511 KEV COLLIMATOR by TRIONIX RESEARCH LABORATORY, INC.

To detect or image the distribution of radionuclides in the body or in 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 photo imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV).

Device Description

511 keV Collimator for TRIONIX Triad

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria, the specific study proving the device meets those criteria, or the various aspects of a clinical study typically associated with device performance (sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).

The documents are FDA 510(k) clearance letters and "Indication For Use" forms for a "511 keV Collimator for TRIONIX Triad" (K964438). These documents confirm that the device is substantially equivalent to legally marketed predicate devices and outline its intended uses (e.g., planar imaging, whole body imaging, tomographic imaging for non-positron emitters, positron imaging without coincidence, all for 511 keV energy range).

However, they do not include:

A table of acceptance criteria and reported device performance: The documents do not list specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution, signal-to-noise ratio) nor any numerical results from tests.
Details about a study: While a 510(k) submission requires evidence of substantial equivalence, the provided letters do not describe the methodology, results, or specifics of such a study.
Sample sizes, data provenance, expert details, or ground truth establishment: Information regarding patients, data sources, or the methodology for confirming diagnoses (ground truth) is absent.
MRMC comparative effectiveness or standalone performance: These types of studies are not mentioned or detailed.

The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or by providing valid scientific evidence to demonstrate substantial equivalence for different technological characteristics without raising new questions of safety or effectiveness. It does not typically involve the detailed disclosure of performance criteria and study results in the same way as a full clinical trial publication.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 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 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 proctibitions against misforanding 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 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 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 predication 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4591 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 (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/dsmamain.html".

Sincerely yours,

William Yu

Lilian 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

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

Response to Question 1 ATTACH ment 1

2 Page_1 . of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

511 keV collimator for T88 (_K873775/A) Device Name: _________________________________________________________________________________________________________________________________________________________________

Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or in organ, using the following technique(s).

		YES	NO	Energy Range (keV)
A.	Planar imaging	x		511 keV
B.	Whole body imaging	x		511 keV
C.	Tomographic imaging (SPECT) for non Positron emitter	x		511 keV
D.	Positron imaging by coincidence		x
E.	Positron imaging without coincidence	x
F.	Other indication(s) in the device label, but not included in above list		Could be used with 511 keV photo 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 Sign-Off)
Division	ductive, Abdominal, ENT,
a	al Devices
510(k) Number	K964438

(Optional Rormat 1-2-96)

{2}------------------------------------------------

Page 2_ of _2

K964438 510(k) Number (if known):_ 511 keV Collimator for cardiac Triad (9" and 20") Devicc Name:_ (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	X		511 keV
B.	Whole body imaging	X		511 keV
C.	Tomographic imaging (SPECT) for non Positron emitter	X		511 keV
D.	Positron imaging by coincidence		X
E.	Positron imaging without coincidence	X
F.	Other indication(s) in the device label, but not included in above list	Could be used with 511 keVphoton imaging and photons ofsmaller 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 L (Per 21 CFR 801.109)

Division Sign Off
OR
Over-the-Counter Use

(Division Sign-Off) Division a Penroductive, Abdominal, ENT, and i crogical Deyic

५ :

i Number

nat 1-2-96)

Regulation Number and Section

N/A