(81 days)
Not Found
No
The summary describes a nuclear imaging system and its components, focusing on hardware, software for image acquisition and processing (SPECT/PET procedures), and intended use. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance summary. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an imaging system used for diagnosis and measurement of internal functions, not for treating any condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is for "use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions".
No
The device description explicitly lists hardware components such as the gantry, patient table, and dual detector heads, in addition to the computer system (hardware and software).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Siemens/CPS E.CAM LSO 311 PET/SPECT System clearly states its intended use is to "image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans". This involves imaging the patient directly, not analyzing samples taken from the patient.
- The device description focuses on imaging modalities and hardware. It describes a nuclear camera system with detectors, a gantry, a patient table, and a computer system. This aligns with an in vivo imaging device, not an in vitro diagnostic device.
Therefore, the Siemens/CPS E.CAM LSO 311 PET/SPECT System is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The E.CAM LSO 311 PET/SPECT system is a dual detector head nuclear camera having the purpose of performing a full range of nuclear medicine procedures, including:
-
- static, dynamic, whole body, and gated planar single photon procedures;
-
- dynamic, whole body, and gated single photon emission computed tomography (SPECT) procedures; and
-
- static, dynamic, whole body, and gated coincidence positron emission tomography (PET) procedures.
The E.CAM LSO 311 system comprises the following components: gantry and patient table mechanical components, computer system (hardware and software), and dual detector heads. Additional features of the system include attenuation correction capabilities and the ability to upgrade existing Siemens E.CAM cameras in the field to the E.CAM LSO 31 l configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine Gamma/PET Camera
Anatomical Site
various organs, tissues and other anatomical structures.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Initial investigation indicates that the CPS E.CAM LSO 311 PET/SPECT System will be capable of performing static, dynamic, whole body and gated planar single photon imaging procedures, as well as single photon emission computed Tomography (SPECT) procedures and positron emission tomography (PET) procedures utilizing a new combination LSO and NaI(TI) crystal detector system developed by CPS.
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.
K952109, K970627, K914350, K962797, K974256
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
JUN - 8 1998
Image /page/0/Picture/1 description: The image shows a logo with the letters 'CTI' in a stylized, bold font. The 'C' is a thick, curved shape, and the 'T' and 'I' are connected, with the 'T' having a thick vertical stroke and a thin horizontal stroke. Above the 'C' and the 'T', there are three horizontal lines that add a sense of motion or technology to the logo. The logo is black and white.
510(k) Summary of Safety and Effectiveness as required by 21CFR 807.87(h)
Identification of Submitter
Submitter:
Telephone No: Fax No: Date of preparation: William Skremsky CTI PET Systems, Inc. 810 Innovation Dr. Knoxville, TN 37932 (423) 966-7539 (423) 966-8955 March 16, 1998
Identification of the Product
Device Proprietary Name: Common Name: Classification Name:
E.CAM LSO 311 PET/SPECT System Nuclear Medicine Gamma/PET Camera Emission Computed Tomography System per 21CFR 892.1200
Marketed Devices to Which Equivalence is Claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| IP500 Nuclear Camera | Siemens Medical Systems | K952109 |
| E.CAM Coincidence | ||
| Mode Option | Siemens Medical Systems | K970627 |
| ICON Computer System | Siemens Medical Systems | K914350 |
| ECAT EXACT & | ||
| ECAT EXACT HR+ | CTI PET Systems | K962797 |
| ECAT PET Scanner | ||
| System & Software V7.1 | CTI PET Systems | K974256 |
Device Description
The E.CAM LSO 311 PET/SPECT system is a dual detector head nuclear camera having the purpose of performing a full range of nuclear medicine procedures, including:
-
- static, dynamic, whole body, and gated planar single photon procedures;
-
- dynamic, whole body, and gated single photon emission computed tomography (SPECT) procedures; and
-
- static, dynamic, whole body, and gated coincidence positron emission tomography (PET) procedures.
The E.CAM LSO 311 system comprises the following components: gantry and patient table mechanical components, computer system (hardware and software), and dual detector heads. Additional features of the system include attenuation correction capabilities and the ability to upgrade existing Siemens E.CAM cameras in the field to the E.CAM LSO 31 l configuration.
1
Indications for Use
The Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in hismans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.
Comparison with Predicate Devices
The E.CAM LSO 311 system is essentially a modified and enhanced version of the Siemens IP500 E.CAM gamma camera and E.CAM Coincidence Mode design and similar products from other vendors, which permits the imaging of positron emitting isotopes in coincidence mode in addition to single photon emitters in the single photon mode. In addition, this new PET/SPECT tomograph utilizes many hardware and software components from currently produced CTI PET Systems (CPS) PET scanners such as the ECAT EXACT and ECAT EXACT HR+. The E.CAM LSO 311 system optimizes the clinical usability of coincidence detection imaging, by enhancing the trues count rate and sensitivity performance of the camera, while still retaining optimum single photon capabilities.
Summaries of Studies
Initial investigation indicates that the CPS E.CAM LSO 311 PET/SPECT System will be capable of performing static, dynamic, whole body and gated planar single photon imaging procedures, as well as single photon emission computed Tomography (SPECT) procedures and positron emission tomography (PET) procedures utilizing a new combination LSO and NaI(TI) crystal detector system developed by CPS.
Conclusion
In the opinion of CTI PET Systems, the E.CAM LSO 311 System is substantially equivalent to the currently distributed Siemens IP500 Gamma Camera System and the associated E.CAM coincidence option. We believe the E.CAM LSO 311 is also substantially equivalent to the Siemens/CPS ECAT EXACT and EXACT HR+ PET systems. The E.CAM LSO 311 has the same intended use and has many of the same technological characteristics as those devices. We do not believe the E.CAM LSO 311 System design raises any new safety and effectiveness concerns.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 abstract symbol that resembles a human figure embracing or protecting another figure, possibly representing care and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 1998
William Skremsky Regulatory Affairs Specialist CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932
Re:
K981027 E.CAM LSO 311 PET/SPECT System Dated: March 16, 1998 Received: March 19, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Skremsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 proctice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Resister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 deving regulation (21 CFR Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmaldsmamain.html".
Sincerely yours,
Kiilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: E.CAM LSO 311 PET/SPECT System
Indications For Use:
The Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David le. Syson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological I : 10/k) Number