MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM

K081542 · Entellus Medical, Inc. · LRC · Jun 27, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K081542
• Device Name: MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Jun 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

The FinESS Sinus Treatment system provides trans-antral access to the maxillary sinus. The system utilizes a balloon catheter, positioned at the ostium and infundibulum under endoscopic guidance. The balloon is inflated with saline to dilate and remodel the bony sinus outflow tract. The device is intended for use by clinicians in a surgical setting. By mechanically displacing adjacent bone, the device facilitates sinus drainage, potentially benefiting patients with sinus outflow tract obstruction.

Clinical Evidence

Bench testing only. Performance data included biocompatibility testing, dimensional verification, and simulated use testing. Results demonstrated that the device meets design specifications and performs as intended.

Technological Characteristics

Trans-antral access and dilation catheter system. Operates via balloon inflation using saline. Designed for endoscopic guidance. Biocompatible materials used. Sterilized device.

Indications for Use

Indicated for adults requiring access and treatment of the sinus and its outflow tract via a trans-antral approach to remodel 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

• K072302

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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: [phone] Fax: [phone] Email: [e-mail]

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 Catheter<br>System |
| Classification Name | Ear, nose, and throat electric or pneumatic surgical drill |
| Classification | 21 CFR 874.4420<br>Class 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.

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#### 12.3 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.

#### 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.

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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 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,

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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 [phone]. 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 [phone] or [phone] 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

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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_

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