(271 days)
K182147 - Analogic CTXX85 CT Scanner
No
The description mentions "LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm" and "Iterative Bone Correction (IBC)", which are described as algorithms, not specifically AI or ML. There is no mention of AI, ML, deep learning, neural networks, or any related terms. The performance studies focus on standard CT performance metrics and compliance with relevant standards, not on AI/ML model validation.
No
The device is described as aiding in diagnosis, treatment preparation, and radiation therapy planning, but it does not directly treat or cure any condition.
Yes
The device's intended use explicitly states that the images produced "can be used by a trained physician and trained healthcare professionals as an aid in diagnosis." Furthermore, the "Device Description" states that the systems produce images and calculations "intended for use by competent medical personnel as part of a clinical diagnosis."
No
The device description explicitly lists multiple hardware components, including a tilting gantry, data management system, patient table, power distribution unit, and operator console. It is a physical CT scanner system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to produce images of the head and body by computer reconstruction of x-ray transmission data. These images are then used by trained medical professionals as an aid in diagnosis, treatment preparation, and radiation therapy planning. This is a diagnostic imaging device, not a device that performs tests on biological samples in vitro (outside of the body).
- Device Description: The description details the components of a CT scanner, which is an imaging modality. It does not 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.
- Performance Studies: The performance studies focus on image quality, safety, and compliance with standards related to CT scanners and medical imaging, not on the analytical or clinical performance of an IVD.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This CT scanner does not perform such tests.
N/A
Intended Use / Indications for Use
The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Analogic intends to market the Analogic CTXX85 CT Scanner with a new software version (version 1.3).
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 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures.
The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy.
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, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
head and whole-body
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
trained physician and trained healthcare professionals
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
Non-clinical testing, including phantom tests, were conducted during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Testing 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. Analogic claims conformance to the following performance standards:
- IEC 61223-2-6 - Evaluation & Routine Testing in Medical Imaging Departments - Part 2-6: Constancy Tests - Imaging Performance of Computed Tomography X-Ray Equipment
- IEC 61223-3-5 Evaluation & Routine Testing in Medical Imaging Departments - Part 3-5: Imaging Performance of Computed Tomography X-Ray Equipment
- NEMA PS 3.1 - 3.20 - Digital Imaging & Communications in Medicine (DICOM) Set
- NEMA XR 25 Computed Tomography Dose Check
- NEMA XR 28 Supplemental Requirements for User Information and System Function Related to Dose in CT
- NEMA XR 29 - Standard Attributes on CT Equipment Related to Dose Optimization and Management
- 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
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted in accordance with the following standards: - AAMI/ANSI/ES 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 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
- 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
In addition to testing to the above-mentioned standards, testing was conducted to evaluate image quality performance of the Metal Artifact Reduction (MAR) algorithm. Testing for computed tomography simulation scan process was also completed in accordance with AAPM TG-66 Appendix D "CT-Simulator Laser QA" and Appendix E "Scanner Table Tests.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing, including phantom tests, were conducted during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. 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.
Animal Testing: Not applicable – animal testing was not required to support substantial equivalence to the predicate device.
Clinical Studies: Not applicable – clinical studies were not required to support substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K182147 - Analogic CTXX85 CT Scanner
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K173607 - SOMATOM CT SCANNER SYSTEMS
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 2, 2021
Analogic Corporation % Ms. Laura Green Regulatory 8 Centennial Drive PEABODY MA 01960
Re: K201231
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: December 21, 2020 Received: December 22, 2020
Dear Ms. Green:
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/cfpmp/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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201231
Device Name CTXX85
Indications for Use (Describe)
The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.
| 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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Analogic Corporation l. Submitter: 8 Centennial Drive Peabody, MA 01960
Tel: (216) 704-1442 Fax: (978) 977-6808 Contact: Laura Green Regulatory Affairs E-mail: Igreen@analogic.com
Date Prepared: April 24, 2020
II. 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: II Regulation Number: 21 CFR §892.1750 Classification Panel: Radiology
lll. Identification of Predicate or Legally Marketed Devices:
Predicate Device(s):
The primary predicate device is Class II per 21 CFR §892.1750, with product code JAK: K182147 - Analogic CTXX85 CT Scanner
The predicate has not been the subject of any design related recalls.
Reference Device:
The reference device is Class II per 21 CFR §892.1750, with product code JAK: K173607 - SOMATOM CT SCANNER SYSTEMS
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IV. Device Description:
Analogic intends to market the Analogic CTXX85 CT Scanner with a new software version (version 1.3).
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 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures.
The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy.
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, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).
Intended Use and Indications for Use: V.
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.
5
The CTXXX85 CT scanner systems are indicated for head and wholebody X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.
VI. Comparison of Technological Characteristics with the Predicate Device:
Analogic intends to market a new version of the Analogic CTXX85 with software version 1.3. The subject device is based on modifications to the legally marketed and commercially available Analogic CTXX85 Scanner platform (K182147).
The CTXX85 CT Scanners (software 1.3) provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate device. The fundamental intended use, scientific technology and principles of operation remains unchanged from the predicate device.
The proposed subject device CTXX85 CT Scanner (software version 1.3) will support the following key modifications in comparison with the predicate device:
- Software-based algorithm to enable Metal Artifact Reduction ● (MAR) post-reconstruction protocol.
- Extended Field of View (FOV) algorithm. ●
- Enable cardiac imaqing with gated ECG function on the ● CT1685 model (which currently exists in the CT6485 and CT12885 models).
- New optional cardiac trigger module accessory which provides ● triggers for ECG-gated scans.
- . Option for use of CIVCO table overlay (K973842/K180021) for radiotherapy planning.
- Modified indication for use statement. .
The software and hardware components have been modified or improved in comparison to the predicate device to support enhanced device functionality. The software has been updated to support additional features as well as provide minor updates for workflow, serviceability, and anomaly corrections as compared to the
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predicate device. The hardware components of the subject device have been modified to include and integrate with a flat table overlay accessory and an integrated cardiac trigger module (CTM) accessory.
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Verification and validation testing is complete. Test results show that the subject device is comparable to the predicate device in terms of technological characteristics and safety and effectiveness, and therefore is substantially equivalent to the predict device. Analogic believes that the subject device is substantially equivalent to the predicate device.
VII. Performance Data:
The Analogic CTXX85 CT Scanners (software 1.3) CTXX85 CT Scanner has been developed in accordance with the requirements of the following standards:
- IEC 62304 Medical Device Software Software Lifecycle . Processes (Software / Informatics)
- IEC 62366 Consolidated version medical devices -● application of usability engineering to medical devices
- ISO 14971 Medical Devices Applications of Risk Management ● to Medical Devices
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Test/Performance Testing - Bench:
Non-clinical testing, including phantom tests, were conducted during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Testing 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. Analogic claims conformance to the following performance standards:
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- . IEC 61223-2-6 - Evaluation & Routine Testing in Medical Imaging Departments - Part 2-6: Constancy Tests - Imaging Performance of Computed Tomography X-Ray Equipment
- IEC 61223-3-5 Evaluation & Routine Testing in Medical . Imaging Departments - Part 3-5: Imaging Performance of Computed Tomography X-Ray Equipment
- . NEMA PS 3.1 - 3.20 - Digital Imaging & Communications in Medicine (DICOM) Set
- NEMA XR 25 Computed Tomography Dose Check ●
- NEMA XR 28 Supplemental Requirements for User . Information and System Function Related to Dose in CT
- NEMA XR 29 - Standard Attributes on CT Equipment Related to Dose Optimization and Management
- 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
Electrical Safety and Electromagnetic Compatibility (EMC)
testing were conducted in accordance with the following standards:
- AAMI/ANSI/ES 60601-1: Medical electrical equipment Part . 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: . General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 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
- 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
In addition to testing to the above-mentioned standards, testing was conducted to evaluate image quality performance of the Metal
8
Artifact Reduction (MAR) algorithm. Testing for computedtomography simulation scan process was also completed in accordance with AAPM TG-66 Appendix D "CT-Simulator Laser QA" and Appendix E "Scanner Table Tests
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