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 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.

AI/ML Overview

This is a submission for a 510(k) premarket notification for a medical device called Sentinella 102, a portable gamma camera system. The submission aims to demonstrate substantial equivalence to predicate devices, namely the LumaGEM™ Scintillation Camera (K993813) and Anzai eZ-Scope AN Portable Gamma Camera (K022342).

The core of the submission relies on comparing technical specifications and performance characteristics of the Sentinella 102 with the predicate devices. The document tables these comparisons, highlighting similarities and providing justifications for any differences.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a typical quantitative pass/fail format for a clinical study with a specified statistical power. Instead, the "acceptance criteria" in this context are demonstrating substantial equivalence to the predicate devices across various technical specifications and functional aspects. The performance of Sentinella 102 is reported as part of a comparative table against two predicate devices.

The table below summarizes the reported performance of the Sentinella 102 and implicitly its "acceptance criteria" through comparison with predicate devices. The "Justification of Substantially Equivalence" column serves as the explanation for how Sentinella 102 meets the implicit acceptance criteria by being equivalent or improved without compromising safety and effectiveness.

Feature	Sentinella 102 Performance	Justification of Substantially Equivalence (Acceptance Criteria Met)
Indications for Use	Mobile gamma camera system for imaging radionuclide distribution in the human body by photon detection, interpreted by qualified personnel. May be used intraoperatively (with sheath) or at patient's bedside/ER/ICU.	Same as predicates. implicitly accepted by matching predicate's indications.
Target Population	Same as predicates	Same as predicates. implicitly accepted.
Anatomical Sites	Same as predicates	Same as predicates. implicitly accepted.
Where Used	Same as predicates	Same as predicates. implicitly accepted.
Personnel	Same as predicates	Same as predicates. implicitly accepted.
Energy Used/Delivered	Same as predicates	Same as predicates. implicitly accepted.
Human Factors	Mobile ergonomic arm and cart, highly adaptable. User autonomous screens with touch-screen. Plug and play. Two screens for simultaneous viewing by surgeon and physician.	Substantially equivalent, allows positioning on interest area. Simultaneous display is an improvement without compromising equivalence.
Design	Ergonomic cart, articulated arm with laser positioning (635nm, 4mW, Class IIIR), handheld gamma camera, 2 pinhole and 1 divergent collimator, 2x 19" screens (one touch), PC, mouse, keyboard, software, QC kit.	Laser positioning system helps locate points more precisely (improvement). Laser risk mitigated by low power, labeled warning, and activation only by user, thus not adding appreciable safety concerns. Quality control kit is an improvement.
Computer Specifications	PC with Intel Core Duo, 1024 MB RAM, 80 GB HDD, Windows XP.	No substantial difference noted; assumed equivalent in function.
Display LCD Specification	Screen size: 19", Resolution: 1280 x 1024.	Equivalent to or better than predicate (LumaGEM 15" screen, 800x600 resolution).
Patient Database Management	Stores patient and intervention info, uses standard SQL (PostgreSQL), local HDD with automatic backups, can be LAN-accessed (not configured by default). Based on Microsoft ADO.net.	Structure different but functioning similar to LumaGEM. Allows patient/visit registration and image display. Accessible locally or via LAN. Based on Microsoft ADO.net, equivalent to DAO. Considered equivalent.
Arm Vertical Movement	65 cm	Range greater than LumaGEM (50.8 cm), allowing precise location. Considered an improvement/equivalent.
Electrical Safety and EMC	Compliance with EN 60601-1, UL 60601-1, EN 60601-1-2.	Complies with FDA-recognized standards. Considered equivalent regarding safety.
Compatibility with Environment	Compliance with DIRECTIVE 2002/96/EC (WEEE).	Same as predicates or environmentally conscious; considered equivalent.
Sterility	Not sterile, not to be sterilized by user. Cleaning standard procedure. Can be used intraoperatively with sterile cover.	Same as predicates. implicitly accepted.
Planar Imaging / Tomography	Planar: Yes, Tomography: No	Planar imaging capability matches LumaGEM. Anzai offers tomography, but Sentinella 102 still offers planar imaging like LumaGEM, thus equivalence is claimed based on LumaGEM's capabilities.
Energy Range	50-200 keVs	Covers major radionuclides (Tc, Co, Ba, Am, Gd) commonly used in surgery. Deemed equivalent despite numerical differences from predicates (LumaGEM: 30-300 keVs, Anzai: 71-364 keVs).
Energy Resolution	15.9 %	Although numerically larger than predicates (LumaGEM: 5%, Anzai: 7%), the energy window is about 10% per NEMA, resulting in detection of same events as predicates. Considered functionally equivalent.
Crystal Technology	Continuous CsI (Na)	Has less electronic noise, better performance in spatial resolution and sensitivity compared to pixelized CZT of predicates. Considered an improvement without compromising equivalence.
Intrinsic Spatial Resolution	1.8 mm	Difference from predicates (2 mm) is not appreciable. Considered equivalent.
Spatial Resolution	Green collimator: 5.4mm @ 3cm, 7.3mm @ 5cm; Blue collimator: 8.2mm @ 3cm, 11.1mm @ 5cm; Grey divergent collimator: 6.3mm@ 3cm, 8.2mm @ 5cm.	Values are within the same range as predicates, although dependent on collimator type. Considered equivalent.
Sensitivity (cpm/uCi)	Green collimator: ~300 @ 3cm, 110 @ 5cm, 38 @ 10cm; Blue collimator: ~600 @ 3cm, 233 @ 5cm, 87 @ 10cm; Grey divergent collimator: 104 @ 5cm, 72 @ 10cm.	Values are within the same range as predicates, although dependent on collimator type and distance. Considered equivalent.
Flood Field Uniformity	5 %	Equivalent with predicates (LumaGEM: < 4%). The difference is acceptable for equivalence.
Field Of View	15 x 15 cm at 20 cm from collimator.	Equivalent with predicates (LumaGEM: 13x13 cm, Anzai: 3.2x3.2 cm). While numerically larger than Anzai, it is equivalent to LumaGEM and therefore considered substantially equivalent.
Height	160 - 215 cm	Taller than LumaGEM (139.7 cm), but allows transport in any medical center. Considered acceptable and not compromising equivalence.
Communication / Power	DICOM / AC100-240V, 50/60 Hz	Equivalent to LumaGEM (DICOM, Interfile). Acceptable.
Compatible Accessories	Gamma Probe S-Probe, Sterile covers, Radioactive Pointer (153Gd, 60 µCi).	Gamma Probe S-Probe and radioactive pointer are improvements not found in predicates. Radioactive pointer deemed safe (exempted activity, negligible patient dose, no safety concerns relative to predicates).

Study Information to Prove Acceptance Criteria:

The provided document describes a technical comparison and performance verification study, rather than a clinical trial with patient outcomes. The study aims to demonstrate that the Sentinella 102 system performs comparably to the predicate devices and adheres to relevant safety and performance standards.

Sample Size used for the test set and the data provenance:
- Test Set: The document does not specify a "test set" in terms of patient samples or images for a diagnostic study. Instead, the "test set" implicitly refers to the technical performance metrics measured on the Sentinella 102 device itself (e.g., energy resolution, spatial resolution, sensitivity). These measurements are typically performed by engineers or physicists under controlled laboratory conditions using phantoms or calibrated radioactive sources.
- Data Provenance: The data appears to be prospective technical performance measurements conducted by the manufacturer, OncoVision GEM-Imaging SA, to characterize their device. There is no information regarding country of origin of patient data or retrospective analysis, as the submission does not detail a clinical study with patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for technical performance metrics (like spatial resolution or energy range) is established by physical laws and established measurement standards (e.g., NEMA), not by expert interpretation of clinical data. For instance, the "true" spatial resolution of a gamma camera is measured using a phantom with known features, not by consensus of radiologists on patient images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. As this is a technical performance assessment, such adjudication is not performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission is for a gamma camera, not an AI-powered diagnostic algorithm. The device's images are "intended to be interpreted by qualified personnel," implying human interpretation, but no study on human reader performance with or without AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. The Sentinella 102 is a hardware device (gamma camera) that produces images for human interpretation. It is not an algorithm designed for standalone diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance metrics reported (e.g., spatial resolution, energy resolution, sensitivity, flood field uniformity, field of view) is based on physical phantom measurements and engineering standards (e.g., NEMA NJ 1: 2007). These are objective, quantifiable measurements of the device's technical capabilities, not clinical ground truth derived from patient diagnostics.
The sample size for the training set:
- This is not applicable. The Sentinella 102 is a gamma camera hardware system, not a machine learning or AI algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above. There is no training set for this device.

Summary

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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: +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 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™ScintillationCamera	Anzai eZ-ScopeAN PortableGamma Camera	Justification ofSubstantiallyEquivalence incase ofdifference withpredicates
	Image: Sentinella 102	Image: LumaGEM	Image: Anzai eZ-Scope
Indications forUse	Sentinella 102 is a mobilegamma camera systemwhich is intended forimaging the distribution ofradionuclides in the humanbody by means of photondetection. The images areintended to be interpreted byqualified personnel.Sentinella 102 may be usedintraoperatively if aprotective sheath is used.Sentinella 102 may be usedat the patient's bedside, or inEmergency Room orIntensive Care Unit.	The LumaGEM™scintillation camera is acamera system, which isintended for measuring andimaging the distribution ofradionuclides in the humanbody by means of photondetection. These imagesare intended to beinterpreted by qualifiedmedical personnel.	The Anzai eZ-Scope ANPortable Gamma Camerais intended to produceboth planar andtomographic images of aradio-marked source.It is indicated for use toimage the distribution ofradionuclides in thehuman body using planarimaging techniques.The eZ-Scope may beused intraoperatively or onpathologicalspecimens if a protectivesheath is used.
Targetpopulation	Same as predicates	Any population group	Any population group
	Sentinella 102	LumaGEM™ScintillationCamera	Anzai eZ-ScopeAN PortableGamma Camera	Justification ofSubstantiallyEquivalence incase ofdifference withpredicates
Anatomicalsites	Same as predicates	Any anatomical site	Any anatomical site
Where used	Same as predicates	Hospitals	Intraoperative and generalambulatory conditions
Personnel	Same as predicates	Physicians	Physicians
Energy usedand/ordelivered	Same as predicates	<20W	<20W
Human factors	Mobile ergonomic arm andcart, highly adaptable formanipulation close to theinterest area.User autonomous screenswith touch-screen options.Plug and play installation.	Mobile ergonomicworkstand easily adjustsfor standing or sittingoperator.The imaging head islocated on the arm thatallows its positioning on theinterest area.Monitor for imaging of theinterest area.	Light, handheld and idealfor manipulation in closeproximity to the body.Operation isstraightforward andintuitive.Connected to a PC toimaging the interest area.	The Sentinella 102 issubstantially equivalentwith the predicates as itallows the positioningon the interest area.The presence of thetwo screens allows tothe surgeon and thephysician to see thesame imagesimultaneously, oneimprovement refers tothe predicates.
Design	The Sentinella 102 iscomposed of the followingparts:- ergonomic cart on wheelbase- articulated arm with laserpositioning system (λ:635nm typ., 640nmmax,Power: 4mW,Class IIIR according to IEC60825)- Handheld gamma cameraincluded in a protectivecarrying case for transport.- Collimators: 2 pinhole andone divergent- 2 Screens 19", one ofthese with touch screenfunctions and PC.- Mouse and keyboard- Sentinella Software- Quality control kit	The LumaGEM iscomposed of the followingparts:- cart on wheel base- articulated arm- detector head- Collimators: parallel- 1 PC with screen of 19"- Mouse and keyboard- LumaGEM Software	The Anzai eZ-scope iscomposed of thefollowing parts:- Handheld gammacamera- Parallel collimators- Connected to aportable computer- eZ-SCOPE ANsoftware- protective carryingcase for transport	The Sentinella 102includes a laserpositioning systemthat helps the user tolocate on the patienta determined point ofthe picture obtainedin the interface, it isan improvementcompared to thepredicates.The laserincorporated in theSentinella 102 has awavelength of 635nmand an output powerof 4mW, as aconsequence it isclassified as Illaaccording to the 21CFR 1041.The only potential riskof such laser is whenit is exposed directlyon the eye, but duringits use, such laserhas not to focus theeyes of the patient orthe user, for anotherpart the Sentinella102 laser pointersystem is labeled withthe indication"DANGER - LASERRADIATION -AVOIDDIRECT EYEEXPOSURE". It isonly used for relativepositioning on thebody and works onlywhen the useractivates it. So it doesnot add anyappreciable safetyconcerns comparedto 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 microprocessor1024 MBytes RAM.80 Gbytes of Hard Disk available.Windows XP Operating System.	- PC with an Intel (Pentium II or higher) microprocessor.It includes a minimum of 32 MB of RAM- a minimum of 4GB local disk space and recording CD-ROM as a secondary mass storage.Windows NT operating system.	Laptop standard PC	-
Display LCD specification	Screen size: 19"Resolution: 1280 x 1024	Screen size: 15 inches or greaterResolution: 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.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™ScintillationCamera	Anzai eZ-ScopeAN PortableGamma Camera	Justification ofSubstantiallyEquivalence incase ofdifference withpredicates
	patients and interventions,Sentinella OR does newinterventions and acquiresimages, Sentinella Viewerallows to visualize theimages for the differentpatients and interventions.	(list mode, result of screen)The operations performedon the database are recordoperations: visit record,study record, visit record,dataset record.The interface is userfriendly: for the operator,patient and visit levels aremerged in one single level.The operator manipulatespatient-visit entities. Theoperator does not have toknow about the datasetlevel. His interaction stopsat the study level.
Arm verticalmovement	65 cm	50.8 cm		The major range of thearm movement of theSentinella 102 allow theprecise location of thegamma camera on theInterest area.
Electricalsafety and EMC	Electrical safety standardcompliance (EN 60601-1, UL60601-1)EMC compliance (EN60601-1-2)	EM emission of theUninterruptible PowerSupply (UPS) complieswith 47 CFR Part 15Subpart B: 1999.EM emission of theViewSonic monitor satisfiesthe standard EEC directive89/336/EEC, 92/31/EEC,93/68/EEC	Meets electrical,electromagneticinterference and safetyinternational standards.Fully compatible withother electronic devicesfor electrical andelectromagneticstandards.	The gamma cameracomplies with thestandard recognised bythe FDA.
Compatibilitywith theenvironment	Same as predicates:Compliance of DIRECTIVE2002/96/EC of 27 January2003 on wasteelectrical and electronicequipment		Enviroment-friendlyduring regular use andstorage. To be disposedof properly.
Sterility	The product is not sterileand has not to be sterilizedby the user.Cleaning standardprocedure of medicaldevices.Can be used under sterile-intraoperative conditions ifdevice is covered with asterile cover as shown inuser manual	The product is not sterileand has not to be sterilizedby the user.Cleaning standardprocedure of medicaldevices.	The product is not sterileand has not to besterilized by the user.Can be used understerile-intraoperativeconditions if probe headIs covered with a sterileprotective sheath.
Planar imagingTomography	YesNo	YesNo	YesYes
Energy range	50-200 keVs	30-300 keVs	71-364 keVs	The energy rangecovered contains themajor part of theradionuclidescommonly used Insurgery (Tc, Co, Ba,Am, Gd)
Energyresolution	15.9 %	5 %	7%	Although the energyresolution is larger, theenergy window is about10% according to theNEMA.As a consequence theSentinella 102 detectsthe same events than
	Sentinella 102	LumaGEM™ScintillationCamera	Anzai eZ-ScopeAN PortableGamma Camera	Justification ofSubstantiallyEquivalence incase ofdifference withpredicatesthe predicates.
CrystalTechnology	Continuous Csl (Na)	Pixelized cadmiun-zinc-telluride (CZT)	Pixelized cadmiun-zinc-telluride (CZT)	The crystal used withthe Sentinella 102 hasless electronic noise,better performance, interms of spatialresolution andsensibility in referenceto the predicates.
Intrinsic spatialresolution	1.8 mm	2 mm	2 mm	The difference ofintrinsic spatialresolution is notappreciable.
Spatialresolution	Green collimator (Ø 2.5 mm)5,4mm @ 3cm7.3 mm @ 5cmBlue Collimator (Ø 4 mm)8,2mm @ 3cm11,1mm @ 5cmGrey collimator, divergent6,3mm@ 3cm8,2mm @ 5cm	LEHR collimator< 4,25 mm @ 2,5cm< 5,5mm @ 5cmLEAP collimator< 6,0mm @ 2,5cm< 7,5mm @ 5cm		The spatial resolutionchanges with thecollimator used.The spatial resolution ofthe Sentinella 102collimators are in thesame range of valuescompared to thepredicates, so theycould be considered asequivalent.
Sensitivity(cpm/uCi)	Green collimator (Ø 2.5 mm)~300 @ 3cm110 @ 5cm38 @ 10cmBlue Collimator (Ø 4 mm)~z<600 @ 3cm233 @ 5cm87 @ 10cmGrey collimator, divergent104 @ 5cm72 @ 10cm	LEHR >130LEAP >250LEHS >500		The sensitivity dependson the distance of thegamma camera to theradioisotope detectedwith pinhole anddivergent collimators.The sensitivity of theSentinella 102collimators are in thesame range of valuescompared to thepredicates, so theycould be considered asequivalent.
Flood fieldUniformity	5 %	< 4%		The data obtained withthe Sentinella 102 areequivalent with thepredicates.
Field Of View	15 x 15 cm at 20 cm fromcollimator	13 x 13 cm (5"x 5")	3.2 x 3.2 cm	Equivalent with thepredicates
Height	160 - 215 cm	139.7 cm		The Sentinella 102 ishigher that thepredicates but its heightallows its transport inany hospital or medicalcentre.
CommunicationPower	DICOMAC100-240V, 50/60 Hz	DICOM, InterfileAC100-240V, 50/60 Hz	Not specifiedAC100-240V, 50/60 Hz
Compatibleaccessories	Gamma Probe S-ProbeSterile coversRadioactive Pointer ( $153$ Gd,activity of 60 µCi)		Sterile protective sheath	Radioactive pointer:According to thestandard RS-G-1.7:"Application of theconcepts ofexclusion, exemptionand clearance" of theIAEA, the gadoliniumpointer of 60µCi isexempted because itsactivity is inferior to10Bq/g (270 µCi). Asa consequence Itsuse and manipulationdoes not present anyrisks for the patients

Sentinella 102	LumaGEM™ScintillationCamera	Anzai eZ-ScopeAN PortableGamma Camera	Justification ofSubstantiallyEquivalence Incase ofdifference withpredicates
			and the sanitarypersonnel.For another part thedose received by thepatient during the useof the pointer (60µCiduring less than 30minutes) is negligiblecompared with thedose injected to thepatient to perform anygammagraphy (forinstance with theLumagem or Anzaigamma camera)which around 20 mCi.The dose of thepointer representsless than 0.3% of thedose injected, so wecould consider thatthe radioactivepointer does not addsafety concernscompared to thepredicates.
			The compatibleaccessories of theSentinella 102, theGamma Probe S-Probeand the radioactivepointer not presented inthe predicates help theuser to locate on thepatient a determinepoint of the pictureobtained in theInterface, they are aimprovement comparedto the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for OncoVision GEM-Imaging SA. The logo consists of a circular graphic on the left and the text "ONCOVISION" on the right. The circular graphic appears to contain a globe-like image inside of a square. The text "GEM-Imaging SA" is located below the word "ONCOVISION".

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Image /page/3/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 words "ONCO VISION" stacked on top of each other on the right. Below the words is the text "GEM-IMAGING SA" in a smaller font. The logo is black and white.

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Image /page/4/Picture/1 description: The image contains a logo with a stylized eye on the left and the text "ONCO VISION" on the right. Below the text, it says "GEM-IMAGING SA". The logo is black and white and appears to be for a company in the medical imaging field. The text is in a sans-serif font and is stacked vertically.

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Image /page/5/Picture/1 description: The image shows the logo for ONCO VISION GEM-IMAGING SA. The logo consists of a black square with a white circle inside, and the words ONCO VISION in black letters. The words GEM-IMAGING SA are printed in smaller letters below ONCO VISION. The logo is simple and modern, and it is likely used to represent a company that specializes in medical imaging.

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Image /page/6/Picture/1 description: The image shows the logo for ONCO VISION GEM-IMAGING SA. The logo consists of a circular graphic on the left and the text "ONCO VISION" on the right. Below the text is the phrase "GEM-IMAGING SA". The logo is black and white.

All the mentioned differences do not compromise the intended use and safety, but in fact, demonstrate that the Sentinella 102 is as effective as the predicates.

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Image /page/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

General Equipment for Medical Imaging, S.A. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd MELVILLE NY 11747

Re: K092471

OCT - 2 2009

Trade/Device Name: Sentinella 102 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: September 18, 2009 Received: September 22, 2009

Dear Mr. Conry:

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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for ONCO VISION 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 the company name is in black sans-serif font.

Indications for Use

FDA CDRH DMC

510(k) Number (if known): K092471

Device Name: Sentinella 102 SEP 22 2009

Indications for Use:

Received

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.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Heilmann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K012471

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Regulation Number and Section

§ 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).