OmniTom

K171183 · Neurologica Corporation · JAK · Aug 18, 2017 · Radiology

Device Facts

• Record ID: K171183
• Device Name: OmniTom
• Applicant: Neurologica Corporation
• Product Code: JAK · Radiology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

OmniTom is a mobile, 16-row, 40 cm bore x-ray computed tomography (CT) system. It utilizes a rotating gantry with a solid-state x-ray generator and Gd2O2S detector array to acquire cross-sectional images. The system features an internal drive and omni-directional wheels for mobility in clinical settings like the ICU, ED, OR, and radiology departments. It is operated via an integrated tablet control unit. The device supports axial, helical, and dynamic scanning, including bolus tracking. It incorporates dose management features (AEC, dose reporting, CT dose check) compliant with XR-29. Output images are used by radiologists for diagnostic assessment. The system benefits patients by providing high-resolution, point-of-care imaging, reducing the need for patient transport.

Clinical Evidence

Bench testing only. Performance validated via phantom image quality tests (noise, slice thickness, low/high contrast resolution, MTF) per FDA diagnostic x-ray standards. Artifact analysis performed for clinical techniques with implants. Pediatric phantom evaluations and adult brain clinical images were reviewed by a board-certified radiologist and confirmed to be of diagnostic quality. Comparable to predicate CereTom.

Technological Characteristics

16-row, 40 cm bore CT system. Materials: Gd2O2S detector array. Energy: X-ray generator, battery-powered (Lithium) or wall power. Connectivity: DICOM 3.1, tablet-based control. Features: Brushless DC servo drive, internal drive system, water-glycol cooling. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, NEMA XR-25, NEMA XR-29, ISO 14971.

Indications for Use

Indicated for x-ray computed tomography imaging of anatomy within a 40 cm aperture, primarily head and neck, in pediatric and adult patients. Images may be obtained with or without contrast.

Regulatory Classification

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.

Predicate Devices

• CereTom (K051765)

Reference Devices

• GR40CW Retrofit Kit (K153401)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | |
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> | |

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# 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: [phone] Fax: [phone] E-mail: [e-mail]

#### 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 Samsung<br>Electronics 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 |

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| 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

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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.

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| Model # Name | OmniTom (subject of<br>this 510(k)) | CereTom<br>(predicate device<br>K051765) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 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.<br>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:<br>6.0 lp/cm | Soft tissue kernel:<br>7.0 lp/cm |
| | MTF at 0% (lp/cm) | High resolution kernel:<br>14.0 lp/cm |
| Model # Name | | OmniTom (subject of<br>this 510(k)) |
| X-ray Tube Type | Grounded/Fixed<br>Anode/Monoblock | Grounded/Fixed<br>Anode/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 phase<br>90 - 264 VAC/1300 watts<br>peak | Single phase<br>90-264VAC |
| 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 of<br>this 510(k)) | CereTom<br>(predicate device<br>K051765) |
| 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 (images<br>per 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 | Yes<br>By Age/weight | Yes<br>By 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,<br>ICU, ED, OR, Clinic,<br>Office | (Mobile) Radiology, ICU,<br>ED, OR, Clinic, Office |
| Anatomical Site | Head and Neck | Head and Neck |

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## 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:

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- 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

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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.