(48 days)
No
The summary describes a standard gamma camera system with software updates focused on obsolescence and cost reduction, and explicitly states no mention of AI, DNN, or ML.
No
This device is an imaging device used for diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states the device is used "To detect or image the distribution of radionuclides in the body or organ," and the "Device Description" states it is "designed for whole-body oncology, neurology, cardiology and general diagnostic examinations." These phrases confirm its purpose is to aid in diagnosis.
No
The device description explicitly states it is a "gamma camera system" and mentions modifications to address obsolescence, cost reduction, and industrial design, indicating it is a hardware device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Symbia-E is a gamma camera used to image the distribution of radionuclides within the human body. It is an in vivo imaging device, meaning it operates inside the living organism.
- Intended Use: The intended use clearly states it's for detecting or imaging radionuclides in the body or organ.
Therefore, the Symbia-E falls under the category of medical imaging devices used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The Symbia-E is a gamma camera used to view and analyze images of the human body and the distribution of administered radionuclides. This system is designed for whole-body oncology, neurology, cardiology and general diagnostic examinations. The Symbia-E is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body.
The Symbia-E system which is the subject of this application is substantially equivalent to the commercially available e.cam gamma camera (K963983) and the commercially available Siemens Enhanced Imaging System (K041166).
The changes incorporated into Symbia E include modifications made to address obsolescence issues, cost reduction efforts and to change the industrial design of the system. Additionally, the system software has been updated (Syngo MI Applications 2007B).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera, planar imaging, whole body imaging, tomographic imaging
Anatomical Site
Body or organ
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)
Not Found
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.
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
Strictly Confidential
510(k) Summary
as required by 21 CFR Part 807.87(h)
007 3 0 2007
Identification of the Submitter
| Submitter: | M. Alaine Medio, RAC |
|---|---|
| Telephone Number: | (865)218-2703 |
| Fax Number: | (865)218-3019 |
| Date of Submission: | September 11, 2007 |
ldentification of the product
| Device Proprietary Name: | Symbia-E |
|---|---|
| Common Name: | Gamma camera |
| Classification Name: | Emission Computed Tomography System per 21 |
| CFR 892.1200 |
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| e.cam | Siemens Medical | |
| Solutions USA, Inc | K963983 | |
| Siemens Enhanced | ||
| Imaging System | Siemens Medical | |
| Solutions USA, Inc | K041166 | |
| Syngo MI Applications | ||
| 2007A | Siemens Medical | |
| Solutions USA, Inc | K063826 | |
| c.cam | Danish Diagnostic | |
| Development | K031825 | |
| c.cam-AC | Danish Diagnostic | |
| Development | K051460 |
1
Device Description:
The Symbia-E is a gamma camera used to view and analyze images of the human body and the distribution of administered radionuclides. This system is designed for whole-body oncology, neurology, cardiology and general diagnostic examinations. The Symbia-E is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body.
The Symbia-E system which is the subject of this application is substantially equivalent to the commercially available e.cam gamma camera (K963983) and the commercially available Siemens Enhanced Imaging System (K041166).
The changes incorporated into Symbia E include modifications made to address obsolescence issues, cost reduction efforts and to change the industrial design of the system. Additionally, the system software has been updated (Syngo MI Applications 2007B).
Indications for Use:
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2007
Ms. M. Alaine Medio, RAC Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60195-5203
Re: K072567
Trade/Device Name: Symbia-E Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography system Regulatory Class: II Product Code: KPS Dated: October 9, 2007 Received: October 10, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Symbia-E
Indications for Use:
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Beproductive Abdominal and
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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