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 Infusion 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. The items packaged with the XprESS Multi-Sinus Dilation Tool include the Inflation Device, Bending Tool and two Infusion Lines.

AI/ML Overview

The provided text describes the XprESS Multi-Sinus Dilation Tool, a medical device, and its 510(k) submission (K121943) for clearance. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device.

Therefore, many of the requested categories related to acceptance criteria, detailed study design, ground truth establishment, expert involvement, and comparative effectiveness studies are not explicitly present in the provided text. The submission is primarily about demonstrating that the new device is as safe and effective as an already marketed predicate device, relying on design verification and simulated use rather than extensive clinical trials or AI performance evaluations.

Here's an analysis based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantified acceptance criteria. Instead, it makes a general statement about meeting design specifications.

Acceptance Criteria Category	Reported Device Performance (from text)
Biocompatibility	"Performance testing of the XprESS device consisted of biocompatibility..."
Design Verification	"...design verification testing..."
Simulated Use Performance	"...simulated use in a cadaver model to support the additional suction tip size."
Withstand Multiple Inflations	"The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations..."
Withstand Device Tip Manipulations	"...and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated."
Meets Design Specifications	"Performance testing showed that the device meets design specifications and performed as intended."
Substantial Equivalence	"The XprESS device is substantially equivalent to the predicate device."
Safety and Effectiveness	"Performance testing has demonstrated that the device is safe and effective..."

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

Test Set Sample Size: Not specified. The text mentions "simulated use in a cadaver model," but the number of cadavers or specific tests performed is not detailed.
Data Provenance: The simulated use was conducted in a "cadaver model." This implies an ex vivo setting, likely in the country where the company (Entellus Medical, Inc. - Plymouth, MN, USA) is based. The data would be considered prospective for the purpose of this submission, as it was generated specifically for the device verification.

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

Not applicable/Not specified. The simulated use involved a cadaver model to test mechanical performance and the ability of the device, not to establish a "ground truth" for diagnostic or AI-related outcomes. The "ground truth" in this context would be related to the device's mechanical integrity and functionality, which is evaluated against engineering specifications, not expert diagnostic consensus.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since this is not a study requiring expert interpretation or consensus for a diagnostic outcome, there is no mention of an adjudication method.

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

No MRMC study was done.
No AI component or human-in-the-loop performance evaluation is mentioned. The device is a surgical tool, not an AI-assisted diagnostic or therapeutic system.

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

Not applicable. The device is a physical surgical tool; there is no "algorithm" in the sense of an AI or diagnostic algorithm being tested in standalone mode.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on engineering specifications and functional performance in a simulated environment. For example, the device must withstand a certain number of inflations without failure, or the balloon must dilate to a specific diameter. These are objective measurements against predefined design requirements.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and testing are based on traditional engineering principles.

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

Not applicable, as there is no training set for this type of device.

Summary

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121943

Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". The logo consists of a circular design on the left, resembling a stylized flower or spiral. To the right of the circular design is the word "entellus" in a sans-serif font. Below "entellus" is the word "MEDICAL" in a smaller, sans-serif font with a trademark symbol.

510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

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

AUG 222 2012

July 2, 2012 Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447

3006345872

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

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

XprESS Multi-Sinus Dilation Tool [K121174]

Predicate Device:

Device Description:

Image /page/0/Figure/17 description: The image shows a medical device with several labeled parts. The curved suction tip is on the left side of the device. The balloon side mechanism is in the middle, and the proximal barbed fitting and balloon inflation luer are on the right side.

XprESS Multi-Sinus Dilation Tool

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 Infusion 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.

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The items packaged with the XprESS Multi-Sinus Dilation Tool include the Inflation Device, Bending Tool and two Infusion Lines.

XprESS is available in the following suction tip sizes and balloon sizes. Both 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)
Balloon Diameter x Length (mm)	Balloon Diameter x Length (mm)
NA	5 x 8
5 x 18	5 x 18
6 x 8	6 x 8
6 x 18	6 x 18
7 x 18	7 x 18

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 [K121174]. 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 and simulated use in a cadaver model to support the additional suction tip size. Sterilization, packaging testing, animal and clinical data was not submitted. 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.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure, composed of three curved lines or strokes.

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

AUG 22222012

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

Re: K121943

Trade Name: XprESS Multi-Sinus Dilation Tool Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 20, 2012 Received: July 23, 2012

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

. Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological,

and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Entellus Medical

K121943

Indications for Use Statement 6.

510(k) Number (if known):

Device Name:

XprESS Multi-Sinus Dilation Tool

Indications for Use

Prescription Use OR/AND X

Over-the-Counter Use

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

Concurrence of CDRH Office of Device Evaluation (ODE)

1943

Nandh. S.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

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.