ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

K082569 · Entellus Medical, Inc. · EOB · Sep 18, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K082569
• Device Name: ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
• Applicant: Entellus Medical, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

Device Story

Flexible fiber optic endoscope with eyepiece; designed for visualization of ear, airway, nose, and sinus cavities. Device connects to compatible external endoscopic video systems for image display. Used by physicians in clinical settings during diagnostic and therapeutic procedures. Provides direct visualization of anatomical structures to assist in clinical decision-making and procedural guidance. Benefits include minimally invasive access to internal cavities for improved diagnostic accuracy and therapeutic intervention.

Clinical Evidence

Bench testing only. Includes biocompatibility testing, dimensional verification, and qualification of reprocessing procedures. No clinical data provided.

Technological Characteristics

Flexible fiber optic endoscope with eyepiece. Compatible with standard endoscopic video systems. Materials verified for biocompatibility. Reprocessable design. No electronic components or software algorithms integral to the device itself.

Indications for Use

Indicated for visualization of internal cavities of ear, airways, nose, and sinus cavities during diagnostic and therapeutic endoscopic procedures in patients requiring such examinations.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Karl Storz Miniature Endoscope (K070752)
• Karl Storz Video Rhino-Laryngoscope System (K072387)
• Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786)

Submission Summary (Full Text)

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### 510(k) Summary K082569

## SEP 1 8 2008

| Date Prepared:<br>Submitted By: | September 17, 2008 |
|---------------------------------|---------------------------------------------------------|
| Company: | Entellus Medical, Inc. |
| Address: | 6705 Wedgwood Court North |
| | Maple Grove, MN 55311 |
| Establishment Reg: | Not Yet Assigned |
| Owner/Operator #: | 10025424 |
| Contact Person: | Deborah Neymark |
| | V.P., Regulatory Affairs, Clinical Research and Quality |
| | 763-463-7056 (phone) |
| | 763-463-1599 (fax) |
| Device Information: | |
| Trade Name: | Entellus Medical Flexible Endoscope and Eyepiece |
| Common Name: | Flexible Endoscope |
| Classification Name: | Nasopharyngoscope (flexible and rigid) |
| Classification: | 21 CFR 874.4760 |
| Product Code: | EOB |

#### Predicate Device:

The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the following devices:

- Karl Storz Miniature Endoscope (K070752) ●
- Karl Storz Video Rhino-Laryngoscope System (K072387) .
- Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786)

#### Device Description:

The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.

#### Indications for Use:

The Entellus Flexible Endoscope and Eyepicce is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

#### Performance Data:

The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures.

#### Conclusion:

The Entellus Medical Flexible Endoscope and Eyepiece is substantially equivalent to the identified predicate device based on a companson of the indications for use, the technological characteristics of the device and an assessment of the submitted performance data.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2008

Entellus Medical Inc. c/o Mark Job Regulatory Technology Services 1394 25th Street. NW Buffalo, MN 55313

Re: K082569

Trade/Device Name: Entellus Medical Flexible Endoscope and Eyepiece Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible and rigid) Regulatory Class: Class II Product Code: EOB Dated: September 4, 2008 Received: September 5, 2008

Dear Mr. Job:

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 mav 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 Prestmarket 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.

M. B. Egerlins, mnd

Malvina B. Evdelman. M.D. 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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KOB-2569

# Indications for Use Statement

510(k) Number:

K082569

Device Name:

Entellus Medical Flexible Endoscope and Eyepiece

Indications for Use:

The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

Prescription Use X (Part 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)

Sein Mardin

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number

X cription Use r 21 CFR 801.109)