(136 days)
The SCENARIA Phase 2 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 2 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
The SCENARIA Phase 2 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 Phase 2 system consists of a Gantry, Operator's Workstation, Patient Table, high-Frequency X-ray Generator, and accessories.
The provided text describes the 510(k) summary for the SCENARIA Phase 2 Whole-body X-ray CT System. However, it does not detail specific acceptance criteria or a study that proves the device meets those criteria in the typical sense of a clinical performance study with defined metrics (e.g., sensitivity, specificity, or accuracy compared to a ground truth) and corresponding acceptance thresholds for a new device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (SCENARIA Whole-body X-ray CT System, K101888) through performance comparisons and compliance with relevant standards.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the primary "acceptance criterion" is implicit: the SCENARIA Phase 2 system must be comparable to and substantially equivalent to the predicate device (SCENARIA K101888) in terms of physical, performance, and technological characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Clinical Performance Equivalence to Predicate Device | A clinical evaluation comparison was conducted. The results found the SCENARIA Phase 2 system to be substantially equivalent to the original SCENARIA System (K101888). |
| Bench Performance Equivalence to Predicate Device | Evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index. The results confirm the performance characteristics of the SCENARIA Phase 2 are comparable to the predicate device and support the conclusion of substantial equivalence. |
| Technological Equivalence to Predicate Device | Gantry, X-ray Tube, X-ray Generator, Patient Table specifications are the same as the predicate. Helical Scanning, Image Processing, Display, Image Storage, and Performance features are equivalent. Dose-related features are also included. The system is technologically equivalent in concept, function, and performance to the predicate device. |
| Compliance with Safety Standards | Designed and manufactured under Quality System Regulations (21 CFR § 820). In conformance with applicable parts of IEC 60601 series standards (IEC 60601-1, -1-1, -1-2, -1-3, -2-32, -2-44). |
| Safety and Effectiveness (Overall Conclusion) | Developed and validated according to applicable standards. Testing has proven the system is safe and effective for the indicated use. Risk and hazard analysis shows no new safety issues compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical evaluation comparison was conducted," but does not provide details on the sample size (number of patients/cases) used for this clinical evaluation.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information about experts used, the number of experts, or their qualifications for establishing ground truth in the clinical evaluation. Given that it's a comparison to a predicate device, the "ground truth" implicitly refers to the predicate device's performance being the established benchmark.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not mentioned or implied. The clinical evaluation was a "comparison" with the predicate device, but its methodology is not detailed enough to suggest an MRMC study or an effect size for human readers with/without AI assistance. This device is a CT scanner, not an AI-assisted diagnostic tool, so an MRMC study in this context would be unusual.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of an algorithm is not applicable here, as the device is a CT imaging system, not an AI algorithm. The performance evaluation focuses on the imaging system's physical and image quality characteristics.
7. Type of Ground Truth Used
Based on the available text, the "ground truth" for the performance claims appears to be:
- Predicate Device Performance: The primary "ground truth" is the established performance of the legally marketed predicate device (SCENARIA K101888). The new device's performance is compared against this standard.
- Bench Test Standards: For specific technical parameters (dose profile, image noise, MTF, etc.), the ground truth would be established by physical measurements and engineering specifications, often against industry-standard phantoms or test objects.
- Compliance with International Standards: Compliance with IEC 60601 series standards serves as a ground truth for safety and general electrical/radiation performance.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a CT imaging system and not a machine learning or artificial intelligence algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is relevant, this question is not applicable.
In summary: The submission for the SCENARIA Phase 2 CT system demonstrates substantial equivalence to its predicate device through a combination of clinical comparison and bench testing that evaluated physical and performance characteristics. It adheres to applicable safety and quality standards. Specific quantitative acceptance criteria for clinical performance (like sensitivity/specificity), detailed test set sizes, expert qualifications, or adjudication methods typically found in AI/CAD device submissions are not provided, as this is a medical imaging device and not an AI-powered diagnostic algorithm.
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K123509
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510(k) Summary of Safety Effectiveness
MAR 29 2013
| Submission Information | |
|---|---|
| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371ph: (330) 425-1313fax: (330) 963-0749 |
| Contact: | Douglas J. Thistlethwaite |
| Date: | November 5, 2012 |
| Establishment Registration No. | 1528028 |
| Trade/Proprietary Name: | SCENARIA Phase 2 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): | SCENARIA Whole-body X-ray CT System (K101888) |
| Reason for Submission | New Technology |
Device Intended Use
The SCENARIA Phase 2 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 2 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
Function
The SCENARIA Phase 2 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
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KB23509
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Scientific Concepts
The SCENARIA Phase 2 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.
Physical and Performance Characteristics
The SCENARIA Phase 2 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 Phase 2 system and the original SCENARIA System (K101888) and found to be substantially equivalent as documented in Section 12 - 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 11 - Performance Testing - Bench.
The evaluation results confirm the performance characteristics of the SCENARIA Phase 2 are comparable to the predicate device and support our conclusion that the SCENARIA Phase 2 system is substantially equivalent.
Device Technological Characteristics
The SCENARIA PHASE 2's Gantry, X-ray Tube, X-ray Generator, and Patient Table specifications are the same as the SCENARIA System (K101888). 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 PHASE 2. See Section 4 - Comparison to Predicate Device for additional information.
Therefore, the SCENARIA Phase 2 system is technologically equivalent in concept, function, and performance to the predicate device.
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Safety and Effectiveness
The SCENARIA Phase 2 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, 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 equipment 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
Conclusions
The SCENARIA Phase 2 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/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2013
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager. Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K123509
Trade/Device Name: SCENARIA Phase 2 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: February 25, 2013 Received: February 26, 2013
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. 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 (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. Thistlethwaite
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.fda.gov/MedicalDevices/Safetv/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/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris 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): K123509
Device Name:
HITACHI SCENARIA Phase 2 Whole-body X-ray CT System
Indications for Use:
The SCENARIA Phase 2 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA). Multiplanar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 2 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Sm. 7).
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K123509 510(k)
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§ 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.