MODEL SENTINELLA 102

K092471 · General Equipment For Medical Imaging, S.A. · IYX · Oct 2, 2009 · Radiology

Device Facts

• Record ID: K092471
• Device Name: MODEL SENTINELLA 102
• Applicant: General Equipment For Medical Imaging, S.A.
• Product Code: IYX · Radiology
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Sentinella 102 is a mobile gamma camera system for imaging small organs and structures labeled with gamma-emitting radionuclides. Input consists of gamma-ray photons detected by a continuous scintillation crystal (CsI(Na)) coupled to position-sensitive photomultipliers. The system transforms these inputs into planar images displayed on a 19-inch monitor. The device includes a cart, ergonomic arm, and laser positioning system (635nm, 4mW) to assist in aligning the camera with the area of interest. Operated by physicians in clinical settings (OR, bedside, ER, ICU). The system includes a radioactive pointer (Gd-153) for relative positioning. Output is visualized by surgeons and physicians to guide clinical decision-making during procedures. Benefits include portability and high-resolution imaging of small structures intraoperatively or at the point of care.

Clinical Evidence

Bench testing only. Performance evaluated against NEMA NJ 1:2007 standards. Metrics reported include intrinsic spatial resolution (1.8 mm), energy resolution (15.9%), flood field uniformity (5%), and sensitivity for various collimators. No clinical data presented.

Technological Characteristics

Mobile gamma camera with continuous CsI(Na) scintillation crystal. Includes articulated arm, laser positioning system (Class IIIR, 635nm, 4mW), and 19-inch touch-screen display. Connectivity via DICOM. Electrical safety per EN/UL 60601-1; EMC per EN 60601-1-2. Software-based image processing and database management (PostgreSQL/ADO.net).

Indications for Use

Indicated for imaging radionuclide distribution in the human body via photon detection. Suitable for use in patients of any age/gender requiring gamma imaging. May be used intraoperatively (with protective sheath), at bedside, in Emergency Rooms, or Intensive Care Units. Images must be interpreted by qualified personnel.

Regulatory Classification

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.

Predicate Devices

• LumaGEM™ Scintillation Camera (K993813)
• Anzai eZ-Scope AN Portable Gamma Camera (K022342)

Submission Summary (Full Text)

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K092471

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: [phone] 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

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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™<br>Scintillation<br>Camera | Anzai eZ-Scope<br>AN Portable<br>Gamma Camera | Justification of<br>Substantially<br>Equivalence in<br>case of<br>difference with<br>predicates |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Sentinella 102 | Image: LumaGEM | Image: Anzai eZ-Scope | |
| Indications for<br>Use | Sentinella 102 is a mobile<br>gamma camera system<br>which is intended for<br>imaging the distribution of<br>radionuclides in the human<br>body by means of photon<br>detection. The images are<br>intended to be interpreted by<br>qualified personnel.<br>Sentinella 102 may be used<br>intraoperatively if a<br>protective sheath is used.<br>Sentinella 102 may be used<br>at the patient's bedside, or in<br>Emergency Room or<br>Intensive Care Unit. | The LumaGEM™<br>scintillation camera is a<br>camera system, which is<br>intended for measuring and<br>imaging the distribution of<br>radionuclides in the human<br>body by means of photon<br>detection. These images<br>are intended to be<br>interpreted by qualified<br>medical personnel. | The Anzai eZ-Scope AN<br>Portable Gamma Camera<br>is intended to produce<br>both planar and<br>tomographic images of a<br>radio-marked source.<br>It is indicated for use to<br>image the distribution of<br>radionuclides in the<br>human body using planar<br>imaging techniques.<br>The eZ-Scope may be<br>used intraoperatively or on<br>pathological<br>specimens if a protective<br>sheath is used. | |
| Target<br>population | Same as predicates | Any population group | Any population group | |
| | Sentinella 102 | LumaGEM™<br>Scintillation<br>Camera | Anzai eZ-Scope<br>AN Portable<br>Gamma Camera | Justification of<br>Substantially<br>Equivalence in<br>case of<br>difference with<br>predicates |
| Anatomical<br>sites | Same as predicates | Any anatomical site | Any anatomical site | |
| Where used | Same as predicates | Hospitals | Intraoperative and general<br>ambulatory conditions | |
| Personnel | Same as predicates | Physicians | Physicians | |
| Energy used<br>and/or<br>delivered | Same as predicates | <20W | <20W | |
| Human factors | Mobile ergonomic arm and<br>cart, highly adaptable for<br>manipulation close to the<br>interest area.<br>User autonomous screens<br>with touch-screen options.<br>Plug and play installation. | Mobile ergonomic<br>workstand easily adjusts<br>for standing or sitting<br>operator.<br>The imaging head is<br>located on the arm that<br>allows its positioning on the<br>interest area.<br>Monitor for imaging of the<br>interest area. | Light, handheld and ideal<br>for manipulation in close<br>proximity to the body.<br>Operation is<br>straightforward and<br>intuitive.<br>Connected to a PC to<br>imaging the interest area. | The Sentinella 102 is<br>substantially equivalent<br>with the predicates as it<br>allows the positioning<br>on the interest area.<br>The presence of the<br>two screens allows to<br>the surgeon and the<br>physician to see the<br>same image<br>simultaneously, one<br>improvement refers to<br>the predicates. |
| Design | The Sentinella 102 is<br>composed of the following<br>parts:<br>- ergonomic cart on wheel<br>base<br>- articulated arm with laser<br>positioning system (λ:<br>635nm typ., 640nm<br>max,Power: 4mW,<br>Class IIIR according to IEC<br>60825)<br>- Handheld gamma camera<br>included in a protective<br>carrying case for transport.<br>- Collimators: 2 pinhole and<br>one divergent<br>- 2 Screens 19", one of<br>these with touch screen<br>functions and PC.<br>- Mouse and keyboard<br>- Sentinella Software<br>- Quality control kit | The LumaGEM is<br>composed of the following<br>parts:<br>- cart on wheel base<br>- articulated arm<br>- detector head<br>- Collimators: parallel<br>- 1 PC with screen of 19"<br>- Mouse and keyboard<br>- LumaGEM Software | The Anzai eZ-scope is<br>composed of the<br>following parts:<br>- Handheld gamma<br>camera<br>- Parallel collimators<br>- Connected to a<br>portable computer<br>- eZ-SCOPE AN<br>software<br>- protective carrying<br>case for transport | The Sentinella 102<br>includes a laser<br>positioning system<br>that helps the user to<br>locate on the patient<br>a determined point of<br>the picture obtained<br>in the interface, it is<br>an improvement<br>compared to the<br>predicates.<br>The laser<br>incorporated in the<br>Sentinella 102 has a<br>wavelength of 635nm<br>and an output power<br>of 4mW, as a<br>consequence it is<br>classified as Illa<br>according to the 21<br>CFR 1041.<br>The only potential risk<br>of such laser is when<br>it is exposed directly<br>on the eye, but during<br>its use, such laser<br>has not to focus the<br>eyes of the patient or<br>the user, for another<br>part the Sentinella<br>102 laser pointer<br>system is labeled with<br>the indication<br>"DANGER - LASER<br>RADIATION -AVOID<br>DIRECT EYE<br>EXPOSURE". It is<br>only used for relative<br>positioning on the<br>body and works only<br>when the user<br>activates it. So it does<br>not add any<br>appreciable safety<br>concerns compared<br>to the predicates |
| | Sentinella 102 | LumaGEM™ Scintillation Camera | Anzai eZ-Scope AN Portable Gamma Camera | Justification of Substantially Equivalence in case of difference with predicates |
| Materials | Same as predicates | Standard Electronic and Medical grade materials | Standard Electronic and Medical grade materials | |
| Computer specifications | - PC with Intel Core Duo microprocessor<br>1024 MBytes RAM.<br>80 Gbytes of Hard Disk available.<br>Windows XP Operating System. | - PC with an Intel (Pentium II or higher) microprocessor.<br>It includes a minimum of 32 MB of RAM<br>- a minimum of 4GB local disk space and recording CD-ROM as a secondary mass storage.<br>Windows NT operating system. | Laptop standard PC | - |
| Display LCD specification | Screen size: 19"<br>Resolution: 1280 x 1024 | Screen size: 15 inches or greater<br>Resolution: 800 x 600 | | |
| Patient database management | Sentinella patient database stores patient information (name, sex, age, address, phone, ID,) and intervention information (date, protocol, comments, acquired images). Each patient can have several interventions. The database relies on standard SQL technology, currently based on well known, reliable and widely used PostgreSQL relational database. The database resides in local hard disk and periodic automatic backups are performed. Database could be located in a server and accessed though LAN, but Sentinella equipments are not delivered configured for LAN usage. The patient database is based on the Microsoft ADO.net engine. Database is managed from Sentinella Suite interface through the different | The patient database management involves both intermediate and historical archiving. The immediate archive database resides on a local or LAN based disk drive and the historical archive resides an a secondary mass storage device. The patient visit entry (patient name, ID, visit date) and each of the data set entries (dataset name, ID and creation date) are avallable from the main database interface. The patient database is based on the Microsoft DAO jet engine. It is a relational database organized in 4 levels: -Patient level: patient name and ID. -Visit level: for each patient, date of the visit, information about the visil -Study level: allows acquisition of protocol data grouping. | | Although the structure of the database of the Sentinella equipment is different, the principle of functioning is similar: - As LumaGEM database, Sentinella database allows to register patients, visits (in this case interventions) and show images obtained at different time. It could be accessed on local or LAN. It is based on Microsoft ADO.net, database communication procedure equivalent to Microsoft DAO. |
| | | | | The pinhole and the divergent collimators have equivalent characteristics and functionality, as detailed along this table. compared to the predicates.<br>The quality control kit is an optional tool included in the equipment to check the calibration of the equipment. It is an improvement in reference to the predicates. |
| | Sentinella 102 | LumaGEM™<br>Scintillation<br>Camera | Anzai eZ-Scope<br>AN Portable<br>Gamma Camera | Justification of<br>Substantially<br>Equivalence in<br>case of<br>difference with<br>predicates |
| | patients and interventions,<br>Sentinella OR does new<br>interventions and acquires<br>images, Sentinella Viewer<br>allows to visualize the<br>images for the different<br>patients and interventions. | (list mode, result of screen)<br>The operations performed<br>on the database are record<br>operations: visit record,<br>study record, visit record,<br>dataset record.<br>The interface is user<br>friendly: for the operator,<br>patient and visit levels are<br>merged in one single level.<br>The operator manipulates<br>patient-visit entities. The<br>operator does not have to<br>know about the dataset<br>level. His interaction stops<br>at the study level. | | |
| Arm vertical<br>movement | 65 cm | 50.8 cm | | The major range of the<br>arm movement of the<br>Sentinella 102 allow the<br>precise location of the<br>gamma camera on the<br>Interest area. |
| Electrical<br>safety and EMC | Electrical safety standard<br>compliance (EN 60601-1, UL<br>60601-1)<br>EMC compliance (EN<br>60601-1-2) | EM emission of the<br>Uninterruptible Power<br>Supply (UPS) complies<br>with 47 CFR Part 15<br>Subpart B: 1999.<br><br>EM emission of the<br>ViewSonic monitor satisfies<br>the standard EEC directive<br>89/336/EEC, 92/31/EEC,<br>93/68/EEC | Meets electrical,<br>electromagnetic<br>interference and safety<br>international standards.<br>Fully compatible with<br>other electronic devices<br>for electrical and<br>electromagnetic<br>standards. | The gamma camera<br>complies with the<br>standard recognised by<br>the FDA. |
| Compatibility<br>with the<br>environment | Same as predicates:<br>Compliance of DIRECTIVE<br>2002/96/EC of 27 January<br>2003 on waste<br>electrical and electronic<br>equipment | | Enviroment-friendly<br>during regular use and<br>storage. To be disposed<br>of properly. | |
| Sterility | The product is not sterile<br>and has not to be sterilized<br>by the user.<br>Cleaning standard<br>procedure of medical<br>devices.<br>Can be used under sterile-<br>intraoperative conditions if<br>device is covered with a<br>sterile cover as shown in<br>user manual | The product is not sterile<br>and has not to be sterilized<br>by the user.<br>Cleaning standard<br>procedure of medical<br>devices. | The product is not sterile<br>and has not to be<br>sterilized by the user.<br>Can be used under<br>sterile-intraoperative<br>conditions if probe head<br>Is covered with a sterile<br>protective sheath. | |
| Planar imaging<br>Tomography | Yes<br>No | Yes<br>No | Yes<br>Yes | |
| Energy range | 50-200 keVs…