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 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 System is intended to 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 System is provided sterile and for single use only. The Xpress Multi-Sinus Dilation System includes the XprESS device, Inflation Syringe, Bending Tool and two Extension Lines. The XprESS LoProfile and Ultra Multi-Sinus Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro Multi-Sinus Dilation System also includes a Tuohy Adapter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the XprESS Multi-Sinus Dilation System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document doesn't explicitly state quantitative acceptance criteria in a typical tabular format with specific thresholds to be met (e.g., "Success Rate > 90%"). Instead, the performance claims are presented as achieved outcomes.

Acceptance Criterion (Implied)	Reported Device Performance
Procedural Technical Success Rate	100% (157 out of 157 attempted dilations)
Complication Rate	0% (No complications reported)
Device or Procedure-Related Adverse Events	0% (No adverse events reported)
Safe and Effective	Demonstrated through clinical testing
Substantially Equivalent to Predicate	Achieved based on technological characteristics and performance data

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

Sample Size (Test Set): 50 subjects (with 157 attempted sinus dilations).
Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on procedural success and complication rates, which were likely determined by the treating physicians and reported in the clinical study. It's not a diagnostic AI device where external expert review of outputs for ground truth is typically required.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given it's a procedural device study focusing on success and complications, data would typically be collected and reported by the clinical sites and then aggregated and analyzed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or AI-assisted interpretation devices to compare human performance with and without AI assistance. The XprESS device is a surgical instrument.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. The XprESS Multi-Sinus Dilation System is a physical medical device, not an algorithm or AI. Its performance is tied to its physical use.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the outcomes measured in the clinical study:

Procedural Technical Success: This would be determined by direct observation during the procedure by the treating physician(s) – i.e., whether the dilation was successfully completed.
Complication Rate: Recorded by clinical staff and physicians based on adverse events occurring during or after the procedure.

8. The Sample Size for the Training Set

Not applicable. The XprESS Multi-Sinus Dilation System is a physical medical device, not an AI or algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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

November 20, 2015

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

Re: K152434

Trade/Device Name: XprESS Multi-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 27, 2015 Received: October 28, 2015

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.

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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

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Indications for Use

510(k) Number (if known) K152434

Device Name XprESS Multi-Sinus Dilation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Date Prepared: Submitter Information: August 26, 2015 Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447

Establishment Registration:

Contact Information:

Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number: 3006345872

Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com

XprESS Multi-Sinus Dilation System [K142252]

XprESS Multi-Sinus Dilation System Balloon Sinus Dilation System ENT Manual Surgical Instrument LRC Class I, 21 CFR 874.4420

Predicate Device:

Device Description:

Image /page/3/Figure/13 description: This image shows a medical device with several labeled parts. The device has a long, thin body with a curved suction tip at one end. A balloon slide mechanism is located along the body of the device. At the opposite end, there is a proximal barbed fitting and a balloon inflation luer.

XprESS Multi-Sinus Dilation Device

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 System is provided sterile and for single use only.

The Xpress Multi-Sinus Dilation System includes the XprESS device, Inflation Syringe, Bending Tool and two Extension Lines. The XprESS LoProfile and Ultra Multi-Sinus Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro Multi-Sinus Dilation System also includes a Tuohy Adapter.

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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.

XprESS Pro	XprESS LoProfile	XprESS Ultra
Standard Suction Tip	LoProfile Suction Tip	Ultra Suction Tip
(2mm ball tip, 1mm ID, 1.5mm OD)	(1.75mm ball tip, 0.7mm ID, .2mm OD)	(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 System 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:

None known.

Technological Characteristics:

The XprESS device has expanded indications for use, identical intended use, and identical scientific technology (i.e., principle of operation, design, function, materials, biocompatibility, packaging, shelf life, and sterilization) as the predicate device.

Substantial Equivalence:

The XprESS device has expanded indications for use, identical intended use, and identical 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 clinical testing to support the expanded indications for use. A prospective, multicenter, single-arm study investigating the use of XprESS in patients aged 2-21 years was conducted in the United States under IDE G140080. The primary outcome measures were procedural technical success rate and complication rate. A total of 157 sinus dilations were attempted in 50 subjects. All 157 attempts were successfully completed for an overall XprESS technical success rate of 100%. No complications (0%) were reported during the study. In addition, no adverse events related to the device or the balloon dilation procedure were reported during the study. Performance testing showed that the device performed as intended.

Conclusion:

In conclusion, the technological characteristics are identical 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.