(233 days)
Not Found
No
The document describes standard image reconstruction techniques and does not mention AI, ML, or related concepts.
No
The device is described as a "diagnostic imaging device" and is used for "detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response," which are all diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a diagnostic imaging device" and is used for "detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases." Additionally, the "Device Description" section refers to it as a "hybrid diagnostic imaging system."
No
The device description explicitly states it is a "hybrid diagnostic imaging system that combines Positron Emission tomography and X-ray computed tomography scanners" and lists hardware components like the PET scanner, CT scanner, and Patient Table. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Philips Ingenuity Digital PET/CT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Philips Ingenuity Digital PET/CT System is a diagnostic imaging device. It uses PET and CT technologies to image the internal structures and radiopharmaceutical distribution within the patient's body. It does not analyze samples taken from the patient.
- Intended Use: The intended use is for "detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases" by imaging the patient directly.
Therefore, the device falls under the category of diagnostic imaging systems, not In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
90KPS, 90JAK
Device Description
The device is a hybrid diagnostic imaging system that combines Positron Emission tomography and X-ray computed tomography scanners that can be utilized in fixed installations. The device is comprised of the following system components/subsystems:
● Positron Emission Tomography (PET) scanner
● X-ray Computed Tomography (CT) scanner
● Patient Table
Mentions image processing
The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
Anatomical Site
whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Tests:
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.
Summary of Clinical Tests:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and appear to have a slightly rough or textured edge. The word is horizontally oriented and centered in the image.
K123599
page 1 of 3
Philips Medical Systems (Cleveland), Inc. 510(k) Premarket Notification Submission
.
. .
JUL 1 2 2013
Section 005 510(k) Summary
1
Image /page/1/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and appear to be slightly pixelated. The word is centered and takes up most of the frame.
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. |
| 595 Miner Road | |
| Cleveland, OH 44143 USA | |
| Establishment Registration: 1525965 | |
| Primary Contact Person: | Michael S. Preto |
| Regulatory Affairs Specialist, CT/NM Regulatory Affairs | |
| Philips Medical Systems (Cleveland), Inc. | |
| Tel: +1 440 483 2295 | |
| Fax: +1 440 483 7355 | |
| E-mail: michael.preto@philips.com | |
| Secondary Contact | |
| Person: | Melinda Novatny |
| Senior Manager, CT/NM Regulatory Affairs | |
| Philips Medical Systems (Cleveland), Inc. | |
| Tel: +1 440 483 4255 | |
| Fax: +1 440 483 7355 | |
| E-mail: melinda.novatny@philips.com | |
| 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 |
| X-ray Computed Tomography, 21 CFR 892.1750 | |
| Product Code: | 90KPS |
| 90JAK | |
| Predicate Device(s): | K052640, Gemini Raptor |
| Device Description: | The device is a hybrid diagnostic imaging system that combines |
| Positron Emission tomography and X-ray computed tomography | |
| scanners that can be utilized in fixed installations. The device is | |
| comprised of the following system components/subsystems: | |
| ● Positron Emission Tomography (PET) scanner | |
| ● X-ray Computed Tomography (CT) scanner | |
| ● Patient Table |
2
K123599
Page 3 of 3
Image /page/2/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and have a slightly textured appearance. The word is centered and takes up most of the frame.
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. |
|---|---|
| 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. |
Summary of Nonclinical Tests:
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.
Summary of Clinical Tests:
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. |
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is encircled by the words "U.S. Department of Health & Human Services" in a circular arrangement.
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.
4
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
Indications for Use Form
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Page 4-2