(52 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on the hardware and basic image acquisition capabilities.
No
The device is a gamma camera system intended for imaging the distribution of radionuclides in the human body for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is a gamma camera system intended for "imaging the distribution of radionuclides in the human body by means of photon detection" to produce images that "are intended to be interpreted by qualified personnel." This process of generating images for interpretation by qualified personnel to understand the distribution of radionuclides in the body is inherently a diagnostic function.
No
The device description explicitly states it is a "portable gamma camera system including a small gamma camera," "analysis and display equipment," a "cart and ergonomic arm," and "accessories," indicating it is a hardware system with software components, not a software-only device.
Based on the provided information, the Sentinella 102 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves blood, urine, tissue samples, etc., that are analyzed outside of the body.
- The Sentinella 102 is a gamma camera system used for in vivo imaging. It detects gamma rays emitted from radionuclides within the human body to create images. This is a form of medical imaging performed directly on the patient.
The description clearly states its purpose is "imaging the distribution of radionuclides in the human body by means of photon detection" and that it is used "intraoperatively," "at the patient's bedside," etc. These are all scenarios where the device is interacting directly with the patient, not analyzing a sample taken from the patient.
N/A
Intended Use / Indications for Use
Sentinella 102 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 may be used intraoperatively if a protective sheath is used.
Sentinella 102 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 portable gamma camera system including 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.
The Sentinella 102 is composed of the following parts:
- ergonomic cart on wheel base
- articulated arm with laser positioning system (λ: 635nm typ., 640nm max,Power: 4mW, Class IIIR according to IEC 60825)
- Handheld gamma camera included in a protective carrying case for transport.
- Collimators: 2 pinhole and one divergent
- 2 Screens 19", one of these with touch screen functions and PC.
- Mouse and keyboard
- Sentinella Software
- Quality control kit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photon detection
Anatomical Site
Any anatomical site
Indicated Patient Age Range
Any population group
Intended User / Care Setting
Qualified personnel.
May be used intraoperatively if a protective sheath is used.
May be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
Hospitals; Intraoperative and general ambulatory conditions.
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.)
Sensitivity: Green collimator (Ø 2.5 mm) ~300 @ 3cm, 110 @ 5cm, 38 @ 10cm; Blue Collimator (Ø 4 mm) ~z
§ 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/2 description: The image shows the logo for OncoVision GEM-Imaging SA. The logo consists of a stylized eye on the left and the company name on the right. The eye is black and white and has a circular shape. The company name is in a sans-serif font and is stacked vertically.
OCT - 2 2009
5/1
510(k) number:
Owner's name: General Equipment for Medical Imaging, S. A. Address: Colón 72-18, 46004-Valencia (Spain) Phone: + 34 96 3722472 Fax number: +34 96 3556532 Name of contact person: Séverine Moine Date: 20th of May 2009
Name of the device: Sentinella 102 System trade name: Sentinella Common name: Portable Gamma Camera Classification name: Scintillation Gamma Camera, Class I. 21 CFR § 892.1100 (1990)
PREDICATED DEVICES . BOOK . FIRST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product: LumaGEM™ Scintillation Camera Manufacturer: Gamma Medica Instruments 510(k) number: K993813 Substantial Equivalence Date: 18/01/2000
Product: Anzai eZ-Scope AN Portable Gamma Camera Manufacturer: Anzai Medical Company, Ltd. 510(k) number: K022342 Substantial Equivalence Date: 09/10/2002
DESCRIPTION OR NO FOR MANAGER OF SCIENCE AND AND AND AND AND
Sentinella 102 is a portable gamma camera system including 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,
INDICATIONS FOR USE IN SELL CONSTITUTION OF THE CONSTITUTION OF
Sentinella 102 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 may be used intraoperatively if a protective sheath is used.
Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
SUBSTANII/ACEQUIVALENCE (CAMM 20) Comment Comment of the Market of
1
Image /page/1/Picture/1 description: The image shows the logo for ONCO VISION GEM-IMAGING SA. The logo consists of a stylized eye on the left and the text "ONCO VISION" on the right. Below the text is the phrase "GEM-IMAGING SA" in a smaller font. The logo is black and white.
Sentinella 102 has the same intended use as the legally marketed predicated
devices LumaGEM™ Scintillation Camera (Gamma Medica Instruments), K993813, and Anzai eZ-Scope AN Portable Gamma Camera (Anzai Medical Company, Ltd.), K022342, and uses the same technology in position sensitive photomultiplier as the former. Instead of pixelated crystals as in all the previously mentioned devices, Sentinella employs continuous scintillation crystals, which give to Sentinella the possibility of mounting not only parallel-hole collimators but also diverging and pinhole.
Sentinella 102 is as safe and effective as the above-mentioned predicated devices. It meets safety requirements, EN 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety, UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety, EN 60601-1-2:2001 + A1:2006, Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: electromagnetic compatibility bears the CE mark in accordance with the Medical Device Directive 91/42/EEC and meets the requirements of the NEMA NJ 1: 2007: Performance Measurements of Gamma Cameras and for the laser mounted on the equipment it complies with the requirements of the IEC 60825-1: 2001: Safety of Laser Products - Part 1: Equipment classification, requirements and user's guide and the 21 CFR 1040: Performance Standards for light-emitting products.
| | Sentinella 102 | LumaGEM™
Scintillation
Camera | Anzai eZ-Scope
AN Portable
Gamma Camera | Justification of
Substantially
Equivalence in
case of
difference with
predicates |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Sentinella 102 | Image: LumaGEM | Image: Anzai eZ-Scope | |
| Indications for
Use | Sentinella 102 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 may be used
intraoperatively if a
protective sheath is used.
Sentinella 102 may be used
at the patient's bedside, or in
Emergency Room or
Intensive Care Unit. | The LumaGEM™
scintillation camera is a
camera system, which is
intended for measuring and
imaging the distribution of
radionuclides in the human
body by means of photon
detection. These images
are intended to be
interpreted by qualified
medical personnel. | The Anzai eZ-Scope AN
Portable Gamma Camera
is intended to produce
both planar and
tomographic images of a
radio-marked source.
It is indicated for use to
image the distribution of
radionuclides in the
human body using planar
imaging techniques.
The eZ-Scope may be
used intraoperatively or on
pathological
specimens if a protective
sheath is used. | |
| Target
population | Same as predicates | Any population group | Any population group | |
| | Sentinella 102 | LumaGEM™
Scintillation
Camera | Anzai eZ-Scope
AN Portable
Gamma Camera | Justification of
Substantially
Equivalence in
case of
difference with
predicates |
| Anatomical
sites | Same as predicates | Any anatomical site | Any anatomical site | |
| Where used | Same as predicates | Hospitals | Intraoperative and general
ambulatory conditions | |
| Personnel | Same as predicates | Physicians | Physicians | |
| Energy used
and/or
delivered | Same as predicates | 130
LEAP >250
LEHS >500 | | The sensitivity depends
on the distance of the
gamma camera to the
radioisotope detected
with pinhole and
divergent collimators.
The sensitivity of the
Sentinella 102
collimators are in the
same range of values
compared to the
predicates, so they
could be considered as
equivalent. |
| Flood field
Uniformity | 5 % |