TruDi NAV Suction Instruments

K180948 · Acclarent, Inc. · PGW · Jul 20, 2018 · Neurology

Device Facts

• Record ID: K180948
• Device Name: TruDi NAV Suction Instruments
• Applicant: Acclarent, Inc.
• Product Code: PGW · Neurology
• Decision Date: Jul 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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 Story

TruDi™ NAV Suction Instruments are reusable, electromagnetically-navigated surgical tools used in ENT and skull base surgery. The device set includes 0°, 70°, and 90° suction instruments and a single-use sterile TruDi™ NAV Cable. The instruments feature an integrated EM sensor at the distal tip. During surgery, the TruDi™ Navigation System tracks the sensor's position and orientation, displaying it in real-time over the patient's pre-operative CT scan. This allows the surgeon to confirm access to target anatomy before performing suctioning. The device is operated by ENT surgeons or support staff in a clinical setting. By providing real-time visualization of the instrument tip relative to patient anatomy, the device assists in precise navigation, potentially improving surgical accuracy and patient outcomes during complex ENT procedures.

Clinical Evidence

Bench testing only. No clinical data was necessary. Performance testing included dimensional specifications, suction flow, deflection, location accuracy (≤ 2mm RMS), electrical functionality, and EEPROM verification. Biocompatibility was confirmed per ISO 10993-1. Sterilization (steam/STERRAD) validated per AAMI/ANSI/ISO 11135:2014 (SAL 10⁻⁶). Simulated use testing with ENT surgeons confirmed mechanical and clinical accuracy.

Technological Characteristics

Reusable stainless steel 316L suction instruments (0°, 70°, 90°). Electromagnetic navigation via integrated distal-tip sensor. Connectivity via single-use sterile TruDi™ NAV Cable (polycarbonate/PVC/copper). Accuracy ≤ 2mm RMS. Reprocessing via manual/automated cleaning and steam/STERRAD sterilization. Biocompatibility per ISO 10993-1. Shelf life validated per ASTM F1980-07, F88/F88M-09, F2096-04.

Indications for Use

Indicated for ENT surgeons or support staff performing ENT medicine and skull base surgery procedures requiring navigation to targeted anatomy and suction of gases, liquids, and fragments.

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

• KARL STORZ EM Navigated Suction Tubes (K161555)

Reference Devices

• Medtronic EM ENT Navigated Suctions (K153555)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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.<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: | July 18, 2018 |
| [807.92(a)(2)] Name of Device | |
| Device Trade<br>Name: | TruDi™ NAV Suction Instruments |
| Classification<br>Name: | Stereotaxic Instrument |
| Common Name: | EM Navigable Suction Instruments |
| 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: | KARL STORZ EM Navigated Suction Tubes, (K161555)<br>(cleared as part of the KARL STORZ NAVI Electromagnetic Navigation System under<br>K161555) |
| 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-<br>navigated reusable devices intended to be used in conjunction with the TruDi™<br>Navigation System. When used with the TruDi™ Navigation System, the<br>TruDi™ NAV Suction Instruments provide navigation of the devices to targeted<br>anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation<br>System is the trade name for the ACCLARENT® ENT Navigation System |
| Indications for<br>Use: | TruDi™ NAV Suction Instruments are intended for use with the TruDi™<br>Navigation System during surgical procedures in ENT medicine and skull base<br>surgery to provide navigation of the instruments to the targeted anatomy, and<br>evacuation of gases, liquids, and fragments. |
| | TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or<br>support staff. |
| Difference in<br>Indications from<br>Predicate Device | 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. |
| [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.

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.

#### [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<br>(KARL STORZ EM Navigated<br>Suction Tubes) | Reference Device<br>(Medtronic EM ENT Navigated<br>Suctions) | Subject Device<br>(TruDi™ NAV Suction<br>Instruments) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K161555 | K153555 | K180948 |
| Manufacturer | KARL STORZ Endoscopy<br>America, Inc. | Medtronic Navigation, Inc. | Acclarent, Inc. |
| Trade Name | KARL STORZ EM Navigated<br>Suction Tubes<br>(Cleared as part of KARL STORZ<br>NAV 1 Electromagnetic Navigation<br>System under K161555) | Medtronic EM ENT<br>Navigated Suctions | TruDi™ NAV Suction<br>Instruments |
| 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<br>(KARL STORZ EM Navigated<br>Suction Tubes) | Reference Device<br>(Medtronic EM ENT Navigated<br>Suctions) | Subject Device<br>(TruDiTM NAV Suction<br>Instruments) |
| Indications for Use | The KARL STORZ NAV1<br>electromagnetic navigation system and<br>its associated applications are intended<br>as an aid for precisely locating<br>anatomical structures in either open or<br>percutaneous procedures under visual<br>control. Their use is indicated for any<br>medical condition in which use of<br>stereotactic surgery may be<br>appropriate, and where reference to a<br>rigid anatomical structure in the field of<br>ENT surgery, such as paranasal<br>sinuses, mastoid anatomy, can be<br>identified relative to radiological image<br>data or digitized landmarks of the<br>anatomy. | EM ENT Instruments are indicated for<br>use in navigated ENT procedures to<br>locate points on patient anatomy relative<br>to a CT-based or MR-based digital model<br>and to remove fluids, semi-fluid<br>substances, tissue, and bone dust. EM<br>ENT Instruments are indicated for use<br>with Medtronic computer-assisted<br>surgery systems. The EM ENT<br>instruments are indicated for use in ENT<br>procedures such as: | TruDiTM NAV Suction Instruments<br>are intended for use with the TruDiTM<br>Navigation System during surgical<br>procedures in ENT medicine and<br>skull base surgery to provide<br>navigation of the instruments to the<br>targeted anatomy, and evacuation of<br>gases, liquids, and fragments. |
| | | • CSF leak repairs related to ENT<br>procedure<br>• Intranasal procedures<br>• Orbital decompression procedures<br>• Polyposis procedures<br>• Endoscopic dacryocystorhinostomy<br>• Sinus procedures, such as maxillary<br>antrostomies<br>• Ethmoidectomies<br>• Sphenoidotomies/sphenoid explorations<br>• Turbinate resections and frontal<br>sinusotomies | |
| | | | The EM ENT instruments can also be<br>used in the ENT surgical approach for the<br>following procedures: |
| | | | • Pituitary tumor removal<br>• Skull base procedures<br>• Transsphenoidal procedures<br>• Optic nerve decompression procedures<br>• Encephalocele procedures |
| Attribute | Predicate Device<br>(KARL STORZ EM Navigated<br>Suction Tubes) | Reference Device<br>(Medtronic EM ENT Navigated<br>Suctions) | Subject Device<br>(TruDi™ NAV Suction<br>Instruments) |
| Intended Use | The navigated suction tubes aid<br>orientation and the suctioning of gases,<br>liquids, and fragments during invasive<br>interventions in ENT medicine and<br>lateral skull base surgery not involving<br>contact with the central nervous<br>system. | The Medtronic computer-assisted<br>surgery system and its associated<br>applications are intended as an aid for<br>precisely locating anatomical structures<br>in either open or percutaneous<br>procedures. Their use is indicated for<br>any medical condition in which the use<br>of stereotactic surgery may be<br>appropriate, and where MR-based<br>model, or digitized landmarks of the<br>anatomy.<br><br>The system and its associated<br>applications should be used only as an<br>adjunct for surgical guidance. They do<br>not replace the surgeon's knowledge,<br>expertise, or judgement. | TruDi™ NAV Suction Instruments<br>are intended for use with the<br>TruDi™ Navigation System during<br>surgical procedures in ENT<br>medicine and skull base surgery to<br>provide navigation of the<br>instruments to the targeted anatomy,<br>and evacuation of gases, liquids,<br>and fragments.<br><br>TruDi™ NAV Suction Instruments<br>are intended to be used by ENT<br>surgeons or support staff. |
| Attribute | Predicate Device<br>(KARL STORZ EM Navigated<br>Suction Tubes) | Reference Device<br>(Medtronic EM ENT Navigated<br>Suctions) | Subject Device<br>(TruDi™ NAV Suction<br>Instruments) |
| Technological<br>Characteristics | The KARL STORZ EM Navigated<br>Suction Tubes are electromagnetically-<br>navigated when used in conjunction<br>with the KARL STORZ NAV1<br>electromagnetic navigation system.<br><br>A sensor is integrated at the distal tip of<br>the suction tubes. The location of the<br>distal tip of the device is identified by<br>the KARL STORZ NAV1<br>electromagnetic navigation system, and<br>displayed in real-time view over the<br>patient's pre-operative CT/MTI scan to<br>confirm access of target anatomy.<br>Following confirmation, the physician<br>operates the suction instrument at the<br>target anatomical structure. | The Medtronic EM Navigated Suction<br>Instruments are electromagnetically-<br>navigated when used in conjunction<br>with the Medtronic StealthStation®<br>System System.<br><br>The EM ENT Instrument Tracker,<br>which includes a single user sensor, is<br>attached to the EM ENT navigated<br>suction to track its position. The<br>location of the instrument tracker is<br>identified by the Medtronic<br>StealthStation® System, and displayed<br>in real-time view over the patient's pre-<br>operative CT/MRI scan to confirm<br>access of target anatomy. Following<br>confirmation, the physician operates the<br>surgical instrument at the target<br>anatomical structure. Following<br>confirmation, the physician operates the<br>suction instrument at the target<br>anatomical structure. | TruDi™ NAV Suction Instruments<br>are electromagnetically-navigated<br>when used in conjunction with the<br>TruDi™ Navigation System.<br><br>A single-axial sensor (SAS) is<br>integrated into the distal tip of the<br>suction instruments. The location of<br>the distal tip of the device is<br>identified by the TruDi™ Navigation<br>System electromagnetic navigation<br>system, and displayed in real-time<br>view over the patient's pre-<br>operative CT scan to confirm access<br>of target anatomy. Following<br>confirmation, the physician operates<br>the suction instrument at the target<br>anatomical structure. |
| Localization Technology | Electromagnetic (sensor integrated into<br>distal tip of suction instrument) | Electromagnetic (proximal tracker<br>attached to suction instrument)<br>EM ENT Navigated Suctions | Electromagnetic (sensor integrated<br>into distal tip of suction instrument) |
| System or Instrument<br>Accuracy Requirements | Unknown | Within a standard controlled<br>environment: navigated peg errors of<br>1.54 mm at 95% confidence and 99%<br>reliability<br><br>Within a simulated surgical<br>environment: navigated peg errors of<br>1.73 mm at 5% confidence and 99%<br>reliability | ≤ 2mm RMS over the entire<br>navigation volume |
| Attribute | Predicate Device<br>(KARL STORZ EM Navigated<br>Suction Tubes) | Reference Device<br>(Medtronic EM ENT Navigated<br>Suctions) | Subject Device<br>(TruDi™ NAV Suction<br>Instruments) |
| Suction Functionality | Yes | Yes | Yes |
| Rigid Suction Device | Yes | Yes | Yes |
| Instrument Tip<br>Configurations | Standard (straight)<br>Olive | Standard (straight)<br>Angle<br>Olive<br>Ball/Angle | Standard (straight)<br>Olive |
| Materials | <b>EM ENT Navigated Suction Tubes:</b><br>Stainless Steel | <b>EM ENT Navigated Suctions</b><br>Stainless Steel, Titanium | <b>TruDi™ NAV Suction Instruments</b><br>Stainless Steel 316L |
| | <b>Cable</b><br>Unknown | <b>Patient and Instrument Trackers</b><br>Patient contacting cable: AES<br>Santoprene® 8281-90 material with<br>Colorant Pantone 301C | <b>TruDi™ NAV Cable</b><br>Polycarbonate, Polyvinyl Chloride<br>(PVC), copper |
| Instrument Shaft<br>Configurations | Straight 0° & Curved (~70°) | Fixed- Straight, Small Straight, 45°<br>frontal, 70º curve, 90° curve, 90° frontal | Straight 0°, 70° curve, 90° curve |
| Supplied as<br>"Reusable Use" | <b>EM ENT Navigated Suction Tubes:</b><br>Yes<br><b>Cable:</b><br>Yes (attached to the Suction Tubes) | <b>EM ENT Navigated Suctions</b><br>Yes<br><b>Patient and Instrument Trackers</b><br>Supplied Sterile Single Use | <b>TruDi™ NAV Suction<br/>Instruments</b><br>Yes<br><b>TruDi™ NAV Cable</b><br>Supplied Sterile Single Use |
| | Location of Sensor | Sensor is built-in at the distal tip of the<br>suction tube | Single-use sensor that is clipped onto<br>the suction instrument |
| Reprocessing methods | Manual Cleaning, Steam Sterilization,<br>STERRAD® 100NX® Standard<br>sterilization cycle, and V-PRO® 1 Plus<br>Lumen sterilization cycle | Manual Cleaning & Steam Sterilization | Manual Cleaning, Automated<br>Cleaning, Steam Sterilizati…