PATHASSIST LIGHT FIBER

K120962 · Entellus Medical, Inc. · LRC · Apr 27, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K120962
• Device Name: PATHASSIST LIGHT FIBER
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1

Intended Use

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

Device Story

PathAssist Light Fiber is a flexible, single-use surgical instrument designed for ENT procedures. It consists of an illumination fiber, protective sheath, and light post, with a 27.6cm working length and 117cm total length. The device connects to an external light source to emit light from its distal end. Used by clinicians to locate, illuminate, and transilluminate nasal and sinus structures, the device aids in visualization during surgery. It is packaged with a male tuohy borst adapter and a sinus cannula. The device is provided sterile.

Clinical Evidence

No clinical data submitted. Performance testing consisted of bench-top design verification, including functional testing for compatibility with LED light sources, sterilization, shelf life, packaging, and biocompatibility testing.

Technological Characteristics

Flexible illumination fiber; 0.5mm outer diameter; 27.6cm working length; 117cm total length. Connects to external light source. Provided sterile for single use. Includes male tuohy borst adapter and sinus cannula.

Indications for Use

Indicated for patients 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

• PathAssist™ Light Fiber™ (K111763)

Submission Summary (Full Text)

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K/20962

APR 2 7 2012

Image /page/0/Picture/3 description: The image shows the logo for "entellus MEDICAL". The logo consists of a circular design on the left, made up of several curved lines that create a swirling effect. To the right of the circular design is the word "entellus" in a simple, sans-serif font. Below "entellus" is the word "MEDICAL" in smaller, capitalized letters with a trademark symbol.

#### 510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

March 29, 2012 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

3006345872

Garrett P. Ahlborg Regulatory Affairs Specialist [phone] [e-mail]

ENT Manual Surgical Instrument

PathAssist™ Light Fiber™

Class I, 21 CFR 874.4420

Sinus Guidewire

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

Predicate Device: PathAssist™ Light Fiber™ [K111763]

#### 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. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.5mm (0.020"). The device consists of a flexible illumination fiber, a protective sheath and a light post, with an overall device length of 117cm. The Light Fiber is provided sterile and is for single use only.

LRC

Image /page/0/Figure/15 description: The image shows a diagram of a light fiber. The diagram labels the different parts of the light fiber, including the light post, strain relief, flexible sheath, and fiber. The light fiber is shown as a long, thin tube with a loop in the middle.

PathAssist Light Fiber

The Light Fiber is packaged with a commercially available male tuohy borst adapter and a sinus cannula.

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### Indications for Use:

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

#### Contraindications:

None

## Technological Characteristics:

The Light Fiber has the same indications for use and fundamental scientific technology as the predicate device [K111763]. The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility and sterility) as the predicate device.

### Substantial Equivalence:

The Light Fiber has the same indications for use and fundamental scientific technology as the predicate device. The Light Fiber is substantially equivalent to the predicate device.

### Performance Data:

Performance testing of the Light Fiber consisted of design verification testing. Design verification testing included functional testing to support compatibility of the Light Fiber with LED light sources. Sterilization, shelf life, packaging testing, biocompatibility, animal and clinical data were not submitted. Performance testing demonstrated that the subject device meets design specifications and performs as intended.

#### Conclusion:

In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

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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 tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

APR 2 7 2012

Entellus Medical, Inc. % Garrett P. Ahlborg 6705 Wedgwood Court North Maple Grove, MN 55311

Re: K120962

Trade/Device Name: PathAssist TM Light FiberTM Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: March 29, 2012 Received: March 30. 2012

Dear Mr. Ahlborg:

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. Ilsting 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 devicerelated 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/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,

R. Hampt

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 6. Indications for Use Statement

510(k) Number (if known):

K120962

Device Name:

PathAssist™ Light Fiber™

Indications for Use

To locate, illuminate within, and transilluminate across nasal and sinus structures in patients 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

K120962 510(k) Number.