(116 days)
The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
The NL5000 CT System is a high resolution, 16 row, 40 cm bore, and 30 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch. x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360 degree movement and electrical drive system so the system can be moved easily to different locations.
Here's a breakdown of the acceptance criteria and study information for the OmniTom device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the OmniTom as a Computed Tomography (CT) X-ray system. The acceptance criteria are implicitly defined by a comparison against a predicate device (CereTom K051765) and adherence to recognized industry standards. The performance is assessed through various tests, including image quality, safety, and functional parameters.
| Acceptance Criteria Category | Specific Metric/Test | Target (Implicitly or Explicitly Stated) | Reported Device Performance (OmniTom NL5000) |
|---|---|---|---|
| Image Quality | Noise (measured via phantom) | Not explicitly quantified, but goal is "comparable image quality" to predicate and "diagnostic quality" for clinical images. | "Image quality metrics such as noise... were measured utilizing phantom image quality tests... The OmniTom scanner successfully demonstrated that it has comparable image quality as the predicate device CereTom (K051765) and meets all the image quality criteria that are used for testing the CereTom." "images reviewed by a board-certified radiologist were of diagnostic quality." |
| Slice Thickness (measured via phantom) | Not explicitly quantified, but goal is "comparable image quality" to predicate and "diagnostic quality" for clinical images. | "Image quality metrics such as... slice thickness... were measured utilizing phantom image quality tests... The OmniTom scanner successfully demonstrated that it has comparable image quality as the predicate device CereTom (K051765) and meets all the image quality criteria that are used for testing the CereTom." | |
| Low/High Contrast Resolution (measured via phantom) | Not explicitly quantified, but goal is "comparable image quality" to predicate and "diagnostic quality" for clinical images. Specific spatial resolution for soft tissue kernel: 6.0 lp/cm. (Predicate: Soft tissue kernel: 7.0 lp/cm, High resolution kernel: 14.0 lp/cm) | "Image quality metrics such as... low and high contrast resolution... were measured utilizing phantom image quality tests... The OmniTom scanner successfully demonstrated that it has comparable image quality as the predicate device CereTom (K051765) and meets all the image quality criteria that are used for testing the CereTom." Spatial Resolution: Soft tissue kernel: 6.0 lp/cm. | |
| Radiation Metrics (measured via phantom) | Not explicitly quantified, but goal is to meet equipment performance standards. | "Image quality metrics such as... radiation metrics... were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA." | |
| Modulation Transfer Function (MTF) (measured via phantom) | Not explicitly quantified, but goal is to meet equipment performance standards. | "Image quality metrics such as... modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA." | |
| Artifact Analysis | Demonstrated performance in the presence of implants. | "Subsequent testing for artifact analyses associated with typical clinical techniques demonstrated the performance of the CT system in the presence of implants." | |
| Safety & Performance | Electrical Safety | Conformance to IEC 60601-1, ETL Testing. | "ETL Testing" passed. |
| Mechanical Safety | Conformance to IEC 60601-1, ETL Testing. | "ETL Testing" passed. | |
| EMI/EMC | Conformance to IEC 60601-1-2, ETL Testing. | "ETL Testing" passed. | |
| Radiation Protection | Conformance to IEC 60601-1-3, 21 CFR §1020.30, §1020.33. | "All components... are certified to meet those requirements." | |
| Software Safety | Risk management analysis, verification/validation testing. | "The risk management analysis identified potential hazards which were controlled and mitigated... The verification/validation testing ensured the safety and effectiveness of OmniTom." | |
| Risk Management | Conformance to ISO 14971. | Explicitly stated adherence to ISO 14971. | |
| CT Dose Check | Conformance to NEMA XR 25. | Explicitly stated adherence to NEMA XR 25 and NEMA XR 29. "Dose Check: Yes" | |
| Dose Optimization/Management | Conformance to NEMA XR 29. Including dose structured reporting, CT dose check, AEC, pediatric/adult reference protocols. | Explicitly stated adherence to NEMA XR 29. "AEC feature has been verified as part of IEC 60601-2-44, clause 203.102." "Pediatric Protocols: Yes By Age/weight." | |
| Functional Equivalence | Overall Functionality | Comparable to predicate device CereTom (K051765) in design, functionality, and technology for intended use. | "NeuroLogica Corporation believes that the OmniTom system, for its intended use, is of comparable type in design, material, functionality, technology and is substantially equivalent to the cleared predicate device - CereTom (K051765)." "The OmniTom CT system performs as well in its intended use as similar devices currently on the market." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Phantom Studies: Not explicitly stated, but "phantom image quality tests" were utilized. Phantoms are typically manufactured objects, not human subjects, so provenance in terms of country of origin is not applicable.
- Clinical Images: "Clinical images for adult brain exams" were used. The document does not specify the number of adult brain exams used to form the test set.
- Pediatric Scans: "Phantom image evaluations were performed for pediatric scans," but it's unclear if actual clinical pediatric images were also used for evaluation or just phantoms.
- Data Provenance: The document does not specify the country of origin for any clinical images used. The studies appear to be retrospective clinical data review, as they refer to "clinical images for adult brain exams" being reviewed, which implies pre-existing scans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: "a board-certified radiologist" (singular) reviewed the clinical images.
- Qualifications of Experts: The expert was "board-certified radiologist." The document does not specify their years of experience.
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned. Given that a single "board-certified radiologist" reviewed the images, a formal multi-reader adjudication method (like 2+1 or 3+1) was not employed for the clinical image review described.
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
- No, an MRMC comparative effectiveness study was not performed. This submission is for a CT system itself, not an AI-assisted interpretation or diagnostic software. The focus is on the device's image quality and safety compared to a predicate device, as well as its compliance with relevant standards. Therefore, the effect size of human readers improving with or without AI assistance is not applicable or discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The OmniTom is a CT scanner, not an independent algorithm or AI diagnostic tool. Its "performance" is its ability to produce high-quality diagnostic images and operate safely, not to autonomously interpret scans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For image quality, the ground truth appears to be established through:
- Phantom studies: These use known physical properties of the phantom to assess image metrics like spatial resolution, noise, and contrast.
- Expert review: A "board-certified radiologist" determined if clinical images were of "diagnostic quality." This could be considered a form of expert consensus, albeit from a single expert, against an internal standard of diagnostically acceptable images.
- For safety and functional performance, the ground truth is established by:
- Conformance to recognized consensus standards (e.g., IEC, NEMA).
- Internal verification and validation testing against defined specifications (e.g., electrical, mechanical, radiation hazards).
8. The sample size for the training set
- The document describes a 510(k) submission for a CT hardware system, not a software algorithm that requires a "training set" in the machine learning sense. Therefore, there is no training set sample size mentioned or applicable.
9. How the ground truth for the training set was established
- As there is no training set for an AI algorithm in this submission, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd. % Dr. Ninad Gujar Director, Regulatory Affairs and Ouality Assurance 14 Electronics Avenue DANVERS MA 01923
Re: K171183
Trade/Device Name: OmniTom Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 21, 2017 Received: July 25, 2017
Dear Dr. Gujar:
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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171183
Device Name OmniTom
Indications for Use (Describe)
The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92
Date: April 21, 2017
Submitter:
NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923
Contact:
Dr. Ninad Gujar Director, Regulatory Affairs & Quality Assurance Telephone: 978-564-8503 Fax: 978-564-8677 E-mail: ngujar@neurologica.com
Device Name:
| Trade Name: | OmniTom |
|---|---|
| Device Model: | NL5000 |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
Predicate Device:
| Trade Name: | CereTom |
|---|---|
| 510(k) number: | K051765 cleared 07/14/2005 |
| Manufacturer: | NeuroLogica Corporation, a subsidiary of SamsungElectronics Co., Ltd (same as that of proposed device) |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
Reference Device:
| Trade Name: | GR40CW Retrofit Kit |
|---|---|
| 510(k) number: | K153401 cleared 12/21/2015 |
| Manufacturer: | Samsung Electronics Co., Ltd |
| Classification Name: | Solid State X-ray Imager (Flat panel/Digital imager) |
| Product Code: | MQB |
{4}------------------------------------------------
| Device Classification: | Class II (per 21 CFR 892.1680) |
|---|---|
| ------------------------ | -------------------------------- |
Device Description:
The NL5000 CT System is a high resolution, 16 row, 40 cm bore, and 30 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch. x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360 degree movement and electrical drive system so the system can be moved easily to different locations.
Indications for Use:
The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
Comparison of Technological Characteristics with the Predicate Device:
NeuroLogica Corporation believes that the OmniTom system, for its intended use, is of comparable type in design, material, functionality, technology and is substantially equivalent to the cleared predicate device - CereTom (K051765).
Similarities
- Material: The OmniTom uses similar material to CereTom (K051765) such as, x-■ ray generator, slip ring, rotational bearing, and motion control systems.
- . Design: The OmniTom is similar in general design principle to CereTom (K051765). Specifically, it shares most of the control system designs and features of the CereTom.
Differences
- I Detector Material: The scintillation properties of the detector material Gadolinium Oxysulfide used in OmniTom CT system are more promising than the detector material Solid State CdWo4 used in the CereTom system (predicate device
{5}------------------------------------------------
K051765). This material has already been cleared for use in the reference device GR40CW Retrofit Kit (K153401 cleared 12/21/2015) which is a Solid State X-ray Imager manufactured by Samsung Electronics Co., Ltd.
- Tablet: OmniTom uses a tablet for running CT application software instead of a PC laptop used with CereTom. A tablet is an accompanying part of each OmniTom scanner and is designed to be used as the control unit to operate all respective functions of the system.
- . Internal Drive System: CereTom had an accessory drive system which when connected with the scanner allowed mobility while OmniTom has an internal drive system providing easy movement of the scanner.
- Battery: Lithium batteries are used in OmniTom instead of the lead acid batteries in CereTom are designed and tested to IEC 62133 and UN/DOT 38.3 for safety and transportation.
- Automatic Exposure Control: AEC was not offered on the CereTom system at the 트 time of 510(k) clearance (K051765) but introduced as a device modification through a software/firmware upgrade. OmniTom is XR-29 compliant and as such includes four key features of CT equipment that enable optimization or management of radiation dose delivery - dose structured reporting, CT dose check, AEC and pediatric and adult reference protocols. AEC feature has been verified as part of IEC 60601-2-44, clause 203.102.
- Contrast and Bolus Tracking: OmniTom does not control the contrast injection or the delivery of the contrast volume however has the ability for helical and dynamic scanning. For example, bolus tracking is used for CT Angiography applications.
The internal verification and validation activities and external testing of product safety and EMC / EMI was completed successfully. The differences noted above raise no new issues of safety or effectiveness based on all testing performed.
{6}------------------------------------------------
| Model # Name | OmniTom (subject ofthis 510(k)) | CereTom(predicate deviceK051765) |
|---|---|---|
| Indications for Use | The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications that produce cross sectional images for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.The OmniTom system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. | The NL3000 [CereTom] is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 32cm aperture. |
| Aperture (cm) | 40 | |
| Image Field Of View (cm) | 30 | 25 |
| Detector Material | Gadolinium Oxysulfide | Solid State CdWO4 |
| Detector coverage (mm) | 16 x 0.625 | 8 x 1.25 |
| Slice Configurations | 16 | 8 |
| Spatial Resolution | Soft tissue kernel:6.0 lp/cm | Soft tissue kernel:7.0 lp/cm |
| MTF at 0% (lp/cm) | High resolution kernel:14.0 lp/cm | |
| Model # Name | OmniTom (subject ofthis 510(k)) | |
| X-ray Tube Type | Grounded/FixedAnode/Monoblock | Grounded/FixedAnode/Monoblock |
| Heat Storage (MHU) | 0.72 | 0.45 |
| Cooling | Water-Glycol | Air cooled |
| Tube Current (mA) | 5 - 45 | 1 - 7 |
| Tube Voltage Range (kV) | 80, 100, 120 | 100, 120, 140 |
| Rotation time (s) | 1,2 | 2, 4, 6 |
| Gantry Weight (lbs) | 1700 | 966 |
| Mobile / Stationary | Mobile | Mobile |
| Battery / Wall power | Lithium battery | Lead acid battery |
| Input Voltage | Single phase90 - 264 VAC/1300 wattspeak | Single phase90-264VAC |
| Max Input Power (kVA) | 5.4 kW | 1.3 kW |
| PACS DICOM 3.1 | Yes | Yes |
| 2D Scout Scan | Yes | Yes |
| Bolus Tracking | Yes | Yes |
| Axial Scan | Yes | Yes |
| Helical Scan | Yes | Yes |
| Dynamic Scan | Yes | Yes |
| Model # Name | OmniTom (subject ofthis 510(k)) | CereTom(predicate deviceK051765) |
| 2D Viewing | Yes | Yes |
| MPR Viewing | Yes | Yes |
| 3D Viewing | Yes | Yes |
| Maximum Scan Range (cm) | 40 | 25 |
| Scan Localizer | Laser | Laser |
| Cardiac/Respiratory Gating | No | No |
| Patient Table | No | No |
| Image recon speed max (imagesper second) | 16 images / sec | 1 image / sec |
| X-ray Warning Lights | Yes | Yes |
| 110% X-ray Timer | Yes | Yes |
| Emergency Stop | Yes | Yes |
| Operator X-ray On Switch | Yes | Yes |
| Quality Test Phantom | Yes | Yes |
| Quality Test Report | Yes | Yes |
| X-ray Filter | Bowtie | Bowtie |
| Administrator Privileges | Yes | Yes |
| Dose Display | Yes | Yes |
| Dose Report / Audit | Yes | Yes |
| Model # Name | OmniTom (subject of this 510(k)) | CereTom (predicate device K051765) |
| Protocol Override Protection | Yes | Yes |
| Dose Check | Yes | Yes |
| Pediatric Protocols | YesBy Age/weight | YesBy Age/weight |
| Automatic Exposure Control | Yes | No |
| Biocompatibility | N/A | N/A |
| Sterility | N/A | N/A |
| Chemical Safety | N/A | N/A |
| EM Emissions | ETL Testing | ETL Testing |
| Electrical Safety (IEC 60601-1) | ETL Testing | ETL Testing |
| Mechanical Safety (IEC 60601-1) | ETL Testing | ETL Testing |
| Where Used | (Mobile) Radiology,ICU, ED, OR, Clinic,Office | (Mobile) Radiology, ICU,ED, OR, Clinic, Office |
| Anatomical Site | Head and Neck | Head and Neck |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
General Safety and Effectiveness Concerns:
All components of the OmniTom CT system that are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR §1020.30 and $1020.33 are certified to meet those requirements. To minimize electrical, mechanical and radiation hazards, NeuroLogica adheres to recognized and established industry practices.
OmniTom CT system is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485 requirements. The device is in conformance with all applicable parts of the following FDA Recognized Consensus Standards:
{10}------------------------------------------------
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for 트 Safety
- l IEC 60601-1-2, Medical electrical equipment - Part 1-2: General Requirements Basic Safety and Essential Performance - Collateral Standard: for Electromagnetic Compatibility. Requirements and Test
- I 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 Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography
- NEMA XR 25: Computed Tomography Dose Check I
- . NEMA XR 29: Standard Attributes on CT Equipment Related to Dose Optimization and Management
- ISO 14971 Medical devices Application of risk management to medical devices 트
In addition to conformance to the above harmonized standards, OmniTom quality assurance activities include the following:
- . Risk analysis and mitigation
- I Software verification and validation testing
- System verification and validation testing l
- I Image quality tests
- 트 Testing at unit level
Guidance documents specifically related to premarket submissions like FDA management of cybersecurity in medical devices, software contained in medical devices, pediatric medical devices and conformance with IEC standards were utilized during the development of OmniTom device.
Software is critical to the operation of the OmniTom CT scanner and a malfunction or design flaw in the software could result in delivery of appropriate medical care. As such, the risk management analysis identified potential hazards which were controlled
{11}------------------------------------------------
and mitigated during development of OmniTom. The verification/validation testing ensured the safety and effectiveness of OmniTom.
Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA. Subsequent testing for artifact analyses associated with typical clinical techniques demonstrated the performance of the CT system in the presence of implants.
Phantom image evaluations were performed for pediatric scans along with clinical images for adult brain exams. The data provided clinical demonstration of the operation of the device and the images reviewed by a board-certified radiologist were of diagnostic quality.
The OmniTom scanner successfully demonstrated that it has comparable image quality as the predicate device CereTom (K051765) and meets all the image quality criteria that are used for testing the CereTom.
Conclusion
Based upon the above considerations, NeuroLogica Corporation, subsidiary of Samsung Electronics, believes that the OmniTom CT system is of comparable type in design, functionality, and technology and is, for its intended use, substantially equivalent to the predicate device CereTom (K051765).
The proposed modifications do not result in any new safety or effectiveness concerns. The OmniTom CT system performs as well in its intended use as similar devices currently on the market.
§ 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.