PATHASSIST LIGHT FIBER

K111763 · Entellus Medical, Inc. · LRC · Sep 15, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111763
• Device Name: PATHASSIST LIGHT FIBER
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1

Intended Use

To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.

Device Story

PathAssist Light Fiber is a flexible, single-use instrument designed to assist in visualizing nasal and sinus structures. The device connects to an external light source via standard light cables and adapters to emit light from its distal tip. It features a male tuohy borst adapter for secure placement within compatible working lumen instruments. During clinical use, the device is inserted into the nasal/sinus cavity; light transmitted through the fiber optic cable allows for transillumination of the sinus structures. This visualization aids clinicians in locating and navigating sinus anatomy. The device is provided sterile and is intended for use by healthcare professionals in a clinical setting.

Clinical Evidence

No clinical data submitted. Performance testing included biocompatibility, design verification (functional and mechanical testing), packaging, sterilization, shelf life, and simulated use in a cadaver model.

Technological Characteristics

Flexible fiber optic instrument; transmits light from proximal to distal tip. Materials are biocompatible per ISO 10993-1. Sterilized via Ethylene Oxide (EtO) per ISO 11135-1 (SAL 10^-6). Includes male tuohy borst adapter for integration with working lumen instruments. Compatible with standard light post adapters and cables. Single-use.

Indications for Use

Indicated for adults aged 18 and over to locate, illuminate, and transilluminate nasal and sinus structures.

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

• Acclarent Relieva Luma Sinus Illumination System (K071845)

Submission Summary (Full Text)

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KIII763

*CONFIDENTIAL*

Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made up of curved lines. Below the word "entellus" is the word "MEDICAL" in a smaller font size.

SEP 1 5 2011

# 510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

6705 Wedgwood Court, North Maple Grove, MN 55311

Entellus Medical, Inc.

3006345872

June 22, 2011

Karen E. Peterson Vice President Clinical, Regulatory and Quality [phone] [e-mail]

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

PathAssist Light Fiber Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC

# Predicate Device:

Acclarent Relieva Luma Sinus Illumination System [K071845]

# Device Description:

The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. The Light Fiber is provided sterile and is for single use only. It comes with a male tuohy borst adapter, which allows the device to be secured within compatible working lumen instruments. The Light Fiber is also compatible with standard light post adapters and light cables.

Image /page/0/Figure/17 description: The image shows a diagram of a fiber optic cable. The cable consists of a light post, strain relief, flexible sheath, and the fiber itself. The flexible sheath is coiled in a loop.

PathAssist Light Fiber

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### Indication for Use

To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.

# Contraindications:

None

# Technological Characteristics:

The subject device has very similar technological characteristics (i.e., design, function, principle of operation, materials, biocompatibility and sterilization) as the predicate device: Acclarent Relieva Luma Sinus Illumination System [K071845].

Both the subject device and predicate device [K071845] are flexible devices that transmit light from the proximal to distal tip of the device via Light Fibers that can be seen via transillumination. Both devices can be connected to a standard light source via a light cable and an adapter.

Both the subject and predicate device [K071845] are sterilized using Ethylene Oxide (EtO), validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 106. Both devices are provided sterile, are for single use only and are biocompatible per ISO 10993-1.

### Substantial Equivalence:

The intended use and indications for use of the subject device are the same as the predicate device [Relieva Luma Sinus Illumination System, K071845]. The technological characteristics of the subject device are very similar to the predicate device [K071845], including: design, function, principle of operation, materials, biocompatibility and sterilization.

#### Performance Data:

Performance testing of the PathAssist Light Fiber consisted of biocompatibility testing, design verification testing, packaging, sterilization, shelf life and simulated use in a cadaver model. Design verification testing included functional and mechanical testing, and compatibility testing. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed as intended.

# Conclusion

In conclusion, the device is substantially equivalent based on a comparison of intended use, indications for use, and technological characteristics. The device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Entellus Medical, Inc. % Ms. Karen E. Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgewood Court North Maple Grove. MN 55311

Re: K111763

1 5 2011 ුදුව

Trade/Device Name: PathAssist Light Fiber Regulation Number: 21 CFR 874.4420 Regulation Name: ENT manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 11, 2011 Received: August 12, 2011

Dear Ms. Peterson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (reporting of medical device-

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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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D.

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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#### 6. Indications for Use Statement

K 111 763 510(k) Number (if known):

Device Name: PathAssist Light Fiber

# Indications for Use

To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| OR/AND | |
| Over-the-Counter Use | |

(Division Sign Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

| 510(k) Number | K111 763 |
|---------------|----------|
|---------------|----------|

510(k) PathAssist Light Fiber