(30 days)
No
The document mentions an "advanced algorithm" for noise reduction (LISA), but does not explicitly state that this algorithm utilizes AI or ML. The description focuses on standard CT technology and image reconstruction techniques.
No.
The device is a CT scanner, which is a diagnostic imaging device used to produce images for clinical diagnosis, not to provide therapy.
Yes
The device description states, "The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging." Also, "The CTXX85 CT Scanner 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." and "Sample clinical images... were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality."
No
The device description clearly outlines multiple hardware components including a gantry, data management system, patient table, power distribution unit, and operator console, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Analogic CTXX85 CT Scanner is an imaging device that uses X-rays to create images of the internal structures of the body. It does not perform tests on biological samples.
- Intended Use: The intended use is to "produce images of the head and body by computer reconstruction of x-ray transmission data" for use by medical personnel as part of a clinical diagnosis. This is consistent with an imaging device, not an IVD.
- Device Description: The description details the physical components of a CT scanner (gantry, detector, table, console) and image processing algorithms, not equipment for analyzing biological samples.
- Input: The input is "x-ray transmission data," not biological samples.
Therefore, the Analogic CTXX85 CT Scanner falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Analogic CTXX85 CT Scanner 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 CT Scanner systems are indicated for pediatric and adult patients.
Product codes
JAK
Device Description
The CTXX85 CT Scanner 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 three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), 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 qantry (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
X-ray transmission data / Computed Tomography
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
Not Found
Summary of Performance Studies
Non-clinical Test/Performance Testing - Bench: Bench testing was performed and the new scanner model CT1685 fulfills the requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33 which are applicable for Computed Tomography X-Ray Systems, 21 CFR §892.1750: IEC61223-2-6, IEC61223-3-5, IEC 60601-2-44, NEMA PS 3.1 - 3.20, IEC 60601-1-3, NEMA XR 25, NEMA XR 28, IEEE Std. 3333.2.1, IEC 62366, IEC 60825. Image Quality performance testing for the CT1685 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 was performed. 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
§ 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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September 7, 2018
Analogic Corporation Karen Provencher Sr. Regulatory Affairs Specialist 8 Centennial Drive PEABODY, MASSACHUSETTS 01960
Re: K182147
Trade/Device Name: CTXX85 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 7, 2018 Received: August 8, 2018
Dear Karen Provencher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-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.
Hole 2. Nils
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) K182147
Device Name CTXX85
Indications for Use (Describe)
The Analogic CTXX85 CT Scanner 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 CT Scanner systems are indicated for pediatric and adult patients.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K182147 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitter: Analogic Corporation l. 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: August 7, 2018
ll. Device Names / Common Names / Classification Names:
Trade Name: CTXX85 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. I dentification of Predicate or Legally Marketed Devices:
The predicate device is Class II per 21 CFR §892.1750, with product code JAK: Analogic CTXX85 CT Scanner – K172058 (2-13-2018)
IV. Device Description:
The CTXX85 CT Scanner 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 three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), 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
4
reduces image noise while maintaining (or improving) spatial resolution.
The following main subsystems make up the scanner platforms: tilting qantry (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 CT Scanner 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 CT Scanner 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 new proposed CTXX85 scanner model is the same as the predicate CTXX85 scanners.
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.
Summary of Differences
The resulting effect of the differences between the proposed and predicate models of the CTXX85 CT Scanners do not impact the performance or image quality as demonstrated in verification and validation testing. The differences in design are summarized below:
- Predicate device models CT6485, CT12885; Proposed new model . CT1685
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- . Detector – CT1685 has a 16 row DMS (data management system) with 20 mm axial coverage; CT6485/CT12885 has a 64 row DMS with 40 mm axial coverage.
- X-Ray Tube CT1685 has an x-ray tube with smaller heat ● storage, compared to CT6485/CT12885.
- Slice configuration CT1685 has 16 slices, CT6485 has 64 slices, ● CT12885 has 128 slices.
- CT1685 has a slower maximum gantry rotation speed, compared . to CT6485/CT12885.
- CT1685 does not support ECG-gated Cardiac scanning. ●
- CT1685 does not support Coronary Artery Calcium Scoring.
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 new scanner model CT1685 fulfills the requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33 which are applicable for Computed Tomography X-Ray Systems, 21 CFR §892.1750:
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
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
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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 CT1685 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 was performed. 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