INGENUITY DIGITAL PET/CT

K123599 · Philips Healthcare (Cleveland) · KPS · Jul 12, 2013 · Radiology

Device Facts

• Record ID: K123599
• Device Name: INGENUITY DIGITAL PET/CT
• Applicant: Philips Healthcare (Cleveland)
• Product Code: KPS · Radiology
• Decision Date: Jul 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Device Story

Hybrid diagnostic imaging system combining PET and CT scanners in a single gantry; utilizes PET radiopharmaceuticals and X-ray transmission data. PET subsystem images radiopharmaceutical distribution; CT subsystem performs anatomical cross-section reconstruction. Operated by clinicians in clinical settings for oncology, cardiology, and neurology applications. Output consists of diagnostic images used by physicians to detect, localize, stage, and monitor disease or plan radiation therapy. Benefits include integrated anatomical and functional imaging for improved diagnostic accuracy and therapy management.

Clinical Evidence

Clinical images were provided in accordance with FDA guidance for Emission Computed Tomography Devices. No specific quantitative clinical study results (e.g., sensitivity, specificity) are reported in the summary.

Technological Characteristics

Hybrid PET/CT system; integrated gantry design; PET detector technology; X-ray transmission CT. Complies with NEMA NU-2 for performance and IEC 60601 series for electrical safety.

Indications for Use

Indicated for patients of all ages and sizes requiring diagnostic imaging for oncology, cardiology, and neurology. Used for detection, localization, diagnosis, staging, re-staging, and therapy monitoring of diseases in the whole body, heart, brain, lung, gastrointestinal, bone, and lymphatic systems. Can be used for radiation therapy planning.

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 Raptor (K052640)

Submission Summary (Full Text)

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K123599
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Philips Medical Systems (Cleveland), Inc. 510(k) Premarket Notification Submission

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JUL 1 2 2013

## Section 005 510(k) Summary

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Philips Medical Systems (Cleveland), Inc. 510(k) Premarket Notification Submission

510(k) Summary in accordance with 21 CFR 807.92

| Date: | 20 November 2012 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Philips Medical Systems (Cleveland), Inc.<br>595 Miner Road<br>Cleveland, OH 44143 USA<br>Establishment Registration: 1525965 |
| Primary Contact Person: | Michael S. Preto<br>Regulatory Affairs Specialist, CT/NM Regulatory Affairs<br>Philips Medical Systems (Cleveland), Inc.<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Secondary Contact<br>Person: | Melinda Novatny<br>Senior Manager, CT/NM Regulatory Affairs<br>Philips Medical Systems (Cleveland), Inc.<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Trade Name: | Ingenuity Digital PET/CT System |
| Common/Usual Name: | Combination PET/CT System |
| Classification Names: | Emission Computed Tomography System, 21 CFR 892.1200<br>X-ray Computed Tomography, 21 CFR 892.1750 |
| Product Code: | 90KPS<br>90JAK |
| Predicate Device(s): | K052640, Gemini Raptor |
| Device Description: | The device is a hybrid diagnostic imaging system that combines<br>Positron Emission tomography and X-ray computed tomography<br>scanners that can be utilized in fixed installations. The device is<br>comprised of the following system components/subsystems:<br>● Positron Emission Tomography (PET) scanner<br>● X-ray Computed Tomography (CT) scanner<br>● Patient Table |

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K123599
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Philips Medical Systems (Cleveland), Inc. 510(k) Premarket Notification Submission

| Intended Use: | The Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning. |
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| Technology: | The Ingenuity Digital PET/CT System has replaced the PET detector design and has integrated both PET and CT subsystems into a single gantry. The system operates on the same principles as the predicate device. |
| Determination of Substantial Equivalence: | The Ingenuity Digital PET/CT System has comparable indications for use as its predicate device.<br><br>Summary of Nonclinical Tests:<br>In accordance with "Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems ", system performance is provided using NEMA NU-2. Safety evidence is provided using IEC 60601 series of standards.<br><br>Summary of Clinical Tests:<br>In accordance with "Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems ", clinical images are included. |
| Conclusion: | Philips Medical Systems (Cleveland), Inc. considers the Ingenuity Digital PET/CT System to be as safe, as effective, and performance is substantially equivalent to the predicate device. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 12, 2013

Philips Medical Systems (Cleveland), Inc. % Mr. Michael S. Preto Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K123599

Trade/Device Name: Ingenuity Digital PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS & JAK Dated: June 6, 2013 Reccived: June 11, 2013

Dear Mr. Preto:

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. Insting 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 cither 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Preto

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## Indications for Use Form

K123599

510(k) Number (if known): Device Name: Ingenuity Digital PET/CT System Indications for Use:

The Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical crosssections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Prescription Use X (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)

AND/OR

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

Michael D. O'Hara

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

510(k)_ K123599

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