DISCOVERY CT750 HD

K120833 · Ge Medical Systems, LLC · JAK · Jun 12, 2012 · Radiology

Device Facts

• Record ID: K120833
• Device Name: DISCOVERY CT750 HD
• Applicant: Ge Medical Systems, LLC
• Product Code: JAK · Radiology
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K120833 · Jun 12, 2012	DISCOVERY CT750 HD	Ge Medical Systems, LLC	In-vivo patient scans (urinary tract stones)	Data from in-vivo patient scans were used to evaluate the performance of the GSI feature in characterizing urinary tract stones (uric acid vs. non-uric acid) compared to ex-vivo gold standard analysis.	Urinary tract stones; In-vivo patient scans; GSI spectral imaging

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Independent clinical study of GSI for urinary tract stone characterization; Retrospective/Observational analysis of patient scans	11 patients with urinary tract stones; Sample Size: 11 patients (subset of 59 total stones including phantom)	Ex-vivo analysis using polarized microscopy with infrared spectrophotometry	Sensitivity and accuracy in characterizing uric acid versus non-uric acid stones

Indications for Use

The Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications for both single kV acquisitions and with the fast kV switching spectral imaging option (GSI). The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures. GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

Device Story

Discovery CT750 HD is a whole-body CT scanner comprising gantry, table, console, and computer. System acquires X-ray transmission data at multiple angles/planes; reconstructs cross-sectional images. Spectral imaging (GSI) option uses fast kV switching to acquire data at different energy levels in a single rotation; enables material decomposition and effective atomic number calculation. Used in clinical settings by trained professionals. Output includes standard CT images, monochromatic images, and material density maps. GSI feature aids in characterizing renal calculi composition (uric acid vs. non-uric acid). Clinicians use outputs to diagnose disease, trauma, or abnormalities and to plan/monitor therapy. Benefits include enhanced tissue visualization and improved characterization of specific pathologies like kidney stones.

Clinical Evidence

Clinical evaluation included 29 subjects for cardiac imaging, assessed by radiologists for diagnostic quality. Additionally, a study of 59 renal stones (20 phantom, 39 in-vivo) compared GSI material density (MD) algorithm results against polarized microscopy/infrared spectrophotometry gold standard. MD images showed 100% sensitivity/accuracy for uric acid vs. non-uric acid stone characterization. HU measurements alone showed 71% sensitivity and 69% accuracy.

Technological Characteristics

Whole-body CT scanner; X-ray source; fast kV switching for spectral imaging (GSI). Compliant with UL 60601-1, IEC 60601-1, 21CFR Subchapter J, and NEMA XR-25. Materials equivalent to existing marketed products. Software-based image reconstruction and material decomposition processing.

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT imaging in patients of all ages. Used for diagnosis of disease, trauma, or abnormality and for therapy planning/monitoring. Spectral imaging (GSI) option indicated as an adjunct for characterizing renal calculi (uric acid vs. non-uric acid).

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

• Discovery CT750 HD (K081105)

Submission Summary (Full Text)

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JUN 1 2 2012

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letters 'K1', followed by the numbers '20833'. The handwriting style is somewhat cursive, with some connections between the characters.

GE Medical Systems, LLC (GE Healthcare)

3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

Date:

June 7, 2012

Submitter:

Primary Contact:

3000 N. Grandview Blvd., W-1140 Waukesha, WI 53188

GE Medical Systems, LLC (GE Healthcare)

John Jaeckle Chief Regulatory Affairs Strategist GE Medical Systems, LLC Tel: [phone] e-mail: [e-mail]

#### Secondary Contact:

Helen Peng Regulatory Affairs Leader, RAC GE Medical Systems, LLC Tel: [phone] e-mail: [e-mail]

# PRODUCT IDENTIFICATION

Device Trade Name:

Common/Usual Name:

Classification Name:

Product Code:

Manufacturer / Design Location:

Manufacturing Location(s):

Distributor:

Discovery CT750 HD

Computed Tomography X-ray System

Computed Tomography X-ray System per 21CFR892.1750

90-JAK

GE Medical Systems, LLC (GE Healthcare) 3000 N. Grandview Blvd. Waukesha, WI 53188

GE Medical Systems, LLC (GE Healthcare) 3000 N. Grandview Blvd. Waukesha, WI 53188

GE Medical Systems, LLC (GE Healthcare) 3000 N. Grandview Blvd.

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3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188

Waukesha, WI 53188

# Marketed Devices:

The Discovery CT750 HD with GSI Cardiac Option is of comparable type and substantially equivalent to GE Medical Systems' currently marketed Computed Tomography X-ray Systems that comply with the same standards. In addition, the system has similar intended use as other GE Computed Tomography X-ray Systems and the same intended use as the unmodified device. However the modified device's indications for use have been revised to match the system capabilities as substantiated in the engineering and clinical testing provided. The system is labeled as the Discovery CT750 HD.

### Predicate (unmodified) Device(s):

K081105 - Discovery CT750 HD

#### DEVICE DESCRIPTION

The Discovery CT750 HD CT Scanner System with GSI Cardiac Option is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories.

The Discovery CT750 HD CT Scanner System with GSI Cardiac Option is intended to be a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, 21CFR Subchapter J, and NEMA XR-25. It has been developed under the same GE quality system and has successfully completed all design controls, including risk management, verification, and validation.

#### Indications for Use:

The Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications for both single kV acquisitions and with the fast kV switching spectral imaging option (GSI).

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3000 N, Grandview Blvd. W-1140 Waukesha, Wi 53188

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

### Technology:

The Discovery CT750 HD with GSI Cardiac Option employs the same fundamental scientific technology as the unmodified device.

### Adverse Effects on Health:

Potential electrical, mechanical, and radiation hazards are identified in risk management including hazard analysis and controlled by:

- · System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
- · Adherence and certification to industry and international standards. (UL/CSA and IEC60601-1 Ed.3 and associated collateral and particular standards for CT).
- · Compliance to applicable CDRH 21CFR subchapter J requirements.
- · Compliance to NEMA XR-25

The device is designed and manufactured under the Quality System Regulations of 21CFR 820.

### Determination of Substantial Equivalence:

The Discovery CT750 HD with GSI Cardiac Option has completed testing and is in compliance with IEC 60601-1 Ed. 3 and its associated collateral and particular standards, 21CFR Subchapter J, and NEMA XR-25. The device has successfully completed all testing per our quality system as well as comparison testing to the unmodified device. It was designed and is manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:

- · Risk Analysis
- · Required Reviews
- · Design Reviews
- Testing on unit level (Module verification)

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3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188

- · Integration testing (System verification)
- Performance testing (Verification)
- · Safety testing (Verification)
- Simulated use testing (Validation) .

### Summary of Additional Testing

In addition to the verification and validation testing successfully completed as required by GE Healthcare's quality system, additional engineering and clinical performance testing was performed to provide the requisite data to substantiate performance claims, revised indications, safety and efficacy, and ultimately substantial equivalence.

#### Engineering Testing

The bench testing used two custom designed phantoms to simulate the cardiac imaging tasks. The test scan techniques used were selected to align with clinically used protocols for cardiac scanning. Statistical analysis of the results demonstrated the significance of the findings.

For coronary plaque modeling the material hydroxyapatite (HAP) was selected because of publications demonstrating that it closely matches the composition of calcified plaques in coronary arteries. To evaluate coronary lumen and plaque visualization, dilute lodine-filled vessels contained in an in-house custom phantom with HAP inserts was used to demonstrate the enhanced assessment capabilities when using GSI cardiac including its material separation capability.

Additionally, three actual clinical cases with an lodine and Calcium MD images and wide range of monochromatic images were shown for comparison.

Testing was also performed to demonstrate the ability for the GSI acquisition to reduce beam hardening artifact in a simulated cardiac environment, and thereby improve CT number accuracy which is important for accurate perfusion calculations. For this test another custom cardiac phantom was utilized. This polyurethane phantom was designed to mimic two heart chambers, an aorta, and a small "myocardial ischemic" defect. The chambers and aorta were filled with water and/or varving concentrations of iodine.

#### Clinical Testing

Sample clinical images were obtained from 29 subjects at 3 sites using the GSI cardiac option under IRB and informed consent. Two radiologists at each site independently assessed, using a Likert scale, the diagnostic quality of the images and additional information from of the output of the GSI cardiac feature (monochromatic + material density images).

The patient population consisted of any patient with known or suspected abnormality involving the heart scheduled for a physician ordered CT exam or who recently had a routine CT scan or cardiac cath procedure within the past 30 days. This patient data was representative of a wide range of heart rates and patient sizes.

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3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188

The results demonstrated that the output of the GSI cardiac feature (monochromatic + material density images) provide diagnostic images and include additional information related to material composition obtained as a result of GSI scanning.

Additionally, data from an independent clinical study using GSI to characterize urinary tract stones in a simulated abdominal phantom and with in-vivo patient scans, was submitted.

Twenty stones of pure crystalline composition [Uric acid (UA), struvite, cystine, and calcium oxalate monohydrate (COM)] were assessed in a phantom as well as 11 patients with urinary tract stones were evaluated. UA and non-UA stones were defined using a two-material decomposition (MD-lodine/Water) algorithm. The stone HU was also studied to determine its performance in predicting the composition. Ex-vivo analysis of the stone using polarized microscopy with infrared spectrophotometry served as the gold standard.

Of the 59 verified stones (phantom=20 and patients=39, mean size- 6 mm) there were 16 UA and 43 non-UA type. The material density (MD) images were 100% sensitive and accurate in characterizing UA versus non-UA stones. In patients, Effective Z identified 83% of calcium stones (n=24) and in stones of mixed type it accurately identified the dominant composition. The HU measurements alone were 71% sensitive and 69% accurate in characterizing the UA stones. The results demonstrate that GSI can provide accurate adjunct information that may predict UA and from non-UA stone composition in-vitro and invivo.

#### Substantial Equivalence Conclusion:

Based on the conformance to standards, development under our quality system, and the engineering and clinical testing provided. GE Medical Systems believes that the Discovery CT750 HD with GSI Cardiac Option is as safe and effective, and performs in a substantially equivalent manner to the predicate device Discovery CT750 HD (K081105).

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUN 1 2 2012

Mr. John Jaeckle Chief Regulatory Affairs Strategist GE Medical Systems, LLC 3000 N. Grandview Blvd., W - 1140 WAUKESHA WI 53188

Re: K120833

Trade/Device Name: Discovery CT750 HD Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 16, 2012 Received: March 19, 2012

#### Dear Mr. Jaeckle:

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting 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): K120833

# Device Name: Discovery CT750 HD

## Indications for Use:

The Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications for both single kV acquisitions and with the fast KV switching spectral imaging option (GSI).

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K120833
510(k)

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