PATHASSIST LIGHT SEEKER

K133563 · Entellus Medical, Inc. · LRC · Dec 20, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K133563
• Device Name: PATHASSIST LIGHT SEEKER
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1

Intended Use

The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

Device Story

PathAssist Light Seeker is a fiber optic, manually operated, reusable sinus seeker; connects to external light source to emit light from distal 1.5mm ball tip. Used by clinicians to locate, illuminate, and transilluminate nasal and sinus structures (frontal, ethmoid, maxillary). Device includes adapters for compatibility with standard 2.5mm-3.5mm light guides. Non-sterile; requires cleaning and sterilization or high-level disinfection between uses. Provides visual guidance for sinus procedures; aids in anatomical navigation.

Clinical Evidence

Bench testing only. Included design verification (dimensional and thermal safety), biocompatibility (ISO 10993-1), and packaging testing (ASTM D4169-09). No clinical or animal data submitted.

Technological Characteristics

Fiber optic sinus seeker with 1.5mm lighted ball tip. Compatible with 2.5mm-3.5mm light guides. Biocompatibility per ISO 10993-1. Packaging per ASTM D4169-09. Manual operation; reusable; requires sterilization or high-level disinfection.

Indications for Use

Indicated for patients aged 18 and over to locate, illuminate, and transilluminate nasal and sinus structures, including frontal, ethmoid, and maxillary sinuses.

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 Seeker™ (K120735)

Submission Summary (Full Text)

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Entellus Medical

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# 510(k) Summary

Date Prepared: Submitter Information: November 19, 2013 Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447

Establishment Registration:

Contact Information:

Garrett P. Ahlborg

3006345872

Sr. Regulatory Affairs Specialist [phone] [e-mail]

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

PathAssist™ Light SeekerTM Illuminating Sinus Seeker ENT Manual Surgical Instrument LRC Class 1, 21 CFR 874.4420

Predicate Device: PathAssist™ Light Seeker™ [K120735]

# Device Description:

The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables),

Image /page/0/Figure/15 description: The image shows a diagram of a medical instrument with several labeled parts. The instrument has a long, thin handle with a light post at the end. The other end has a curved, tapered probe with a 1.5mm lighted ball tip.

PathAssist™ Light Seeker™

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## Indications for Use:

The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

#### Contraindications:

None

## Technological Characteristics:

The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device [K 120735]. The subject device has the same technological characteristics (i.e., principle of operation, basic design, function, materials, biocompatibility and reprocessing methods) as the predicate device.

#### Substantial Equivalence:

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

## Performance Data:

Performance testing of the Light Seeker consisted of design verification, biocompatibility and packaging testing. Design verification testing included dimensional, and thermal safety testing to support the device modifications. Biocompatibility testing was performed per ISO 10993-1. Packaging testing was performed per ASTM D4169-09. Sterilization, cleaning, high level disinfection, 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.

Public Health Service

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

December 20, 2013

Entellus Medical Mr. Garrett P. Ahlborg Sr. Regulatory Affairs Specialist 3600 Holly Lane North, Suite 40 Plymouth, MN 55447

Re: K133563

Trade/Device Name: PathAssist™ Light Seeker™ Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 19, 2013 Received: November 20, 2013

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, 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,

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Page 2 - Mr. Garrett P. Ahlborg

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-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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -S

for 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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# Indications for Use

510(k) Number (if known): K133563

Device Name: PathAssist™ Light Seeker™

Indications For Use:

The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Sunny Park : 上 2013.12.19 17:13:38 -05'00'

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