(124 days)
The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to
- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or
- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.
The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.
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.
The provided text describes a 510(k) premarket notification for the NuVent EM Sinus Dilation System. This device is an ear, nose, and throat (ENT) manual surgical instrument used in conjunction with a computer-assisted surgery system for sinus procedures. The submission seeks to expand the indications for use to include procedures on scarred, granulated, or previously surgically altered tissue, and also to explicitly state facilitating "dilation of the sinus ostia" in the indications.
The submission does not contain acceptance criteria for specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be expected for a diagnostic or AI-driven device. This is primarily because the device is a surgical instrument for physical manipulation and guidance, not a diagnostic tool that produces classification or quantitative results.
The "study" described is a clinical study to support the expanded indications, focusing on the safe and intended performance of the device in a specific patient population, not on meeting predefined statistical performance thresholds for an AI algorithm.
Based on the provided text, here is the information requested, with "N/A" where the information is not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a surgical instrument and not an AI or diagnostic device, the "acceptance criteria" discussed are related to the broader concepts of "substantial equivalence," "performance as intended," and "no new safety concerns." There are no quantitative performance metrics like sensitivity or specificity.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended for expanded indications (on scarred, granulated, or previously surgically altered tissue). | The subject device performed as intended in a clinical study conducted in subjects with scarred, granulated, or previously surgically altered tissue. |
| No new safety concerns are raised. | The clinical study reported no adverse events attributed to the subject device. |
| Device is substantially equivalent to predicate device. | The subject and predicate EM Sinus Dilation System devices are identical in design and performance specifications. The difference in indications for use (specifically the addition of "scarred, granulated, or previously surgically altered" tissue and explicit mention of "dilation of the sinus ostia") was supported by the clinical study. No additional non-clinical testing was required as there were no design changes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not explicitly stated as a number of "subjects." The text mentions "subjects with scarred, granulated or previously surgically altered tissue were enrolled and treated in at least one frontal, sphenoid, or maxillary sinus." The exact number of subjects is not provided in this excerpt.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. This is a study to demonstrate the performance and safety of a surgical instrument in a clinical setting, not a study involving expert-derived ground truth for diagnostic accuracy. The "truth" is whether the device could be used as intended without issue and without new safety concerns, as observed by the operating surgeons. Though not called out explicitly regarding "ground truth," the study involved "surgeons" performing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This type of adjudication is not applicable to a clinical study evaluating the performance and safety of a surgical instrument. The study was described as "non-randomized, non-blinded, single arm."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is a surgical instrument assisted by a computer navigation system, not an AI-assisted diagnostic imaging interpretation tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. The device is a physical surgical instrument that functions "in conjunction with the Medtronic Computer-Assisted Surgery System." It is inherently a "human-in-the-loop" device as it aids the surgeon, rather than performing tasks autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly assessed was clinical outcome and observed safety/performance during live surgical procedures. The clinical study evaluated whether the device "performed as intended and did not raise new safety concerns" in patients with the expanded indications.
8. The sample size for the training set
N/A. This submission describes a modification to an existing surgical device. There is no mention of an algorithm or AI model that would require a "training set."
9. How the ground truth for the training set was established
N/A. As there is no training set for an algorithm, this question is not applicable.
{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 NorthJacksonville, FL 32216 USA | |
| Phone and Fax Numbers | Phone: (904) 279-7550Fax: (904) 296-2386 | |
| Name of Contact Person | Gabriela AnchondoRegulatory 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 Systemcomprises sterile, single-use instruments thatcombine electromagnetic (EM) "plug and play"tracking capability with the pathway expansioneffects of balloon dilation technology and aninflator. Each of the three types of sinus seekers(frontal, maxillary and sphenoid) has a uniqueshape and angle that allows for entry into the sinusoutflow tract. The inflator consists of a plunger,barrel and extension tube. | |
| Each sinus seeker is intended for use inconjunction with the Fusion software on aMedtronic computer-assisted surgery system.Inside each sinus seeker is an EM tracker.The emitter on the EM Computer-Assisted SurgerySystem generates a low-energy magnetic field tolocate 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 SurgicalInstrument | LRC - ENT Manual SurgicalInstrument | SAME |
| Intended Use | The EM Sinus Dilation System isintended for use in conjunctionwith the Medtronic Computer-Assisted Surgery System duringsinus procedures when surgicalnavigation or image-guidedsurgery may be necessary.When used concomitantly, thesesystems may be used to:locate and move tissue,bone or cartilaginous tissuesurrounding the drainagepathways of frontal,maxillary, and sphenoidsinuses to facilitatedilation of the sinus ostia; orlocate and move tissue,bone or cartilaginous tissuesurrounding the drainagepathways of frontal,maxillary, and sphenoidsinuses that is scarred,granulated or previouslysurgically altered tofacilitate dilation of thesinus ostia. The Medtronic computer-assisted surgery system and itsassociated applications areintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures. Their use isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and where | The EM Sinus Dilation Systemis intended for use in sinusprocedures when surgicalnavigation or image-guidedsurgery may be necessary tolocate and move tissue, bone orcartilaginous tissue surroundingthe drainage pathways of thefrontal, maxillary, and sphenoidsinuses.The EM Sinus Dilation system isused in conjunction with theMedtronic computer-assistedsurgery system.The Medtronic computer-assisted surgery system and itsassociated applications areintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures. Their use isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigid anatomicalstructure, such as the skull, canbe identified relative to a CT- orMR-based model, or digitizedlandmarks of the anatomy.The system and its associatedapplications should be usedonly as an adjunct for surgicalguidance. They do not replacethe surgeon's knowledge,expertise, or judgment. | SAME with exception of:"scarred, granulated andpreviously surgicallyaltered" :This use has beenvalidated in a humanclinical study."facilitate dilation of thesinus ostia."This use was previouslycleared via K132297 assupported by cadaver data.The cleared instructions foruse included instructionsabout the dilation of thesinus ostia. However, theindications for usestatement did not. Thedilation of the sinus ostia isnow being added to theindications for use forclarity. |
| Attributes | EM Sinus Dilation System(Subject Device) | EM Sinus Dilation System(Predicate Device) | Comparison |
| be identified relative to a CT- orMR-based model, or digitizedlandmarks of the anatomy.The system and its associatedapplications should be used onlyas an adjunct for surgicalguidance. They do not replacethe surgeon's knowledge,expertise, or judgment. | |||
| LocationMethod | Location of tissue accomplishedvia electromagnetic (EM) "plugand play" tracking capabilityusing image guidance (IG). | Location of tissue accomplishedvia electromagnetic (EM) "plugand play" tracking capabilityusing image guidance (IG). | SAME |
| MovementMethod | Movement of tissueaccomplished using a rigidseeker with unique angles toallow entry of frontal, maxillary orsphenoid sinuses. | Movement of tissueaccomplished using a rigidseeker with unique angles toallow entry of frontal, maxillaryor sphenoid sinuses. | SAME |
| DilationMethod | Balloon is inflated with salinesolution by using the inflator toexpand outflow track of targetedsinus ostia. | Balloon is inflated with salinesolution by using the inflator toexpand outflow track of targetedsinus ostia. | SAME |
| Balloon Size | 5mm, 6mm and 7mm | 5mm, 6mm and 7mm | SAME |
| PatientContactingMaterials | SAME | SAME | SAME |
| TrackingMethod | Electromagnetic | Electromagnetic | SAME |
| SystemAccuracy | Clinical environment | Benchtop and simulatedenvironment | No device changes wereimplemented as a result ofthe proposed expandedindications; therefore, noadditional benchtop orsimulated environmenttesting was required todemonstrate substantialequivalence. The systemaccuracy for a patientpopulation with scarred,granulated and previouslysurgically altered tissuewas verified with a clinicalstudy. |
| Method ofAction | Reusable instrument for dilationof sinus ostia with balloon | Reusable instrument for dilationof 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 withscarred, granulated or previously surgically alteredtissue to support the proposed expanded indication.The subject device performed as intended and didnot raise new safety concerns; there were noadverse 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.
§ 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.