(222 days)
Not Listed
No
The document mentions an "advanced algorithm" for noise reduction (LISA), but does not use terms like AI, ML, deep learning, or neural networks. The description of performance studies focuses on traditional image quality metrics and phantom testing, not on training or validation of an AI/ML model.
No.
The device is described as a diagnostic imaging system used to produce images for clinical diagnosis, not for treating or preventing diseases.
Yes
Explanation: The device description states, "The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging." It also mentions that the systems "produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis," directly indicating a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a gantry, data management system, patient table, power distribution unit, and operator console, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes." This describes an imaging device used for diagnostic purposes, but it does not involve testing samples taken from the human body (like blood, urine, tissue, etc.) in vitro (outside the body).
- Device Description: The description details a CT scanner, which is an imaging modality. It doesn't mention any components or processes related to analyzing biological samples.
- Input Imaging Modality: The input is "x-ray transmission data," which is characteristic of imaging devices, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This CT scanner does not fit that definition.
N/A
Intended Use / Indications for Use
The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.
Product codes
JAK
Device Description
The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration).
The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.
The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).
Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
head and body
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
competent medical personnel
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
Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body.
Additionally, testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test/Performance Testing - Bench: Bench testing was performed and the CTXX85 scanners fulfilled the requirements of the following FDA consensus standards and performance requirements for 21CFR Part 1020.30, Part 1020.33 which are applicable to Computed Tomography X-Ray Systems, 21 CFR 8892.1750. The results of these tests demonstrate that the proposed device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Clinical Studies: Sample clinical images of the brain, chest, abdomen and extremity, reconstructed via FBP and LISA with different strengths were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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February 13, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Analogic Corporation % Ms. Karen Provencher Sr. Regulatory Affairs Specialist 8 Centennial Drive PEABODY MA 01960
Re: K172058
Trade/Device Name: CT6485, CT12885 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 29, 2018 Received: January 30, 2018
Dear Ms. Provencher:
We have reviewed vour 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. 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, Parts 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 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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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of 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) K172058
Device Name CT6485, CT12885
Indications for Use (Describe)
The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.
Type of Use (Select one or both, as applicable)
|--|--|
x Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Analogic. The logo features the word "analogic" in a blue sans-serif font, with the "a" in lowercase. Above and to the right of the word is a blue sphere with a white sine wave running through it. Below the word "analogic" is the tagline "Innovative Solutions for Life" in a smaller blue font.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- l. Submitter: Analogic Corporation 8 Centennial Drive Peabody, MA 01960
Tel: (978) 326-4668 Fax: (978) 977-6808 Contact: Karen Provencher Sr. Regulatory Affairs Specialist E-mail: kprovencher@analogic.com
Date Prepared: January 29, 2018
ll. Device Names / Common Names / Classification Names:
Trade Name: CT6485, CT12885 Common Name: Computed Tomography (CT) Scanner Classification Name: Computed Tomography X-Ray System Product Code: JAK Class: 11 Regulation Number: 21 CFR §892.1750 Classification Panel: Radiology
III. Identification of Predicate or Legally Marketed Devices:
The predicate devices are Class II per 21 CFR §892.1750, with product code JAK: Siemens Somatom Definition AS - K103127 (03/04/2011) Siemens Somatom Definition Edge - K120579 (05/23/2012)
IV. Device Description:
The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration).
4
The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.
The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).
Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.
V. Indications / Intended Use:
The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.
VI. Comparison of Technological Characteristics with the Predicate Device:
Summary of Similarities
The indication for use and intended use of the proposed CTXX85 CT Scanners are equivalent to the predicate device scanners Siemens Somatom Definition AS and Somatom Definition Edge.
The overall system technology and principles of operation are equivalent.
The performance results of scanning and image reconstruction is comparable as demonstrated in verification and validation testing.
The following list of features are available in all proposed and predicate systems: radiation dose control, in room start, remote gantry tilt, rear gantry keypads, adaptive filtration for noise reduction, spiral scanning, artifact reduction algorithms, slice doubling, DICOM, MPR (multi-planar reconstruction), MIP/MinIP (maximum/minimum intensity projection), 3D shaded surface display, 3D volume rendering, bolus trigger, iterative
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reconstruction, Cardiac Imaging with Gated ECG Monitor and CT Angiography.
Summary of Differences
The differences between the proposed CTXX85 CT Systems and the predicate devices are in the design of the subsystems. The resulting effect of these differences do not impact the performance or image quality as demonstrated in verification and validation testing. The differences in design are summarized below:
- . Gantry Design – The proposed and predicate devices have gantry designs with an x-ray tube fixed opposite from the detector that rotates around the patient. The difference between the proposed systems and the predicate device is in the operation of the electromechanical components that allow the transfer of power and data from the stationary to rotating structure.
- Gantry & Table Design The overall dimensions, weight and . gantry aperture are different in the proposed devices.
- . Method for slice doubling – the proposed CTXX85 CT Scanners use a reconstruction software approach while the predicate device uses X-ray tube focal spot deflection to produce a similar effect.
- X-Ray Tube the methods for heat dissipation are different. ●
VII. Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Test/Performance Testing - Bench:
Bench testing was performed and the CTXX85 scanners fulfilled the requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33 which are applicable to Computed Tomography X-Ray Systems, 21 CFR 8892.1750:
IEC61223-2-6 - Evaluation & Routine Testing in Medical Imaging Departments - Part 2-6: Constancy Tests - Imaging Performance of Computed Tomography X-Ray Equipment
IEC61223-3-5 - Medical Electrical Equipment - Part 2-44: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography
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IEC 60601-2-44 - Medical Electrical Equipment - Part 2-44: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography
NEMA PS 3.1 - 3.20 - Digital Imaging & Communications in Medicine (DICOM) Set
IEC 60601-1-3 - Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance -Collateral Standard Radiation Protection in Diagnostic X-Ray Equipment
NEMA XR 25 - Computed Tomography Dose Check
NEMA XR 28 - Supplemental Requirements for User Information and System Function Related to Dose in CT
IEEE Std. 3333.2.1 - IEEE Recommended Practice for Three Dimensional Medical Modeling
IEC 62366 - Consolidated version medical devices - application of usability engineering to medical devices
IEC 60825 - Safety of laser products - Part 1: Equipment classification and requirements
Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body.
Testing to the above-mentioned standards were performed on the proposed CTXX85 devices. Additionally, testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm. The results of these tests demonstrate that the proposed device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Biocompatibility:
The main CTXX85 units are not patient contacting. However, there are several system accessories (patient table CT slicker cushion, head holder, wedge knee pad, table top and patient restraints) which are patient contacting and categorized per Section 5.2 and Table A1 of AAMI/ANSI/ISO 10993-1 as Surface Contact: Skin, Duration: Limited