(78 days)
Not Found
No
The summary describes a standard digital gamma camera system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on hardware components and standard image acquisition and processing.
No
This device is for acquiring, processing, display, and analyzing planar images for diagnostic purposes, not for treating a disease or condition.
Yes
The device is used for the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs, which is a key step in diagnosing medical conditions. The performance studies and predicate device information also support its role in medical imaging for diagnostic purposes.
No
The device description explicitly details hardware components such as a detector, photomultipliers, acquisition console with a PCI bus interface, gantry, and collimators, indicating it is a hardware device with integrated software for image processing and analysis.
Based on the provided information, this device 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.
- Device Function: The Scandia-45 is a gamma camera system used for imaging the thyroid and other small organs. It acquires, processes, displays, and analyzes planar images. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use clearly states "For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs." This describes an imaging procedure, not a laboratory test on a sample.
Therefore, the Scandia-45 falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs.
Product codes
IYX
Device Description
The Scandia-45 is a high resolution, SFOV digital gamma camera for thyroid and small organs imaging. The Scandia-45, is made up of a single, small-field detector assembled with high optical and mechanical quality. The systems has 45 high quantum efficiency photomultipliers characterized by improved energy resolution, magnetic shielding and long-term stability and utilizes a compact, highly integrated, one board, easily serviceable construction without tuning potentiometers. The acquisition console has full-digital electronics, including fast PCI bus acquisition interface. The system also has a light-weight, easilyadjustable gantry and light, easily-exchangeable microcast collimators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintillation (Gamma) Camera
Anatomical Site
thyroid 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
Performance testing was performed using NEMA NU1 phantoms, under the NEMA Standard test protocols. In all cases, performance of the Scandia-45 device met or exceeded that of predicate device. Clinical images were obtained using the Scandia-45 in human subjects. Image quality was at least equal to images produced by reference predicate devices. Electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Scandia Corporation 10200 Dennis Drive, Suite 5 Urbandale, Iowa 50322 Phone: 515-334-5131
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads as 'K101391'. The characters are written in a simple, slightly irregular style, typical of handwriting. The image is in black and white, with the characters standing out against the background.
AUG 0 4 2010
SECTION G . 510(K) SUMMARY
In accordance with 21CFR 807.92
1.0 Submitter Information
Scandia Corporation Name: Address: 10200 Dennis Drive, Suite 5 Urbandale, Iowa 50322 Phone: 515-334-5131 Fax: 515-334-5145
Contact Person: David Askew, Chief Operations Officer
Date of Submission: April 16, 2010
2.0 Device Identification
Name of Device: Scandia-45
Common Name: Scintillation (Gamma) Camera System
Classification Name: Emission Computed Tomography System
3.0 Identification of Equivalent Device
- T-Quest - MEDX Corporation - [K073456]
4.0 Description of Device
The Scandia-45 is a high resolution, SFOV digital gamma camera for thyroid and small organs imaging. The Scandia-45, is made up of a single, small-field detector assembled with high optical and mechanical quality. The systems has 45 high quantum efficiency photomultipliers characterized by improved energy resolution, magnetic shielding and long-term stability and utilizes a compact, highly integrated, one board, easily serviceable construction without tuning potentiometers. The acquisition console has full-digital electronics, including fast PCI bus acquisition interface. The system also has a light-weight, easilyadjustable gantry and light, easily-exchangeable microcast collimators.
G-1
1
Intended Use / Indications for Use 5.0
For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs.
6.0 Technological Characteristics
The Scandia-45 Gamma Camera System is a small, mobile scintillation camera with a gantry, a single small-field detector, an acquisition station, and related hardware and software components. The characteristics of the Scandia-45 compare substantially with the predicate device in materials used, technology applied, and functional methodology.
Thus, the Scandia-45 Gamma Camera System raises no new issues of safety or efficacy.
7.0 Performance Testing and Data
Performance testing was performed using NEMA NU1 phantoms, under the NEMA Standard test protocols. In all cases, performance of the Scandia-45 device met or exceeded that of predicate device.
Clinical images were obtained using the Scandia-45 in human subjects. Image quality was at least equal to images produced by reference predicate devices.
Furthermore, electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.
8.0 Substantial Equivalence
The Scandia-45 Gamma Camera System has the same intended use, similar principles of operation, and consistent technological characteristics as the predicate devices. Thus, the Scandia-45 is substantially equivalent to the predicate devices and no new safety or effectiveness concerns are raised.
G-2
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Image /page/2/Picture/0 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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and 10;ng Administration 10903 News ampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. David Askew Chief Operations Officer Scandia Corporation 10200 Dennis Drive, Suite 5 URBANDALE IA 50322
AUG 0 4 2010
Re: K101391
Trade/Device Name: Scandia-45 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: II Product Code: IYX Dated: May 1, 2010 Received: May 18, 2010
Dear Mr. Askew:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(V), remarket 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101391
Device Name: Scandia-45
AUG 0 4 2010
Indications for Use:
The Scandia-45 is indicated for use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use , (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K.
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