FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

K091681 · Entellus Medical, Inc. · LRC · Jul 8, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K091681
• Device Name: FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Jul 8, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

FinESS Sinus Treatment Access Sheath; manual surgical instrument. Components: polycarbonate flange over-molded on stainless steel fluted tube; used with trocar to gain access to maxillary sinus. Once trocar removed, sheath allows delivery of cannula, endoscope, and balloon catheter. Used in clinical setting by physicians. Device facilitates balloon displacement of bone/paranasal structures to remodel sinus outflow tract; benefits patient by providing minimally invasive access for sinus treatment.

Clinical Evidence

Bench testing only. No clinical data.

Technological Characteristics

Materials: grey polycarbonate, stainless steel. Design: fluted tube with over-molded flange. Manual surgical instrument. No energy source. Non-sterile/sterilization not specified.

Indications for Use

Indicated for adults requiring access and treatment of the maxillary sinus ostium and ethmoid infundibulum via trans-antral approach for remodeling of the bony sinus outflow tract.

Regulatory Classification

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.

Predicate Devices

• FinESS Sinus Treatment (K073202)

Submission Summary (Full Text)

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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 [phone] (phone) [phone] (fax) [e-mail]

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:

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.

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 [phone] or [phone] 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:

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.

| 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