GEMINI GXL

K051170 · Philips Medical Systems (Cleveland), Inc. · KPS · May 23, 2005 · Radiology

Device Facts

• Record ID: K051170
• Device Name: GEMINI GXL
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: May 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

Device Story

Hybrid diagnostic imaging system combining PET and CT scanners; utilized in fixed or mobile environments. Inputs: X-ray transmission data (CT) and PET radiopharmaceutical distribution data. Operation: CT subsystem performs computer reconstruction of X-ray data; PET subsystem acquires metabolic data; CTAC used for attenuation correction. System supports list mode, dynamic, and gated acquisitions. Output: Cross-sectional, registered, and fused PET/CT images. Operated by trained professionals (physicians/technicians) via acquisition and processing workstations. Clinical use: Evaluation/diagnosis of lesions, tumors, cardiovascular, and neurological conditions; treatment planning; interventional procedures. Cardiac software quantifies myocardial perfusion, wall motion, and left-ventricular function; performs 3D alignment of coronary angiography images. Benefits: Provides combined metabolic and anatomical data for improved diagnostic accuracy and staging.

Clinical Evidence

Bench testing only. Performance measured in accordance with NEMA NU-2 standards. Electrical and mechanical safety verified via IEC 60601-1 series. Radiation safety verified via compliance with 21 CFR 1020.30 and 1020.33.

Technological Characteristics

Hybrid PET/CT system. Components: PET scanner, X-ray CT scanner (up to 64-slice), patient table, gantry separation unit, acquisition/processing workstations. Connectivity: Networked workstations. Standards: 21 CFR 1020.30/1020.33 (radiation), IEC 60601-1 (electrical/mechanical), NEMA NU-2 (performance).

Indications for Use

Indicated for patients requiring diagnostic imaging for evaluation, detection, and diagnosis of lesions, disease, and organ function (e.g., cancer, cardiovascular disease, neurological disorders); tumor detection, localization, and staging; treatment planning; and interventional radiology procedures. Used for whole body, head, heart, and other organ imaging.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Gemini System (K042935)
• Philips Plus CT Scanner (K0333326)

Submission Summary (Full Text)

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K051170

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## General Information

# MAY 2 3 2005

| A. | Submitter/ Contact Person: | | Rae Ann Farrow | |
|----|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------|----------------|
| | Philips Medical Systems (Cleveland), Inc.<br>595 Miner Rd.<br>Cleveland, OH 44143 | | Tel: | [phone] |
| | | | Fax: | [phone] |
| B. | Device Trade Name: | Gemini GXL | | |
| | Common Name: | Positron Emission Tomography<br>Computed Tomography X-Ray | | |
| | Classification Name: | System, Emission Computed Tomography, (892.1200)<br>System, Computed Tomography X-Ray, (892.1750) | | |
| | Device Class: | 21CFR 892.1200, Class II<br>21 CFR 892.1750, Class II | | |
| | Product Code: | 90 KPS and 90 JAK | | |
| | Classification Panel: | Radiology | | |
| C. | Date prepared: | April 8, 2005 | | |

(K042935) Gemini System D. Predicate Device: "Philips Plus" CT Scanner (K0333326)

#### Performance Standards: E.

- 21 CFR 1020.30 1020.33 Performance Standards for Ionizing Radiation . Emitting Products, Computed Tomography Equipment (Applicable Sections)
- . NEMA NU-2

#### F. Intended Use:

The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.

Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:

Section X .- 1

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- o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
- · The detection, localization, and staging of tumors and diagnosing cancer patients.
- · Treatment planning and interventional radiology procedures.

Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

#### G. Device Description/ Comparison with Predicate Device:

The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.

#### H. System Performance Test/ Summary of Studies:

To minimize electrical, mechanical and radiation hazards, Philips Medical System adheres to recognized and established industry practice. Radiation safety is assured by compliance and certification to the performance standards for ionizing radiation cmitting product, 21CFR 1020.30 and 21CFR 1020.33. The radiation safety product report will be filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the TEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU2 standard.

#### I. Comparison to Predicate Devices:

The basic differences in the system include the following:

- . The option a 64-slice CT subsystem.
- Addition of Syntermed NeuroO Software Application .

In conclusion, the device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance.

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized bird-like figure in the center. The text around the circle appears to be the name of a department or organization. The bird-like figure is composed of three curved lines that suggest movement or flight. The logo is black and white and has a simple, clean design.

MAY 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Morten Simon Christensen Underwriters Laboratories, Inc. 1655 Scott Blvd. SANTA CLARA CA 95050-4169

Re: K051170

Trade/Device Name: Gemini GXL Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Product Code: KPS Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Product Code: JAK Regulatory Class: II Dated: May 5, 2005 Received: May 6, 2005

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leveleved your becared by the promised in the indications for use stated in above and have decommised at predicate devices marketed in interstate commerce prior to the closere) to rogally matterial property many of the Medical Devices that have been May 20, 1770, dic claculture and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassition in accordation market approval application (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act device, subject to the general volusion, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (360 able additional controls. Existing major regulations affecting your Apploval), it they of subject of aderal 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 Please be advised that I DA's issualled of a vith other requirements of the Act or any FDA has made a decemination adaly other Federal agencies. You must comply with all the Federal Statues and regulations actimation to registration and listing (21 CFR Part 807); labeling ACL S requirements, modulity, but not a more a cause entrements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 leadly This letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notitication. The FDA tinding of Sabstantial of Color States of Sales of Court device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased
ation with advice for your a 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -If you desire specific advice for your device on our lasening organisation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Frisonalians on your responsibilities under the Act from the 180 807.97). You may onliner general international and Consumer Assistance at its toll-free number (800) Drvision of Small Manufacturers, International and Solaration
638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): Not-Known):

K051170

Device Name: Gemini GXL

### Indications for Use:

The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission The device is a ulagioste maging with to mography (CT) systems. The CT subsytem produces coss-Tomography (FET) and X-lay Computer reconstruction of x-ray transmission data. The PET subsystem sectional miages of the distribution of PET radiopharmaceuticals in the patient body (specific produces " the used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.

Image processing and display workstations provide software applications to process, analyze, display, quantify mage processing and display wonomicals pro and CT images may be registered and displayed in a "fused" and intelpret medical mages/data. - The TES and Of Mages that of the metabolic and anatomical data at different angles. Trained professionals use the images in:

- I The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to o cancer, cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients. O
- Treatment planning and interventional radiology procedures. O

Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of leftventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Both subsystens (PET and CT) can also be operated independently as fully functional, diagnostic imaging isystems including application of the CT scanner as a radiation therapy simulation scanner.

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Narsicbrodins

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051170