TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S

K991565 · Smv America · KPS · Aug 2, 1999 · Radiology

Device Facts

• Record ID: K991565
• Device Name: TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
• Applicant: Smv America
• Product Code: KPS · Radiology
• Decision Date: Aug 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

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.

Device Story

TAC-2 is an accessory for DST/DST-XL gamma cameras; consists of two sliding line source emitter block/collimator assemblies. Assemblies travel in synchrony axially across detector faces. Uses Gd-153 radionuclide transmission sources to measure patient attenuation; transmission data used to generate attenuation maps. Maps applied to emission data to correct for photon attenuation effects. Operated by nuclear medicine technologists/physicians in clinical settings. Output is enhanced emission image depicting patient anatomy. Benefit is improved image quality/contrast for bone, soft tissue, and lung structures by reducing attenuation artifacts.

Clinical Evidence

Clinical and non-clinical studies conducted using TAC-2 with DST-XL and VCAR option. Images compared to those from predicate devices; reported to be of same quality.

Technological Characteristics

Hardware accessory for gamma cameras; two sliding line source emitter block/collimator assemblies. Energy source: Gd-153 radionuclide transmission source. Connectivity: Integrated with DST/DST-XL gamma camera systems. Principle: Transmission-based attenuation measurement.

Indications for Use

Indicated for patients undergoing cardiac or whole-body imaging in single photon mode or coincidence mode (VCAR option) on SMV dual-head emission tomographic systems to enhance emission images by compensating for body-related photon attenuation.

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

• 90KPS TAC (K952190)
• 90 KPS MCD-AC (K971980)

Submission Summary (Full Text)

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

Page D-1

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

## Section D. 510 (k) Summary of Safety and Effectiveness

The following information is in conformance with 21 CFR 807.92.

K991565

| Date Prepared: | March 11, 1999 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | SMV America<br>8380 Darrow Road<br>Twinsburg, Ohio 44087<br>[phone]<br>[phone] |
| Contact: | Philip Vernon (extension 6018) |
| Proprietary name: | TAC-2, Transmission Attenuation Correction and DST,<br>DST-XL Gamma Cameras and VISION Power Station<br>computer (K921008, K942837, K912573), for use in single<br>photon mode and in conjunction with VCAR (Coincidence)<br>option (K972686). |
| Common names: | Attenuation correction |
| Classification name: | System, Emission Computed Tomography |
| Predicate device: | (K952190) 90KPS<br>TAC<br>SMV<br>(K971980) 90 KPS<br>MCD-AC<br>ADAC Laboratories |
| Device Description: | The TAC-2 hardware consists of two sliding line source<br>emitter block/collimator assemblies. Each assembly extends<br>transaxially across the face of each detector of a DST series<br>gamma camera oriented 180°. When in use each emitter<br>block exposes the collimator in the opposing assembly. The<br>assemblies travel in synchrony along the axial direction. |
| Intended Use: | The TAC-2 accessory to the DST and DST-XL Gamma<br>Cameras and VISION Power Station produces images that<br>depict the anatomy of a patient. The accessory is intended to<br>provide an enhancement to emission images acquired using<br>the in SPECT mode or using the VCAR option to the DST<br>and DST-XL Gamma Cameras by correcting for photon<br>attenuation effects of the patient's anatomy. |

{1}------------------------------------------------

Page D-2

0.

| Technological<br>Comparison: | TAC-2 is similar to the TAC and MCD-AC in that all<br>devices measure attenuation using external transmission<br>radionuclide sources. In each device, the transmission data<br>acquired is used to form attenuation maps to correct emission<br>data for attenuation. The transmission radionuclide of TAC-<br>2 ( $^{153}Gd$ ) is the same as in TAC, but is different from<br>MCD/AC ( $^{137}Cs$ ). The lower energy emissions from $^{153}Gd$ )<br>provide transmission images with increased contrast of bone,<br>soft tissue and lung. The source geometry is also different in<br>that MCD-AC uses point sources while TAC and TAC-2 use<br>line sources | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Testing: | Clinical and non-clinical studies were conducted using the<br>TAC-2 attenuation correction device with a DST-XL with<br>the VCAR option. Images produced were of the same<br>quality as those provided by the manufacturers of the<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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<br>(Per 21 CFR 801.109) | ✓ |
| | (Optional Format 3-10-98) |

Final