(104 days)
No
The document describes standard PET/CT imaging technology and software for image reconstruction and management, with no mention of AI or ML capabilities.
No.
The device is described as a diagnostic imaging system used for detecting, localizing, diagnosing, staging, and restaging diseases, and for aiding in treatment planning. It does not actively treat or alleviate a disease or condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders." It also mentions "single modality CT and /or PET diagnostic imaging."
No
The device description explicitly states that the system includes hardware components such as PET and CT scanners, a patient handling system, and acquisition and processing workstations, in addition to software.
Based on the provided information, the Siemens Biograph Horizon PET/CT system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Biograph Horizon PET/CT system is an imaging device that directly scans the human body using X-rays and radiopharmaceuticals. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use describes imaging and diagnostic purposes within the body. The description clearly states the system is used to "aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function" by imaging the distribution of radiopharmaceuticals and using CT for anatomical reference. This is in vivo imaging, not in vitro testing.
- The device description details imaging components and software. The description focuses on the hardware (CT and PET scanners, patient handling system) and software for image acquisition, reconstruction, and evaluation. This aligns with an imaging device, not an IVD.
Therefore, the Siemens Biograph Horizon PET/CT system is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Siemens Biograph Horizon PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and /or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
The Biograph Horizon PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon scanners provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph Horizon software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph Horizon system which is the subject of this application is substantially equivalent to the commercially available Biograph mCT family of PET/CT systems (K151486). Differences compared to the Biograph mCT include:
- . The PET subsystem has been modified to provide for an air-cooled only PET system with a 70 cm bore size. The detectors, electronics, etc... are substantially equivalent to the current Biograph mCT system.
- . The commercially available Perspective 16 slice system (K133590) has been incorporated as the CT subsystem for the Biograph Horizon.
- . The software integrated into the Biograph Horizon systems is based upon the mCT software and includes a subset of features that are commercially available with the Biograph mCT systems. Major updates to the software system for use on the Biograph Horizon include:
- o limiting of high end features available with the mCT
- changes in software to support the modified PET and CT subsystems O
- updates for workflow and anomaly corrections. O
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-Ray Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
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
PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon PET/CT systems, a 3 rinq version and a 4 ring version.
CT Testing in accordance with the requirements of the following FDA Performance Standards for lonizing Radiation Emitting Products and Light emitting products for CT equipment with a laser localizer was performed and documented in a Dosimetry and Imaging Performance Report. Further, each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment:
- 21 CFR 1020.30 (a)
- 21 CFR 1020.30 (b)(36)(iii)-(v)
- 21 CFR 1020.30 (b)(58)-(62)
- 21 CFR 1020.30 (h)(3)(vi)-(viii)
- 21 CFR 1020.33
- 21 CFR 1040.10
- 21 CFR 1040.11
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PET Testing (NEMA NU2:2012) - Results (Average) vs. Acceptance (Standard PET) / Acceptance (TrueV PET)
| Performance Criteria | Results (Average) | Acceptance (Standard PET) | Acceptance (TrueV PET) |
|---|---|---|---|
| Resolution – Full Size | |||
| Transverse Resolution FWHM @ 1 cm | Pass | = 5.8 cps/MBq | >= 10.9 cps/MBq |
| Count Rate peak NECR | Pass | >= 78 kcps @ = 135 kcps @ = 285 kcps @ = 465 kcps @ |
§ 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Siemens Medical Solutions USA, Inc. % Ms. Alaine Medio PET and PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932
Re: K152880
Trade/Device Name: Biograph Horizon PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: December 1, 2015 Received: December 2, 2015
Dear Ms. Medio:
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'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
2
Indications for Use
510(k) Number (if known) K152880
Device Name Biograph Horizon PET/CT
Indications for Use (Describe)
The Siemens Biograph Horizon PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and /or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
as required by 21 CFR Part 807.87(h)
| Identification of the Submitter | |
|---|---|
| Submitter: | M. Alaine Medio, RAC |
| PET and PCS Regulatory Projects Manager | |
| Siemens Medical Solutions USA, Inc. | |
| Molecular Imaging | |
| 810 Innovation Drive | |
| Knoxville, TN 37932 | |
| Manufacturers: | Siemens Medical Solutions USA, Inc. |
| Molecular Imaging | |
| 810 Innovation Drive | |
| Knoxville, TN 37932 | |
| Siemens Medical Solutions USA, Inc. | |
| Molecular Imaging | |
| 2501 North Barrington Road | |
| Hoffman Estates, IL 60192 | |
| Telephone Number: | (865)218-2703 |
| Fax Number: | (865)218-3019 |
| Date of Submission: | September 29th, 2015 |
| Identification of the product | |
| Device Proprietary Name: | Biograph Horizon PET/CT |
| Common Name: | Positron Emission Tomography (PET) System |
| Computed Tomography (CT) System | |
| Classification Name: | Emission Computed Tomography System per 21 CFR |
| 892.1200 | |
| Computed Tomography X-Ray System per 21 CFR | |
| 892.1750 | |
| Product Code: | 90 KPS and 90 JAK |
| Classification Panel: | Radiology |
| Device Class: | Class II |
4
Marketed Devices to which Equivalence is claimed
Predicate:
| Device Proprietary Name: | Biograph mCT PET/CT |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | 90 KPS and 90 JAK |
| Device Class: | Class II |
| 510(k) Number: | K151486 |
| Reference Devices: | |
| Device Name: | Somatom Perspective |
| 510(k) Numbers: | K133590 |
Device Description:
The Biograph Horizon PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon scanners provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph Horizon software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph Horizon system which is the subject of this application is substantially equivalent to the commercially available Biograph mCT family of PET/CT systems (K151486). Differences compared to the Biograph mCT include:
- . The PET subsystem has been modified to provide for an air-cooled only PET system with a 70 cm bore size. The detectors, electronics, etc... are substantially equivalent to the current Biograph mCT system.
- . The commercially available Perspective 16 slice system (K133590) has been incorporated as the CT subsystem for the Biograph Horizon.
- . The software integrated into the Biograph Horizon systems is based upon the mCT software and includes a subset of features that are commercially available with the Biograph mCT systems. Major updates to the software system for use on the Biograph Horizon include:
- o limiting of high end features available with the mCT
5
- changes in software to support the modified PET and CT subsystems O
- updates for workflow and anomaly corrections. O
Intended Use:
The Siemens Biograph Horizon systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Performance Testinq / Safety and Effectiveness:
PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon PET/CT systems, a 3 rinq version and a 4 ring version.
| Performance Criteria | Results
(Average) | Acceptance
(Standard PET) | Acceptance
(TrueV PET) |
|------------------------------------|----------------------|------------------------------|---------------------------|
| Resolution – Full Size | | | |
| Transverse Resolution FWHM @ 1 cm | Pass | = 5.8 cps/MBq | >= 10.9 cps/MBq |
| Count Rate peak NECR | Pass | >= 78 kcps @ = 135 kcps @ = 285 kcps @ = 465 kcps @