(275 days)
The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Scenaria can be transferred to external devices via a DICOM standard interface.
The SCENARIA is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. The SCENARIA system consists of a Gantry, Operator's Workstation. Patient Table, high-Frequency X-ray Generator, and accessories.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Preamble: The provided document is a 510(k) summary for the HITACHI SCENARIA Whole-body X-ray CT System (K101888). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive novel clinical trials. Therefore, the "acceptance criteria" discussed are primarily about matching or demonstrating comparable performance to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall Performance (Clinical Equivalence to Predicate) | "A clinical evaluation comparison was conducted with the SCENARIA system and the TOSHIBA Aquilion 64 Slice System and found to be substantially equivalent." |
| Dose Profile | Evaluations were conducted for "dose profile." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Image Noise | Evaluations were conducted for "image noise." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Modulation Transfer Function (MTF) | Evaluations were conducted for "Modulation Transfer Function (MTF)." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Slice Thickness | Evaluations were conducted for "slice thickness." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Sensitivity Profile | Evaluations were conducted for "sensitivity profile." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Slice Plane Location | Evaluations were conducted for "slice plane location." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| CT Dose Index (CTDI) | Evaluations were conducted for "CT dose index." The evaluation results confirm "the performance characteristics of the SCENARIA are comparable to the predicate device." |
| Technological Characteristics (Gantry, X-ray Tube, Generator, Table) | "The SCENARIA's Gantry, X-ray Tube, X-ray Generator, and Patient Table specifications are substantially equivalent to the TOSHIBA Aquilion 64 Slice System." |
| Technological Characteristics (Scanning, Processing, Display, Storage, Performance, Dose Features) | "Likewise, the Helical Scanning, Image Processing, Display, Image Storage, and Performance features are equivalent to the predicate device. Lastly, the features related to dose which are available on the predicate device are also included on the SCENARIA." "Therefore, the SCENARIA system is technologically equivalent in concept, function, and performance to the predicate device." |
| Safety and Effectiveness (Regulatory Compliance) | "The SCENARIA is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this system is in conformance with the applicable parts of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-32, IEC 60601-2-44." "Testing has proven that the system is safe and effective for the indicated use." |
Study Proving Acceptance Criteria:
The primary study proving these criteria is a "clinical evaluation comparison" and "bench testing."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for the clinical evaluation comparison. It simply states "A clinical evaluation comparison was conducted." For bench testing, it refers to "evaluations were conducted" for various physical and performance characteristics, but again, no specific sample sizes for tests are given.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission focusing on substantial equivalence to an existing device, it's possible that the "clinical evaluation comparison" involved comparing image quality or diagnostic utility, but the details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention using experts to establish ground truth in the context of the clinical evaluation. As this is a comparison study against a predicate device, the "ground truth" implicitly would be the established diagnostic capabilities of the predicate device. The study seems to rely on demonstrating comparable imaging performance rather than an independent diagnostic accuracy assessment against a definitive ground truth.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method (e.g., 2+1, 3+1). This implies that such a process was either not part of the comparative evaluation or not deemed necessary for a 510(k) submission where the primary goal is substantial equivalence rather than establishing new diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a CT scanner, not an AI-assisted diagnostic tool. The comparison is between two CT systems.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a CT scanner, which inherently involves human operation and interpretation. It is not an algorithm for standalone diagnosis.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The document does not explicitly state a specific type of ground truth was used beyond the implicit "performance characteristics of the SCENARIA are comparable to the predicate device." For a medical imaging device, the ultimate ground truth would typically involve pathology, clinical outcomes, or follow-up, but the 510(k) focusses on demonstrating equivalent imaging capabilities and safety without explicitly stating how diagnostic accuracy against a definitive ground truth was established. The clinical evaluation likely focused on qualitative assessment of image quality and diagnostic interpretability relative to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device (CT scanner), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
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Section 6
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510(k) Summary
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| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371ph: (330) 425-1313fax: (330) 963-0749 |
|---|---|
| Contact: | Douglas J. Thistlethwaite |
| Date: | July 1, 2010 |
| Establishment Registration No. | 1528028 |
| Trade/Proprietary Name: | HITACHI SCENARIA Whole-body X-ray CT System |
| Classification Name: | Computed Tomography X-ray System |
| Product Code | JAK |
| C.F.R. Section: | 892.1750 |
| Regulatory Class | Class II |
| Predicate Device(s): | TOSHIBA AQUILION 64 Slice System (K080211) |
| Reason for Submission | New Device |
Submission Information
Device Intended Use
The SCENARIA system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA can be transferred to external devices via a DICOM standard interface.
Device Description
Function
The SCENARIA is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
Scientific Concepts
The SCENARIA system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at m ultiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
Image /page/1/Picture/15 description: The image shows the text 'K161887' on the top line and 'Page 2 of 4' on the second line. The text is in black and the background is white. The text appears to be part of a document or form.
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Physical and Performance Characteristics
The SCENARIA system consists of a Gantry, Operator's Workstation. Patient Table, high-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device.
Performance Comparison
A clinical evaluation comparison was conducted with the SCENARIA system and the TOSHIBA Aquillion 64 Slice System and found to be substantially equivalent as documented in Section 17 - Performance Testing - Clinical.
In addition, evaluations were conducted for dose profile, image noise. Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index as documented in Section 16 - Performance Testing - Bench.
The evaluation results confirm the performance characteristics of the SCENARIA are comparable to the predicate device and support our conclusion that the SCENARIA system is substantially equivalent.
Device Technological Characteristics
The SCENARIA's Gantry, X-ray Tube, X-ray Generator, and Patient Table specifications are substantially equivalent to the TOSHIBA Aquilion 64 Slice System. Likewise, the Helical Scanning, Image Processing, Display, Image Storage, and Performance features are equivalent to the predicate device. Lastly, the features related to dose which are available on the predic ate device are also included on the SCENARIA. See Section 11 - Substantial Equivalence Discussion for additional information.
Therefore, the SCENARIA system is technologically equivalent in concept, function, and performance to the predicate device.
Safety and Effectiveness
The SCENARIA is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820.
Additionally this system is in conformance with the applicable parts of:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; Amendment 1, 1991-11, Amendment 2, 1995
- . IEC 60601-1-1:2000 Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard; Safety Requirements for Medical Electrical Systems
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))
- IEC 60601-1-3: 1994 Edition 1.0, Medical electrical equipment Part 1-3 Collateral . Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment.
- IEC 60601-2-32: 1994 Edition 1.0, Medical electrical equipment Part 2: Particular . requirements for the safety of associated equipm ent of X-ray equipment
- IEC 60601-2-44 (2002-11) Edition 2.1, Medical electrical equipment Part 2-44: . Particular requirements for the safety of X-ray equipment for computed tomography
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Conclusions
The SCENARIA system has been developed and validated according to applicable standards. Testing has proven that the system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
APR - 8 2011
Re: K101888
Trade/Device Name: HITACHI SCENARIA Whole-body X-ray CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 25, 2011 Received: March 29, 2011
Dear Mr. Thistlethwaite:
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 (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(k) premarket 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.
Mary Patel
Mary S. Pastel. Sc.D. 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): K |01888
Device Name: HITACHI SCENARIA Whole-body X-ray CT System
Indications For Use:
The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Scenaria can be transferred to external devices via a DICOM standard interface.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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 Device Evaluation (ODE)
Office of In Vitro
510K K101888
Page 1 of 1
§ 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.