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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical PathAssist™ Light Seeker™:

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed are primarily related to design specifications, safety, and equivalence to the predicate, not clinical performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (as stated in submission)
Design Verification	Dimensional Testing	Meets design specifications
	Thermal Safety Testing	Meets design specifications
Biocompatibility	Performed per ISO 10993-1	Device is safe
Packaging	Performed per ASTM D4169-09	Performs as intended
Functional Equivalence	Same Indications for Use as Predicate	Confirmed
	Same Fundamental Scientific Technology as Predicate	Confirmed
	Same Technological Characteristics (principle of operation, basic design, function, materials, reprocessing) as Predicate	Confirmed

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical performance data. The performance testing focused on design verification, biocompatibility, and packaging. These tests would have involved specific units of the device or its components for each test (e.g., a certain number of devices for dimensional checks, samples of materials for biocompatibility, packaged units for shipping tests), but the exact sample sizes are not specified in this summary.

Data Provenance: The data is generated internally by Entellus Medical, Inc. based on their design, manufacturing, and testing processes. No external data provenance (e.g., country of origin, retrospective/prospective) is applicable in the sense of clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission does not involve a clinical "test set" requiring expert ground truth in the way a diagnostic AI device would. The "ground truth" for design verification tests would be established by engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and safety tests performed:

Design Verification (Dimensional, Thermal Safety): Ground truth is established by the device's own engineering design specifications, industry standards, and test protocols.
Biocompatibility: Ground truth is established by the criteria and methods outlined in ISO 10993-1.
Packaging: Ground truth is established by the specified standards in ASTM D4169-09.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

Summary

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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 (763) 463-7074 gahlborg@entellusmedical.com

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:

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:

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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
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.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.