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. XprESS is offered in three balloon sizes: 5mm, 6mm and 7mm diameter balloons. The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated. The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. 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 and Infusion Line.

AI/ML Overview

This 510(k) summary describes a medical device, the XprESS Multi-Sinus Dilation Tool, and its performance data. However, it does not contain the detailed information typically found in studies designed to establish acceptance criteria for AI/ML devices or studies that directly "prove" a device meets those criteria with specific statistical metrics.

The provided document is for a manual surgical instrument and the performance data presented is for design verification and simulated use in a cadaver model, not for an AI/ML algorithm.

Therefore, many of the requested categories (like MRMC studies, standalone algorithm performance, training/test set sizes, expert ground truth for AI, etc.) are not applicable to this specific device and the information provided.

However, I can extract the acceptance criteria for the design verification and the reported device performance from the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Durability	Withstand multiple inflations and device tip manipulations (up to 25) in a surgical case (wherein all 6 sinus ostia are being dilated).	"The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated." (Implies it met this criterion)
Tip Design	Curved suction tip with a 2 mm atraumatic ball tip and a 1 mm inside diameter.	"The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter." (Implies it met this criterion by design)
Suction/Irrigation	Suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. Prevent fluid from exiting the suction vent during irrigation. Infusion Line connected to a syringe may be connected for irrigation.	"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." (Implies it met this criterion by design and testing)
Sterility	Provided sterile.	"The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only." (Met by manufacturing process)
Biocompatibility	Biocompatible per ISO 10993.	"Both devices are biocompatible per ISO 10993." (Met through testing)
Functionality	Meet design specifications and perform as intended.	"Performance testing showed that the device meets design specifications and performed as intended."
Substantial Equivalence	Same indications for use and fundamental scientific technology as the predicate device [K102003]. Same technological characteristics (basic design, function, mode of operation, packaging, shelf life, sterilization) as predicate.	"The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K102003]. The device has the same technological characteristics... The XprESS device is substantially equivalent to the predicate device."

Due to the nature of the device (a manual surgical instrument, not an AI/ML system), most of the subsequent questions are not directly applicable. However, I will answer them based on what can be inferred from the provided text for completeness, noting where the information is not present or relevant to AI/ML.

Additional Information (Contextualized for a Non-AI Device)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Description: The "test set" for this device consisted of "simulated use in a cadaver model" and "design verification" which included dimensional, functional, and simulated use testing.
- Sample Size: Not explicitly stated for the cadaver model or other tests. The durability test mentions "all 6 sinus ostia" being dilated in a surgical case, implying at least one full cadaver head or simulated model.
- Data Provenance: Not specified, but implied to be from laboratory testing and potentially cadaver labs, likely within the US where the company is based (Maple Grove, MN). It is "prospective" in the sense that tests were conducted specifically for this submission.
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):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but implied that the testing was overseen by product engineers, clinical experts, and regulatory personnel familiar with surgical instrument performance and medical device standards. Given the nature of a manual surgical instrument, "ground truth" is typically established by engineering specifications, validated test methods, and clinical assessment of usability/effectiveness by surgeons.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this type of device testing. Performance is measured against engineering specifications and functional benchmarks, not through expert adjudication of output.
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, an MRMC study was not done. This is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device that involves human "readers" or "AI assistance" in the sense of an algorithm.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance test was not done. This device is a manual surgical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering design specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional benchmarks observed during simulated use (e.g., ability to withstand a certain number of inflations, proper fluid flow, physical dimensions).
The sample size for the training set:
- Not applicable. There is no "training set" as this is a non-AI manual surgical instrument. Device design and validation are based on engineering principles and performance testing, not machine learning.
How the ground truth for the training set was established:
- Not applicable. No training set; therefore, no ground truth needed to be established for it.

Summary

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K112506

DEC 2 1 2011

Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". The logo consists of a circular design on the left, made up of several curved lines that create a sense of rotation or movement. To the right of the circular design is the word "entellus" in a lowercase, sans-serif font. Below "entellus" is the word "MEDICAL" in smaller, uppercase letters.

510(k) Summary

Date Prepared: Submitter Information: November 4, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

XprESS Multi-Sinus Dilation Tool

ENT Manual Surgical Instrument

Sinus Balloon Dilation System

Class I, 21 CFR 874.4420

Establishment Registration: Contact Information:

3006345872

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

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

Predicate Device:

XprESS Multi-Sinus Dilation Tool [K102003]

Device Description:

LRC

The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated.

The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. 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.

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Image /page/1/Figure/0 description: The image shows a diagram of a medical device with several labeled parts. The device has a long, thin body with a curved suction tip at one end. The other end has a proximal barbed facing and a balloon inflation luer. The diagram also labels the balloon slide mechanism and the suction vent.

XprESS Multi-Sinus Dilation Tool

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 and Infusion Line.

Indication for Use:

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.

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 [K102003]. The device has the same technological characteristics (i.e., basic design, function, mode of operation, packaging, shelf life and sterilization) as the predicate device. Both devices are sterilized using Ethylene Oxide (EtO) and are not labeled as nonpyrogenic. Both devices are for single use only. Both devices are biocompatible per ISO 10993l .

Substantial Equivalence:

The XprESS device was modified to provide additional balloon sizes, a suction vent, and the device handle was modified to improve ergonomics. The XprESS device has the same indications for use and fundamental scientific technology as the predicate device [K 102003]. The XprESS device is substantially equivalent to the predicate device.

Performance Data:

Performance testing of the XprESS device consisted of biocompatibility, design verification and simulated use in a cadaver model. Design verification included dimensional, functional and simulated use 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines.

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

Entellus Medical c/o Ms. Karen Peterson VP Clinical, Regulatory and Quality 6705 Wedgewood Rd. Maple Grove, MN 55311

DEC 2 1 2011

Re: K112506

Trade/Device 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: November 4, 2011 Received: November 7, 2011

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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Debra Falls

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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Indications for Use

510(k) Number (if known): K12506

Device Name: XprESS Multi-sinus Dilation Tool

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rudy, CRNP
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112506

Page 1 of _ 1

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.