(24 days)
Not Found
No
The summary describes a gamma camera system with an optical camera for coregistration, but there is no mention of AI or ML being used for image processing, analysis, or interpretation. The text explicitly states the gammagraphy is not reprocessed or modified.
No
The device is described as a mobile gamma camera system intended for imaging the distribution of radionuclides in the human body, which is for diagnostic purposes, not therapeutic.
Yes
The device is a gamma camera system intended for imaging the distribution of radionuclides in the human body, and these images are "intended to be interpreted by qualified personnel," which implies its use in diagnosing conditions based on the observed distribution.
No
The device description explicitly states it is a "mobile gamma camera system" and includes hardware components such as a gamma camera, analysis and display equipment, a cart, and an ergonomic arm.
Based on the provided information, the Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- 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 examination of specimens.
- Intended Use: The intended use clearly states it's for "imaging the distribution of radionuclides in the human body." This aligns with medical imaging, not laboratory testing of samples.
Therefore, the Sentinella 102 falls under the category of medical imaging devices, not In Vitro Diagnostics.
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 and Sentinella 102 Horus) may be used intraoperatively if a protective 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 (comma separated list FDA assigned to the subject device)
IYX
Device Description
Sentinella 102 is a currently marketed portable gamma camera system which includes a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays.
The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.
Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera, optical camera
Anatomical Site
human body, small organs and structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified personnel, intraoperatively, patient's bedside, Emergency Room, Intensive Care Unit.
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)
Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) has the same performance specifications than the previous models already certificated by the FDA (predicates). Because of this, no new NEMA performance tests were necessary for the present submission. The previous NEMA test report was carried out using the NEMA NU-1:2007.
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.
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
§ 892.1100 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
General Equipment for Medical Imaging (Oncovision-Gem Imaging S.A.) August 18, 2016 % Mr. Jose Montes Ouality and Regulatory Affairs Manager Eduardo Primo Yúfera, nº 3 Valencia, 46012 SPAIN
Re: K162052
Trade/Device Name: Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: June 27, 2016 Received: July 25, 2016
Dear Mr. Montes:
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)
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 and Sentinella 102 Horus) may be used intraoperatively if a protective 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Special 510 (K) GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. SENTINELLA 102 (MODELS SENTINELLA 102 AND SENTINELLA 102 HORUS) 510(k) Summarv
Image /page/3/Picture/1 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue and "VISION" in green on the right. The sphere has a white swirl design on it.
510(k) number:
Owner's name: General Equipment for Medical Imaging, S. A.(Oncovision Gem-Imaging S.A.) Address: Eduardo Primo Yúfera, 3, 46012, Valencia (Spain) Phone: + 34 96 372 24 72 Fax number: +34 96 355 65 32 Name of contact person: Jose Montes, Quality and Regulatory Affairs Manager Date: 06/27/2016
Name of the device: Sentinella 102 / Sentinella 102 Horus System trade name: Sentinella 102 Common name: Portable Gamma Camera Classification name: Scintillation Gamma Camera, Class I. 21 CFR § 892.1100 (1990) Requlatory Class: I Product Code: IYX
A. LEGALLY MARKETED PREDICATED DEVICES
Product: Sentinella 102 Manufacturer: General Equipment for Medical Imaging, S. A. (Oncovision-GEM Imaging S.A.) 510(k) number: K143156 Substantial Equivalence Date: 11/18/2014
B. DEVICE DESCRIPTION
Sentinella 102 is a currently marketed portable gamma camera system which includes a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays.
The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.
Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.
4
Special 510 (K) GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. SENTINELLA 102 (MODELS SENTINELLA 102 AND SENTINELLA 102 HORUS) 510(k) Summarv
Image /page/4/Picture/1 description: The image contains the logo for OncoVision. On the left side of the logo is a blue sphere with a gradient effect. To the right of the sphere is the word "ONCO" in blue, stacked on top of the word "VISION" in green. The logo is clean and modern, with a focus on the company name.
C. INDICATIONS FOR USE
Sentinella 102 (models Sentinella 102 and 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 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used.
Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
There are not new indications for use with respect to the previous model certified (K143156), so no new clinical testing has been carried out. The yellow collimator does not modify the indications for use of the equipment.
D. SUBSTANTIAL EQUIVALENCE CLAIM
The present Special 510(k) has been prepared to communicate the new model of collimator for both models of Sentinella 102 (Sentinella 102 and Sentinella 102 Horus).
The new model of collimator has been validated as it is shown in Annex of Section 11.1 Change description summary.
E. BIOCOMPATIBILITY
As a consequence of the new model of collimator for both models of Sentinella 102 (Sentinella 102 and Sentinella 102 Horus), the Biocompatibility Section has not been modified. It is exactly the same as presented in the K143156 Submission.
F. ELECTRICAL SAFETY TESTING
As a consequence of the new model of collimator for both models of Sentinella 102 (Sentinella 102 and Sentinella 102 Horus), Safety Electrical Test Report has not been modified. It is exactly the same as presented in the K143156 Submission.
G. ELECTROMAGNETIC COMPATIBILITY TESTING
As a consequence of the new model of collimator for both models of Sentinella 102 (Sentinella 102 and Sentinella 102 Horus), EMC Test Report has not been modified. It is exactly the same as presented in the K143156 Submission.
5
Special 510 (K) GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. SENTINELLA 102 (MODELS SENTINELLA 102 AND SENTINELLA 102 HORUS) 510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue and "VISION" in green on the right. The sphere has a gradient of blue colors, with the darkest blue on the left and the lightest blue on the right.
H. PERFORMANCE TESTING
Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) has the same performance specifications than the previous models already certificated by the FDA (predicates). Because of this, no new NEMA performance tests were necessary for the present submission. The previous NEMA test report was carried out using the NEMA NU-1:2007.
SOFTWARE TESTING l.
As a consequence of the new model of collimator for both models of Sentinella 102 (Sentinella 102 and Sentinella 102 Horus), the Software has not been modified. It is exactly the same as presented in the K143156 Submission.
J. CONCLUSION
Based upon a comparison of devices and performance testing results, Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) is substantially equivalent to the predicate device.
INNOVATIVE MEDICAL IMAGING