(89 days)
No
The summary describes a hardware accessory for attenuation correction in SPECT imaging, focusing on physical components and their function. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as an accessory that produces images and compensates for attenuation effects, which are image processing functions, not therapeutic actions.
Yes
The device aids in producing images of a patient's anatomy to enhance emission images by compensating for attenuation effects, which is a diagnostic function.
No
The device description explicitly details hardware components (sliding line source emitter block/collimator assemblies) and their function, indicating it is a hardware accessory, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device produces images of a patient's anatomy and enhances emission images by compensating for attenuation effects within the human body. This is an in vivo application, meaning it's used directly on a living patient.
- Device Description: The description details hardware that interacts with a gamma camera and is positioned relative to the patient's body. This further supports an in vivo use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine these types of samples.
Therefore, the SMV TAC-2 accessory is a medical device used for in vivo imaging, not an IVD.
N/A
Intended Use / Indications for Use
The TAC-2 accessory to the DST and DST-XL Gamma Cameras and VISION Power Station produces images that depict the anatomy of a patient. The accessory is intended to provide an enhancement to emission images acquired using the in SPECT mode or using the VCAR option to the DST and DST-XL Gamma Cameras by correcting for photon attenuation effects of the patient's anatomy.
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option). The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The TAC-2 hardware consists of two sliding line source emitter block/collimator assemblies. Each assembly extends transaxially across the face of each detector of a DST series gamma camera oriented 180°. When in use each emitter block exposes the collimator in the opposing assembly. The assemblies travel in synchrony along the axial direction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical and non-clinical studies were conducted using the TAC-2 attenuation correction device with a DST-XL with the VCAR option. Images produced were of the same quality as those provided by the manufacturers of the predicate devices.
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.
K921008, K942837, K912573, K972686
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
Page D-1
Section D. 510 (k) Summary of Safety and Effectiveness
The following information is in conformance with 21 CFR 807.92.
| Date Prepared: | March 11, 1999 |
|---|---|
| Manufacturer: | SMV America |
| 8380 Darrow Road | |
| Twinsburg, Ohio 44087 | |
| (330) 425-1340 | |
| (330) 405-7682 | |
| Contact: | Philip Vernon (extension 6018) |
| Proprietary name: | TAC-2, Transmission Attenuation Correction and DST, |
| DST-XL Gamma Cameras and VISION Power Station | |
| computer (K921008, K942837, K912573), for use in single | |
| photon mode and in conjunction with VCAR (Coincidence) | |
| option (K972686). | |
| Common names: | Attenuation correction |
| Classification name: | System, Emission Computed Tomography |
| Predicate device: | (K952190) 90KPS |
| TAC | |
| SMV | |
| (K971980) 90 KPS | |
| MCD-AC | |
| ADAC Laboratories | |
| Device Description: | The TAC-2 hardware consists of two sliding line source |
| emitter block/collimator assemblies. Each assembly extends | |
| transaxially across the face of each detector of a DST series | |
| gamma camera oriented 180°. When in use each emitter | |
| block exposes the collimator in the opposing assembly. The | |
| assemblies travel in synchrony along the axial direction. | |
| Intended Use: | The TAC-2 accessory to the DST and DST-XL Gamma |
| Cameras and VISION Power Station produces images that | |
| depict the anatomy of a patient. The accessory is intended to | |
| provide an enhancement to emission images acquired using | |
| the in SPECT mode or using the VCAR option to the DST | |
| and DST-XL Gamma Cameras by correcting for photon | |
| attenuation effects of the patient's anatomy. |
1
Page D-2
| Technological
Comparison: | TAC-2 is similar to the TAC and MCD-AC in that all
devices measure attenuation using external transmission
radionuclide sources. In each device, the transmission data
acquired is used to form attenuation maps to correct emission
data for attenuation. The transmission radionuclide of TAC-
2 ( $^{153}Gd$ ) is the same as in TAC, but is different from
MCD/AC ( $^{137}Cs$ ). The lower energy emissions from $^{153}Gd$ )
provide transmission images with increased contrast of bone,
soft tissue and lung. The source geometry is also different in
that MCD-AC uses point sources while TAC and TAC-2 use
line sources | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Testing: | Clinical and non-clinical studies were conducted using the
TAC-2 attenuation correction device with a DST-XL with
the VCAR option. Images produced were of the same
quality as those provided by the manufacturers of the
predicate devices. | | |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with three horizontal lines extending from its body, creating a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 1999
Philip Vernon SMV America A Nuclear Medicine Company 8380 Darrow Road Twinsburg, Ohio 44087
Re:
K991565 TAC-2 option for use with DST, DST-XL Gamma Cameras Dated: April 21, 1999 Received: May 5, 1999 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Vernon:
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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 II (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 regulation entitled, "Misbranding by reference to premarket notification"(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
3
Page E-1
Section E. Indications for Use Form
Section E. Indications for Use Form
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: TAC-2
Indications For Use:
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991565 |
| Prescription Use | |
| (Per 21 CFR 801.109) | ✓ |
| (Optional Format 3-10-98) |
Final