PATHASSIST LED LIGHT FIBER

K130503 · Entellus Medical, Inc. · LRC · Jun 11, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K130503
• Device Name: PATHASSIST LED LIGHT FIBER
• Applicant: Entellus Medical, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Jun 11, 2013
• 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 patients aged 18 and over.

Device Story

PathAssist LED Light Fiber is a single-use, sterile, flexible surgical instrument used to illuminate nasal and sinus structures. The device features a flexible illumination fiber, a protective sheath, and an integrated battery-powered LED light source. During ENT procedures, the clinician inserts the device to emit red light from the distal tip, enabling transillumination of sinus structures to assist in anatomical localization. The device is operated by a physician. It provides visual guidance for the surgeon, potentially improving procedural accuracy and patient outcomes during sinus surgery. It is a self-contained unit, eliminating the need for external light source connections.

Clinical Evidence

No clinical data or animal studies were submitted. Evidence consists of bench testing, including EMC and electrical safety (IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2), design verification (functional, mechanical, and compatibility testing), packaging, and shelf-life validation. Simulated use was performed in a cadaver model. Biocompatibility and sterilization (EtO per ISO 11135-1) were validated.

Technological Characteristics

Flexible illumination fiber (27.6cm length, 0.5mm diameter) with integrated battery-powered LED. Biocompatible per ISO 10993-1. Sterilized via Ethylene Oxide (EtO) per ISO 11135-1. Electrical safety/EMC tested per IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Single-use, sterile.

Indications for Use

Indicated for locating, illuminating, and transilluminating nasal and sinus structures in patients aged 18 and older.

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 (K120962)
• "PLS" Portable Light Source (K091829)

Submission Summary (Full Text)

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Entellus Medical

K13.0503

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 several curved lines. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font.

February 26, 2013

3006345872

Karen E. Peterson

[phone]

Sinus Guidewire

21 CFR 874.4420

Entellus Medical, Inc.

Plymouth, MN 55447

3600 Holly lane North, Suite 40

[e-mail]

ENT Manual Surgical Instrument

PathAssist LED Light Fiber

Vice President Clinical, Regulatory and Quality

JUN 1 1 2013

## 510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

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

Predicate Devices: PathAssist Light Fiber [K120962] "PLS" Portable Light Source [K091829]

#### Device Description:

The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.5mm (0.020").

ENT

LRC

Class I

Image /page/0/Figure/12 description: This image shows a diagram of a medical device. The device has a housing with an integrated light source and a pull tab. A flexible sheath extends from the housing, and a fiber is connected to the sheath.

PathAssist LED Light Fiber

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#### Indication for Use

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

The intended use of the subject device is the same as the predicate devices: PathAssist Light Fiber [K120962] and "PLS" Portable Light Source [K091829], and the indications for use of the subject device is the same as the predicate device [K120962].

#### Contraindications:

None

#### Technological Characteristics:

The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility, shelf life, packaging, sterilization and energy source) as the predicate devices: PathAssist Light Fiber [K120962] and/or "PLS" Portable Light Source [K091829].

Both the subject device and predicate device [K120962] are flexible devices that transmit light from the proximal to distal tip of the device via a light fiber that can be seen via transillumination. Both devices are sterilized using Ethylene Oxide (EtO) and validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10 . Both devices are provided sterile, are for single use only and are biocompatible per ISO 10993-1. The subject device has an internal light source whereas the predicate device [K120962] must be connected to a light source.

Both the subject device and the predicate device [K091829] incorporate an internal battery operated LED light source. Both devices have undergone EMC and electrical safety testing per IEC 60601-1. IEC 60601-2-18 and IEC 60601-1-2. The subject device is provided sterile and is for single use only whereas the predicate device is provided non-sterile and must be cleaned and high level disinfected between each use.

#### Substantial Equivalence:

The intended use of the subject device is the same as the predicate devices [K120962] and [K091829] and the indications for use is the same as the predicate device [K120962]. The technological characteristics of the subject device are the same as the predicate device [K120962] and/or predicate device [K091829], including: principle of operation, design, function, materials, biocompatibility, shelf life, packaging, sterilization and energy source.

#### Performance Data:

Performance testing of the PathAssist LED Light Fiber consisted of EMC and electrical safety, ~ design verification (functional, mechanical, and compatibility testing), packaging, shelf life, and simulated use in a cadaver model. ' Biocompatibility testing and sterilization validation was referenced. 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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June 11, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Entellus Medical, Inc. Karen E. Peterson Vice President Clinical, Regulatory and Quality 3600 Holly lane North, Suite 40 Plymouth, MN 55447

Re: K130503

Trade Name: PathAssist LED Light Fiber Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: February 26, 2013 Received: February 28, 2013

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. Issting 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 - Ms. Peterson

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 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.

# Eric A. Mann -S

for Malvina B. Eydelman, MD

-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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Entellus Medical

ר

#### Indications for Use Statement 6.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PathAssist LED 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 OR/AND Over-the-Counter Use

EricAMann-S

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