Who is the manufacturer of EM SINUS DILATION SYSTEM?

Medtronic Xomed, Inc. filed the 510(k) submission for EM SINUS DILATION SYSTEM (K132297).

What is the FDA product code for EM SINUS DILATION SYSTEM?

LRC. It is classified under 21 CFR 874.4420 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for EM SINUS DILATION SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EM SINUS DILATION SYSTEM?

ENTrigue Sinus Dilation System (K121351); XprESS Multi-Sinus Dilation Tool (K102003).

Who can help prepare an FDA 510(k) submission like EM SINUS DILATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EM SINUS DILATION SYSTEM

K132297 · Medtronic Xomed, Inc. · LRC · Nov 5, 2013 · Ear, Nose, Throat

Device Facts

Record ID	K132297
Device Name	EM SINUS DILATION SYSTEM
Applicant	Medtronic Xomed, Inc.
Product Code	LRC · Ear, Nose, Throat
Decision Date	Nov 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4420
Device Class	Class 1
Attributes	Therapeutic

Indications for Use

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 Story

EM Sinus Dilation System consists of sterile, single-use sinus seekers (frontal, maxillary, sphenoid) with integrated electromagnetic (EM) trackers and balloon dilation capability. Used in conjunction with Medtronic computer-assisted surgery system (Fusion software). Emitter generates low-energy magnetic field to locate tracker; software displays instrument tip location within patient image planes/anatomic renderings. Surgeon confirms placement via navigation; inflates balloon with saline using provided inflator to expand sinus outflow tract. Used in clinical/surgical settings by physicians. Provides real-time visualization of instrument position relative to patient anatomy; aids in precise navigation during sinus procedures; facilitates minimally invasive tissue/bone displacement.

Clinical Evidence

Bench testing only. Testing conducted to ensure functionality and compatibility with Medtronic navigation systems and Fusion software. Simulated real-life use conditions were employed to verify navigational accuracy and device performance.

Technological Characteristics

System comprises sterile, single-use sinus seekers with integrated EM trackers and balloon dilation components. Materials include balloon and seeker assembly. Energy source: low-energy magnetic field (for tracking). Connectivity: integrates with Medtronic computer-assisted surgery system (Fusion software). Form factor: specialized seekers for frontal, maxillary, and sphenoid sinuses. Sterilization: sterile, single-use.

Indications for Use

Indicated for patients undergoing sinus procedures requiring surgical navigation or image-guided surgery to locate and move tissue, bone, or cartilage in the frontal, maxillary, or sphenoid sinus drainage pathways. Used as an adjunct for surgical guidance in open or percutaneous procedures where stereotactic surgery is appropriate and anatomical structures can be referenced to CT/MR models or digitized landmarks.

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

ENTrigue Sinus Dilation System (K121351)
XprESS Multi-Sinus Dilation Tool (K102003)

Reference Devices

XprESS Multi-Sinus Dilation Tool (K093007)
FinESS Sinus Treatment System (K081542)

Submission Summary (Full Text)

{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: 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. {1}------------------------------------------------ ## VII. Indications for Use: 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, sphenoid sinuses. 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 Dilation System Proposed | ENTrigue Sinus Dilation System K121351 Predicate | XprESS Multi- Sinus Dilation Tool K102003 Predicate | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------| | 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 and Classification | LRC/Class I | LRC/Class I | LRC/Class I | | | 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 low-energy magnetic field to locate | The ENTrigue Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. | The XprESS Multi- Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of a balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endscopic visualization. Since the distal end of the device is re- shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS Multi- Sinus Dilation Tool has been tested to withstand multiple inflations 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}------------------------------------------------ | Common Name/Classification Name | Sinus Balloon Dilation System ENT Manual Surgical Instrument | Sinus Dilation System | Sinus Balloon Dilation System ENT Manual Surgical Instrument | |---------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Tracking Method | Electromagnetic | Device cannot connect to IGS for tracking. | Device is compatible with IGS. | | System Accuracy Method | Benchtop and simulated environment | Not applicable | Not applicable | | Predicate | XprESS Multi-Sinus Dilation Tool (K102003) ENTrigue Sinus Dilation System (K121351) | Entellus Medical Inc. XprESS Multi- Sinus Dilation Tool (K102003) | XprESS Multi- Sinus Dilation Tool (K093007) FinESS Sinus Treatment System (K081542) | | Method of Action | Reusable instrument for dilation of sinus with balloon attached using navigation | Reusable instrument for dilation of sinus with balloon sleeve. | Reshapeable balloon used in multiple 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 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. 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

EM SINUS DILATION SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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EM SINUS DILATION SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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