TruDi Shaver Blade

K221037 · Acclarent, Inc. · PGW · Jul 20, 2022 · Neurology

Device Facts

• Record ID: K221037
• Device Name: TruDi Shaver Blade
• Applicant: Acclarent, Inc.
• Product Code: PGW · Neurology
• Decision Date: Jul 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. TruDi® Shaver Blades may be used in, but is not limited to, the following procedures: · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater · Orbital decompression · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit · Access to the sphenoid sinus

Device Story

TruDi® Shaver Blade is a single-use, sterile, electromagnetically (EM) navigated instrument. It connects to the Bien-Air S120 Shaver Handpiece and operates within the EM field generated by the TruDi® Navigation System. The system tracks a sensor integrated into the distal tip of the blade. During ENT, maxillofacial, or head and neck surgery, the navigation system displays the blade's tip position in real-time over the patient's preoperative CT or MRI scans. This visual feedback allows the surgeon to confirm access to target anatomy and precisely locate structures during tissue incision and removal. The device is used in clinical settings by surgeons. It benefits patients by providing real-time navigational guidance, potentially increasing surgical precision and safety during complex procedures involving the paranasal sinuses, orbit, or skull base.

Clinical Evidence

Bench testing only. Testing included dimensional specifications, electrical tests, connector joint separation force, heat shrink slip, strain relief axial force, and navigational location accuracy (< 2mm RMS). Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2. Sterilization validated per ISO 11135:2014 (SAL 10^-6). Biocompatibility per ISO 10993-1. Shelf life established via ASTM F1980-16, F88-15, and F2096-11. Design validation (simulated use on cadavers) verified functionality in a clinical setting.

Technological Characteristics

Single-use, sterile, EM-navigated shaver blade. Materials: 304L stainless steel. Sensing: Integrated EM sensor at distal tip. Connectivity: Connects to Bien-Air S120 Shaver Handpiece and TruDi® Navigation System. Sterilization: Ethylene Oxide. Form factor: Straight and curved (15°, 40°, 60°) configurations. Accuracy: < 2mm RMS.

Indications for Use

Indicated for patients requiring incision and removal of soft/hard tissue or bone in ENT, Maxillofacial, Head and Neck, and ENT skull base surgery where navigated surgery is appropriate and rigid anatomical structures can be referenced to CT/MR models.

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

• Medtronic Navigated Quadcut Blades (K130608)

Reference Devices

• Bien-Air OSSEODUO S120 Shaver Handpiece (K083720)
• TruDi® Curette (K201174)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 20, 2022

Acclarent, Inc. Leena Zalavadia Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K221037

Trade/Device Name: TruDi Shaver Blade Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW, ERL Dated: June 16, 2022 Received: June 17, 2022

## Dear Leena Zalavadia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221037

Device Name TruDi® Shaver Blade

#### Indications for Use (Describe)

TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
- · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- · Access to the sphenoid sinus

| 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 logo for "Acclarent", which is partially covered by a purple arc. Below the logo, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi® Shaver Blade" is at the bottom of the image.

# 510(K) SUMMARY- K221037

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

| Sponsor/Submitter: | Acclarent, Inc.<br>31 Technology Drive, Suite 200<br>Irvine, CA 92618 |
|--------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Zalavadia<br>Regulatory Affairs Manager<br>Email: [e-mail]<br>Tel: [phone] |

Date Summary Prepared: July 20, 2022

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

| Device Trade<br>Name: | TruDi® Shaver Blade |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------|
| 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 |
| Primary Product<br>Code: | PGW |
| Secondary Product<br>Code: | ERL |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | Medtronic Navigated Quadcut Blades (K130608) |
| Reference Devices: | Bien-Air OSSEODUO S120 Shaver Handpiece<br>(Cleared OSSEODUO Shaver and Drill System under K083720) |
| | TruDi® Curette (K201174) |

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Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a combination of black and purple lettering, with a curved purple line above the "ent" portion of the name. Below the name, in smaller font, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."

#### [807.92(a)(4)] Device Description

#### Device Description: The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

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

#### TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Indications for Use: Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression

· Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit

- Access to the sphenoid sinus
#### Difference in The indications for use and intended use of the subject device, TruDi® Shaver Indications from Blade, are similar to the predicate device and reference device (Bien-Air Predicate Device OSSEODUO S120 Shaver Handpiece). Both the subject device and predicate device are electromagnetically navigated shaver blades intended to aid in the incision and removal of soft and hard tissue or bone during head and neck and ENT surgery. One of the reference devices, Bien-Air S120 Shaver Handpiece (K083720), is intended to be used with the subject device, therefore relevant parts of the indications for use of the reference device have been added to the indications for use for the subject device.

For a comparison of the indications for use/intended use of the subject device and its predicate device, please reference Table 1.

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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. The logo features the word "Acclarent" in a bold, sans-serif font, with a purple swoosh above the "ent". Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The Johnson & Johnson part of the phrase is in red.

| [807.92(a)(6)] Technical Characteristics | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The subject device, TruDi® Shaver Blade, is substantially equivalent in<br>technological characteristics, as there are no significant differences in design,<br>fundamental scientific technology, or other features of the device from the<br>predicate device. |
| | Both the subject device and predicate device (Medtronic Navigated Quadcut<br>Blades, K130608) are electromagnetically navigated shaver blades, which are<br>intended to aid in the incision and removal of soft and hard tissue or bone during<br>head and neck and ENT surgery. Similar to the predicate device, the subject<br>device incorporates a sensor, which is tracked by its navigation system. The<br>location of the sensor is identified by the navigation system and displayed in<br>real-time view over the patient's pre-operative CT/MRI scan to confirm access,<br>and to locate anatomical structures during ENT surgical procedures. |
| | The primary differences between the subject and predicate device are the<br>following:<br>The subject device has a sensor integrated at the distal tip of the device,<br>whereas the predicate device has a tracker with a sensor inside mounted<br>on the proximal end of the blade to allow for navigation during the ENT<br>surgical procedures The subject device is available in a variety of blade angles, 0° (straight),<br>15°, 40°, and 60° angles, while the predicate device is only available in<br>0° (straight) angle. The subject device uses a different handpiece and navigation system to<br>operate the device than the predicate device. The subject device is<br>intended for use with the Bien-Air S120 Shaver Handpiece (K083720),<br>OSSEODUO control unit (K083720) and TruDi® Navigation System<br>(K192397), whereas the predicate device is intended for use with the<br>Medtronic M4 and M5 hand piece and Medtronic's navigation system. |
| | However, these differences do not raise new concerns of safety and effectiveness<br>for the subject device as demonstrated by performance testing and design<br>validation testing (simulated use testing). See Table 1 for a comparison of the<br>technological characteristics between the subject device and the predicate<br>device. |
| | In order to operate the subject device, it must connect to the Bien-Air S120<br>Shaver Handpiece (K083720), which is why it was selected as the reference |

device. The TruDi® Curette (K201174) is also presented as a reference device

due to similarities in testing methods.

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Image /page/6/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® Shaver Blade". The Acclarent logo is in black font, while the Johnson & Johnson text is in red font.

# Table 1: Substantial Equivalence Table

| Attribute | Predicate Device:<br>Medtronic Navigated<br>Quadcut Blades | Reference Device:<br>Bien-Air OSSEODUO S120<br>Shaver Handpiece | Reference Device:<br>TruDi® Curette | Subject Device:<br>TruDi® Shaver Blade | Substantial Equivalence<br>Rationale |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>number | K130608 | K083720 | K201174 | K221037 | N/A |
| Manufacturer | Medtronic Navigation, Inc. | Bien-Air Surgery SA | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | Quadcut | OSSEODUO Shaver and Drill<br>System | TruDi® Curette | TruDi® Shaver Blade | N/A |
| Classification<br>Name | Neurological Stereotaxic<br>Instrument | Drill, Surgical, ENT (Electric<br>or Pneumatic) including<br>Handpiece | Ear, Nose, and Throat<br>Stereotaxic Instrument | Ear, Nose, and Throat<br>Stereotaxic Instrument | Same as the reference<br>device (TruDi® Curette). |
| Class | II | II | II | II | Same |
| Classification<br>Product Code | HAW | ERL | PGW | PGW | Same as reference device<br>(TruDi® Curette). |
| Secondary<br>Product Code | N/A | N/A | N/A | ERL | Same as reference device<br>(Bien-Air OSSEODUO<br>S120 Shaver Handpiece). |
| Classification<br>Section | 21 CFR 882.4560 | 21 CFR 874.4250 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same as predicate and<br>reference device (TruDi®<br>Curette). |
| | | | | | |
| Attribute | Predicate Device:<br>Medtronic Navigated<br>Quadcut Blades | Reference Device:<br>Bien-Air OSSEODUO S120<br>Shaver Handpiece | Reference Device:<br>TruDi® Curette | Subject Device:<br>TruDi® Shaver Blade | Substantial<br>Equivalence<br>Rationale |
| Indications<br>for Use | The XPS/IPC System is<br>intended for the incision and<br>removal of soft and hard tissue<br>or bone in general<br>otorhinolaryngology, head and<br>neck, and otoneurological<br>surgery.<br><br>The Medtronic computer-<br>assisted surgery system and its<br>associated applications are<br>intended as an aid for<br>precisely locating anatomical<br>structures in either open or<br>percutaneous procedures.<br><br>The system and its associated<br>applications should be used<br>only as an adjunct for surgical<br>guidance. They do not replace<br>the surgeon's knowledge,<br>expertise, or judgment. | The OSSEODUO is a drill and<br>shaver system that has been<br>designed for drilling and shaping<br>bone and for<br>"the resection of soft and hard<br>tissues as part of surgical<br>operations in the areas of<br>otorhinolaryngology,<br>otoneurology, maxillofacial<br>surgery, and head and neck<br>surgery."<br><br>The shaver handpiece S80 or<br>S120 is designed for cutting and<br>removal of soft and hard tissue<br>in the fields of:<br>- Endoscopic sinus surgery (such<br>as ethmoidectomy,<br>polypectomy, septoplasty)<br>- Endoscopic<br>dacryocystorhinostomy (DCR)<br>- Nasopharyngeal and laryngeal<br>prodedures (such as<br>adenoidectomy, polypectomy,<br>tonsillectomy)<br>- Head and neck surgery (such<br>as acoustic-neuroma removal,<br>tumor removal, rhinoplasty,<br>adipose tissue<br>removal, plastic, reconstructive | TruDi® Curette is intended<br>for use with the TruDi®<br>Navigation System to<br>manipulate, dissect and/or<br>remove tissue, cartilage and<br>bone during surgical<br>procedures in ENT and<br>ENT skull base surgery. | TruDi® Shaver Blades are intended<br>for use with the Bien-Air S120<br>Shaver Handpiece and the TruDi®<br>Navigation System to aid in the<br>incision and removal of soft and hard<br>tissue or bone in ENT, Maxillofacial<br>surgery, Head and Neck and ENT<br>skull base surgery. Their use is<br>indicated for any medical condition<br>in which the use of navigated surgery<br>may be appropriate, and where<br>reference to a rigid anatomical<br>structure can be identified relative to<br>a CT or MR based model.<br><br>TruDi® Shaver Blades may be used<br>in, but is not limited to, the following<br>procedures:<br>• Endoscopic sinus surgery (such as<br>ethmoidectomy, polypectomy,<br>septoplasty)<br>• Drainage of mucoceles or abscesses<br>that have extended from the<br>paranasal sinuses and up to the dura<br>mater<br>• Orbital decompression<br>• Any other of a number of tumors<br>involving the lateral nasal wall,<br>paranasal sinuses and orbit<br>• Access to the sphenoid sinus | The indications for use<br>for the subject device is<br>aligned with the<br>indications for use of<br>the predicate and<br>reference device (Bien-<br>Air OSSEODUO S120<br>Shaver Handpiece). |
| | Predicate Device: | Reference Device: | Reference Device: | Subject Device: | Substantial Equivalence |
| Attribute | Medtronic Navigated<br>Quadcut Blades | Bien-Air OSSEODUO S120<br>Shaver Handpiece | TruDi® Curette | TruDi® Shaver Blade | Rationale |
| Intended Use | The Quadcut blades are<br>intended for the incision and<br>removal of soft and hard tissue<br>or bone in general<br>otorhinolaryngology, head and<br>neck, and otoneurological<br>surgery. | The shaver handpiece S80 or<br>S120 is designed for cutting<br>and removal of soft and hard<br>tissue | TruDi® Curette is intended<br>for use with the TruDi®<br>Navigation System to<br>manipulate, dissect and/or<br>remove tissue, cartilage and<br>bone during surgical<br>procedures in ENT and<br>ENT skull base surgery. | TruDi® Shaver Blades are<br>intended for use with the Bien-<br>Air S120 Shaver Handpiece and<br>the TruDi® Navigation System<br>to aid in the incision and removal<br>of soft and hard tissue or bone in<br>ENT, Maxillofacial surgery, Head<br>and Neck and ENT skull base | The intended use for the<br>subject device is aligned<br>with the intended use of<br>the predicate and reference<br>device (Bien-Air<br>OSSEODUO S120 Shaver<br>Handpiece). |
| Technological<br>Characteristics | Quadcut is intended for<br>attachment to the Medtronic<br>M4 hand piece for use in<br>conjunction with Fusion ENT<br>software on a Medtronic<br>computer-assisted surgery<br>system. Each blade has a<br>tracker mounted on it to allow<br>for navigation during the ENT<br>surgical procedure. The<br>system's mobile emitter<br>generates a low-energy<br>magnetic field to locate the<br>tracker mounted on the blade.<br>Then, the software displays the<br>location of the blade's tip<br>within multiple patient image<br>planes and other anatomical<br>renderings. | The Bien-Air S120 shaver<br>handpiece includes a<br>micromotor, a gear set, a<br>coupling system for shaver<br>blades and connections for<br>irrigation and suction. Through<br>the control unit it can operate<br>in oscillating modus (reversing<br>after a user-defined number of<br>turns in each direction) or in<br>continuous CW and CCW<br>rotation. | The TruDi® Curette is a<br>single-use electro-<br>magnetically-navigated<br>instrument, which is<br>intended to be used with the<br>TruDi® Navigation System.<br>The device incorporates a<br>sensor within the distal<br>shaft, which is tracked by<br>the TruDi® Navigation<br>System. The location of the<br>distal tip of the device is<br>identified by the navigation<br>system and displayed in<br>real-time view over the<br>patient's pre-operative<br>CT/MRI scan to confirm<br>access of target anatomy.<br>Following confirmation, the<br>physician operates the<br>instrument at the target<br>anatomical structure. | surgery.<br>The TruDi® Shaver Blade is a<br>single-use electromagnetically-<br>navigated instrument, which is<br>intended to be used with the<br>TruDi® Navigation System.<br>The device incorporates a sensor<br>within the distal shaft, which is<br>tracked by the TruDi®<br>Navigation System. The location<br>of the distal tip of the device is<br>identified by the navigation<br>system and displayed in real-time<br>view over the patient's pre-<br>operative CT/MRI scan to<br>confirm access of target anatomy.<br>Following confirmation, the<br>physician operates the instrument<br>at the target anatomical structure. | The technological<br>characteristics of the<br>subject device are<br>similar to the predicate and<br>reference devices. |
| Attribute | Predicate Device:<br>Medtronic Navigated<br>Quadcut Blades | Reference Device:<br>Bien-Air OSSEODUO S120<br>Shaver Handpiece | Reference Device:<br>TruDi® Curette | Subject Device:<br>TruDi® Shaver Blade…