(197 days)
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No
The document does not mention AI, ML, or any related concepts, and the device description is very basic.
No
The device is used for detection and imaging of radionuclides, which is a diagnostic function, not a therapeutic one.
Yes
The device's intended use is to "detect or image the distribution of radionuclides in the body or organ," which falls under the definition of a diagnostic device as it gathers information about a patient's health condition.
No
The summary describes a "Coincidence Mode Option" for a Siemens E.CAM, which is a hardware device (likely a gamma camera or PET scanner). The description focuses on the imaging technique and intended use related to radionuclide detection, not on software functionality as a standalone device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect or image the distribution of radionuclides in the body or organ." This describes an in vivo imaging procedure, where the device interacts with the patient's body directly to acquire images.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living body.
- Device Description: The description mentions "Positron imaging by coincidence" and "Positron Whole Body Imaging by coincidence," which are techniques used in nuclear medicine imaging, an in vivo modality.
- Input Imaging Modality: "Computed Emission Tomography" is also an in vivo imaging modality.
Therefore, the function and application of this device clearly fall under the category of medical imaging equipment used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuctides in the body or argan, using the following technique(s).
D. Positron imaging by coincidence
F. Positron Whole Body Imaging by coincidence.
Product codes
90KPS
Device Description
The Siemens E.CAM Coincidence Mode Option is a product which is substantially couvalent to legally marketed devices.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
All
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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)
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§ 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
K970627 SUMMARY OF SAFETY AND EFFECTIVENESS
SEP - 4 1997
Teneral Information
| Classification Name: | System, Tomography, Computed Emission | ||
|---|---|---|---|
| Product Code: | 90KPS | ||
| Device Trade Name: | E.CAM Coincidence Mode Option | ||
| Classification: | Class II Medical Device | ||
| Intended Uses: | Anatomical Region: | ||
| Diagnostic Uses: | All | ||
| Imaging | |||
| Establishment Name and Address: | Siemens Medical Systems, Inc. | ||
| Nuclear Medicine Group | |||
| 2501 N. Barrington Road | |||
| Hoffman Estates, Illinois 60195-7372 | |||
| Establishment Registration Number: | Owner/Operator No. 9010023 | ||
| Performance Standard: | None established under Section 514 of the | ||
| Food, Drug and Cosmetic Act |
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence
The Siemens E.CAM Coincidence Mode Option is a product which is substantially couvalent to legally marketed devices.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the symbol. The symbol is composed of three curved lines that form the shape of a person with arms reaching upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paul G. Oris Manager, Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203
Re:
SFP - 4
K970627 E.CAM™ Coincidence Mode Option (CM) Dated: June 5, 1997 Received: June 6, 1997 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Oris:
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 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 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 requirement, 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing 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 device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 mimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
h.J.Liau Yi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
.510(k) Number (If Known):
510(k) Number (If Known): __ K990627
Siemens E.CAM Coincidence Mode Option Device Name _
Nuclear Medicine Device
Indications For Use: To detect or image the distribution of radionuctides in the body or argan, using the -----following technique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar Imaging | X | ||
| B. | Whole Body Imaging | X | ||
| C. | Tomographic Imaging (SPECT) for non | |||
| Positron emitter | X | |||
| D. | Positron imaging by coincidence | X | Camera range | |
| increases to 560 keV | ||||
| E. | Positron imaging without coincidence | X | ||
| F. | Positron Whole Body Imaging by | |||
| coincidence. | X | Camera range | ||
| increases to 560 keV |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH. Office of Device Evaluation (ODI)
Porscription Use 1, (Per 21 (FR 801 109)
( )[ર
Over-the Counter Use_
Olin A. Regner
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
r Optional Formal 1-2-96)