K Number
K073456
Device Name
T-QUEST SYSTEM
Manufacturer
Date Cleared
2007-12-20

(10 days)

Product Code
Regulation Number
892.1100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.
Device Description
The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.
More Information

No
The document describes standard image processing software and hardware for nuclear medicine imaging and does not mention AI or ML.

No
Explanation: The device is described as being used for the acquisition, processing, display, and analysis of planar images, which are diagnostic functions, not therapeutic.

Yes

The device acquires, processes, displays, and analyzes planar images of the thyroid gland and other small organs, which are functions commonly associated with diagnostic imaging to identify medical conditions.

No

The device description explicitly states it includes hardware components such as a mobile scintillation camera, accessories, patient bed, notebook computer, and acquisition board, in addition to software.

Based on the provided information, the T-Quest™ System 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. They are used outside of the body (in vitro).
  • T-Quest System Function: The T-Quest System is described as a system for acquiring, processing, displaying, and analyzing planar images of the thyroid gland and other small organs using approved pharmaceuticals. This involves imaging the organs within the body (in vivo) after the administration of a radioactive tracer.

Therefore, the T-Quest System is an in vivo imaging system, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

Product codes (comma separated list FDA assigned to the subject device)

IYX

Device Description

The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Scintillation (Gamma) Camera

Anatomical Site

thyroid gland and other small organs

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)

Non-Clinical Data: The T-Quest™ System performance characteristics with respect to Linearity, Resolution, Uniformity, and of the thyroid gland phantom images were deemed to be excellent. The conclusion drawn from this data is that the T-Quest™ System provides effective results as expected from similar devices in the marketplace.

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.

K052473

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.

K945792, K961104

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

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).

0

173456

510(k) SUMMARY

DEC 2 0 2007

Submitted by: MEDX, Incorporated 3456 N. Ridge Ave., #100 Arlington Heights, IL 60004 Telephone: (847)-463-2020 FAX: (847)-463-2019 Contact Person Floyd R. Rowan, Executive Vice President Date Summary Prepared: November 9, 2007

Trade Name of Device

Common Name

Classification Name:

Classification:

Substantial Equivalence:

T-Quest™ System

Scintillation (Gamma) Camera System.

Scintillation (Gamma) Camera

This Device is Classified as a Class I Device. Ref. 21 CFR 892.1100. Product Code IYX.

The T-Quest™ System is Substantially Equivalent to the Inter Medical Gamma Camera System Model CX 250 C Plus. 510(k) Number K052473.

Description of Device: The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.

1

Scientific Concepts: Diagnostic Nuclear Medicine began in early 1950's with the availability of short half-life radioisotopes. Isotopes such I 131 were administered to the patient and were selectively taken up by organ systems such as the thyroid. Measurement of the resulting radioactivity in the organ provided information on both the size of the organ and the relative amount of the isotope taken up.

Nuclear Medicine cameras work on the principle similar to television cameras. A collimator (lens) "focuses" gamma ravs on a scintillation crystal. The scintillation crystal converts the gamma rays into light. Photomultiplier tubes are then used to convert the light into an electrical signal proportional to the energy of the detected gamma ray. Early instruments used a single hole lead collimator and detector moved in a raster pattern forming a 2-D image of the organ of interest. In the late 1950's methods were developed for directly obtaining a 2-D image by using a large crystal with multiple photomultiplier tubes and electronically calculating the position and energy of the gamma event. As computers became available the resulting images were portrayed on computer screens.

Indication for Use: The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

Note: The predicate device in its indication for use does not include the word "analysis", this refers to the analysis of energy levels. It the physician who interprets the data and makes the clinical decisions, not the gamma camera system.

| Safety Information: | The T-Quest™ System
Meets UL 60601-1 and CAN/CSA
C22.2 No. 601-1 Standards and
is In Compliance with EMI
Standards. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Performance Standard: | This Device Meets NEMA NU 1-
2001 Standard for Uniformity,
Linearity, and Resolution. |

Non-Clinical Data: The T-Quest™ System performance characteristics with respect to Linearity, Resolution, Uniformity, and of the thyroid gland phantom

2

images were deemed to be excellent. The conclusion drawn from this data is that the T-Quest™ System provides effective results as expected from similar devices in the marketplace..

Device Technological Characteristics: The characteristics of the T-Quest™ Scintillation Camera when used with the NuQuest™ computer and NuQuest™ (IM512P) Software compare substantially with the predicate device, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate device.

| | T-Quest System | Inter Medical CX250C
510(k); K052473 |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The intended uses are
the acquisition, proces-
sing, display and analysis
of planar images of the
thyroid gland and other
small organs using
approved pharmaceuti-
cals. | The CX250Plus Gamma
Camera is a mobile
system for acquisition
and processing nuclear
medicine diagnostic.
Note: this camera also
displays the planar
images and requires the
use of approved
pharmaceuticals. |
| Compact Mobile
Gamma camera for
acquisition, processing
representation and
documentation of
patient isotope
studies. | Yes, but only for small
organs such as the
thyroid. | Yes, for both small and
large organs. |
| Thyroid Collimator | Yes | Yes |
| Iodine 131 Studies | No | Yes |
| Iodine 123 Studies | Yes | Yes |
| Technetium 99m
Studies | Yes | Yes |
| DICOM Data Transfer
Capability | Yes | Yes |
| Adjustable Head | Yes | Yes |
| Pinhole Collimator | Yes | Yes |
| General Purpose | Yes | Yes |
| Collimator | | |
| Computer | External Notebook PC
Providing the Keyboard
and Viewing Screen. | Built-in Computer with
external Keyboard and
Viewing Screen. |
| Operating System | Windows XP | Windows XP |
| Display | Color or Grayscale | Color or Grayscale |
| Number of
Photomultiplier Tubes | 19 | 19 or 37 |
| Corrections | Linearity, Energy, and
Uniformity | SAME |
| Acquisition Matrixes | 64x64, 128x128,
256x256, 512x512, and
1024x1024. | 64x64, 128x12, 256x256.
and 512x512 |
| Frame Mode | Static, Dynamic, and
Gated. | Static, Dynamic, and
Gated. |
| Patient Archive | CD/DVD | CD/DVD, PLUS Magneto
Optical Drive is Available |
| Acquisition Board | Nuquest™ Acquisition
Board is Located Below
the Shelf that Holds the
Notebook PC. | Proprietary electronics
performing the same
function. |
| Software | Uses previously 510(k)
Cleared Software Called
IM512P which is
Marketed by MEDX, INC
under the trade name of
NuQuest™ Software.
This software was
cleared in the following
510(k)'s for FDA Code
IYX Products: K945792
and K961104 | Gamma XP Acquisition
and Processing Software.
Its previous history is
unknown to us. |

COMPARISON OF T-Quest™ SYSTEM TO PREDICATE DEVICE

3

EXPLANATIONS PERTAINING TO 510(K) NUMBERS PROVIDED IN THE COMPARISSON TABLE ABOVE. s

K052473 is the FDA cleared 510(k) for the model CX250C Plus Gamma Camera System manufactured by Inter Medical. This is the predicate device to which we are comparing our T-Quest System.

4

K945792 is the FDA cleared 510(k) for IM512P software filed by Globus Industries which is the U.S. Agent for Alfanuclear S.A. I. y C. in Buenos Aires Argentina which designs and markets the IM512P software.

K961104 is the FDA cleared 510(k) for Notebook Imager a product of Digirad Corp. This device uses IM512P software cleared Sitco 510(k) K945792 which is now owned by MEDX, Inc.

The purpose of discussing the 510(k)'s (other than K052473) is to demonstrate that the Alfanuclear IM512P software has been in use for over 12 years, that it has been cleared by the FDA and that is not a new technology for acquisition and imaging of scintillation (gamma) camera images .

DISCUSSION OF THE DIFFERENCES LISTED IN THE COMPARISSON OF T-QUEST SYSTEM TO THE INTER MEDICAL PREDICATE DEVICE.

The T-Quest System is a smaller gamma camera system as is observed that it uses only 19 Photomultiplier tubes (PMT)s whereas the Inter Medical Device uses both 19 and 37 PMTs. For thyroid and other small organ imaging the 19 PMT detector heads are used by us and the predicate device.

As for acquisition matrixes, which define the resolution of the images, the 1024x1024 mode can be used but it is impractical for thyroid imaging because it takes a longer time to acquire the image and requires large amount of storage memory.

Patient Archives - we do not view the use of Magneto Optical Storage Devices as a detraction from our system which does not use them. The CD and DVD data storage methods are widely used and preferred by users of gamma camera systems

lodine 131 Studies the T-Quest System would require a greater level of lead shielding to handle this isotope. The Technetium 99m and lodine 123 provide very usable thyroid images.

Overall both systems are substantially equivalent in the acquisition, processing, display and analysis of planar images of the thyroid and other small organs using approved pharmaceuticals.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

MEDX, Inc. % Mr. Jeff D. Rongero Senior Project Engineer, Medical Business Unit Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

Re: K073456

Trade/Device Name: T-Quest™ System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: November 30, 2007 Received: December 10, 2007

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

6

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known):

073456/

Device Name: T-Quest™ System

Indications For Use:

The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arquihi Whay
(Division Sign-Off)

് Malon of Reproductive, Abdominal and Adjological Devices 510(k) Number __

Page 1 of _ l _ _