(124 days)
No
The document describes a system for surgical navigation and balloon dilation using electromagnetic tracking and pre-existing CT/MR images. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on the surgeon's judgment and the display of the instrument's location within the pre-acquired images.
Yes
The device is used to facilitate dilation of sinus ostia by locating and moving tissue, bone, or cartilaginous tissue, which directly contributes to a therapeutic outcome for a medical condition.
No
The device is described as an "EM Sinus Dilation System" used to facilitate dilation of sinus ostia, and the Medtronic computer-assisted surgery system is intended as an aid for precisely locating anatomical structures. Neither description indicates a primary function of diagnosing medical conditions.
No
The device description explicitly states that the system comprises sterile, single-use instruments (sinus seekers and an inflator) and an EM tracker embedded within the sinus seeker. While it uses software for navigation, it is fundamentally a hardware system with software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Function: The EM Sinus Dilation System is a surgical instrument used during a surgical procedure to physically manipulate tissue and facilitate dilation of sinus ostia. It uses electromagnetic tracking for navigation and a balloon for dilation.
- Intended Use: The intended use clearly describes a surgical procedure involving the physical manipulation of anatomical structures within the body, guided by imaging. It does not involve the analysis of biological specimens.
The device is a surgical tool used in conjunction with an image-guided surgery system, not a diagnostic test performed on a sample.
N/A
Intended Use / 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 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.
Product codes
LRC
Device Description
The NuVent EM Sinus Dilation System comprises sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the sinus outflow tract. The inflator consists of a plunger, barrel and extension tube. Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate the tracker mounted inside of the sinus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, or digitized landmarks of the anatomy.
Anatomical Site
frontal, maxillary, and sphenoid sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical guidance. 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.
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, sample size, AUC, MRMC, standalone performance, key results)
A prospective, non-randomized, non-blinded, single arm, multicenter clinical study was conducted in subjects with scarred, granulated or previously surgically altered tissue to support the proposed expanded indication. Subjects 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (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
2
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)
3
5. 510(k) Summary
[807.92(a)(1)] 510(k) Owner
| Name | Medtronic Xomed, Inc. | |
|---|---|---|
| Address | 6743 Southpoint Drive North | |
| Jacksonville, FL 32216 USA | ||
| Phone and Fax Numbers | Phone: (904) 279-7550 | |
| Fax: (904) 296-2386 | ||
| Name of Contact Person | Gabriela Anchondo | |
| 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 | |
| (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 | |
| comprises sterile, single-use instruments that | ||
| combine electromagnetic (EM) "plug and play" | ||
| tracking capability with the pathway expansion | ||
| effects of balloon dilation technology and an | ||
| inflator. Each of the three types of sinus seekers | ||
| (frontal, maxillary and sphenoid) has a unique | ||
| shape and angle that allows for entry into the sinus | ||
| outflow tract. The inflator consists of a plunger, | ||
| barrel and extension tube. | ||
| Each sinus seeker is intended for use in | ||
| conjunction with the Fusion software on a | ||
| Medtronic computer-assisted surgery system. | ||
| Inside each sinus seeker is an EM tracker. | ||
| The emitter on the EM Computer-Assisted Surgery | ||
| System generates a low-energy magnetic field to | ||
| locate the tracker mounted inside of the sinus |
4
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
5
[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
(Subject Device) | EM Sinus Dilation System
(Predicate Device) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152121 | K132297 | -- |
| 510(k)
Submitter | Medtronic Xomed | Medtronic Xomed | SAME |
| Class & Reg | Class I -21 CFR 874.4420 | Class I - 21 CFR 874.4420 | SAME |
| Product Code
& Class Name | LRC - ENT Manual Surgical
Instrument | LRC - ENT Manual Surgical
Instrument | SAME |
| 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 | 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. | SAME with exception of:
"scarred, granulated and
previously surgically
altered" :
This use has been
validated in a human
clinical study.
"facilitate dilation of the
sinus ostia."
This use was previously
cleared via K132297 as
supported by cadaver data.
The cleared instructions for
use included instructions
about the dilation of the
sinus ostia. However, the
indications for use
statement did not. The
dilation of the sinus ostia is
now being added to the
indications for use for
clarity. |
| Attributes | EM Sinus Dilation System
(Subject Device) | EM Sinus Dilation System
(Predicate Device) | Comparison |
| | 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. | | |
| Location
Method | Location of tissue accomplished
via electromagnetic (EM) "plug
and play" tracking capability
using image guidance (IG). | Location of tissue accomplished
via electromagnetic (EM) "plug
and play" tracking capability
using image guidance (IG). | SAME |
| Movement
Method | Movement of tissue
accomplished using a rigid
seeker with unique angles to
allow entry of frontal, maxillary or
sphenoid sinuses. | Movement of tissue
accomplished using a rigid
seeker with unique angles to
allow entry of frontal, maxillary
or sphenoid sinuses. | SAME |
| Dilation
Method | Balloon is inflated with saline
solution by using the inflator to
expand outflow track of targeted
sinus ostia. | Balloon is inflated with saline
solution by using the inflator to
expand outflow track of targeted
sinus ostia. | SAME |
| Balloon Size | 5mm, 6mm and 7mm | 5mm, 6mm and 7mm | SAME |
| Patient
Contacting
Materials | SAME | SAME | SAME |
| Tracking
Method | Electromagnetic | Electromagnetic | SAME |
| System
Accuracy | Clinical environment | Benchtop and simulated
environment | No device changes were
implemented as a result of
the proposed expanded
indications; therefore, no
additional benchtop or
simulated environment
testing was required to
demonstrate substantial
equivalence. The system
accuracy for a patient
population with scarred,
granulated and previously
surgically altered tissue
was verified with a clinical
study. |
| Method of
Action | Reusable instrument for dilation
of sinus ostia with balloon | Reusable instrument for dilation
of sinus ostia with balloon | SAME |
6
7
[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
scarred, granulated or previously surgically altered
tissue to support the proposed expanded indication.
The subject device performed as intended and did
not raise new safety concerns; there were no
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.