The EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses.

The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.

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 Description

The EM Sinus Dilation System composes of sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilatation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape with the appropriate angle that allow for entry into the scarred sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.

Each sinus dilation instrument is intended to be used in conjunction with the Fusion software on a Medtronic computer-assisted surgery system.

Inside of each sinus seeker is an EM tracker. The emitter on the Fusion System generates a low-energy magnetic field to locate the tracker mounted on the sinus seeker. Then, the software displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seeker's balloon can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.

AI/ML Overview

The provided 510(k) summary for the Medtronic EM Sinus Dilation System (K132297) focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and intended use. It does not include a detailed study proving the device meets specific performance acceptance criteria in the way a diagnostic AI device summary might.

The submission is for a surgical instrument with electromagnetic tracking, rather than an AI/ML-driven diagnostic tool. Therefore, the typical acceptance criteria and study designs (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) for AI-powered devices are not applicable or detailed in this document.

However, based on the information provided, I can extract what is stated regarding performance testing and how it relates to ensuring "acceptable navigational accuracy."

Here's a breakdown of the available information in the requested format, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (as stated)
Functional navigation capability with Medtronic systems	Testing conducted to ensure functionality and compatibility with identified Medtronic products.
Acceptable navigational accuracy	Testing conducted to ensure acceptable navigational accuracy with Medtronic Navigation systems and Fusion software.
Performance under simulated real-life use	Test samples subjected to simulated real-life use conditions during functional testing.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Test samples" but does not quantify them or describe the nature of these samples (e.g., physical phantoms, cadaveric models, clinical data).
Data Provenance: The testing was "Benchtop and simulated environment." There is no mention of country of origin for data, nor whether it was retrospective or prospective, as it appears to be primarily lab-based testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided because the device is a surgical instrument with navigation capabilities, not a diagnostic tool requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for navigational accuracy would likely be established by known physical measurements in the simulated environment.

4. Adjudication Method for the Test Set

Not applicable/Not described. Given the nature of the device and testing, expert adjudication in the context of diagnostic performance is not relevant here. Navigational accuracy would typically be objectively measured against known spatial references.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not done. This type of study is relevant for evaluating human reader performance, particularly with diagnostic imaging tools where human interpretation is a key component. This device is a surgical instrument, and its performance is evaluated in terms of its physical function and navigational accuracy rather than diagnostic reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, effectively. The "System Accuracy Method" is described as "Benchtop and simulated environment." This indicates that the functional and navigational accuracy of the device, likely using its electromagnetic tracking algorithm, was evaluated in a controlled setting without a human surgeon performing a full procedure. The document states the system "displays the location of the sinus dilation instrument's tip," implying an objective measurement of this display accuracy.

7. The Type of Ground Truth Used

Implied objective measurements in a simulated environment. While not explicitly stated with details like "pathology" or "outcomes data," the "Benchtop and simulated environment" testing for "System Accuracy" and "navigational accuracy" suggests that the "ground truth" would be precisely known physical positions or measurements within the controlled test setup. For example, a known target position versus the device's reported position.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is a mechanical surgical instrument with electromagnetic tracking. It does not refer to an AI/ML algorithm that would typically require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). The "Fusion software" mentioned is likely a deterministic navigation system rather than a machine learning model that undergoes training.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there is no explicit mention of a "training set" or an AI/ML model being trained with data in this submission, the method for establishing ground truth for such a set is not discussed.

Summary

{0}------------------------------------------------

K132297

510(k) Summary

July 23, 2013

I. Company: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone Number: 904-332-8233 Fax Number: 904-296-2386
NOV 0 5 2013
Contact: Rozanne Paciej Regulatory Affairs Manager
Proprietary Trade Name: To Be Determined
II. Common Name: EM Sinus Dilation System
III. Classification Name: Ear. Nose, and Throat Manual Surgical Instrument (21 CFR 874.4420)
Classification: Class I (21 CFR 874.4420) IV.
V. Product Code: LRC

VI. Product Description:

Each sinus dilation instrument is intended to be used in conjunction with the Fusion software on a Medtronic computer-assisted surgery system.

{1}------------------------------------------------

VII. Indications for Use:

The EM Sinus Dilation system is used in conjunction with the Medtronic computerassisted surgery system.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or perculaneous 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.

VIII. Identification of Legally Marketing Devices (Predicate Devices)

EM Dilation Sinus System is substantially equivalent in intended use and performance characteristics to the follow predicate devices:

Description	510(k) Number	Clearance Date	Product/510(k)Number		EM Sinus DilationSystemProposed	ENTrigue SinusDilation SystemK121351Predicate
ENTrigue Sinus Dilation System	K121351	08/29/2013	Clearance Date	TBD	08/29/2012	10/22/2010
XprESS Multi-Sinus Dilation Tool	K102003	10/22/2010	Product Code andClassification	LRC/Class I	LRC/Class I	LRC/Class I
Device Description	The EM Sinus DilationSystem composes ofsterile, single-useinstruments thatcombineelectromagnetic (EM)"plug and play" trackingcapability with thepathway expansioneffects of balloondilatation technologyand an inflator. Each ofthe three types of sinusseekers (frontal,maxillary and sphenoid)has a unique shape withthe appropriate anglethat allow for entry intothe scarred sinusoutflow tract. Theinflator consists of aplunger, barrel andextension tube.Each sinus dilationinstrument is intendedto be used inconjunction with theFusion software on aMedtronic computer-assisted surgery system.Inside of each sinusseeker is an EM tracker.The emitter on theFusion Systemgenerates low-energymagnetic field to locate	The ENTrigue SinusDilation Systemconsists of adisposable balloonwhich is mountedon a reusabledelivery instrumentto allow for dilationof sinus ostia in theparanasal cavityunder endoscopicguidance. The SinusBalloon componentsinclude a balloonsleeve to slide overthe tip of thedelivery instrument,a connecting collarto latch the balloonsleeve to thedelivery instrument,and an inflation lineto connect to theballoon inflationdevice. The featuresof this device enablea physician to guidethe device to thesinus ostium usingendoscopicvisualization.	The XprESS Multi-Sinus Dilation Toolis intended toremodel or recreatethe sinus outflowtract via trans-nasalballoon dilation.The XprESS devicecombines featuresof a curved suctiontip and a frontalostium seeker withthe tissueexpansion effect ofa balloon dilation.The familiarfeatures of thisdevice enable aphysician to trackthe device to thesinus ostium usingendscopicvisualization. Sincethe distal end of thedevice is re-shapeable, oneballoon can bemodified to workon multiple sinuseswithin the samepatient. TheXprESS Multi-Sinus Dilation Toolhas been tested towithstand multipleinflations and

The table comparing the proposed and predicate devices is presented on the next page.

{2}------------------------------------------------

IX. Comparison of the Technological Characteristics:

・

has been tested to
withstand multiple
inflations and

{3}------------------------------------------------

Intended use	the tracker mounted on the sinus seeker. Then, the software displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seeker's balloon can be inflated with saline solution by using the inflator to expand the outflow track of the targeted sinus.	The ENTrigue Sinus Dilation System is intended for use in the surgical procedures to access, examine or treat the nasal and paranasal tissues leading to the ostia.	device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated. The XprESS device curved suction tip has a 2mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction. To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remolded by balloon displacement of adjacent bone and paranasal sinus structures.
	The EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses.The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.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

. .

. . . . . .

{4}------------------------------------------------

CommonName/ClassificationName	Sinus Balloon DilationSystemENT Manual SurgicalInstrument	Sinus DilationSystem	Sinus BalloonDilation SystemENT ManualSurgical Instrument
Tracking Method	Electromagnetic	Device cannotconnect to IGS fortracking.	Device iscompatible withIGS.
System AccuracyMethod	Benchtop and simulatedenvironment	Not applicable	Not applicable
Predicate	XprESS Multi-SinusDilation Tool(K102003)ENTrigue SinusDilation System(K121351)	Entellus MedicalInc. XprESS Multi-Sinus Dilation Tool(K102003)	XprESS Multi-Sinus Dilation Tool(K093007)FinESS SinusTreatment System(K081542)
Method of Action	Reusable instrument fordilation of sinus withballoon attached usingnavigation	Reusable instrumentfor dilation of sinuswith balloon sleeve.	Reshapeableballoon used inmultiple sinuses,suction tip,
Balloon Size	3 balloon sizes (5mm,6mm, and 7mm)	10mm long, 6mm	18mm long; 5,6

{5}------------------------------------------------

			specified) this
		•	balloon is a sleeve
		-


		•
		:
		::







	•

		·		・
•
		All and the same of the same
		: 2017

. .

{6}------------------------------------------------

X. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with Medtronic Navigation systems and Fusion software was conducted to ensure acceptable navigational accuracy. Test samples were subjected to simulated real-life use conditions during functional testing.

XI. Conclusions

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" a comparison of key characteristics demonstrates that the proposed EM Sinus Dilation System is substantially equivalent to the predicate device in terms of performance characteristics. The EM Sinus Dilation System is as safe, as effective, and performs as well as the predicate devices.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 16, 2014

Medtronic Xomed, Inc. c/o Ms. Rozanne Paciei Regulatory Affairs Manager 6743 Southpoint Drive North Jacksonville, FL 32256

Re: K132297

Trade/Device Name: 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 8, 2013 Received: October 8, 2013

Dear Ms. Paciej:

This letter corrects our substantially equivalent letter of November 5, 2013.

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.

{8}------------------------------------------------

Page 2 - Ms. Rozanne Paciej

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 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

{9}------------------------------------------------

Indications for Use

510(k) Number (if known): K132297

Device Name:

EM Sinus Dilation System

Indications for Use:

The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.

Prescription Use × AND/OR Over-The-Counter Use - - -(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vasant G.
Malshet

Page I of

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
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.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.