(111 days)
Not Found
No
The device description and performance studies focus on mechanical dilation and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is described as treating conditions like Eustachian tube dysfunction and remodeling sinus outflow tracts, which are therapeutic interventions.
No
The device is described as an ENT Dilation System used to access, treat, and dilate anatomical structures, rather than to diagnose conditions.
No
The device description clearly outlines physical components like a curved suction tip, balloon, syringe, bending tool, and extension lines, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The XprESS ENT Dilation System is a surgical device used to physically remodel bony structures and dilate the Eustachian tube. It is used in vivo (within the body) during a medical procedure.
- Intended Use: The intended use clearly describes a surgical intervention to treat anatomical issues, not a diagnostic test performed on a sample.
Therefore, the XprESS ENT Dilation System falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating tube dysfunction in patients 18 years and older using a transnasal approach.
Product codes
PNZ, LRC
Device Description
The XprESS ENT Dilation System is intended to recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian tubes within the same patient.
The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.
The Xpress ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and two Extension Lines. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro ENT Dilation System also includes a Tuohy Adapter.
XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are appropriate for treating all sinuses and Eustachian tubes; selection is based on physician preference. If treating only Eustachian tubes, the longer length balloons may be more efficient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary ostia/ethmoid infundibula, frontal ostia/recesses, sphenoid sinus ostia, Eustachian tube
Indicated Patient Age Range
The maxillary ostia/ethmoid infundibula, and frontal ostia/recesses and sphenoid sinus ostia in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older.
Eustachian tube in patients 18 years and older.
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, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the XprESS device consisted of clinical testing to support the expanded indications for use. A prospective, multicenter, randomized controlled trial, comparing XprESS balloon dilation vs control (continued medical therapy) for patients with Eustachian tube dysfunction (ETD) was conducted under IDE G140214. The study included 60 patients diagnosed with ETD for over 12 months, with 3 or more ETD symptoms, and who failed medical therapy. The primary efficacy endpoint was the comparison of mean change in overall Eustachian tube dysfunction questionnaire-7 item (ETDQ-7) score between the XprESS balloon dilation arm and the control arm. The primary safety endpoint was complication rate. The primary efficacy endpoint was met with Eustachian tube balloon dilation demonstrating superiority over medical management for improvement in ETDQ-7 symptom scores (p
§ 874.4180 Eustachian tube balloon dilation system.
(a)
Identification. A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Mechanical testing, including tensile and flexural testing of catheter joints and materials.
(ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
(iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon.
(iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
(2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life.
(6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
(7) Labeling must include:
(i) Detailed instructions for use.
(ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
(iii) A shelf life.
0
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Entellus Medical, Inc. Ms. Karen E. Peterson Vice President, Clinical, Regulatory and Quality 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
Re: K163509/S002
Trade/Device Name: XprESS ENT Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Eustachian Tube Balloon Dilation Device Regulatory Class: Class II Product Code: PNZ, LRC Dated: March 7, 2017 Received: March 9, 2017
Dear Ms. Peterson:
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.
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
1
(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.
Eric A. Mann -S
for Malvina 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) K163509
Device Name XprESS ENT Dilation System
Indications for Use (Describe)
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating tube dysfunction in patients 18 years and older using a transnasal approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
Image /page/3/Picture/2 description: The image shows the logo for "entellus MEDICAL". To the left of the company name is a circular graphic made up of blue and black curved shapes. The company name is in all lowercase letters, and below it is the word "MEDICAL" in smaller, uppercase letters.
3600 Holly Lane North. Suite 40
XprESS ENT Dilation System
Balloon Sinus Dilation System
Class I, 21 CFR 874.4420
Class II, 21 CFR 874.4180
ENT Manual Surgical Instrument
Balloon Eustachian Tube Dilation System
Eustachian Tube Balloon Dilation Device
XprESS Multi-Sinus Dilation System [K152434]
Aera Eustachian Tube Balloon Dilation System [DEN150056]
Vice President Clinical, Regulatory and Quality
April 5 2017
3006345872
Entellus Medical, Inc.
Plymouth, MN 55447
Karen E. Peterson
(763) 463-7066
LRC
PNZ
510(k) Summary
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
Device Information:
Trade Name: Sinus Dilation Common Name: Classification Name: Product Code: Regulation Number:
Eustachian Tube Dilation Common Name: Classification Name: Product Code: Regulation Number:
Predicate Devices:
Device Description:
The XprESS ENT Dilation System is intended to recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian tubes within the same patient.
Image /page/3/Figure/13 description: The image shows a medical device labeled as the XprESS ENT Dilation Device. Several parts of the device are labeled with arrows. These parts include the curved suction tip, balloon slide mechanism, suction vent, proximal barbed fitting, and balloon inflation luer.
The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.
The Xpress ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and two Extension Lines. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro ENT Dilation System also includes a Tuohy Adapter.
XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are appropriate for treating all sinuses and Eustachian tubes; selection is based on physician preference. If treating only Eustachian tubes, the longer length balloons may be more efficient.
4
| XprESS Pro | XprESS LoProfile | XprESS Ultra |
|---|---|---|
| Standard Suction Tip | LoProfile Suction Tip | Ultra Suction Tip |
| (2 mm ball tip, 1 mm ID, 1.5 mm OD) | (1.75 mm ball tip, 0.7 mm ID, 1.2 mm OD) | (1.5 mm ball tip, 0.5 mm ID, 1.0 mm OD) |
| Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) | Balloon Diameter x Length (mm) |
| NA | 5 x 8 | 5 x 8 |
| NA | 5 x 20 | 5 x 20 |
| 6 x 8 | 6 x 8 | 6 x 8 |
| 6 x 18 | 6 x 20 | 6 x 20 |
| 7 x 18 | 7 x 20 | NA |
The XprESS ENT Dilation System has been tested to withstand multiple inflations and device tip manipulations in a surgical case.
Indication for Use:
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.
Contraindications:
None known.
Warnings:
- · Do not use XprESS to dilate Eustachian tubes in patients with a history of patulous Eustachian tubes.
- · Due to the variability of anatomy, review appropriate radiographic imaging (eg, a CT scan) prior to treatment. Do not use the XprESS device to treat patients with evidence of internal carotid artery dehiscence.
Technological Characteristics:
The XprESS device has expanded indications for use, similar intended use, and identical scientific technology (i.e. principle of operation, design, function, materials, biocompatibility, packaging, shelf life, and sterilization) as the predicate XprESS device [K152434].
The XprESS device has the same expanded indications for use and imilar scientific technology as the predicate Aera device [DEN150056].
Substantial Equivalence:
The XprESS device has the same indications for use, intended use, and fundamental scientific technology as the predicate devices. The XprESS device is substantially equivalent to the predicate devices.
Performance Data:
Performance testing of the XprESS device consisted of clinical testing to support the expanded indications for use. A prospective, multicenter, randomized controlled trial, comparing XprESS balloon dilation vs control (continued medical therapy) for patients with Eustachian tube dysfunction (ETD) was conducted under IDE G140214. The study included 60 patients diagnosed with ETD for over 12 months, with 3 or more ETD symptoms, and who failed medical therapy. The primary efficacy endpoint was the comparison of mean change in overall Eustachian tube dysfunction questionnaire-7 item (ETDQ-7) score between the XprESS balloon dilation arm and the control arm. The primary safety endpoint was complication rate. The primary efficacy endpoint was met with Eustachian tube balloon dilation demonstrating superiority over medical management for improvement in ETDQ-7 symptom scores (p