(15 days)
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Not Found
No
The summary describes a standard gamma camera system for imaging radionuclide distribution and does not mention any AI/ML capabilities, image processing beyond basic photon detection, or performance studies related to algorithmic analysis.
No
The device is described as an "imaging" system for "photon detection" to show the "distribution of radionuclides in the human body." It is for diagnostic purposes, not therapeutic.
Yes
The device is a mobile gamma camera system intended for imaging the distribution of radionuclides in the human body, with the images to be interpreted by qualified personnel. This process of using imaging to assess a patient's condition for diagnosis or treatment planning classifies it as a diagnostic device.
No
The device description explicitly states it is a "mobile gamma camera system," which is a hardware device used for photon detection and imaging. It is not solely software.
Based on the provided information, the Sentinella 102 (Models Sentinella 102 Horus) 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 to examine these samples outside of the body.
- Sentinella 102 function: The Sentinella 102 is a gamma camera system that images the distribution of radionuclides within the human body. It detects photons emitted from radionuclides that have been administered to the patient. This is an in vivo imaging technique, not an in vitro test.
The device's intended use and description clearly indicate it's used for imaging the patient directly, not for analyzing samples taken from the patient.
N/A
Intended Use / Indications for Use
Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.
Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used.
Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
Product codes
IYX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
gamma camera
Anatomical Site
human body
Indicated Patient Age Range
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Intended User / Care Setting
qualified personnel/intraoperatively, patient's bedside, Emergency Room or Intensive Care Unit.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
General Equipment for Medical Imaging S.A. (Oncovision-Gem Imaging S.A.) November 18, 2014 % Mr. Harry van Vugt DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O.Box. 5185, 6802 ED Arnhem THE NETHERLANDS
Re: K143156
Trade/Device Name: Sentinella 102 and 102 Horus (Models: FP-0040 and FP-0055) Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: October 29, 2014 Received: November 3, 2014
Dear Mr. van Vugt:
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. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143156
Device Name
Sentinella 102 (Models Sentinella 102 and Sentinella 102 Horus)
Indications for Use (Describe)
Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.
Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used.
Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
| 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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