FinESS is indicated to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Device Description

The access sheath component of the FinESS Sinus Treatment System is comprised of a polycarbonate flange that is over-molded on a stainless steel fluted tube which, when mated with the trocar provided in the kit, gains access to the maxillary sinus. Once the trocar is removed, the access sheath allows delivery of the FinESS cannula, endoscope and balloon catheter.

AI/ML Overview

The FinESS™ Sinus Treatment Access Sheath (K091681) did not have specific acceptance criteria for performance defined by clinical studies. Instead, its acceptance was based on a demonstration of substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Properties	Biocompatibility of new material (grey polycarbonate)	Biocompatibility of the new material (grey polycarbonate) was "completed." (This implies it met the necessary standards, though specific values are not provided).
Mechanical Properties	Outer profile of the modified access sheath	Assessed. (Implies satisfactory, though details are not provided).
	Fit of the trocar to the sheath	Assessed. (Implies satisfactory, though details are not provided).
	Tensile strength of the overmolded component	Assessed. (Implies satisfactory, though details are not provided).
	Torque strength of the overmolded component	Assessed. (Implies satisfactory, though details are not provided).
Clinical Performance	No clinical performance acceptance criteria were established or met as "No clinical evaluations were conducted."	No clinical evaluations were conducted. The device was deemed substantially equivalent based on non-clinical testing and comparison of indications for use and device technology with the predicate.
Substantial Equivalence	Equivalence to the existing access sheath in the FinESS Sinus Treatment System based on indications for use and technology.	The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology. This was the overarching "acceptance criterion" for market clearance.

2. Sample Size for Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. No clinical test set was used for performance evaluation. Non-clinical testing was performed on device components, but the sample sizes for these tests are not specified in the summary.
Data Provenance: Not applicable for a clinical test set. The non-clinical test data provenance is not detailed (e.g., in-house lab, third-party lab).

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. No clinical evaluations were conducted, thus no expert-established ground truth for a test set was required.

4. Adjudication Method for Test Set:

Not applicable. No clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states, "No clinical evaluations were conducted." Therefore, no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a manual surgical instrument, not an algorithm or AI-driven system. Therefore, a standalone algorithm performance study was not conducted.

7. Type of Ground Truth Used:

Not applicable for clinical performance. For the non-clinical tests, the "ground truth" would be established by engineering specifications, material standards, and validated test methods to ensure the device met its design requirements.

8. Sample Size for Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study that "proves" the device meets its acceptance criteria is a summary of non-clinical testing. This testing focused on:

Assessments of the outer profile
Fit of the trocar to the sheath
Tensile strength of the overmolded component
Torque strength of the overmolded component
Biocompatibility of the new material (grey polycarbonate)

The conclusion of this non-clinical testing, in conjunction with a comparison of the device's indications for use and technology to the predicate device (FinESS Sinus Treatment (K073202)), led to the Statement of Equivalence. This statement asserts that "The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology."

Therefore, the device was deemed acceptable and received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device, supported by non-clinical device characteristic testing rather than clinical performance data.

Summary

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K091681

JUL - 8 2009

510(k) Summary

Date Prepared:

Submitter Information:

June 1, 2009

3006345872

Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

Establishment Registration:

Contact Information:

Deborah L. Neymark V.P. Regulatory Affairs (763) 463-7056 (phone) (763) 463-1599 (fax) dneymark@entellusmedical.com

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

FinESS™ Sinus Treatment Access Sheath Ear, nose and throat manual surgical instrument LRC Class I, 21 CFR 874.4420

Predicate Device:

FinESS Sinus Treatment (K073202)

Device Description:

Indication for Use:

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

Entellus Medical, Inc. FinESS™Sinus Treatment June 4, 2009

Page 7-2

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Summary of Non-Clinical Testing:

Non-clinical testing of the modified access sheath included assessments of the outer profile, fit of the trocar to the sheath, as well as tensile and torque strength of the overmolded component. Biocompatibility of the new material (grey polycarbonate) was also completed.

Summary of Clinical Data:

No clinical evaluations were conducted.

Statement of Equivalence:

The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology.

Entellus Medical, Inc. FinESS™Sinus Treatment June 4, 2009

Page 7-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 overlapping wings, representing service, knowledge, and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2009

Entellus Medical, Inc. c/o Deborah L. Neymark V.P. Regulatory Affairs Clinical Research and Quality 6705 Wedgwood Court North Maple Grove, MN 55311

Re: K091681

Trade/Device Name: FinESS™ Sinus Treatment Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose and Throat Manual Surgical Instrument Regulatory Class: I Product Code: LRC Dated: June 4, 2009 Received: June 10, 2009

Dear Ms. Neymark:

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 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 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.

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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Eydelman, M.I 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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K09168/

Indications for Use Statement

510(k) Number: K091681

FinESS™ Sinus Treatment Device Name:

Indications for Use:

Prescription Use	X
(21 CFR 801 Subpart D)

AND/OR

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)

Daniel C. Cepp

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

510(k) Numb

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.