ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

K262235 · Medtronic Xomed, Inc. · PGW · Sep 4, 2026 · Neurology

Device Facts

• Record ID: K262235
• Device Name: ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)
• Applicant: Medtronic Xomed, Inc.
• Product Code: PGW · Neurology
• Decision Date: Sep 4, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ApexCut™ EM navigated blades are surgical instruments used in conjunction with IPC/XPS and Medtronic computer-assisted surgery systems which are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology (ENT) and head and neck surgery and as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated accessories should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Device Story

ApexCut™ EM Navigated Blades are sterile, single-use surgical instruments for ENT/head and neck procedures; used with Medtronic StraightShot™ M Series microdebrider handpieces, IPC/XPS powered consoles, and Medtronic computer-assisted navigation systems. Device features a distal cutting window, suction/irrigation lumen, and an embedded electromagnetic (EM) tracker. During surgery, the navigation system's mobile emitter generates a low-energy magnetic field to track the blade's position; software displays the blade tip location relative to preoperative CT/MR image planes or anatomical renderings. Surgeons use the visual output as an adjunct for guidance during tissue resection. The device assists in precise anatomical localization; it does not replace surgeon judgment. Benefits include real-time visualization of the cutting tip relative to patient anatomy, aiding in surgical accuracy during open or percutaneous procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by nonclinical bench testing, including functional performance, mechanical integrity, navigation accuracy, system compatibility, sterilization validation, packaging validation, shelf-life evaluation, and biocompatibility assessment.

Technological Characteristics

Materials: 304L stainless steel. Principle: Powered oscillating microdebrider with integrated electromagnetic tracking. Energy: Powered by Medtronic IPC/XPS consoles. Connectivity: Wired connection to Medtronic navigation systems. Sterilization: Ethylene oxide (10^-6 SAL). Form factor: Various shaft diameters (2.9mm–4.0mm) and lengths/angles. Software: Integrated EM tracker interface for navigation system display.

Indications for Use

Indicated for adolescents and adults undergoing ENT, head, and neck surgery requiring incision/removal of soft/hard tissue or bone where stereotactic guidance relative to CT/MR models or digitized anatomical landmarks is appropriate.

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

• QuadCut® Navigated Blades (K130608)

Reference Devices

• TruDi® Shaver Blade (K221037)

Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 4, 2026

Medtronic Xomed, Inc.
Penny Goodman
Senior Regulatory Affairs Specialist
6743 Southpoint Dr. N.
Jacksonville, Florida 32216

Re: K262235

Trade/Device Name: ApexCut™ Blade with Automated EM Tracking (187BL4012EM); ApexCut™ Blade with Automated EM Tracking (187BL4040EM); ApexCut™ Blade with Automated EM Tracking (187BL4060EM); ApexCut™ Blade with Automated EM Tracking (187BL2975EM); ApexCut™ Blade with Automated EM Tracking (187BL3590EM); ApexCut™ Blade with Automated EM Tracking (187BL4000LEM)

Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic Instrument

Regulatory Class: Class II

Product Code: PGW

Dated: June 30, 2026

Received: July 1, 2026

Dear Penny Goodman:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K262235 - Penny Goodman

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assistance/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,

JOYCE C.

LIN -S

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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262235 | ? |
| Please provide the device trade name(s). | | ? |
| ApexCut™ Blade with Automated EM Tracking (187BL4012EM); ApexCut™ Blade with Automated EM Tracking (187BL4040EM); ApexCut™ Blade with Automated EM Tracking (187BL4060EM); ApexCut™ Blade with Automated EM Tracking (187BL2975EM); ApexCut™ Blade with Automated EM Tracking (187BL3590EM); ApexCut™ Blade with Automated EM Tracking (187BL4000LEM) | | |
| Please provide your Indications for Use below. | | ? |
| The ApexCut™ EM navigated blades are surgical instruments used in conjunction with IPC/XPS and Medtronic computer-assisted surgery systems which are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology (ENT) and head and neck surgery and as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated accessories should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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Medtronic

# ApexCut™ EM Navigated Blades

## 510(k) Summary

**Company (Submitter):**

Medtronic Xomed, Inc.

6743 Southpoint Drive North

Jacksonville, Florida 32216 USA

Telephone Number: [phone]

**Date Prepared:** June 30, 2026

**Official Correspondent:**

Penny Goodman

Senior Regulatory Affairs Specialist

Telephone: [phone]

Email Address: [e-mail]

**Alternative Contact:**

Alexandra Oliver

Regulatory Affairs Manager

Telephone: [phone]

Email Address: [e-mail]

**I. DEVICE**

| Item | Description |
| --- | --- |
| Proprietary / Trade Name | ApexCut™ EM Navigated Blades |
| Common Name | Stereotaxic instrument |
| Regulation Name / Classification Name | Stereotaxic instrument |
| Regulation Number | 21 CFR 882.4560 |
| Product Code | PGW |
| Classification | Class II |
| Panel | Ear Nose & Throat |

**II. PREDICATE DEVICE**

The ApexCut™ EM Navigated Blades are substantially equivalent in intended use and technological characteristics to the following primary predicate device:

| 510(k) Number | 510(k) Device Name | 510(k) Clearance Date |
| --- | --- | --- |
| K130608 | QuadCut® Navigated Blades | August 7, 2013 |

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Medtronic

ApexCut™ EM Navigated Blades

### III. DEVICE DESCRIPTION

The ApexCut™ EM Navigated Blades are sterile, single-use surgical instruments intended for use with compatible Medtronic powered ENT systems and compatible Medtronic computer-assisted surgical navigation systems. The blades are intended for attachment to StraightShot™ M Series microdebrider handpieces, which are used with the XPS™ and IPC™ powered systems.

Each ApexCut™ EM Navigated Blade includes a blade assembly and a navigation assembly. The blade assembly includes a shaft with a distal cutting surface, an outer cannula or sheath, an inner cutting member, a distal cutting window, a blade lumen for suction-assisted tissue evacuation, and a proximal hub that interfaces with the compatible microdebrider handpiece. When the blade is attached to a powered handpiece and console, the inner cutting member moves relative to the outer cannula to incise, cut, debride, or remove soft tissue, hard tissue, or bone. Suction and irrigation support tissue engagement, visualization, cooling, and evacuation during use.

The navigation assembly includes an embedded electromagnetic tracker and connection cable. When connected to a compatible Medtronic computer-assisted surgical navigation system, the system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. The navigation software displays the location of the blade tip within patient image planes and other anatomical renderings. Navigation is intended only as an adjunct for surgical guidance and does not replace the surgeon's knowledge, expertise, or judgment.

The ApexCut™ EM Navigated Blades are provided sterile by ethylene oxide sterilization and are intended for single patient use only.

The subject device family includes the following configurations:

| Description | Shaft Dimensions |
| --- | --- |
| ApexCut™ EM Navigated Blade, 4.0 mm, 12" | 12" / 4.0 mm / 11 cm |
| ApexCut™ EM Navigated Blade, 4.0 mm, 40" | 40" / 4.0 mm / 11 cm |
| ApexCut™ EM Navigated Blade, 4.0 mm, 60" | 60" / 4.0 mm / 11 cm |
| ApexCut™ EM Navigated Blade, 2.9 mm, 75" | 75" / 2.9 mm / 11 cm |
| ApexCut™ EM Navigated Blade, 3.5 mm, 90" | 90" / 3.5 mm / 11 cm |
| ApexCut™ EM Navigated Blade, 4.0 mm, straight long | Straight / 4.0 mm / 13 cm |

### IV. INTENDED USE

ApexCut™ EM navigated blades are intended to be used by medical professionals such as surgeons or other medical staff and monitoring professionals during nasal or sinus procedures to remove tissue and bone.

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Medtronic

# ApexCut™ EM Navigated Blades

# V. INDICATIONS FOR USE

The ApexCut™ EM navigated blades is a surgical instrument used in conjunction with IPC/XPS and Medtronic computer-assisted surgery systems which are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology (ENT) and head and neck surgery and as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated accessories should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

# VI. SUBSTANTIAL EQUIVALENCE

The ApexCut™ EM Navigated Blades have the same intended use as the primary predicate device, QuadCut® Navigated Blades cleared under K130608. Both devices are sterile, single-use navigated ENT blade instruments intended for use with compatible Medtronic powered ENT systems and compatible Medtronic computer-assisted surgical navigation systems.

The ApexCut™ EM Navigated Blades have similar technological characteristics to the predicate device. Both devices include a powered microdebrider blade component and an electromagnetic tracker that enables the compatible navigation system to display the blade tip location relative to patient image data. Differences between the subject and predicate devices include ApexCut blade geometry, blade design features, available blade angles and diameters, handpiece compatibility within the StraightShot™ M Series family, packaging configuration, and labeled shelf life. These differences do not raise different questions of safety or effectiveness because they are addressed through design verification, navigation accuracy testing, system compatibility assessment, sterilization validation/adoption, packaging validation, shelf-life evaluation, biocompatibility assessment, labeling, and risk management.

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Medtronic

# ApexCut™ EM Navigated Blades

Substantial Equivalence / Device Comparison

| Attribute | Primary Predicate Device: QuadCut® Navigated Blades K130608 | Reference Precedent Only: TruDi® Shaver Blade K221037 | Subject Device: ApexCut™ EM Navigated Blades K262235 | SE Rationale |
| --- | --- | --- | --- | --- |
| 510(k) number | K130608 | K221037 | K262235 | N/A |
| Manufacturer | Medtronic Navigation, Inc. | Acclarent, Inc. | Medtronic Xomed, Inc. | N/A |
| Device trade name | QuadCut® Navigated Blades | TruDi® Shaver Blade | ApexCut™ EM Navigated Blades | N/A |
| Classification name | Neurological Stereotaxic Instrument | Ear, Nose, and Throat Stereotaxic Instrument | Neurological Stereotaxic Instrument | Same/similar |
| Classification | II | II | II | Same |
| Product code | HAW EQJ | PGW | PGW | Same/similar. HAW and PGW are both Class II stereotaxic instrument classifications under 21 CFR 882.4560. PGW was created to categorize ENT-specific stereotactic instruments. |
| Classification regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Device type | Sterile, single-use navigated powered ENT blade | Sterile, single-use navigated shaver blade | Sterile, single-use navigated powered ENT blade | Same |
| Intended use | The QuadCut™ blades are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. | ** Not relied upon for substantial equivalence; reference device only. | ApexCut™ EM navigated blades are intended to be used by medical professionals such as surgeons or other medical staff and monitoring professionals during nasal or sinus procedures to remove tissue and bone. | Same/similar. |
| Indications for Use | The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, | ** Not relied upon for substantial equivalence; reference device only. | The ApexCut™ EM navigated blades is a surgical instrument used in conjunction with IPC/XPS and Medtronic computer-assisted surgery systems which are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology (ENT) and head and neck surgery and as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of | Same/similar. See Discussion 1 below. |

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Medtronic

# ApexCut™ EM Navigated Blades

| | and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment. | | stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated accessories should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment. | |
| --- | --- | --- | --- | --- |
| Technological Characteristics | QuadCut® Navigated Blades are intended for attachment to compatible Medtronic powered ENT handpieces and for use in conjunction with Medtronic computer-assisted surgical navigation software. Each navigated blade has an electromagnetic tracker mounted to the blade to allow navigation during the ENT surgical procedure. The navigation system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. The software then displays the location of the blade tip within multiple patient image planes and other anatomical renderings. | The TruDi® Shaver Blade is a single-use electromagnetically navigated shaver instrument intended for use with the TruDi® Navigation System. The device incorporates a sensor that is tracked by the TruDi® Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's preoperative CT/MRI scan to confirm access of target anatomy. Following confirmation, the physician operates the instrument at the target anatomical structure. TruDi is included only as PGW/ERL reference precedent and is not used as the predicate device for ApexCut™ EM Navigated Blades. | ApexCut™ EM Navigated Blades are sterile, single-use stainless steel powered microdebrider blades with integrated electromagnetic tracking for use with compatible StraightShot™ M4/M5 microdebriders, Medtronic powered ENT consoles, and compatible Medtronic image-guided surgery systems. Each subject blade incorporates the ApexCut powered blade subassembly with an integrated electromagnetic tracker and connection interface. The tracker-to-blade relationship enables the compatible Medtronic navigation system to display the location of the blade tip relative to patient image planes and anatomical renderings. | Difference. See below Discussion 2. |
| Localization Technology | Electromagnetic tracking | Electromagnetic tracking | Electromagnetic tracking | Same |
| Navigation accuracy | 95% confidence / 99.5% reliability, as dictated by risk analysis, of ≤ 3.00 mm. | The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is ≤2 mm RMS over the entire navigation volume. | 95% confidence upper bound on mean <1.2 mm and 95% confidence upper bound on 99% population <2.0 mm | Difference. See below Discussion 3. |
| Material – Blades | 304L Stainless Steel | 304L Stainless Steel | 304L Stainless Steel | Same |
| Sterilization | Ethylene Oxide sterilization | Ethylene Oxide sterilization | Ethylene Oxide sterilization | Same |
| Single-use status | Single use | Single use | Single use | Same |
| Shelf life | 2 years | 3 months | 18 months | Difference. See below Discussion 4. |
| Cutting mechanism | Powered oscillating microdebrider blade | Powered shaver blade | Powered oscillating microdebrider blade | Same |
| Blade geometry / configurations | 3.0 mm 0" Straight 3.4 mm 0" Straight 4.3 mm 0" Straight | 3.0 mm 0" Straight 4.0 mm 0" Straight 4.0 mm 15" Curved 4.0 mm 40" Curved 4.0 mm 60" Curved | 2.9 mm 75" Curved 3.5 mm 90" Curved 4.0 mm 12" Curved 4.0 mm 40" Curved 4.0 mm 60" Curved 4.0 mm 0" Straight Long | Difference. See below Discussion 5. |

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Medtronic

# ApexCut™ EM Navigated Blades

| Compatible handpieces | Medtronic StraightShot / M Series handpieces; predicate historically M4 | Bien-Air S120 Shaver Handpiece | ApexCut Navigated supports M4/M5 handpiece compatibility | Same /similar.. |
| --- | --- | --- | --- | --- |
| Compatible powered systems | Medtronic power consoles, including IPC/XPS | OSSEODUO / TruDi system context | Medtronic power consoles, including IPC/XPS | Same / similar. |
| Compatible navigation systems | Medtronic image-guided surgery systems / computer-assisted surgery systems. | TruDi® Navigation System | Medtronic image-guided surgery systems / computer-assisted surgery systems. | Same/similar.. |

** Not relied upon for substantial equivalence; reference device only.**

Discussion 1: The subject device maintains the predicate's core navigated ENT blade function: incision/removal of soft and hard tissue or bone with adjunctive computer-assisted localization of anatomical structures relative to CT- or MR-based image data or digitized landmarks. The labeling also maintains the predicate limitation that the navigation system and associated accessories are adjuncts for surgical guidance and do not replace the surgeon's knowledge, expertise, or judgment.

The differences in indication wording do not raise different questions of safety or effectiveness. The subject device is narrower than the predicate with respect to removal of otoneurological surgery, while maintaining the same tissue/bone removal and adjunctive navigation functions relevant to ENT and head and neck procedures. Navigation-specific risks are addressed through predicate comparison and final ApexCut™ EM Navigated verification evidence, including navigation accuracy.

Discussion 2: The subject device is technologically similar to the predicate because both devices are powered ENT blade instruments with electromagnetic tracking for adjunctive navigation. The subject device differs in ApexCut blade design, M4/M5 handpiece compatibility, final sterile barrier configuration, and compatible current Medtronic system workflow. These differences do not change the powered cutting mechanism, electromagnetic localization principle, or adjunctive navigation function. Final ApexCut™ EM Navigated verification evidence supports the integrated blade, tracker, handpiece, powered-system, and navigation-system interfaces.

Discussion 3: Final-configuration navigation accuracy testing was conducted using predefined, risk-based acceptance criteria to evaluate tracker-to-blade integration and displayed blade-tip localization before and after conditioning/simulated use. The testing supports the subject device's intended adjunctive navigation function and does not raise different questions of safety or effectiveness compared with the predicate.

Discussion 4: The ApexCut™ EM Navigated Blades have an 18-month shelf life, which differs from the predicate shelf life. The shelf-life claim is supported by final ApexCut™ EM Navigated evidence addressing sterile barrier integrity, package integrity, device performance, and navigation-related shelf-life considerations. The shelf-life difference does not raise different questions of safety or effectiveness.

Discussion 5: The subject device includes straight and curved ApexCut configurations, while the primary predicate QuadCut® Navigated Blades include straight configurations. TruDi® is included only as reference precedent for curved ENT navigated shaver/blade configurations. ApexCut-

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Medtronic

# ApexCut™ EM Navigated Blades

specific geometries were addressed through final-configuration testing and representative configuration analysis. The tested configurations bracket key design variants, including blade angle, tube diameter, blade length, distal tip offset, and tracker-to-tip relationship. These configuration differences do not raise different questions of safety or effectiveness. TruDi® device is described as a shaver blade and ApexCut™ as a microdebrider blade, both are functionally similar powered ENT tissue-resection blades used with a motorized handpiece to incise and remove soft and hard tissue or bone. The difference in terminology does not represent a different device function.

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Medtronic

# ApexCut™ EM Navigated Blades

## VII. PERFORMANCE DATA

Performance data were provided to support substantial equivalence of the ApexCut™ EM Navigated Blades to the predicate device. The performance evidence includes nonclinical bench testing, verification by analysis where appropriate, and risk-based assessments. The testing and assessments support the safety and effectiveness of the final subject device configuration, including the blade subsystem, electromagnetic tracking integration, compatibility, sterilization, packaging, shelf life, and biological safety.

### Nonclinical Performance Testing and Assessments

Nonclinical bench performance testing and assessments included the following:

| Test / Assessment Area | Summary |
| --- | --- |
| Blade functional performance and simulated use | Testing assessed tissue resection, cutting-window function, irrigation and suction pathways, handpiece compatibility, and simulated use. Three representative configurations were tested, with analysis supporting applicability to all six subject configurations. Results support that the devices perform as intended with compatible Medtronic powered ENT systems and handpieces. |
| Mechanical integrity | Testing evaluated hub/tube axial integrity, tracker-to-blade bond strength, torque resistance, blade engagement, marking durability, and stability after conditioning. |
| Navigation accuracy | Navigation accuracy testing evaluated tracker-to-blade integration and displayed blade-tip location before and after performance conditioning. |
| System compatibility | Compatibility testing and analysis evaluated applicable handpieces, Medtronic powered console systems, and compatible Medtronic computer-assisted surgical navigation systems. The evidence supports the final device configuration and related blades, handpiece, powered-system, and navigation-system interfaces. |
| Electrical safety and EMC impact | Electrical safety and EMC were addressed at the compatible system level. Tested system configurations met applicable IEC 60601-1 and IEC 60601-1-2 requirements; the mechanical blades are not critical to EMC performance. |
| Packaging performance | Packaging validation and/or package performance testing evaluated sterile barrier integrity, seal strength, seal integrity, distribution simulation, environmental conditioning, and package labeling/legibility, as applicable. |
| Shelf life | Shelf-life evaluation supports the 18-month labeled shelf life for the final single-use sterile configuration, including packaging integrity and relevant performance attributes. Navigation-related shelf-life considerations were addressed through analysis and applicable final-configuration evidence. |
| Sterilization | The devices are sterilized by ethylene oxide to a sterility assurance level of 10^{-6}. Sterilization validation/adoption activities evaluated product bioburden, sterility assurance, EO/ECH residuals, and process suitability for the subject device family. |

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Medtronic

# ApexCut™ EM Navigated Blades

| Bacterial endotoxins / pyrogenicity | Bacterial endotoxin testing and pyrogenicity assessment were performed, as applicable. Results were within predefined acceptance criteria and support the pyrogenicity assessment for the subject device family. |
| --- | --- |
| Biocompatibility | Biocompatibility was evaluated using a risk-based assessment of patient-contacting materials, contact type, and contact duration. The assessment leveraged applicable blade-subsystem evidence and addressed the final navigated configuration, including any new or modified material/contact considerations. The evaluation supports biological safety for the labeled use. |
| Labeling and use-related risk | Use-related risks and labeling were evaluated for relevant blade and navigation use tasks. Labeling includes compatibility information, warnings, precautions, and instructions to support safe use by the intended users. |

The nonclinical performance testing and assessments support that the ApexCut™ EM Navigated Blades meet their design and performance requirements and perform as intended under the specified conditions of use.

### Clinical Testing

No clinical testing was performed or required to support substantial equivalence.

### Animal Testing

No animal testing was performed or required to support substantial equivalence.

### VIII. CONCLUSION

The ApexCut™ EM Navigated Blades and the predicate QuadCut® Navigated Blades have the same intended use and similar technological characteristics. The subject device differences, including ApexCut blade geometry, blade design features, StraightShot™ M Series handpiece compatibility, packaging configuration, and 18-month shelf life, do not raise different questions of safety or effectiveness.

The nonclinical performance testing, navigation accuracy assessment, compatibility assessment, sterilization validation/adoption, packaging validation, shelf-life evaluation, biocompatibility assessment, labeling, and risk management activities support substantial equivalence. Based on the information provided in this 510(k), the ApexCut™ EM Navigated Blades are substantially equivalent to the legally marketed predicate device.