TruDi NAV Wire

K190532 · Acclarent, Inc. · PGW · May 3, 2019 · Neurology

Device Facts

• Record ID: K190532
• Device Name: TruDi NAV Wire
• Applicant: Acclarent, Inc.
• Product Code: PGW · Neurology
• Decision Date: May 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.

Device Story

TruDi™ NAV Wire is a single-use, flexible, 0.035" electromagnetically (EM) navigable guidewire; features an EM sensor at the distal tip for real-time tracking. Used during ENT/paranasal surgeries; connects to the TruDi™ Navigation System. The system tracks the wire within an EM field, displaying sensor position relative to pre-operative CT scans. The device includes a fixed proximal connector, spiral coil body, and pre-shaped atraumatic distal tip; allows distal tip rotation for steering. Used with compatible non-ferromagnetic instruments (lumen >1mm, luer lock). Provides surgeons with real-time visualization to confirm instrument placement in nasal anatomy; facilitates accurate access to rigid anatomical structures.

Clinical Evidence

Bench testing only. Performance data included simulated use, dimensional specifications, insertion/rotational/suction durability, joint separation force, stiffness, swivel performance, frictional force, and location accuracy. Biocompatibility per ISO 10993-1 and sterilization validation per ISO 11135:2014 (SAL 10^-6) were completed. Shelf life established via ASTM F1980-07, F88/F88M-09, and F2096-11.

Technological Characteristics

0.035" EM navigable guidewire; EM sensor at distal tip; flexible spiral coil body; fixed proximal connector. Compatible with TruDi™ Navigation System. Sterilized via Ethylene Oxide (EtO) per ISO 11135:2014. Biocompatible per ISO 10993-1. Non-ferromagnetic construction.

Indications for Use

Indicated for use in ENT procedures requiring electromagnetic navigation to provide access and confirm placement within patient anatomy relative to a CT-based model. Compatible with non-ferromagnetic instruments having a lumen >1mm and a luer lock mechanism.

Regulatory Classification

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.

Predicate Devices

• Acclarent® NavWire Sinus Navigation Guidewire (K161697)

Reference Devices

• Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687)

Submission Summary (Full Text)

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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 agency's name, "U.S. Food & Drug Administration."

May 3, 2019

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

Re: K190532

Trade/Device Name: TruDi NAV Wire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: March 1, 2019 Received: March 4, 2019

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. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Michael Ryan 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 Ouality 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190532

Device Name TruDi™ NAV Wire

Indications for Use (Describe)

TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.

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

X 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/1 description: The image contains the Acclarent logo, which is a medical technology company. Below the logo is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The image also contains the text "TruDi™ NAV Wire", which is likely a product name.

# 510(K) SUMMARY

#### [807.92(a)(1)] Submitter Information

| Sponsor/Submitter: | Acclarent, Inc.<br>33 Technology Drive<br>Irvine, CA 92618 |
|--------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Sorathia<br>Sr. Regulatory Affairs Specialist<br>Email: [e-mail]<br>Tel: [phone] |

Date Summary Prepared: May 3, 2019

#### [807.92(a)(2)] Name of Device

| Device Trade<br>Name: | TruDi™ NAV Wire | | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Classification<br>Name: | Stereotaxic Instrument | | |
| Common Name: | Image Guided Surgery System | | |
| Device<br>Classification: | Class II | | |
| Regulation<br>Number: | 21 CFR 882.4560 | | |
| Review Panel: | Ear, Nose, and Throat | | |
| Product Code: | PGW | | |
| [807.92(a)(3)] Legally Marketed Devices | | | |
| Predicate Device: | Acclarent® NavWire Sinus Navigation Guidewire, (K161697) | | |
| Reference Device: | Relieva SpinPlus® Nav Balloon Sinuplasty System, (K171687) | | |
| [807.92(a)(4)] Device Description | | | |
| Device Description: | The subject device, TruDi™ NAV Wire, is a single-use electromagnetically<br>(EM) navigated, flexible guidewire, which is compatible for use with the<br>TruDi™ Navigation System to provide access and confirmation of placement in<br>patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV | | |

Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.

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Image /page/4/Picture/1 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi™ NAV Wire". The Acclarent logo is in black and purple.

The subject device, TruDi™ NAV Wire, is a modification to the predicate device, Acclarent® NavWire Sinus Navigation Guidewire (K161697), and is similar to the guidewire construction of the reference device, Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687). The TruDi™ NAV Wire, like the predicate Acclarent® NavWire Sinus Navigation Guidewire and reference Relieva SpinPlus® Nav Balloon Sinuplasty System consists of a 0.035" EM navigable guidewire with an EM trackable sensor incorporated at the distal tip to provide access to a rigid anatomical structure that can be identified relative to a CT-based model of the anatomy, and confirm placement in the accessed anatomy when used with the TruDi™ Navigation System. The same EM trackable sensor used in the subject TruDi™ NAV Wire device was cleared in the predicate Acclarent® NavWire Sinus Navigation Guidewire (K161697) and reference Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687).

## [807.92(a)(5)] Intended Use

| Indications for<br>Use: | The TruDi™ NAV Wire is intended for use as an electromagnetically navigable<br>guidewire to provide access and confirmation of placement in the patient<br>anatomy. The device is intended for use during ENT procedures where reference<br>to a rigid anatomical structure can be identified relative to a CT-based model of<br>the anatomy. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in<br>Indications from<br>Predicate Device | The indications for use statement of the subject TruDi™ NAV Wire device is<br>similar to the predicate NavWire device (K161697). The subject and predicate<br>devices are both indicated for use in ENT procedures where image-guided<br>surgery is used to provide access to the patient anatomy and to confirm placement<br>of the device in the accessed anatomy. |
| | The subject device is compatible with non-ferromagnetic instruments that have a<br>lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire<br>onto the instrument. Whereas, the predicate device is compatible with the<br>RELIEVA ULTIRRA Nav™ Sinus Balloon Catheter (K161698). |
| | The changes in indications for use of the subject device do not raise any<br>significant issues of safety and effectiveness when used as labeled, as<br>demonstrated by performance testing. |
| | The difference in indications for use between the subject device and the<br>predicate/reference devices is supported is presented in Table 1 of this summary. |

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Image /page/5/Picture/1 description: The image contains the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Wire" is displayed in a bold font. The Acclarent logo features the company name in a combination of black and purple, with a stylized swoosh above the "ent" portion of the name.

# [807.92(a)(6)] Technical Characteristics

| Technological<br>Characteristics: | The subject TruDi™ NAV Wire device is a modification to the predicate<br>NavWire device (K161697) and is similar to the guidewire construction of the<br>reference SpinPlus Nav device (K171687). | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The subject TruDi™ NAV Wire device, like the predicate NavWire device and<br>reference SpinPlus Nav device, consists of a 0.035" EM navigable guidewire<br>with an EM trackable sensor incorporated at the distal tip to provide<br>confirmation in the accessed anatomy when used with the TruDi™ Navigation<br>System. The same EM trackable sensor used in the TruDi™ NAV Wire device<br>was cleared in the predicate NavWire device (K161697) and reference SpinPlus<br>Nav device (K171687). | |
| | Similar to the reference SpinPlus Nav device, the subject TruDi™ NAV Wire<br>device consists of a fixed proximal connector, a flexible spiral coil instrument<br>body, and a pre-shaped atraumatic distal tip housing a sensor. Like the reference<br>SpinPlus Nav device, the subject device incorporates a feature, which allows<br>rotation of the distal tip of guidewire for steering functionality. | |
| | The TruDi™ NAV Wire, like the predicate NavWire device and reference<br>SpinPlus Nav device, connects with the TruDi™ Navigation System to track the<br>EM navigable guidewire within an electromagnetic field, which displays the<br>magnetic sensor position relative to a patient's pre-operative CT scan. | |
| | The only difference in technological characteristics between the subject TruDi™<br>NAV Wire device and reference SpinPlus Nav device is how the rotation of the<br>distal region of the device is achieved. This feature is similar in the subject<br>device and reference device and do not raise any significant issues of safety and<br>effectiveness when used as labeled, as demonstrated by performance testing. | |
| | See Table 1 for a comparison of the technological characteristics between the<br>subject device and the predicate/reference devices. | |

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Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a black, bolded font with a purple swoosh above the 'ent'. Below the logo, in smaller font, it says 'PART OF THE Johnson & Johnson FAMILY OF COMPANIES'. Underneath that, the text 'TruDi™ NAV Wire' is displayed in a bold font.

| Attribute | Primary Predicate Device<br>(Acclarent® NavWire) | Reference Device<br>(Relieva SpinPlus Nav™ Balloon<br>Sinuplasty System) | Subject Device<br>(TruDi™ NAV Wire) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acclarent, Inc. | Acclarent, Inc. | Acclarent, Inc |
| 510(k) Number | K161697 | K171687 | K190532 |
| Proprietary Trade<br>Name | Acclarent® NavWire Sinus Navigation<br>Guidewire | Relieva SpinPlus Nav™ Balloon Sinuplasty<br>System | TruDi™ NAV Wire |
| Common Name | Stereotaxic Instrument | Sinus Dilation System | Stereotaxic Instrument |
| Class | Class II | Class I | Class II |
| Product Code | PGW | LRC | PGW |
| Classification Section | 21 CFR 882.4560 | 21 CFR 874.4420 | 21 CFR 882.4560 |
| Indications for Use | The NavWire is intended for use as a<br>navigable guidewire to provide access<br>to nasal and sinus spaces, and<br>confirmation of placement in the<br>accessed anatomy. The NavWire is<br>designed for use during procedures<br>where reference to a rigid anatomical<br>structure in the field of ENT surgery,<br>such as the paranasal sinuses, can be<br>identified relative to a CT-based model<br>of the anatomy. | The RELIEVA SPINPLUS™ Nav Balloon<br>Sinuplasty System is intended to provide a<br>means to access the sinus space, within and<br>across nasal and sinus structures; dilate the<br>sinus ostia and spaces associated with the<br>paranasal sinus cavities for diagnostic and<br>therapeutic procedures; and irrigate from<br>within a target sinus for therapeutic<br>procedures and to facilitate diagnostic<br>procedures.<br>For children aged 17 and under, the<br>RELIEVA SPINPLUS™ Nav Balloon<br>Sinuplasty System is intended to provide a<br>means to access the sinus space, within and<br>across nasal and sinus structures; dilate sinus<br>ostia and spaces associated with the<br>maxillary sinus for diagnostic and<br>therapeutic procedures; and irrigate from<br>within the maxillary sinus for therapeutic<br>procedures and to facilitate diagnostic<br>procedures. | The TruDi™ NAV Wire is intended for<br>use as an electromagnetically<br>navigable guidewire to provide access<br>and confirmation of placement in the<br>patient anatomy. The device is<br>intended for use during ENT<br>procedures where reference to a rigid<br>anatomical structure can be identified<br>relative to a CT-based model of the<br>anatomy. |
| Attribute | Primary Predicate Device<br>(Acclarent® NavWire) | Reference Device<br>(Relieva SpinPlus Nav™ Balloon<br>Sinuplasty System) | Subject Device<br>(TruDi™ NAV Wire) |
| | | The RELIEVA SPINPLUS™ Nav Balloon<br>Sinuplasty System may be utilized in<br>conjunction with the ACCLARENT® ENT<br>Navigation System, to provide access to<br>nasal and sinus spaces, and to confirm<br>placement in the accessed anatomy. | |
| Single-Use | Yes | Yes | Yes |
| Sterile | EtO Sterile | EtO Sterile | EtO Sterile |
| Direct Patient Contact | Yes<br>Limited Duration < 24 hours | Yes<br>Limited Duration < 24 hours | Yes<br>Limited Duration < 24 hours |
| Labeled as Non-<br>pyrogenic? | No | No | No |
| Guidewire Diameter | 0.035 inches | 0.035 inches | 0.035 inches |
| Tracking Method | Electromagnetic<br>with Magnetic Sensor<br>at Distal Wire Tip | Electromagnetic<br>with Magnetic Sensor<br>at Distal Wire Tip | Electromagnetic<br>with Magnetic Sensor<br>at Distal Wire Tip |
| Flexible | Yes- flexible guidewire | Yes- flexible sinus balloon catheter and<br>guidewire | Yes- flexible guidewire |
| Principle of Operation | The Acclarent® NavWire Sinus<br>Navigation Guidewire utilizes<br>electromagnetic image-guided sinus<br>surgery and is used in conjunction with<br>a compatible surgical navigation<br>system which consists of computer-<br>aided software, CT-imaging, patient<br>tracker, registration probe, and various<br>instruments used in sinus surgery.<br>Acclarent® NavWire Sinus Navigation<br>Guidewire provides real-time tracking | Combines a Sinus Guide Catheter and<br>Handle Assembly (integrated with Sinus<br>Balloon Catheter, Sinus Irrigation and Sinus<br>Navigation System) into a single device.<br>The device is connected to the TruDi™<br>Navigation System to provide location<br>information via EM navigation relative to a<br>pre-loaded scan. | The TruDi™ NAV Wire utilizes<br>electromagnetic image-guided ENT<br>surgery and is used in conjunction with<br>a compatible surgical navigation<br>system which consists of computer-<br>aided software, CT-imaging, patient<br>tracker, registration probe, and various<br>instruments used in sinus surgery.<br>TruDi™ NAV Wire provides real-time<br>tracking at the distal tip of the<br>guidewire in the nasal anatomy. |

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Image /page/7/Picture/0 description: The image contains the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Wire" is displayed in a bold font. The logo features the company name in a stylized font, with a purple arc above it.

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Image /page/8/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a bold, sans-serif font, with the "ent" portion of the name in purple and slightly curved upwards. Below the name, in smaller text, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The logo is simple and modern, reflecting the company's focus on innovation in the medical field.

| Attribute | Primary Predicate Device<br>(Acclarent® NavWire) | Reference Device<br>(Relieva SpinPlus Nav™ Balloon<br>Sinuplasty System) | Subject Device<br>(TruDi™ NAV Wire) |
|--------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | at the distal tip of the guidewire in the<br>nasal anatomy. | | |
| Compatible devices | TruDi™ Navigation System and<br>UltirraNav™ Sinus Balloon Catheter | TruDi™ Navigation System | TruDi™ Navigation System and non-<br>ferromagnetic instruments that have a<br>lumen of greater than 1mm in diameter<br>and a luer lock mechanism to fix the<br>wire onto the instrument. |

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Image /page/9/Picture/0 description: The image shows the Acclarent logo, which includes the company name in a stylized font with a purple arc above it. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The text "Traditional 510(k)" and "TruDi™ NAV Wire" are also present, indicating the document relates to a medical device submission.

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

| Non-Clinical Performance<br>Data: | Bench testing has been performed and met all acceptance criteria for<br>attributes, such as simulated use testing, dimensional specifications,<br>insertion durability, rotational durability, suction durability, joint<br>separation force, stiffness, swivel functional performance, frictional<br>force, and location accuracy (sensor sensitivity).<br><br>The sterilization process has been validated per ISO 11135:2014 and<br>demonstrated a sterility assurance level of 10-6. The method used for<br>sterilization validation is the overkill (half-cycle approach) in a fixed<br>chamber. Ethylene oxide residuals have been tested and meet ISO<br>10993-7:2008 requirements. The subject device is not tested nor labeled<br>as "non-pyrogenic".<br><br>Biocompatibility testing was successfully completed to determine that<br>the TruDi™ NAV Wire is biocompatible per ISO 10993-1.<br><br>Packaging shelf life for the TruDi™ NAV Wire was established through<br>accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and<br>ASTM F2096-11 requirements and confirmed to meet a shelf life of<br>three months.<br><br>The TruDi™ NAV Wire passed all intended criteria in accordance with<br>appropriate test criteria and standards. |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi™ NAV Wire. The<br>performance data demonstrated that the device performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-<br>Clinical and Clinical Tests | Based on the information provided in this premarket notification,<br>Acclarent concludes that the TruDi™ NAV Wire is as safe and<br>effective and substantially equivalent to the predicate device. |