TruDi™ NAV Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments.

TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

Device Description

TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically- navigated reusable devices intended to be used in conjunction with the TruDi™ Navigation System. When used with the TruDi™ Navigation System, the TruDi™ NAV Suction Instruments provide navigation of the devices to targeted anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation System is the trade name for the ACCLARENT® ENT Navigation System cleared in K173628.

TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System.

The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the TruDi™ NAV Suction Instruments. It outlines the regulatory process, device description, comparison to predicate devices, and non-clinical performance data.

However, it does not contain information related to a study proving the device meets acceptance criteria regarding clinical performance or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or details about the training and test sets as typically found in submissions for AI/ML-based medical devices.

The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." and "The performance data demonstrated that the device performs as intended." This indicates that substantial equivalence was primarily established through non-clinical testing and comparison to predicate devices, rather than a clinical trial involving human performance assessment with the device.

Therefore, many of the requested details, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC study results, and specifics on AI algorithm ground truth establishment, are not present in the provided text because the device is a navigation suction instrument and not an AI/ML diagnostic tool.

I can, however, extract the acceptance criteria related to the device's physical and functional performance, along with the reported outcomes from the non-clinical tests.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Dimensional Specifications	Not explicitly stated in quantitative terms but implied to be within design specifications.	Met all performance acceptance criteria including dimensional specifications.
Suction Flow Performance	Not explicitly stated in quantitative terms but implied to be sufficient for intended use.	Met all performance acceptance criteria including suction flow performance. Simulated use testing successfully tested suction performance.
Deflection	Not explicitly stated in quantitative terms.	Met all performance acceptance criteria including deflection.
Location Accuracy (Sensor Sensitivity)	≤ 2mm RMS over the entire navigation volume (as stated under "System or Instrument Accuracy Requirements"). The predicate device also provided 1.54 mm at 95% confidence and 99% reliability in controlled environment and 1.73 mm at 5% confidence and 99% reliability in simulated surgical environment.	Met all performance acceptance criteria including location accuracy (sensor sensitivity). Testing was performed to verify the navigation accuracy of the subject device when used with the TruDi™ Navigation System (K173628). Performance data demonstrated the device performs as intended. Specific quantitative results matching the ≤ 2mm RMS acceptance criteria are implied to have been met.
Reprocessing Reliability	Capable of thorough cleaning and sterilization via specified methods, demonstrating sterility assurance level of 10⁻⁶.	Reprocessing and sterilization testing was conducted and met all acceptance criteria. Sterilization process validated per AAMI/ANSI/ISO 11135:2014, demonstrating a sterility assurance level of 10⁻⁶ via steam or STERRAD methods (overkill/half-cycle).
Electrical Functionality	Not explicitly stated in quantitative terms.	Met all performance acceptance criteria including electrical functionality.
EEPROM Verification	Not explicitly stated in quantitative terms.	Met all performance acceptance criteria including EEPROM verification.
Biocompatibility	Biocompatible per ISO 10993-1.	Biocompatibility testing was successfully completed to determine that the TruDi™ NAV Suction Instruments are biocompatible per ISO 10993-1.
Mechanical Aspects	Functions in accordance with design specifications.	Simulated use testing successfully tested the mechanical aspects of the subject device.
Clinical Accuracy (Simulated Use)	Functions in accordance with design specifications and intended use.	Simulated use testing was performed with ENT surgeons and support staff, which successfully tested the clinical accuracy of the subject device. The testing demonstrated that the subject device functions in accordance with design specifications and intended use.
TruDi™ NAV Cable Functionality	Functions as intended with the suction instruments.	Simulated use testing successfully tested the functionality of the TruDi™ NAV cable. Testing included sensitivity and connectivity verification.
Packaging Shelf Life (TruDi™ NAV Cable)	Meet a shelf life of two months.	Established through accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements and confirmed to meet a shelf life of two months.

Here's an analysis of the requested information based on the provided document, highlighting what is not applicable (N/A) given the nature of the device and the submission:

A table of acceptance criteria and the reported device performance: See table above.
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: Not explicitly stated for specific non-clinical tests (e.g., number of instruments tested for accuracy, deflection, etc.). The mention of "simulated use testing with ENT surgeons and support staff" doesn't provide the number of participants or simulated cases.
- Data Provenance: Not specified. As these are non-clinical tests, country of origin is less relevant than for clinical data. This was a premarket notification (510(k)) based on non-clinical performance and substantial equivalence.
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):
- N/A. Ground truth in the context of AI/ML diagnostic devices (e.g., disease presence/absence) is not relevant here. For the "simulated use testing," the "experts" were "ENT surgeons and support staff," who were evaluating the device's functional and mechanical performance, not establishing a diagnostic ground truth. No specific number or qualifications beyond "ENT surgeons and support staff" are provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically used to resolve discrepancies in expert labeling a dataset for AI/ML ground truth. This is not applicable to the non-clinical and simulated use testing described.
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. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." This means no MRMC study was conducted. This device is a surgical instrument, not an AI-based diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. There is no standalone AI algorithm discussed for this device. The device itself is an instrument that works with a navigation system. Its "performance" (accuracy) is a standalone measurement of the physical system (instrument + navigation system), but this is not an AI algorithm's standalone performance in the typical sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For the non-clinical tests, "ground truth" was established through engineering measurements, validated test methods (e.g., AAMI/ANSI/ISO for sterility, ASTM for packaging), and design specifications. For "clinical accuracy" in simulated use, it implies the device performed as expected by the ENT surgeons and support staff based on its design and intended function, not against a medical ground truth (like a biopsy result or patient outcome).
The sample size for the training set:
- N/A. This device does not involve a training set for an AI/ML algorithm.
How the ground truth for the training set was established:
- N/A. This device does not involve a training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 20, 2018

Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, CA 92618

Re: K180948

Trade/Device Name: TruDi™ NAV Suction Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: June 21, 2018 Received: June 22, 2018

Dear Leena Sorathia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180948

Device Name TruDi™ NAV Suction Instruments

Indications for Use (Describe)

TruDi™ NAV Suction Instruments are intended for use with the TruDi™ System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the targeted anatomy, and evacuation of gases, liquids, and fragments.

TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

Type of Use (Select one or both, as applicable)

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

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Image /page/3/Picture/0 description: The image displays the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Suction Instruments" is written in a bold font. The logo features the company name "Acclarent" in a large, bold font, with a purple curved line above it.

510(K) SUMMARY

[807.92(a)(1)] Submitter Information

Sponsor/Submitter:	Acclarent, Inc.33 Technology DriveIrvine, CA 92618
Contact Person:	Leena SorathiaSr. Regulatory Affairs SpecialistEmail: lsorathi@its.jnj.comTel: 949-923-4118
Date Summary Prepared:	July 18, 2018
[807.92(a)(2)] Name of Device
Device TradeName:	TruDi™ NAV Suction Instruments
ClassificationName:	Stereotaxic Instrument
Common Name:	EM Navigable Suction Instruments
DeviceClassification:	Class II
RegulationNumber:	21 CFR 882.4560
Review Panel:	Ear, Nose, and Throat
Product Code:	PGW
[807.92(a)(3)] Legally Marketed Devices
Predicate Device:	KARL STORZ EM Navigated Suction Tubes, (K161555)(cleared as part of the KARL STORZ NAVI Electromagnetic Navigation System underK161555)
Reference Device:	Medtronic EM ENT Navigated Suctions, (K153555)
[807.92(a)(4)] Device Description
Device Description:	TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically-navigated reusable devices intended to be used in conjunction with the TruDi™Navigation System. When used with the TruDi™ Navigation System, theTruDi™ NAV Suction Instruments provide navigation of the devices to targetedanatomy and evacuate gases, liquids, and fragments. The TruDi™ NavigationSystem is the trade name for the ACCLARENT® ENT Navigation System
Indications forUse:	TruDi™ NAV Suction Instruments are intended for use with the TruDi™Navigation System during surgical procedures in ENT medicine and skull basesurgery to provide navigation of the instruments to the targeted anatomy, andevacuation of gases, liquids, and fragments.
	TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons orsupport staff.
Difference inIndications fromPredicate Device	The difference in indications for use between the subject device and thepredicate/reference devices is supported is presented in Table 1 of this summary.
[807.92(a)(6)] Technical Characteristics

cleared in K173628.

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Image /page/4/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold black letters and a purple arc above the "ent" portion. Below the logo, it states "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold black letters below the company information. The image is a product advertisement.

[807.92(a)(5)] Intended Use

Technological See Table 1 for a comparison of the technological characteristics between the Characteristics: subject device and the predicate/reference devices.

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Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi™ NAV Suction Instruments". The Acclarent logo is in black and purple.

Table 1: Comparison of Technological Characteristics between ACCLARENT® Navigable Suction Instruments and Predicate and Reference devices.

Attribute	Predicate Device(KARL STORZ EM NavigatedSuction Tubes)	Reference Device(Medtronic EM ENT NavigatedSuctions)	Subject Device(TruDi™ NAV SuctionInstruments)
510(k) number	K161555	K153555	K180948
Manufacturer	KARL STORZ EndoscopyAmerica, Inc.	Medtronic Navigation, Inc.	Acclarent, Inc.
Trade Name	KARL STORZ EM NavigatedSuction Tubes(Cleared as part of KARL STORZNAV 1 Electromagnetic NavigationSystem under K161555)	Medtronic EM ENTNavigated Suctions	TruDi™ NAV SuctionInstruments
Classification Name	Stereotaxic Instrument	Stereotaxic Instrument	Stereotaxic Instrument
Class	II	II	II
Product Code	PGW	PGW	PGW
Classification Section	21 CFR 882.4560	21 CFR 882.4560	21 CFR 882.4560
Attribute	Predicate Device(KARL STORZ EM NavigatedSuction Tubes)	Reference Device(Medtronic EM ENT NavigatedSuctions)	Subject Device(TruDiTM NAV SuctionInstruments)
Indications for Use	The KARL STORZ NAV1electromagnetic navigation system andits associated applications are intendedas an aid for precisely locatinganatomical structures in either open orpercutaneous procedures under visualcontrol. Their use is indicated for anymedical condition in which use ofstereotactic surgery may beappropriate, and where reference to arigid anatomical structure in the field ofENT surgery, such as paranasalsinuses, mastoid anatomy, can beidentified relative to radiological imagedata or digitized landmarks of theanatomy.	EM ENT Instruments are indicated foruse in navigated ENT procedures tolocate points on patient anatomy relativeto a CT-based or MR-based digital modeland to remove fluids, semi-fluidsubstances, tissue, and bone dust. EMENT Instruments are indicated for usewith Medtronic computer-assistedsurgery systems. The EM ENTinstruments are indicated for use in ENTprocedures such as:	TruDiTM NAV Suction Instrumentsare intended for use with the TruDiTMNavigation System during surgicalprocedures in ENT medicine andskull base surgery to providenavigation of the instruments to thetargeted anatomy, and evacuation ofgases, liquids, and fragments.
		• CSF leak repairs related to ENTprocedure• Intranasal procedures• Orbital decompression procedures• Polyposis procedures• Endoscopic dacryocystorhinostomy• Sinus procedures, such as maxillaryantrostomies• Ethmoidectomies• Sphenoidotomies/sphenoid explorations• Turbinate resections and frontalsinusotomies
			The EM ENT instruments can also beused in the ENT surgical approach for thefollowing procedures:
			• Pituitary tumor removal• Skull base procedures• Transsphenoidal procedures• Optic nerve decompression procedures• Encephalocele procedures
Attribute	Predicate Device(KARL STORZ EM NavigatedSuction Tubes)	Reference Device(Medtronic EM ENT NavigatedSuctions)	Subject Device(TruDi™ NAV SuctionInstruments)
Intended Use	The navigated suction tubes aidorientation and the suctioning of gases,liquids, and fragments during invasiveinterventions in ENT medicine andlateral skull base surgery not involvingcontact with the central nervoussystem.	The Medtronic computer-assistedsurgery system and its associatedapplications are intended as an aid forprecisely locating anatomical structuresin either open or percutaneousprocedures. Their use is indicated forany medical condition in which the useof stereotactic surgery may beappropriate, and where MR-basedmodel, or digitized landmarks of theanatomy.The system and its associatedapplications should be used only as anadjunct for surgical guidance. They donot replace the surgeon's knowledge,expertise, or judgement.	TruDi™ NAV Suction Instrumentsare intended for use with theTruDi™ Navigation System duringsurgical procedures in ENTmedicine and skull base surgery toprovide navigation of theinstruments to the targeted anatomy,and evacuation of gases, liquids,and fragments.TruDi™ NAV Suction Instrumentsare intended to be used by ENTsurgeons or support staff.
Attribute	Predicate Device(KARL STORZ EM NavigatedSuction Tubes)	Reference Device(Medtronic EM ENT NavigatedSuctions)	Subject Device(TruDi™ NAV SuctionInstruments)
TechnologicalCharacteristics	The KARL STORZ EM NavigatedSuction Tubes are electromagnetically-navigated when used in conjunctionwith the KARL STORZ NAV1electromagnetic navigation system.A sensor is integrated at the distal tip ofthe suction tubes. The location of thedistal tip of the device is identified bythe KARL STORZ NAV1electromagnetic navigation system, anddisplayed in real-time view over thepatient's pre-operative CT/MTI scan toconfirm access of target anatomy.Following confirmation, the physicianoperates the suction instrument at thetarget anatomical structure.	The Medtronic EM Navigated SuctionInstruments are electromagnetically-navigated when used in conjunctionwith the Medtronic StealthStation®System System.The EM ENT Instrument Tracker,which includes a single user sensor, isattached to the EM ENT navigatedsuction to track its position. Thelocation of the instrument tracker isidentified by the MedtronicStealthStation® System, and displayedin real-time view over the patient's pre-operative CT/MRI scan to confirmaccess of target anatomy. Followingconfirmation, the physician operates thesurgical instrument at the targetanatomical structure. Followingconfirmation, the physician operates thesuction instrument at the targetanatomical structure.	TruDi™ NAV Suction Instrumentsare electromagnetically-navigatedwhen used in conjunction with theTruDi™ Navigation System.A single-axial sensor (SAS) isintegrated into the distal tip of thesuction instruments. The location ofthe distal tip of the device isidentified by the TruDi™ NavigationSystem electromagnetic navigationsystem, and displayed in real-timeview over the patient's pre-operative CT scan to confirm accessof target anatomy. Followingconfirmation, the physician operatesthe suction instrument at the targetanatomical structure.
Localization Technology	Electromagnetic (sensor integrated intodistal tip of suction instrument)	Electromagnetic (proximal trackerattached to suction instrument)EM ENT Navigated Suctions	Electromagnetic (sensor integratedinto distal tip of suction instrument)
System or InstrumentAccuracy Requirements	Unknown	Within a standard controlledenvironment: navigated peg errors of1.54 mm at 95% confidence and 99%reliabilityWithin a simulated surgicalenvironment: navigated peg errors of1.73 mm at 5% confidence and 99%reliability	≤ 2mm RMS over the entirenavigation volume
Attribute	Predicate Device(KARL STORZ EM NavigatedSuction Tubes)	Reference Device(Medtronic EM ENT NavigatedSuctions)	Subject Device(TruDi™ NAV SuctionInstruments)
Suction Functionality	Yes	Yes	Yes
Rigid Suction Device	Yes	Yes	Yes
Instrument TipConfigurations	Standard (straight)Olive	Standard (straight)AngleOliveBall/Angle	Standard (straight)Olive
Materials	EM ENT Navigated Suction Tubes:Stainless Steel	EM ENT Navigated SuctionsStainless Steel, Titanium	TruDi™ NAV Suction InstrumentsStainless Steel 316L
	CableUnknown	Patient and Instrument TrackersPatient contacting cable: AESSantoprene® 8281-90 material withColorant Pantone 301C	TruDi™ NAV CablePolycarbonate, Polyvinyl Chloride(PVC), copper
Instrument ShaftConfigurations	Straight 0° & Curved (~70°)	Fixed- Straight, Small Straight, 45°frontal, 70º curve, 90° curve, 90° frontal	Straight 0°, 70° curve, 90° curve
Supplied as"Reusable Use"	EM ENT Navigated Suction Tubes:YesCable:Yes (attached to the Suction Tubes)	EM ENT Navigated SuctionsYesPatient and Instrument TrackersSupplied Sterile Single Use	TruDi™ NAV SuctionInstrumentsYesTruDi™ NAV CableSupplied Sterile Single Use
	Location of Sensor	Sensor is built-in at the distal tip of thesuction tube	Single-use sensor that is clipped ontothe suction instrument
Reprocessing methods	Manual Cleaning, Steam Sterilization,STERRAD® 100NX® Standardsterilization cycle, and V-PRO® 1 PlusLumen sterilization cycle	Manual Cleaning & Steam Sterilization	Manual Cleaning, AutomatedCleaning, Steam Sterilization(autoclave) & STERRAD
Compatible NavigationSystem	KARL STORZ EM Navigated SuctionTubes are compatible with KARLSTORZ NAV1 ElectromagneticNavigation System	Medtronic EM ENT NavigatedSuctions are compatible withMedtronic StealthStation® System	TruDi™ NAV Suction Instrumentsare electromagnetically-navigatedwhen used in conjunction with theTruDi™ Navigation System

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Image /page/6/Picture/0 description: The image displays the Acclarent logo, which is the company's name in bold, black font with a purple arch above the "ent." Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi™ NAV Suction Instruments" is written in bold, black font below the company information.

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Image /page/7/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a combination of black and purple font. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

TruDi™ NAV Suction Instruments

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Image /page/8/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a combination of black and purple font. Below the name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

TruDi™ NAV Suction Instruments

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Image /page/9/Picture/0 description: The image shows the Acclarent logo. The word "Acclarent" is written in a bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the word "rent" is a purple swoosh. Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.

TruDi™ NAV Suction Instruments

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Image /page/10/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold, black font and a purple arc above the "ent" portion of the name. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold, black font below the company information.

[807.92(b) (1)] Determination of Substantial Equivalence

Non-Clinical PerformanceData:	TruDi™ NAV Suction Instruments met all performance acceptancecriteria including dimensional specifications, suction flow performance,deflection, location accuracy (sensor sensitivity), reprocessingreliability, electrical functionality, and EEPROM verification.TruDi™ NAV Suction Instruments are supplied non-sterile; they must becleaned and sterilized prior to the initial use and before each subsequentuse. Reprocessing and sterilization testing was conducted and met allacceptance criteria. When used in accordance with the Instructions forUse, the TruDi™ NAV Suction Instruments may be thoroughly cleanedand sterilized using, a combination of manual or automated cleaningmethods, and steam or STERRAD sterilization. The TruDi™ NAVCable is provided sterile and is for single use.
The sterilization process has been validated per AAMI/ANSI/ISO11135:2014 and demonstrated a sterility assurance level of 10⁻⁶ whenthe device is sterilized via either steam or STERRAD methods. Themethod used for steam and STERRAD sterilization validation wasoverkill (half-cycle approach) in a fixed chamber.Biocompatibility testing was successfully completed to determine thatthe TruDi™ NAV Suction Instruments are biocompatible per ISO10993-1.
Simulated use testing was performed with ENT surgeons and supportstaff, which successfully tested the mechanical aspects, suctionperformance, clinical accuracy of the subject device, along with thefunctionality of the TruDi™ NAV cable. The packaging and instructionsfor use were also successfully assessed by evaluators as part of thestudy. The testing demonstrated that the subject device functions inaccordance with design specifications and intended use. Clinical datawas not necessary for the TruDi™ NAV Suction Instruments
Testing was performed to verify the navigation accuracy of the subjectdevice when used with the TruDi™ Navigation System (K173628).Testing included sensitivity and connectivity verification.The performance data demonstrated that the device performs asintended.
Packaging shelf life for the TruDi™ NAV Cable was established throughaccelerated aging via ASTM F1980-07, ASTM F88/F88M-09, andASTM F2096-04 requirements and confirmed to meet a shelf life of twomonths.
Clinical Performance Data	Clinical data was not necessary for the TruDi™ NAV Suction Instruments. The performance data demonstrated that the device performs as intended.
[807.92(b) (3)] Conclusion
Conclusion from Non-Clinical and Clinical Tests	Based on the information provided in this premarket notification, Acclarent concludes that the TruDi™ NAV Suction Instruments are safe and effective and substantially equivalent to the predicate and reference devices.

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Image /page/11/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold, black letters and a purple arc above the "ent" portion of the name. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold, black letters below the company information.

[807.92(b) (2)] Determination of Substantial Equivalence

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).