(78 days)
For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs.
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.
The Scandia-45 device's performance was evaluated through NEMA NU1 phantoms and clinical imaging in human subjects.
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NEMA Standard Test Protocols (using NEMA NU1 phantoms) | "In all cases, performance of the Scandia-45 device met or exceeded that of predicate device." |
| Clinical Image Quality (in human subjects) | "Image quality was at least equal to images produced by reference predicate devices." |
| Electrical Safety | "Electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance:
- NEMA NU1 Phantoms: The sample size for the phantom testing is not explicitly stated, but it would involve a set of calibrated phantoms as defined by the NEMA NU1 standard.
- Clinical Images: "Clinical images were obtained using the Scandia-45 in human subjects." The exact number of human subjects is not specified in the provided text.
- Provenance: The clinical images were obtained from "human subjects," implying a prospective collection within a clinical setting. While the specific country of origin is not mentioned, it would typically be the country where the manufacturer (Scandia Corporation, based in Urbandale, Iowa, USA) conducts its studies or where the device is intended for initial market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the clinical images. The phrasing "Image quality was at least equal to images produced by reference predicate devices" suggests a subjective comparison, likely by experienced personnel, but details are not provided. For NEMA phantom tests, the "ground truth" is inherent in the known physical properties and measurements of the phantoms themselves, not requiring expert anatomical interpretation.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for either the NEMA phantom tests or the clinical image quality assessment. The comparison for clinical images appears to be a direct qualitative comparison to images from predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The Scandia-45 is a gamma camera system, a medical imaging device, and the evaluation focuses on its inherent performance characteristics and image quality, not specifically on an AI assistance component for human readers.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The performance testing (NEMA NU1 phantoms) and the generation of clinical images with the Scandia-45 itself directly evaluate the algorithm/device performance without explicit human-in-the-loop assistance being part of the primary performance claim. The "image quality" assessment for clinical images is comparing the output of the Scandia-45 device standalone against predicate devices.
7. Type of Ground Truth Used:
- For NEMA NU1 Phantoms: The ground truth is established by the physical properties and known measurements of the NEMA NU1 phantoms, which are industry standards for characterizing gamma camera performance.
- For Clinical Images: The ground truth is implied to be a qualitative assessment of image quality compared to "reference predicate devices." This suggests a consensus among experienced observers regarding acceptable diagnostic image quality, rather than a definitive "pathology" or "outcomes" ground truth in this context. The focus is on the diagnostic capability of the image, rather than the definitive diagnosis itself for specific conditions.
8. Sample Size for the Training Set:
The document does not mention a training set in the context of device performance. This device is a hardware imaging system, and its performance evaluation does not involve machine learning models that require a separate training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set or a machine learning component for this device in the provided text, this question is not applicable.
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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
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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
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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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