The Acclarent® NavWire Sinus Navigation Guidewire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent® NavWire Sinus Navigation Guidewire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.

Device Description

The Acclarent® NavWire Sinus Navigation Guidewire an electromagnetically (EM) trackable guidewire that provides surgeons a means to access the intranasal and paranasal sinus spaces in endoscopic and image guided sinus surgeries. It is compatible with the CARTO® ENT System to track the NavWire within an electromagnetic field, which displays the magnetic sensor position relative to a patient's pre-operative CT scan.

AI/ML Overview

The provided text describes the Acclarent NavWire Sinus Navigation Guidewire. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria in a format that allows direct extraction of a table of acceptance criteria and reported performance with numerical values and statistical analyses.

The document is a 510(k) summary, which typically provides a high-level overview of testing rather than granular study details.

Here's what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (General): The document states "The Acclarent NavWire passed all intended criteria in accordance with appropriate test criteria and standards." This implies that specific, pre-defined acceptance criteria were met for each test listed. However, the specific numerical criteria for "accuracy and precision," "functionality," "accelerated aging," "simulated use," and "sterilization" are not provided.
Reported Device Performance: Similarly, the specific results (e.g., "accuracy was X mm," "precision was Y mm," "device remained functional for Z cycles") are not provided. The text only confirms that the device "passed all intended criteria."

Therefore, I cannot construct a table with specific criteria and performance values as requested due to the lack of this detailed information in the provided text.

2. Sample Size for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing" and "Nonclinical accuracy testing," "Nonclinical performance testing," "Simulated use testing," but does not specify the number of samples, trials, or units tested for any of these.
Data Provenance (Country of Origin, Retrospective/Prospective): Implied as bench testing, which is laboratory-based, often conducted in the manufacturer's facilities. The country of origin of the data is not specified a part of the test description itself. As it's bench testing, the terms "retrospective" or "prospective" don't directly apply in the clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This question is highly relevant for studies involving human interpretation or expert review of clinical data. For bench testing of a guidewire's mechanical and navigational performance, the "ground truth" is typically established by engineering measurements against known physical standards, rather than expert consensus on medical images or diagnoses.
Therefore, this information is not applicable and not provided in the context of the described bench and non-clinical tests.

4. Adjudication Method for the Test Set:

Similar to point 3, adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies among human experts in interpreting clinical data. Since the tests described are bench and non-clinical, involving physical measurements and performance verification, an adjudication method is not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not done. The document describes bench and non-clinical testing of the device itself (accuracy, precision, functionality, sterilization) and its compatibility with a navigation system. It does not describe a study involving human readers or a comparison of human performance with and without AI assistance. The device is a physical guidewire, not an AI software for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study of the device performance was done. The described "Bench testing" and "Nonclinical accuracy testing," "Nonclinical performance testing," "Functionality... after accelerated aging," and "Simulated use testing" all represent evaluations of the device's inherent capabilities (accuracy, precision, durability, etc.) independent of a human operator's skill in a clinical setting. It's a standalone performance evaluation of the physical medical device.

7. Type of Ground Truth Used:

For "Bench testing" and "Nonclinical accuracy/performance testing," the ground truth would be established through engineering measurement standards, calibrated instruments, and physical test fixtures. For example, an "accuracy" test would compare the device's reported position to a known, precisely measured physical location. For "sterilization verification," the ground truth is the absence of viable microorganisms as per specified sterility assurance levels (SAL).

8. Sample Size for the Training Set:

This device is a physical medical guidewire, not an AI algorithm that requires a "training set" in the machine learning sense. Therefore, this concept is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established:

As the device is not an AI algorithm requiring a training set, this information is not applicable and not provided.

In summary, the provided document focuses on the regulatory submission for a physical medical device (a guidewire) and outlines the types of non-clinical, bench tests performed to demonstrate its safety and effectiveness. It does not contain the detailed numerical acceptance criteria or performance results that would be needed to complete the requested table, nor does it describe studies involving AI, human readers, or clinical image interpretation, as many of the prompt's questions imply.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right. The profiles are stylized and appear to be made of flowing lines.

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

October 24, 2016

Acclarent, Inc. Ms. Anna Hwang Regulatory Affairs Specialist 33 Technology Drive Irvine, CA 92618

Re: K161697

Trade/Device Name: Acclarent Navwire Sinus Navigation Guidewire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 21, 2016 Received: September 22, 2016

Dear Ms. Hwang:

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 of medical 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.

Eric A. Mann -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161697

Device Name

Acclarent® Nav Wire Sinus Navigation Guidewire

Indications for Use (Describe)

The Acclarent Nav Wire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent NavWire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Acclarent® NavWire Sinus Navigation Guidewire

Traditional 510(k) Premarket Notification CONFIDENTIAL

APPENDIX A: 510(K) SUMMARY

Sponsor/Submitter:	Acclarent, Inc.33 Technology DriveIrvine, CA 92618
Contact Person:	Anna HwangRegulatory Affairs SpecialistEmail: ahwang@its.jnj.comTelephone: 949-923-4134Mobile: 310-780-8792
Date of Submission:	June 17, 2016
Device Trade Name:	Acclarent® NavWire Sinus Navigation Guidewire
Common Name:	Image Guided Surgery System
Device Classification:	Class II
Regulation Number:	21 CFR 882.4560
Classification Name:	Ear, Nose, and Throat Stereotaxic Instrument
Product Code:	PGW
Predicate Device:	The Fiagon Navigation Extended Instrument Set ENT (K141456)Relieva Spin Sinus Dilation System (K111875)
Device Description:	The Acclarent® NavWire Sinus Navigation Guidewire anelectromagnetically (EM) trackable guidewire that provides surgeons ameans to access the intranasal and paranasal sinus spaces in endoscopicand image guided sinus surgeries. It is compatible with the CARTO®ENT System to track the NavWire within an electromagnetic field,which displays the magnetic sensor position relative to a patient's pre-operative CT scan.
Indications for Use:	The Acclarent® NavWire Sinus Navigation Guidewire is intended foruse as a navigable guidewire to provide access to nasal and sinusspaces, and confirmation of placement in the accessed anatomy. TheAcclarent® NavWire Sinus Navigation Guidewire is designed for useduring procedures where reference to a rigid anatomical structure in thefield of ENT surgery, such as the paranasal sinuses, can be identifiedrelative to a CT-based model of the anatomy.

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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "ent" in purple. There is a purple swoosh above the "ent" portion of the word.

Acclarent® NavWire Sinus Navigation Guidewire

Traditional 510(k) Premarket Notification CONFIDENTIAL

conjunction with a compatible surgical navigation system which consists of computer-aided software, CT-imaging, patient tracker, registration probe, and various instruments used in sinus surgery. Acclarent® NavWire Sinus Navigation Guidewire provides real-time tracking at the distal tip of the guidewire in the nasal anatomy. Performance Data: Bench testing was performed in order to determine device accuracy and precision. The following nonclinical tests were performed to determine substantial equivalence: Nonclinical accuracy testing of the Acclarent® NavWire Sinus . Navigation Guidewire with the CARTO® ENT System Nonclinical performance testing of the Acclarent® NavWire ● Sinus Navigation Guidewire with the CARTO® ENT System Functionality of the Acclarent® NavWire Sinus Navigation ● Guidewire after accelerated aging and user conditions . Simulated use testing of the NavWire with the CARTO® ENT System according to user's needs and intended use . Sterilization verification to effectively EtO sterilize the NavWire (SAL 106) and EtO residuals are within defined limits General requirements and performance testing of Acclarent® ● NavWire Sinus Navigation Guidewire to assure conformance with identified design and performance specifications The Acclarent NavWire passed all intended criteria in accordance with appropriate test criteria and standards. The Acclarent® NavWire Sinus Navigation Guidewire is substantially Summary of Substantial Equivalence: equivalent to the predicate device Fiagon Navigation Extended Instrument Set ENT (K141456) and reference device Relieva Luma Sentry Sinus Illumination System, cleared as part of the Relieva Spin Sinus Dilation System (K1118755). Like the predicate device, the Acclarent® NavWire Sinus Navigation Guidewire is an electromagnetically trackable guidewire which can be used to navigate tortuous sinus anatomy when used in conjunction with an ENT software application for computer assisted surgery. NavWire, like the predicate and reference devices, consists of a long flexible guidewire with a distal tip used to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The proposed navigation wire is similar in connectivity, technological characteristics, intended use, and design as the predicate device. The primary differences between the Acclarent® NavWire Sinus Navigation Guidewire and predicate device do not raise new issues of safety and effectiveness.

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).