NuVent EM Sinus Dilation System

K152121 · Medtronic Xomed, Inc. · LRC · Dec 1, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K152121
• Device Name: NuVent EM Sinus Dilation System
• Applicant: Medtronic Xomed, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Dec 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to - locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or - locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia. 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, 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.

Device Story

The NuVent EM Sinus Dilation System consists of sterile, single-use sinus seekers (frontal, maxillary, sphenoid) and an inflator. Each seeker contains an electromagnetic (EM) tracker. Used with the Medtronic Computer-Assisted Surgery System, the device utilizes a low-energy magnetic field generated by an emitter to track the seeker's tip. The Fusion software displays the tip's location within patient CT/MR image planes or anatomical renderings. Surgeons use the seeker to navigate to the sinus ostia; once positioned, the integrated balloon is inflated with saline via the inflator to dilate the sinus outflow tract. The system provides real-time surgical guidance, aiding in precise anatomical localization during sinus procedures. It is intended for use by surgeons in clinical settings. The device benefits patients by enabling precise, image-guided dilation of sinus pathways, including in complex cases involving scarred or previously altered anatomy.

Clinical Evidence

Prospective, non-randomized, non-blinded, single-arm, multicenter clinical study. Enrolled subjects with scarred, granulated, or previously surgically altered tissue. Primary endpoint: performance of the device in the intended population. Results: device performed as intended; no adverse events attributed to the device.

Technological Characteristics

Single-use sinus seekers with integrated EM tracking; balloon dilation mechanism; inflator (plunger, barrel, extension tube). Operates with Medtronic Computer-Assisted Surgery System (Fusion software). Electromagnetic sensing principle. Sterile, single-use.

Indications for Use

Indicated for patients undergoing sinus procedures requiring surgical navigation or image-guided surgery for the frontal, maxillary, and sphenoid sinuses, including cases with scarred, granulated, or previously surgically altered tissue, to facilitate dilation of the sinus ostia.

Regulatory Classification

Identification

An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Predicate Devices

• EM Sinus Dilation System (K132297)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

December 1, 2015

Medtronic Xomed, Inc. Ms. Gabriela Anchondo Regulatory Affairs 6743 Southpoint Drive North Jacksonville, FL 32216

Re: K152121

Trade/Device Name: Nuvent EM Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: October 30, 2015 Received: November 2, 2015

Dear Ms. Anchondo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K152121

# Device Name:

EM Sinus Dilation System

# Indications for Use:

The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-quided surgery may be necessary. When used concomitantly, these systems may be used to

- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways ● of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or
- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways 0 of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.

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, 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 quidance. They do not replace the surgeon's knowledge, expertise, or judgment.

× Prescription Use _ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 5. 510(k) Summary

# [807.92(a)(1)] 510(k) Owner

| Name | Medtronic Xomed, Inc. | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address | 6743 Southpoint Drive North<br>Jacksonville, FL 32216 USA | |
| Phone and Fax Numbers | Phone: [phone]<br>Fax: [phone] | |
| Name of Contact Person | Gabriela Anchondo<br>Regulatory Affairs Manager | |
| Date Summary Prepared | July 24, 2015 | |
| [807.92(a)(2)] Name of Device | | |
| Trade or Proprietary Name | NuVent™ EM Sinus Dilation System | |
| Common or Usual Name | EM Sinus Dilation System | |
| Classification Name | Ear, nose and throat manual surgical instrument<br>(21 CFR 874.4420, Product Code LRC) | |
| [807.92(a)(3)] Legally Marketed Device | | |
| Predicate Device | K132297 EM Sinus Dilation System | |
| [807.92(a)(4)] Description of Device | | |
| Device Description | The NuVent™ EM Sinus Dilation System<br>comprises sterile, single-use instruments that<br>combine electromagnetic (EM) "plug and play"<br>tracking capability with the pathway expansion<br>effects of balloon dilation technology and an<br>inflator. Each of the three types of sinus seekers<br>(frontal, maxillary and sphenoid) has a unique<br>shape and angle that allows for entry into the sinus<br>outflow tract. The inflator consists of a plunger,<br>barrel and extension tube. | |
| | Each sinus seeker is intended for use in<br>conjunction with the Fusion software on a<br>Medtronic computer-assisted surgery system.<br>Inside each sinus seeker is an EM tracker.<br>The emitter on the EM Computer-Assisted Surgery<br>System generates a low-energy magnetic field to<br>locate the tracker mounted inside of the sinus | |

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seeker. The software displays the location of the sinus seeker's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seekers balloon can be inflated with saline solution by using the inflator to expand the outflow of the targeted sinus.

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

#### Indications for Use Statement

The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to

- locate and move tissue, bone or . cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia: or
- locate and move tissue, bone or . cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.

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, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CTor MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The difference in indications for use is supported by clinical data and does not affect the safety and effectiveness of the device.

Difference in Indications from Predicate Device

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

## Comparison

The subject device has the same technological characteristics as the predicate device. The only difference is in the indications for use. Refer to the table that follows for a comparison.

| Attributes | EM Sinus Dilation System<br>(Subject Device) | EM Sinus Dilation System<br>(Predicate Device) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152121 | K132297 | -- |
| 510(k)<br>Submitter | Medtronic Xomed | Medtronic Xomed | SAME |
| Class & Reg | Class I -21 CFR 874.4420 | Class I - 21 CFR 874.4420 | SAME |
| Product Code<br>& Class Name | LRC - ENT Manual Surgical<br>Instrument | LRC - ENT Manual Surgical<br>Instrument | SAME |
| Intended Use | The EM Sinus Dilation System is<br>intended for use in conjunction<br>with the Medtronic Computer-<br>Assisted Surgery System during<br>sinus procedures when surgical<br>navigation or image-guided<br>surgery may be necessary.<br>When used concomitantly, these<br>systems may be used to:<br>locate and move tissue,<br>bone or cartilaginous tissue<br>surrounding the drainage<br>pathways of frontal,<br>maxillary, and sphenoid<br>sinuses to facilitate<br>dilation of the sinus ostia; or<br>locate and move tissue,<br>bone or cartilaginous tissue<br>surrounding the drainage<br>pathways of frontal,<br>maxillary, and sphenoid<br>sinuses that is scarred,<br>granulated or previously<br>surgically altered to<br>facilitate dilation of the<br>sinus ostia. The Medtronic computer-<br>assisted surgery system and its<br>associated applications are<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures. Their use is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where | The EM Sinus Dilation System<br>is intended for use in sinus<br>procedures when surgical<br>navigation or image-guided<br>surgery may be necessary to<br>locate and move tissue, bone or<br>cartilaginous tissue surrounding<br>the drainage pathways of the<br>frontal, maxillary, and sphenoid<br>sinuses.<br><br>The EM Sinus Dilation system is<br>used in conjunction with the<br>Medtronic computer-assisted<br>surgery system.<br><br>The Medtronic computer-<br>assisted surgery system and its<br>associated applications are<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures. Their use is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the skull, can<br>be identified relative to a CT- or<br>MR-based model, or digitized<br>landmarks of the anatomy.<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. | SAME with exception of:<br><b>"scarred, granulated and<br/>previously surgically<br/>altered"</b> :<br>This use has been<br>validated in a human<br>clinical study.<br><br><b>"facilitate dilation of the<br/>sinus ostia."</b><br>This use was previously<br>cleared via K132297 as<br>supported by cadaver data.<br>The cleared instructions for<br>use included instructions<br>about the dilation of the<br>sinus ostia. However, the<br>indications for use<br>statement did not. The<br>dilation of the sinus ostia is<br>now being added to the<br>indications for use for<br>clarity. |
| Attributes | EM Sinus Dilation System<br>(Subject Device) | EM Sinus Dilation System<br>(Predicate Device) | Comparison |
| | be identified relative to a CT- or<br>MR-based model, or digitized<br>landmarks of the anatomy.<br><br>The system and its associated<br>applications should be used only<br>as an adjunct for surgical<br>guidance. They do not replace<br>the surgeon's knowledge,<br>expertise, or judgment. | | |
| Location<br>Method | Location of tissue accomplished<br>via electromagnetic (EM) "plug<br>and play" tracking capability<br>using image guidance (IG). | Location of tissue accomplished<br>via electromagnetic (EM) "plug<br>and play" tracking capability<br>using image guidance (IG). | SAME |
| Movement<br>Method | Movement of tissue<br>accomplished using a rigid<br>seeker with unique angles to<br>allow entry of frontal, maxillary or<br>sphenoid sinuses. | Movement of tissue<br>accomplished using a rigid<br>seeker with unique angles to<br>allow entry of frontal, maxillary<br>or sphenoid sinuses. | SAME |
| Dilation<br>Method | Balloon is inflated with saline<br>solution by using the inflator to<br>expand outflow track of targeted<br>sinus ostia. | Balloon is inflated with saline<br>solution by using the inflator to<br>expand outflow track of targeted<br>sinus ostia. | SAME |
| Balloon Size | 5mm, 6mm and 7mm | 5mm, 6mm and 7mm | SAME |
| Patient<br>Contacting<br>Materials | SAME | SAME | SAME |
| Tracking<br>Method | Electromagnetic | Electromagnetic | SAME |
| System<br>Accuracy | Clinical environment | Benchtop and simulated<br>environment | No device changes were<br>implemented as a result of<br>the proposed expanded<br>indications; therefore, no<br>additional benchtop or<br>simulated environment<br>testing was required to<br>demonstrate substantial<br>equivalence. The system<br>accuracy for a patient<br>population with scarred,<br>granulated and previously<br>surgically altered tissue<br>was verified with a clinical<br>study. |
| Method of<br>Action | Reusable instrument for dilation<br>of sinus ostia with balloon | Reusable instrument for dilation<br>of sinus ostia with balloon | SAME |

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

#### Non-Clinical Performance Data The subject device did not undergo any design changes as a result of the proposed expanded indications. As a result, no additional non-clinical performance testing was required to demonstrate substantial equivalence.

#### [807.92(b)(2)] Determination of Substantial Equivalence

| Clinical Performance Data | A clinical study was conducted in subjects with<br>scarred, granulated or previously surgically altered<br>tissue to support the proposed expanded indication.<br>The subject device performed as intended and did<br>not raise new safety concerns; there were no<br>adverse events attributed to the subject device. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [807.92(b)(3)] Conclusion | |

Conclusions from Non-Clinical and Clinical Tests

The subject and predicate EM Sinus Dilation System devices are identical in design and performance specifications. Bench and animal testing was not required to demonstrate substantial equivalence. The proposed expanded indications were supported with a prospective, non-randomized, non-blinded, single arm, multicenter clinical study. Subjects with scarred, granulated or previously surgically altered tissue were enrolled and treated in at least one frontal, sphenoid, or maxillary sinus with the subject device. The subject device performed as intended and did not raise new safety concerns; there were no adverse events attributed to the subject device.