No
The summary describes standard image processing and reconstruction techniques for SPECT imaging, with no mention of AI or ML algorithms.
No.
The device is used for imaging and detection of radionuclides, which is a diagnostic function, not a therapeutic one. It processes and reconstructs images to generate attenuation maps and perform corrections on SPECT images, aiding in diagnosis rather than treatment.
Yes
The device is used to detect or image the distribution of radionuclides in the body or organ, which is a process to collect information about the body's state, fitting the definition of a diagnostic device.
No
The device is described as a "software option" for an existing gamma camera system (ECAM). While the software performs processing and reconstruction, it is explicitly stated to be installed into a hardware component (GMS-5500A/UI image processor) which is part of a larger hardware system (ECAM gamma camera system). The functionality is also tied to the use of an external flood source and a parallel-hole collimator, which are hardware components. Therefore, it is not a standalone software-only medical device.
Based on the provided information, 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 description clearly states the device is used to "detect or image the distribution of radionuclides in the body or organ" using SPECT imaging. This is an in vivo imaging technique, meaning it is performed within the living body.
- Input Data: The input data is "Transmission CT data (TCT) and emission data from a gamma camera system," which are acquired from the patient's body, not from a sample taken from the body.
- Anatomical Site: The anatomical site is "Body or organ," further indicating an in vivo application.
Therefore, the device described is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is designed to be used in combination with E.CAM gamma camera systems to process and reconstruct acquired transmission CT data (TCT) and emission data. When the external flood source of the E.CAM Profile system is combined with a parallel-hole collimator, this software can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images. The intended uses of this product are commensurate with other products currently in the marketplace.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):
C. Tomographic Imaging (SPECT) for non Positron Emitter, Energy Range (keV): 50-400.
Product codes
90 KPS
Device Description
The Transmission Kit, Trans-CT for E.CAM, Model NSTR-050A is a software option for the ECAM gamma camera system that will be used to process and reconstruct acquired transmission and emission data. This software will be installed into the GMS-5500A/UI image processor which is part of the ECAM system. When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transmission CT (TCT)
SPECT (Single-photon emission computed tomography)
Anatomical Site
Body or organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens E.CAM Profile Attenuation Correction (K963983)
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
DEC 2 3 1998
510(k) Summary
| Date: | September 10, 1998 |
|---|---|
| Submitter's Name: | |
| Submitter's Address: | Toshiba America Medical Systems, Inc. |
| P.O. Box 2068, 2441 Michelle Drive, | |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | Donelle Krajewski, Regulatory Affairs Specialist, |
| (714)730-5000, Extension 4121 | |
| Device Proprietary Name: | |
| Classification Name: | |
| Common Name: | Transmission Kit, Trans-CT, Model NSTR-050A |
| Emission Computed Tomography System | |
| Gamma Camera Option | |
| [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] | |
| Predicate Devices: | Siemens E.CAM Profile Attenuation Correction (K963983) |
| Reason for Submission | New option for existing product |
Description of this Device:
The Transmission Kit, Trans-CT for E.CAM, Model NSTR-050A is a software option for the ECAM gamma camera system that will be used to process and reconstruct acquired transmission and emission data. This software will be installed into the GMS-5500A/UI image processor which is part of the ECAM system. When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.
Summary of Intended Uses:
This device is designed to be used in combination with E.CAM gamma camera systems to process and reconstruct acquired transmission CT data (TCT) and emission data. When the external flood source of the E.CAM Profile system is combined with a parallel-hole collimator, this software can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images. The intended uses of this product are commensurate with other products currently in the marketplace.
Technological Characteristics:
This software employs the same technological characteristics as the predicate device. Both systems employ the use of a transmission source to provide the attenuation map. This attenuation map is then used to perform attenuation corrections on SPECT images along with scatter correction. Attenuation correction using transmission systems is well understood and is documented in peer reviewed scientific publications.
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Image /page/1/Picture/0 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 stripes forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEC 2 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Donelle Krajewski Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068
Re:
Toshiba's Transmission Software. Trans-CT for E.CAM. Model NSTR-050A Dated: September 10, 1998 Received: October 7, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Krajewski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requiration entitled, "Misbranding by reference to premarket notfication"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if Known):
Toshiba's Transmission Software, Trans-CT for E.CAM, Model NSTR-050A Device Name:
_ K983516 ____________________________________________________________________________________________________________________________________________________________________
Nuclear Medicine Device
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| | | YES | NO | Energy Range
(keV) |
|----|------------------------------------------------------|-----|----|-----------------------|
| A. | Planar Imaging | | X | |
| B. | Whole Body Imaging | | X | |
| C. | Tomographic Imaging (SPECT) for non Positron Emitter | X | | 50-400 |
| D. | Positron Imaging by Coincidence | | | |
| E. | Positron Imaging without Coincidence | | X | |
| F. | Positron Whole Body Imaging by Coincidence | | X | |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
510 (k) Number:
983516