(104 days)
No
The description focuses on electromagnetic tracking and software displaying the instrument's location on pre-acquired images (CT/MR). There is no mention of AI/ML for image analysis, decision support, or other functions. The software is described as an "aid for precisely locating anatomical structures" and an "adjunct for surgical guidance," which aligns with traditional navigation systems, not AI/ML-driven systems.
Yes
The device is intended for use in sinus procedures to locate and move tissue, bone, or cartilaginous tissue and to expand the outflow tract of targeted sinuses using balloon dilation technology, which directly addresses a medical condition.
No
The device is a surgical tool used for dilating sinuses during a procedure, guided by a computer-assisted surgery system. While it uses imaging for guidance, its primary function is therapeutic (dilation), not diagnostic.
No
The device description explicitly states it is composed of sterile, single-use instruments with integrated EM trackers and an inflator, which are hardware components. While it uses software for navigation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for use in sinus procedures to locate and move tissue, bone, or cartilaginous tissue. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details instruments used for surgical procedures (sinus seekers, balloon dilation, inflator) and their integration with a surgical navigation system. It does not describe any components or processes for analyzing biological samples.
- Functionality: The core function is surgical guidance and tissue manipulation through balloon dilation, not the diagnosis of a disease or condition based on in vitro analysis.
- Input: While it uses imaging data (CT/MR) and digitized landmarks, this data is used for surgical planning and navigation during a procedure, not for in vitro diagnostic testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such analysis.
N/A
Intended Use / 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.
Product codes
LRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Sinuses (frontal, maxillary, sphenoid), Skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Benchtop and simulated environment testing.
Key Results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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