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 adults 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 prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).

AI/ML Overview

The Entellus Medical PathAssist Light Seeker is a manual surgical instrument intended to locate, illuminate within, and transilluminate across nasal and sinus structures in adults. The device demonstrated substantial equivalence to predicate devices through various performance tests.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics that would be applicable to a diagnostic or AI-driven device. The "performance data" section details the types of testing performed to confirm the device's design specifications and intended function.

Acceptance Criteria (Implied)	Reported Device Performance
Technological Equivalence (Principle of Operation, Design, Function, Materials, Biocompatibility, Reusability, Reprocessing) to predicate devices [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K071845].	Met: The subject device and predicate device [Sinus Seekers, 510(k) exempt] are both shaped like a sinus seeker, advanced under endoscopic visualization, made of stainless steel, non-sterile, reusable, and require cleaning/sterilization. Both are biocompatible per ISO 10993-1. The subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] both transmit light from proximal to distal tip via light fibers, can be connected to a standard light source via a light cable and adapter, and are biocompatible per ISO 10993-1. Performance testing validated that the device meets design specifications and performs as intended.
Biocompatibility	Met: Biocompatibility testing was performed, and the device is biocompatible per ISO 10993-1.
Design Verification (Dimensional and Functional Testing)	Met: Design verification testing, including dimensional and functional testing, was performed to support the useful life of the device.
Simulated Use Design Validation	Met: Simulated use design validation testing was performed in a cadaver model.
Sterilization Efficacy	Met: Steam sterilization testing was conducted. The device is labeled non-sterile and must be cleaned and sterilized prior to each use. Cleaning validation testing performed on device [K102366] was referenced.
Compatibility with Light Guides	Met: Compatibility testing confirmed the device's ability to connect to commonly used 2.5mm light guides (cables) via two standard light post adapters.
Storage and Transportation Stability	Met: Storage and transportation testing was performed.

2. Sample size used for the test set and the data provenance

The submission refers to "simulated use design validation testing in a cadaver model." However, it does not specify the sample size (number of cadavers) used for this test set.

The data provenance is from simulated use testing in a cadaver model, which would be considered prospective in the context of device validation. The country of origin of the data is not specified, but given the submitter's location (Maple Grove, MN, USA), it's likely from the US.

It's important to note that no animal or clinical data were submitted. This is typical for Class I devices seeking substantial equivalence where non-clinical testing is deemed sufficient.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide details on the number of experts used or their specific qualifications for evaluating the cadaver model testing. Given the nature of this type of testing (design validation for a manual surgical instrument), it would typically involve experienced surgical professionals or engineers assessing the device's function and performance within the cadaveric anatomy. However, this information is not explicitly stated.

4. Adjudication method for the test set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaver model testing. For this type of design validation, observations and assessments are usually made by the testing personnel, and consensus would be implied if multiple individuals were involved, but a formal adjudication process is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a manual surgical instrument for illumination and transillumination, not an AI-driven or diagnostic imaging tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone (algorithm only) performance study was not done. The PathAssist Light Seeker is a physical, manually operated device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "simulated use design validation testing in a cadaver model," the "ground truth" would implicitly be the anatomical structures within the cadaver and the observed functionality of the device (its ability to locate, illuminate, and transilluminate as intended) as assessed by the testing personnel. This is a form of direct observation and functional assessment rather than a diagnostic 'ground truth' like pathology or expert consensus on image interpretation.

8. The sample size for the training set

Not applicable. This device is a manual surgical instrument and does not involve machine learning or an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As a manual surgical instrument, there is no training set or machine learning algorithm for which ground truth would be established.

Summary

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Entellus Medical

K110158

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JUN - 7 2011

510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

May 10, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

3006345872

Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com

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

PathAssist Light Seeker Sinus Seeker ENT Manual Surgical Instrument LRC Class I, 21 CFR 874.4420

Predicate Devices:

Sinus Seekers - Surgical Instrument - [510(k) exempt] Relieva Luma™ Sinus Illumination System [K071845]

Device Description:

Image /page/0/Figure/17 description: The image shows a diagram of a PathAssist Light Seeker. The diagram labels the different parts of the device, including the 1.5 mm Lighted Ball Tip, Curved Tapered Probe, Handle, and Light Post. The PathAssist Light Seeker appears to be a medical device with a curved, tapered probe and a lighted ball tip.

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Indication for Use:

Contraindications:

None

Technological Characteristics:

The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods) as the predicate devices: [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K0930071.

Both the subject device and predicate device [Sinus Seekers, 510(k) exempt] are shaped like a sinus seeker and are advanced under endoscopic visualization into the sinus, are made of stainless steel, are provided non-sterile, are reusable, and must be cleaned and sterilized between each use. Both devices are biocompatible per ISO 10993-1.

Both the subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] 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 devices are biocompatible per ISO 10993-1.

Substantial Equivalence:

The intended use and indications for use of the subject device is the same as the intended use and indications for use of the predicate device [Relieva Luma Sinus Illumination System, K093007]. The technological characteristics of the subject device are the same as the predicate devices. [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System. K093007], including: principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods.

Performance Data:

Performance testing of the device consisted of biocompatibility testing, design verification testing, simulated use design validation testing in a cadaver model, steam sterilization, compatibility testing, and storage and transportation testing. Design verification testing included dimensional and functional testing to support the useful life of the device. Cleaning validation testing performed on device [K102366] was submitted. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performs 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Entellus Medical, Inc. c/o Karen E. Peterson Vice President, Clinical, Regulatory and Quality 705 Wedgwood Court North Maple Grove, MN 55311 USA

JUN - 7 2011

Re: K110158

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: May 12, 2011 Received: May 13, 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

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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/ycm115809.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/ReportalProblem/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/Resourcesfor.You/Industry/default.htm.

Sincerely yours.

Signature

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

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Indications for Use Statement

KI10158 510(k) Number (if known):

Device Name: PathAssist Light Seeker

Indications for Use

(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

Susan Rudy CRNP

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110158

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.