511 KEV COLLIMATOR

K964438 · Trionix Research Laboratory, Inc. · KPS · May 29, 1997 · Radiology

Device Facts

• Record ID: K964438
• Device Name: 511 KEV COLLIMATOR
• Applicant: Trionix Research Laboratory, Inc.
• Product Code: KPS · Radiology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). Planar imaging, Whole body imaging, Tomographic imaging (SPECT) for non Positron emitter, Positron imaging without coincidence. Could be used with 511 keV photon imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV).

Device Story

511 keV collimator designed for TRIONIX Triad nuclear medicine systems; enables imaging of radionuclides emitting 511 keV photons. Device functions as physical component for gamma camera; restricts photon path to allow spatial localization of radiation source. Used in clinical nuclear medicine departments; operated by trained technologists/physicians. Output consists of raw radiation detection data processed by host system into diagnostic images. Facilitates visualization of radionuclide distribution; aids clinical decision-making regarding patient pathology. Benefits include expanded imaging capabilities for high-energy isotopes on existing SPECT platforms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-energy collimator designed for 511 keV photon imaging. Mechanical component for gamma camera systems. Compatible with simultaneous multi-isotope imaging (e.g., 140 keV and 511 keV).

Indications for Use

Indicated for detection or imaging of radionuclide distribution in the body or organs via planar, whole body, or SPECT imaging at 511 keV energy levels. For prescription use only.

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

• T88 (K873775/A)
• Cardiac Triad (9" and 20") (K920776)
• Cardiac Triad (9" and 20") (K923345)

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Ms. Daphne Reed
Manager, Regulatory Affairs
TRIONIX Research Laboratory, Inc.
8037 Bavaria Road
Twinsburg, OH 44087

Re: K964438
511 keV Collimator for TRIONIX Triad
Dated: April 4, 1997
Received: April 8, 1997
Regulatory Class: II
21 CFR 892.1200/Procode: 90 KPS

Dear Ms. Reed:

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 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). 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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07/16/96 09:21 301 480 4224
Response to Question 1
ATTACHMENT 1
002

Page 1 of 2

510(k) Number (if known): K964438

Device Name: 511 keV collimator for T88 (K873775/A)

## Nuclear Medicine Device

Indication 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 | ☑ | ☐ | 511 keV |
| B. Whole body imaging | ☑ | ☐ | 511 keV |
| C. Tomographic imaging (SPECT) for non Positron emitter | ☑ | ☐ | 511 keV |
| D. Positron imaging by coincidence | ☐ | ☑ | |
| E. Positron imaging without coincidence | ☑ | ☐ | |
| F. Other indication(s) in the device label, but not included in above list | Could be used with 511 keV photon imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV) | | |

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR Over-the-Counter Use

(Division Sign-Off)

Division: Productive, Abdominal, ENT,

a Division: General Devices

510(k), Number K964438

(Optional Format 1-2-96)

{2}

07/16/96 09:21 301 480 4224
F
002
Response to
Question 1
Page 2 of 2

510(k) Number (if known): K964438

Device Name: 511 keV Collimator for cardiac Triad (9" and 20") (K920776) (K923345)

# Nuclear Medicine Device

Indication 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 | ☑ | ☐ | 511 keV |
| B. Whole body imaging | ☑ | ☐ | 511 keV |
| C. Tomographic imaging (SPECT) for non Positron emitter | ☑ | ☐ | 511 keV |
| D. Positron imaging by coincidence | ☐ | ☑ | |
| E. Positron imaging without coincidence | ☑ | ☐ | |
| F. Other indication(s) in the device label, but not included in above list | Could be used with 511 keV photon imaging and photons of smaller energy simultaneously (e.g 140 keV and 511 keV) | | |

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Biological Devices
511 Number K964438
(Optional Format 1-2-96)