(121 days)
For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.
The provided text describes the 510(k) Premarket Notification for the AnyScan-S SPECT Imaging System. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (AnyScan-S) |
|---|---|
| Performance of predicate devices (Symbia-E - Siemens [K072567]) based on NEMA Standard test protocols (implied baseline for performance in SPECT systems) | Met or exceeded that of predicate devices (using NEMA NU1 phantoms, under NEMA Standard test protocols). |
| Tomographic image quality comparable to reference predicate devices for clinical images | Tomographic image quality was at least equal to images produced by reference predicate devices (in human subjects). |
| Applicable electrical safety standards and defined acceptance criteria | Met applicable electrical safety standards and defined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Clinical images were obtained using the AnyScan-S in human subjects." However, it does not specify the exact number of human subjects or the sample size of the clinical images used for the test set.
- Data Provenance: The document implies that the clinical images were obtained from human subjects directly during the testing of the AnyScan-S device, suggesting a prospective nature for this specific part of the evaluation. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This document describes a SPECT Imaging System, which is a medical imaging device. It does not involve an AI component or human-in-the-loop performance evaluation, therefore, an MRMC comparative effectiveness study regarding AI assistance would not be applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone SPECT imaging system. The performance testing described (NEMA phantoms, clinical image quality) reflects the standalone performance of the device's imaging capabilities without human intervention in image acquisition or processing beyond standard operational procedures. There is no explicit "algorithm only" component mentioned as distinct from the device's overall function.
7. The Type of Ground Truth Used
- For the NEMA phantom testing, the "ground truth" is established by the physical properties and known measurements of the NEMA NU1 phantoms, according to NEMA Standard test protocols.
- For clinical images in human subjects, the document states "Tomographic image quality was at least equal to images produced by reference predicate devices." This implies a comparison to a clinical standard established by existing, legally marketed predicate devices, rather than a singular, independently established "ground truth" like pathology or outcomes data specifically for this study. The implication is that if the images are "at least equal," they meet the clinically acceptable standard.
8. The Sample Size for the Training Set
The document does not mention a training set for an algorithm, as the device is a hardware imaging system and not primarily an AI algorithm. Its performance is based on the physical characteristics and design of the SPECT system.
9. How the Ground Truth for the Training Set Was Established
As no training set for an algorithm is mentioned or implied, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows a logo with the letters 'ais' in a stylized font. Above the letters, there is a graphic that resembles a burst or a cluster of dots, possibly representing energy or innovation. The letters 'ais' are bold and appear to be the focal point of the logo. Below the letters, there is some smaller text that is difficult to read due to the image quality.
Absolute Imaging Solutions 8205 Boo G Court. Stokesdate. NC 27357 . Phone: 800-856-1671
AnyScan-S 5 10(k) Premarket Notification
SECTION G 510(K) SUMMARY
In accordance with 21CFR 807.92
Submitter Information 1.0
Absolute Imaging Solutions Name:
8205 B&G Court Address: Stokesdale, NC 27357 USA
336-643-2000 Phone: 336-643-2555 Fax:
ОСТ 0 3 2013
Contact Person: Mark Shina, President
Date of Submission: 22 May 2013
Device Identification 2.0
AnyScan-S SPECT Imaging System Name of Device: Gamma Camera – SPECT Imaging System Common Name: Classification Name: Emission Computed Tomography System (ECT)
Predicate Devices 3.0
- Symbia-E - Siemens [K072567]
Intended Use / Indications for Use 4.0
For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
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Absolute Imuging Solutions 8205 BerG Court. Stokesdale, NC 27357 . Phone: 800-856-1671
Image /page/1/Picture/2 description: The image shows a logo with the letters 'ais' in a stylized font. Above the letters, there is a circular design with dots around it, resembling a stylized eye or a technological symbol. Below the letters, there is a smaller line of text that reads 'accurate imaging solutions'.
Technological Characteristics 5.0
The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.
As such, the AnyScan-S SPECT Imaging System raises no new issues of safety or efficacy.
Performance Testing and Data 6.0
Performance testing was performed using NEMA NUI phantoms, under the NEMA Standard test protocols. In all cases, performance of the AnyScan-S device met or exceeded that of predicate devices.
Clinical images were obtained using the AnyScan-S in human subjects. Tomographic 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.
Substantial Equivalence 7.0
The AnyScan-S SPECT Imaging System has the same intended use, similar principles of operation, and consistent technological characteristics as the predicate devices. Thus, the AnyScan-S is substantially equivalent to the predicate devices and no new safety or effectiveness concerns are raised.
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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 stylized eagle with three lines representing its wings and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WObti-GoDS Silver Spring, MD 20993-0002
October 3. 2013
Absolute Imaging Solutions % Mr. Mark Shina President 8205 B&G Court STOKESDALE NC 27357
Re: K131625
Trade/Device Name: AnyScan-S SPECT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: September 18, 2013 Received: September 27, 2013
Dear Mr. Shina:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Paris 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 - Mr. Mark Shina
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.ida.gov/MedicalDevices/Safety/ReportalProblem/default.html 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director, Division Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131625
Device Name: AnyScan-S
Indications for Use:
For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
Prescription Use X (Part 21 CFR 801 Subpart D)
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 In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K131625
AND/OR
Page I of I
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.