To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses.

Device Description

The Entellus Medical FinESS Sinus Treatment allows for trans-antral access of the maxillary sinus, placement of the balloon catheter with endoscopic guidance at the ostium and infundibulum. The ostium and infundibulum is widened by balloon dilated using saline.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical FinESS Sinus Treatment device:

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It outlines the regulatory process for demonstrating substantial equivalence to a predicate device. It does not contain a detailed report of a clinical study or performance study with specific acceptance criteria, sample sizes, or ground truth methodologies for a diagnostic or AI-based device. The device described is a surgical instrument (a balloon catheter system for sinus treatment), not a diagnostic device or one that incorporates AI. Therefore, many of the requested points related to AI, ground truth, and reader studies are not applicable to this document.

Acceptance Criteria and Device Performance (Based on provided text)

Acceptance Criteria Category	Reported Device Performance (Summary)
Meets Specification	The device meets design specifications.
Intended Use	Performed as intended.
Biocompatibility	Meets biocompatibility standards.
Sterility	Meets sterility standards.

Study Information (Based on provided text)

Since this is a surgical instrument and not an AI-powered diagnostic device, the following points are largely not applicable (N/A) based on the provided 510(k) summary. The "study" mentioned is a general performance test for mechanical, biological, and sterility aspects, typical for medical devices.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. The summary mentions "dimensional verification, bench testing, and simulated use testing," which would involve samples of the device, but the number is not given.
- Data Provenance: Not specified. This would typically be from the device manufacturer's internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device does not have a "ground truth" established by human experts in the way a diagnostic AI device would. Its performance is assessed against engineering specifications, biocompatibility standards, and sterility standards.
Adjudication method for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving human interpretation of data. This is not reported for mechanical or biological performance tests.
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:
- N/A. This is a surgical device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical surgical device; it does not have an algorithm operating in a standalone capacity.
The type of ground truth used:
- For mechanical performance: Engineering specifications and benchmarks (e.g., burst pressure, tensile strength, dimensions).
- For biocompatibility: ISO standards for medical devices (e.g., cytotoxicity, irritation, sensitization).
- For sterility: Sterility assurance levels (SALs) defined by international standards.
- No "expert consensus," "pathology," or "outcomes data" are presented as the primary ground truth for device function in this type of submission. Outcomes data would be relevant for clinical efficacy, which is usually demonstrated in larger post-market studies or more extensive clinical trials, not typically fully detailed in a 510(k) summary focused on substantial equivalence.
The sample size for the training set:
- N/A. This is not an AI device, so there is no "training set."
How the ground truth for the training set was established:
- N/A. As it's not an AI device, there's no training set or corresponding ground truth establishment process in this context.

Summary

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

JUN 2 7 2008

510(K) SUMMARY SECTION 12.

ADMINISTRATIVE INFORMATION 12.1

12.1.1 Name and address

Sponsor: Entellus Medical, Inc. 6705 Wedgwood Court N, Maple Grove, MN 55311 Tel: 1-763-463-1595 Fax: 1-763-463-1599

FDA Est. Reg #: NA Owner/Operator# 10025424

Submitted on behalf of sponsor by: Sew-Wah Tay, Ph.D. (Regulatory Consultant) 18555 37th Ave North Plymouth, MN 55446 Tel: 612-801-6782 Fax: 763-208-4465 Email: swtay@libramed.com

May 30, 2008 Date Prepared:

12.1.2 Device Name

Trade Name	Entellus Medical FinESS Sinus Treatment
Common Name	Trans-mucocutaneous Sinus Access and Dilation CatheterSystem
Classification Name	Ear, nose, and throat electric or pneumatic surgical drill
Classification	21 CFR 874.4420Class II
Product Code	LRC

12.2 INDICATION FOR USE

To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses.

{1}------------------------------------------------

12.3 DEVICE DESCRIPTION

12.4 SUBSTANTIAL EQUIVALENCE

The Entellus Medical FinESS Sinus Treatment is substantially equivalent to the previously cleared device (K072302).

The Entellus Medical FinESS Sinus Treatment (FinESS) has the same Intended Use as its predicate. Like its predicate, it uses balloon to dilate tissue to remodel the sinus structures.

12.5 Performance Data

The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included biocompatibility testing, dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification and performed as intended.

{2}------------------------------------------------

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 stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 2008

Entellus Medical c/o Sew-Wah Tay, PhD Regulatory Consultant Libra Medical, LLC 18555 37th Ave. N. Plymouth, MN 55446

Re: K081542

Trade/Device Name: Entellus FinESS Sinus Treatment Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: June 23, 2008 Received: June 24, 2008

Dear Dr. Tay:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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,

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, und

Malvina B. Evdelman. M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K081542

INDICATION FOR USE STATEMENT SECTION 7.

510(k) Number (if known):	K081542
---------------------------	---------

Device Name: Entellus Medical FinESS Sinus Treatment

Indications for Use

To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses

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

Concurrence of CDRH Office of Device Evaluation (ODE)

6/26/08

(Division Sign)
Division
Nose and

V081542

510(k) Number

Prescription Use X OR/AND

Over-the-Counter Use_

Page 7-1

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.