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 remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Device Description

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 balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic 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 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 Multi-Sinus Dilation Tool is provided sterile and for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "XprESS Multi-Sinus Dilation Tool". It is a submission to the FDA seeking clearance to market the device, claiming substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a typical format. Instead, it discusses the outcomes of various tests. Based on the "Performance Data" section (Page 4), the implicit acceptance criteria are that the device meets design specifications and performs as intended.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility (Device materials are safe for human contact)	"Performance testing of the XprESS device consisted of biocompatibility..." (Implies successful testing without specific details, but the FDA clearance suggests it met the necessary standards.)
Design Verification (Device meets its design specifications)	"Performance testing of the XprESS device consisted of ... design verification testing..." (Implies successful verification that the device met its specifications as designed.)
Simulated Use Performance (Device functions as intended in a simulated environment)	"Performance testing of the XprESS device consisted of ... simulated use in a cadaver model..." (Implies successful performance in simulating clinical use.) The document also states: "The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated."
Sterilization Efficacy (Device can be effectively sterilized)	"Performance testing of the XprESS device consisted of ... sterilization to support the additional Ultra suction tip and balloon size." (Implies successful sterilization validation.)
Substantial Equivalence (Device is as safe and effective as the predicate)	"Performance testing showed that the device meets design specifications and performed as intended." and "In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "simulated use in a cadaver model." However, it does not specify the sample size (e.g., number of cadavers or number of procedures performed).
The data provenance is retrospective/simulated, as it was done in a cadaver model, not live patients. The country of origin for the cadaver model data is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information regarding the number of experts or their qualifications for establishing ground truth in the simulated use testing. For a device like this, ground truth would likely be based on successful access, dilation, and lack of damage in the cadaveric sinuses, assessed by qualified medical professionals (e.g., ENT surgeons).

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method for the simulated use testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is a surgical tool, not an AI diagnostic imaging device that would typically involve human readers interpreting images. The evaluation primarily focuses on the device's physical performance, safety, and functionality.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable to the XprESS Multi-Sinus Dilation Tool. This is a manual surgical instrument, not an AI algorithm. Its performance is always with a human (surgeon) in the loop.

7. The Type of Ground Truth Used

The ground truth for the performance testing (e.g., in the cadaver model) would have been based on direct observation and assessment of the physical outcomes (e.g., successful dilation, structural integrity, absence of damage) within the simulated environment by qualified personnel. It's a functional ground truth rather than a diagnostic one like pathology or expert consensus on an image. For biocompatibility, the ground truth is established by standardized testing protocols for material safety.

8. The Sample Size for the Training Set

This question is not applicable. The XprESS Multi-Sinus Dilation Tool is a mechanical surgical instrument, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for a mechanical surgical instrument.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and dimension.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2014

Entellus Medical, Inc. % Ms. Karen Peterson Vice President, Clinical, Regulatory and Quality 3600 Holly Lane North. Suite 40 Plymouth, MN 55447

Re: K142252

Trade/Device Name: Xpress Multi-Sinus Dilation Tool Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 16, 2014 Received: September 17, 2014

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.

{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 (reporting of medical devicerelated 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 Statement

Applicant:	Entellus Medical, Inc.
510(k) Number (if known):	K142252
Device Name:	XprESS Multi-Sinus Dilation Tool
Indications for Use

Prescription Use X - OR/AND (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made of blue and black curved lines. The text "entellus" is in a sans-serif font, and the word "MEDICAL" is in smaller, all-caps letters below the first word.

510(k) Summary

Date Prepared:	August 13, 2014
Submitter Information:	Entellus Medical, Inc.3600 Holly Lane North, Suite 40Plymouth, MN 55447
Establishment Registration:	3006345872
Contact Information:	Karen E. PetersonVice President Clinical, Regulatory and Quality(763) 463-7066kpeterson@entellusmedical.com
Device Information:
Trade Name:	XprESS Multi-Sinus Dilation Tool
Common Name:	Sinus Balloon Dilation System
Classification Name:	ENT Manual Surgical Instrument
Product Code:	LRC
Regulation Number:	Class I, 21 CFR 874.4420
Predicate Device:	XprESS Multi-Sinus Dilation Tool [K132440]

Device Description:

Image /page/3/Figure/5 description: The image shows a diagram of the XprESS Multi-Sinus Dilation Tool. The diagram labels the different parts of the tool, including the curved suction tip, balloon slide mechanism, proximal barbed fitting, and balloon inflation luer. The tool is used for sinus dilation.

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

{4}------------------------------------------------

XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are appropriate for treating all sinuses: selection is based on physician preference.

Standard Suction Tip(2mm ball tip, 1mm ID,1.5mm OD)	LoProfile Suction Tip(1.75mm ball tip, 0.7mm ID,1.2mm OD)	Ultra Suction Tip(1.5mm ball tip, 0.5mm ID,1.0mm OD)
Balloon Diameter x Length (mm)	Balloon Diameter x Length (mm)	Balloon Diameter x Length (mm)
NA	5 x 8	5 x 8
5 x 18	5 x 18	5 x 20
6 x 8	6 x 8	6 x 8
6 x 18	6 x 18	6 x 20
7 x 18	7 x 18	NA

The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated.

Indication for Use:

Contraindications:

Do not use this XprESS device in patients who are allergic to nickel or barium sulfate.
Do not attach the XprESS device directly to the CT Image Guidance systems. This may result in inaccurate device positioning.

Technological Characteristics:

The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K132440]. The subject device has the same technological characteristics (i.e., principle of operation, basic design, function, basic materials, biocompatibility, packaging, shelf life and sterilization) as the predicate device.

Substantial Equivalence:

The XprESS device has the same indications for use and fundamental scientific technology as the predicate device. The XprESS device is substantially equivalent to the predicate device.

Performance Data:

Performance testing of the XprESS device consisted of biocompatibility, design verification testing, simulated use in a cadaver model, and sterilization to support the additional Ultra suction tip and balloon size. Animal and clinical data was not required for this change. Performance testing showed that the device meets design specifications and performed as intended.

Conclusion:

In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.