The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.

Device Description

The proposed Stimuplex® Onvision® system is an add-on device to the Philips Xperius ultrasound system (K182529) that is intended to be used during peripheral nerve block (PNB) procedures. The proposed Stimuplex® Onvision® system consists of:

a sterile, dedicated single-use Stimuplex® Onvision® needle (manufactured by B. Braun)
Onvision system (manufactured by Philips) which contains:
- a non-sterile reusable hardware with battery,
- needle tip tracking software
- and a system cable.
  The Stimuplex Onvision system is also compatible with the Stimuplex HNS 12 nerve stimulator( K070134).

AI/ML Overview

The following information is extracted from the provided text regarding the acceptance criteria and the study proving the device meets these criteria for the Stimuplex Onvision system.

1. A table of acceptance criteria and the reported device performance:

The document states that "Results of the functional and performance testing conducted on the proposed device demonstrate that the Stimuplex® Onvision® system complies with user need requirements as well as the requirements specified in the international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use." However, it does not provide a quantitative table of specific acceptance criteria values and the measured performance of the device against those values. Instead, it lists the types of nonclinical and validation testing performed and states that they were "successfully completed" or "passed."

Based on the information provided, the acceptance criteria are generalized as meeting specifications and user needs. The reported performance is that the device "performs as intended," "verifies the requirements," and "all tests were passed."

Here's a table based on the types of tests and their stated outcomes, as quantitative data for acceptance criteria and performance data points are not explicitly provided in the furnished text.

Acceptance Criteria Category (Implied)	Stated Device Performance
Material Biocompatibility	Passed (ISO 10993-1)
Cvtoxicity	Passed
Sensitization	Passed
Irritation/Intracutaneous reactivity	Passed
Material mediated Pyrogenicity	Passed
Acute Systemic Toxicity	Passed
Hemocompatibility	Passed
Sterilization Efficacy	Passed
Sterilization Residual testing	Passed (ISO 10993-7)
Sterilization Validation	Passed (ISO 11135)
Cannula Mechanical Properties	Passed
Cannula stiffness	Passed (ISO 9626, ISO 7864)
Tensile load	Passed (ISO 9626, ISO 7864)
Resistance to breakage	Passed (ISO 9626, ISO 7864)
Needle Performance & Function	Passed
Flowrate	Passed
Liquid Tightness	Passed
Compatibility with Philips Xperius System	Passed
Shelf Life Testing	Passed (2 years)
Electrical Safety	Passed (ANSI AAMI ES 60601-1)
EMC Safety	Passed (IEC 60601-1-2)
Software Life Cycle Processes	Passed (IEC 62304)
Non-clinical Performance (System)	Passed
Functional requirements	Passed
Performance requirements	Passed
Service requirements	Passed
Physical requirements	Passed
Interface requirements	Passed
Bench-top System Validation	Passed
Needle tip position	Passed
Connectivity	Passed
Power indicator	Passed
Battery	Passed
Boot-up time	Passed
System cable clip	Passed
Operational	Passed
Self-test	Passed
Needle tip not shown	Passed
Preclinical Cadaver Testing (Workflow)	Passed
Intended use validation	Passed
User needs validation	Passed
Safety related measure effectiveness	Passed
Usability Evaluation	Passed (IEC 62366-1)
Safety for intended use/users/env.	Passed
Effectiveness for intended use/users/env.	Passed

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of patients or images for a dedicated test set in the way a clinical trial would. The testing described is primarily non-clinical, including bench-top testing, and a preclinical cadaver study.
- For bench-top testing, "an artificial media" was used. The number of tests/runs is not specified.
- For preclinical testing, "human cadaver" was used. The number of cadavers or distinct use cases is not specified.
- Usability evaluation was performed with "anesthesiologist(s)" in a simulated environment; the number of participants is not specified.
Data Provenance: The document does not explicitly state the country of origin for the non-clinical and preclinical testing data. Philips Medical Systems Nederland B.V. (The Netherlands) is the submitter. The studies are described as "nonclinical testing" and "preclinical testing," suggesting they are newly generated specifically for this submission (prospective in that sense, rather than retrospective analysis of existing data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: For the preclinical cadaver study and usability evaluation, "physician (anesthesiologist)" or "anesthesiologist" were involved. The exact number of individuals is not specified.
Qualifications of Experts: The experts were identified as "clinically trained physicians" or specifically "anesthesiologist(s)." No further details about their experience level (e.g., years of experience) are provided. Their role appears to be as users and evaluators of the device's performance in a simulated/cadaver environment, rather than establishing numerical "ground truth" data points for an algorithm in an image dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method (like 2+1 or 3+1) for establishing ground truth, as the testing performed is not a multi-reader imaging study. The "ground truth" for the non-clinical tests would be defined by the pre-specified technical requirements and measurements, and for the cadaver study and usability, the observed operational success and safety aspects assessed by the participating anesthesiologist(s).

5. 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 MRMC comparative effectiveness study was conducted or described in the provided text. The device is a "needle tip tracking system" used during regional anesthesia, not an AI-assisted diagnostic imaging device requiring human reader improvement comparison. The FDA states, "No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies standalone performance testing of the system's components and the integrated system during bench-top testing. For example, "Needle tip position" verification in artificial media would be an assessment of the algorithm's performance. However, the exact "standalone" performance metrics (e.g., accuracy of needle tip tracking in mm) are not quantified in the text. The closest is the statement that "functional and performance testing to internal specifications" was conducted and "Non-clinical validation testing has been performed to validate that the proposed Stimuplex® Onvision® system conforms its intended use and user needs."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation can be inferred from the types of testing:

Bench-top testing: The ground truth would be defined by engineering specifications and physical measurements (e.g., for flowrate, liquid tightness, accuracy of simulated needle tip position).
Preclinical Cadaver Testing: The ground truth for this validation would be the successful execution of the specified workflow, the system functioning as intended, and the evaluation of safety measures within the simulated clinical environment, assessed by the anesthesiologist.
Usability Evaluation: The ground truth would be based on the qualitative and quantitative observations of user interaction, identification of usability issues, and the overall assessment by the anesthesiologists that the system is safe and effective for its intended use and environment.

No pathological or outcomes data-based ground truth is discussed, as this is a device for real-time guidance during a procedure, not a diagnostic device.

8. The sample size for the training set

The document does not mention any "training set." This type of device (needle tip tracking system) is not typically developed using machine learning models that require a separate, large training set of data in the way AI/ML algorithms for image analysis are. The "training" in this context refers to the development and refinement of the tracking algorithm based on engineering principles and iterative testing, not statistical model training.

9. How the ground truth for the training set was established

As no training set (in the AI/ML sense) is described, the concept of establishing ground truth for it is not applicable here. The device's functionality is based on its physical design and real-time sensor processing, not a trained AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Philips Medical Systems Nederland B.V. Gert De Vries Senior Regulatory Affairs Manager Veenpluis 4-6 Best, 5684 PC N1

Re: K192914

Trade/Device Name: Stimuplex Onvision System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP, IYO Dated: April 24, 2020 Received: April 27, 2020

Dear Gert De Vries:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192914

Device Name Stimuplex Onvision system

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

SUBMITTER INFORMATION:

Name:	Philips Medical Systems B.V.Philips Image Guided Therapy – Business Incubation
Address:	Building QG-132, Veenpluis 4-6, 5684 PC Best,The Netherlands
Telephone Number:	+31 (0)6 182 06 281
Contact Person:	Gert de Vries, Senior Regulatory Affairs Manager
Telephone Number:	+31 (0)6 182 06 281
Email:	gert.de.vries@philips.com
Date Prepared:	April 23rd, 2020
CE NAME:

DEVIC

Device Trade Name:	Stimuplex® Onvision® system
Common Name:	Anesthesia Conduction Needle with Ultrasonic TipTracking System
Classification Name:	Anesthesia conduction needle 21 CFR §868.5150:Class II, Product code BSP and System, Imaging,Pulsed Echo, Ultrasonic 21 CFR §892.1560, Class IIProduct code IYO

PREDICATE DEVICES:

Primary predicate device: SonixGPS Nerve Block Needle Kit, Ultrasonix ● Medical Corporation (K121812)
Additional predicate devices: ●
- PercuNav Image Fusion and Interventional Navigation (K170716) o
- B.Braun Stimuplex® D Plus Insulated Echogenic Needle(K100241) o

DEVICE DESCRIPTION:

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Onvision® dedicated single-use Stimuplex® • a sterile, needle(manufactured by B. Braun)
Onvision system (manufactured by Philips) which contains: ●
- o a non-sterile reusable hardware with battery,
- o needle tip tracking software
- o and a system cable.

The Stimuplex Onvision system is also compatible with the Stimuplex HNS 12 nerve stimulator( K070134).

INDICATIONS FOR USE:

The Stimuplex® Onvision® System is intended for clinically trained physicians to perform reqional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaving a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.

TECHNOLOGICAL CHARACTERISTICS:

The Stimuplex® Onvision® system has the same intended use as the primary predicate device of SonixGPS Nerve Block Needle kit (K121812), and an additional predicate device of Stimuplex D Plus Insulated Echogenic Needle(K100241). It also has the same intended use as another additional predicate device of PercuNav Image Fusion and Interventional Navigation (K170716) for the purpose of use during PNB procedures (nerve block and pain management). The predicate device of PercuNav has wider scope of intended use in other procedures.

Both proposed device and primary predicate device of SonixGPS needle kit:

contain a needle to inject a single dose of anesthetic or analgesic for the ● purpose of regional anesthesia and pain management during PNB procedures
contain a tracking technology to calculate the position of needle tip and . display the position on live ultrasound image

For the tracking technology, the proposed device and the primary predicate device and an additional predicate device of PercuNav:

use of an external energy field [ultrasound (acoustic) vs electromagnetic] ● for tracking
use the ultrasound transducer for image processing
overlay/fuse image of tracked instrument / needle with live ultrasound ● image
calculate location of the tracked instrument / needle in 3D and ● visualization in 2D ultrasound image

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use real-time visualization of Ultrasound during interventional procedure ●
The proposed Stimuplex Onvision needle has fundamentally the same materials of composition as the additional predicate device of Stimuplex D Plus needle. and both the proposed and predicate devices are covered and insulated needles.

There is technological difference between the proposed and predicate devices. Stimuplex® Onvision® system uses ultrasound (acoustic) low energy field while SonixGPS needle and PercuNav employs electromagnetic energy field for tracking the needle. They are all using an external low energy field. The proposed Stimuplex® Onvision® System, SonixGPS needle and PercuNav calculate the positional information of tracked instrument/needle by utilizing the signal converted from external energy field, and overlay/fuse the image of tracked instrument/needle with ultrasound image.

The technological difference does not raise any new questions regarding safety and effectiveness, with the assessment performed in multiple aspects, including electrical safety, EMC evaluation, thermal effect etc.

Based on the information provided above, the Stimuplex Onvision system is considered substantially equivalent to the predicate devices, SonixGPS Nerve Block Needle Kit, PercuNav and Stimuplex D Plus needle, from a technical characteristics perspective.

Item	Proposed Stimuplex®Onvision® System	Primary Predicate DeviceSonixGPS Nerve BlockNeedle Kit (K121812)	Predicate DevicePercuNav Image Fusionand InterventionalNavigation (K170716)	Predicate DeviceB.BraunStimuplex® D PlusInsulatedEchogenic Needle(K100241)	Analysis and conclusion
Indications forUse	The Stimuplex®Onvision® System isintended for clinicallytrained physicians toperform regionalanesthesia and paintherapy to targetperipheral nerves bytracking the B.BraunStimuplex®Onvision® needle tipposition by overlayinga circle at the givenlocation using thePhilips Xperius®Ultrasound andOnvision® System.The B. BraunStimuplex®Onvision® needle isused to inject localanesthesia oranalgesic to thetargeted nerve bundleto induce regionalanesthesia for surgicalprocedures. TheStimuplex® HNS 12can also be used fornerve stimulationwhen connected tothe system cable.	The SonixGPS NerveBlack Needle Kit isintended for use inregional anesthesia andpain therapy by a trainedphysician, to targetperipheral nerves byvisualization at theneedle tip using anultrasound imagingdevice. The needle isused to inject localanesthesia or analgesicto the targeted nervebundle to induce regionalanesthesia for surgicalprocedures.	The PercuNav system is astereotaxic accessory forcomputed tomography(CT), magnetic resonance(MR), ultrasound (US),and positron emissiontomography (PET). CT, Ultrasound, PET, and MRmay be fused in variouscombinations, such as CTwith MR, MR withultrasound, and so on. Itmay includeinstrumentation to displaythe simulated image of atracked insertion tool suchas a biopsy needle orprobe on a computermonitor screen that showsimages of the targetorgans and the currentand the projected futurepath of the interventionalinstrument. The PercuNavsystem is intended fortreatment planning andguidance for clinical,interventional, ordiagnostic procedures.The PercuNav system alsosupports an image-freemode in which theproximity of theinterventional device isdisplayed relative to	The B. BraunStimuplex® D PlusInsulatedEchogenic Needleis intended for usein regionalanesthesia andpain therapy totarget peripheralnerves bytransferringelectrical impulsesfrom a nervestimulator and forvisualization of anechogenicreflective pattern atthe needle tip usingan ultrasoundimaging device.The needle is usedto inject a singledose of localanesthetic oranalgesic to thetargeted nervebundle for generaland orthopedicsurgery.	Both devices utilizeultrasound and electricalnerve stimulation fornerve detection whileperforming PeripheralNerve Blocks.Both devices are used toinject a single dose ofanesthetic or analgesic.The proposed device isexclusively for the PhilipsOnvision system.

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B|BRAUN | PHILIPS Prem

narket Notification: Traditional 510(k)

Item	Proposed Stimuplex®Onvision® System	Primary Predicate DeviceSonixGPS Nerve BlockNeedle Kit (K121812)	Predicate DevicePercuNav Image Fusionand InterventionalNavigation (K170716)	Predicate DeviceB.BraunStimuplex® D PlusInsulatedEchogenic Needle(K100241)	Analysis and conclusion
			another device. ThePercuNav system isintended to be used ininterventional anddiagnostic procedures in aclinical setting. ThePercuNav system is alsointended for use in clinicalinterventions to determinethe proximity of one devicerelative to another.Example proceduresinclude, but are not limitedto, the following:• Image fusion fordiagnostic clinicalexaminations andprocedures• Soft tissue biopsies(liver, lung, kidney, breast,pancreas, bladder, adrenalglands, lymph node,mesentery, and so on.)• Soft tissue ablation (liver,kidney, breast, pancreas,lung, and so on)• Bone ablations• Bone biopsies• Nerve blocks and painmanagement• Drainage placements• Tumor resections
Intended Use	Regional anesthesiaand Pain Therapy	Regional anesthesia andPain Therapy	Nerve blocks and painmanagementSee part of indication ofuse	Regionalanesthesia andPeripheral NerveBlocks	The Intended Use is thesame. However, theIntended Use forPercuNav is broader
Classification	Class II	Class II	Class II	Class II	Same
Product Code	BSP,IYO	BSP	IYO,LLZ	BSP	Same, combination ofthe two predicates
UltrasoundVisibility	Shaft identificationand needle tiptracking in ultrasoundimage whenconnected to PhilipsOnvision System	Shaft identification andvisualization at theneedle tip using anultrasound imagingdevice	Shaft identification andvisualization at the needletip using an ultrasoundimaging device	Needle tip andshaft identificationin an ultrasoundimage	Same
Biocompatibilityclassification	Externalcommunicating devicebone/tissue/dentinlimited exposure	Information is notpublicallyavailable	N/A	Externalcommunicatingdevice bone/tissue/dentinlimited exposure	Same
Needle tube	Stainless steel	Information is notpublicallyavailable	see CIVCO needleinformation	Needle tube:Stainless steel	The materials ofconstruction of theproposed device and thepredicate devices aresimilar.
NeedleDimensionsNeedle Gauge /Outer diameterx Length]	22 Ga. X 2in.22 Ga. X 3 1/8in.20 Ga. X 4in.20 Ga. X 4 3/4in.20 Ga. X 6in.	19Ga X .55mm	Compatible with CIVCOneedles	25 Ga. x 1 3/8in.22 Ga. x 2in.22 Ga. x 4 3/4in.	The devices offerclinicians gauge andlength options that do notaffect the safety andeffectiveness of thedevices.
Sterilization	Ethylene Oxide	Ethylene Oxide	N/A	Ethylene Oxide	Same
SterilityAssuranceLevel (SAL)	106	Information is notpublically available	N/A	106	Same
Shelf Life	2 years	Information is notpublicallyavailable	N/A	5 years	Proposed device has ashelf life of 2 years. Theshelf life does not affectthe safety andeffectiveness of theproposed device.
Item	Proposed Stimuplex®Onvision® System	Primary Predicate DeviceSonixGPS Nerve BlockNeedle Kit (K121812)	Predicate DevicePercuNav Image Fusionand InterventionalNavigation (K170716)	Predicate DeviceB.BraunStimuplex® D PlusInsulatedEchogenic Needle(K100241)	Analysis and conclusion
Stimulationability	Yes	No	N/A	Yes	Same as Stimuplex DPlus predicate devicedoes not affect the safetyand effectiveness of theproposed device.
Connectivity toNerveStimulator	Direct	N/A	N/A	Direct	Same as Stimuplex DPlus predicate devicedoes not affect the safetyand effectiveness of theproposed device.
TrackingTechnology	sensor in needle,sends signal back tosoftware whichcalculates anddisplays on ultrasoundscreen	Sensor coil placed inneedle and in transducersends signal back tosoftware whichcalculates and displayson ultrasound screen	Sensor within CNT placedin needle and intransducer sends signalback to software whichcalculates and displays onultrasound screen	N/A	Equivalent, each trackingtechnology make use ofan external energy fieldfor tracking and displayson ultrasound screen
Sensor	Passive; receivesenergy fromultrasound probe anduses this to determinethe needle tip position	Passive; receives energyfrom an electromagneticsource and uses this todetermine the sensorposition	Passive; receives energyfrom an electromagneticsource and uses this todetermine the sensorposition	N/A	Equivalent, all sensorsare passive and receiveenergy from an externalfield to determine thesensor position
Image Modality	Live Ultrasound	Live Ultrasound	Live Ultrasound	N/A	Same
Sensorconnection totrackinghardware	The lead wires fromthe sensor areconnected back to theOnvision system(tracking hardware)through a cable and aunique connector toprevent connection toan incorrect socket.	The lead wires from theneedle sensor areconnected back to thetracking hardware thougha cable and a uniqueconnector to preventconnection to anincorrect socket. Inaddition the sensor withinthe ultrasound probe isconnected to theultrasound system.	The lead wires from thesensor are connectedback to the PositionSensor unit (trackinghardware) through a cableand a unique connector toprevent connection to anincorrect socket	N/A	Same
Software	The software takesthe calculatedpositional informationand displays thepositional informationof the tracked deviceconnected to thesystem.	The software takes thecalculated positionalinformation and predictedneedle trajectory todisplay the locationwhere the needle willintersect with theultrasound beam anddisplays the positionalinformation of the trackeddevice connected to thesystem.	The software takes theposition data provided bythe hardware and displayspatient imaging data aswell as the location andorientation of the trackedinstruments connected tothe system.	N/A	Equivalent. Each takesthe position data anddisplays the positionalinformation of the trackeddevice.
TrackedInstrumentation/accessory	Needle tip tracking	Needle tip tracking	Patient trackerUltrasound trackerCoaxial needle tracker(CNT)Adaptive needletracker (ANT)Button probesBiopsy and RFAIntroducers	N/A	Same for primarypredicate device,equivalent for PercuNavpredicate device
Clinicalapplication	Soft tissues (skin,muscle, tendon, fatetc.)	Soft tissues (skin,muscle, tendon, fat etc.)	Soft tissues (skin,muscle, tendon, fat etc.)	Soft tissues (skin,muscle, tendon, fatetc.)	Same
Targeted useareas	Hospitals, surgerycenters, clinics:emergency room,examination room,PNB room, operatingroom.	Hospitals, surgerycenters, clinics:emergency room,examination room, PNBroom, operating room.	Hospital operating rooms,outpatient surgery centers,ultrasound, CT and otherscanner suites, andprocedure rooms.	Hospitals, surgerycenters, clinics:emergency room,examination room,PNB room,operating room.	Same.

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B BRAUN PHILIPS Premarket Notification: Traditional 510(k)

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B BRAUN PHILIPS Premarket Notification: Traditional 510(k)

NONCLINICAL TESTING:

Bench testing performed on Stimuplex® Onvision® system demonstrates that the device performs as intended, verifies the requirements, as well as the identified risk control measures from risk management and supports substantial equivalence of the proposed device. No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing. The following testing has been successfully completed for the proposed device:

Single Use components (Stimuplex® Onvision® needle) .
- o Biocompatibility in accordance with ISO 10993-1
  - = Cvtoxicity
  - · Sensitization
  - · Irritation/Intracutaneous reactivity
  - · Material mediated Pyrogenicity
  - · Acute Systemic Toxicity
  - · Hemocompatibility
- o Sterilization Residual testing in accordance with ISO 10993-7
- o Sterilization Validation in accordance with ISO 11135
- o Testing in accordance with Requirements from, ISO 9626 and ISO 7864 that include:
  - · Cannula stiffness
  - Tensile load
  - · Resistance to breakage
- o Performance and functional testing to internal specifications that include:
  - = Flowrate
  - · Liquide Tightness
  - · Compatibility with Philips Xperius System
  - = Shelf Life Testing
Hardware and Software components (Onvision system) ●
- Electrical safety in accordance with ANSI AAMI ES 60601-1 o
- EMC safety in accordance with IEC 60601-1-2 O
- O Software Life Cycle Processes in accordance with IEC 62304
- Non-clinical performance testing to verify the requirements as specified O in the System Requirement Specifications that include:
  - Functional requirements
  - l Performance requirements
  - Service requirements
  - l Physical requirements and
  - Interface requirements I

Non-clinical validation testing has been performed to validate that the proposed Stimuplex® Onvision® system conforms its intended use and user needs. The

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validation was performed with the following testing:

Bench-top testing was performed in an artificial media to validate user need specification associated with system function and system performance such as:
- Needle tip position O
- o Connectivity
- Power indicator o
- Battery O
- Boot-up time O
- System cable clip O
- Operational O
- o Self-test
- o Needle tip not shown
Preclinical testing on human cadaver was performed with physician ● (anesthesiologist) in a simulated clinical environment. The participants executed the test in the form of a system workflow to validate the intended use, user needs, and effectiveness of the safety related measure. As part of the validation, the implemented software was evaluated as part of the workflow. Results demonstrated all tests were passed.
Usability evaluation in accordance with IEC 62366-1 was performed ● with anesthesiologist in a simulated use environment. Results from the usability evaluation demonstrated the proposed Stimuplex Onvision system is safe and effective for the intended use, users and use environment.

CONCLUSION:

The proposed Stimuplex Onvision system is substantially equivalent to the predicate devices, in terms of intended use, technological characteristics and safety and effectiveness.

Substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. Results of the functional and performance testing conducted on the proposed device demonstrate that the Stimuplex® Onvision® system complies with user need requirements as well as the requirements specified in the international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use. It is considered substantially equivalent to the predicate device in terms of safety and effectiveness. The differences, between proposed device and predicate device, do not raise any new issues of safety and effectiveness. Therefore, proposed Stimuplex® Onvision® system is as safe and effective as predicate devices and substantially equivalent to the predicate devices.

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).