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 light guides (cables).

AI/ML Overview

The provided 510(k) summary for the PathAssist™ Light Seeker™ (K113522) focuses on demonstrating substantial equivalence to a predicate device (K110158), rather than a detailed clinical study proving specific performance metrics against pre-defined acceptance criteria for a novel device. As such, many of the requested elements (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with explicit metrics, and ground truth establishment for novel algorithms) are not applicable or not reported in this type of submission.

The "acceptance criteria" in this context are primarily related to maintaining functionality and safety after reprocessing, aligning with the predicate device's performance, and meeting design specifications.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Reported)	Reported Device Performance
Functional Performance	Device performs as intended (locate, illuminate, transilluminate nasal/sinus structures).	Performance testing showed that the subject device meets design specifications and performs as intended. Functional testing supported the useful life of the device after repetitive reprocessing cycles.
Reprocessing Effectiveness	Device maintains functionality and safety after manual cleaning and manual high-level disinfection/sterilization.	Reprocessing validation (cleaning, HLD, sterilization) was performed, with validation results referenced from predicate devices ([K102366] for cleaning/HLD, [K110158] for sterilization).
Biocompatibility	Device materials are biocompatible (per ISO 10993-1).	Biocompatibility was established as having the same technological characteristics as the predicate device (same materials). No new biocompatibility data were submitted.
Substantial Equivalence	Device has the same indications for use and fundamental scientific technology as the predicate, with equivalent technological characteristics (principle of operation, design, function, materials).	The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device. It is substantially equivalent to the predicate device.
Safety	Device is safe for its intended use.	Performance testing demonstrated that the device is safe and effective.

Study Information

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not reported. This submission describes design verification testing and reprocessing validation, not a clinical study on patient data with a "test set" in the sense of an algorithm. The testing involved repetitive reprocessing cycling of the device itself.
- The document implies laboratory/engineering testing rather than patient-based data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth in the context of clinical expert review of diagnostic output is established or mentioned, as this is a surgical instrument, not an interpretive diagnostic device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
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. This is a Class I manual surgical instrument. No MRMC comparative effectiveness study was performed or is relevant to this device type. There is no AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a manual surgical instrument. There is no standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance testing of this surgical instrument would be its adherence to engineering specifications and demonstrated functionality (e.g., light output, structural integrity, cleanability, sterilizability) after simulated use and reprocessing cycles. This is based on design specifications and engineering validation.
The sample size for the training set
- Not applicable. No training set for an algorithm is described.
How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is described.

Summary

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K113522

Entellus Medical

JAN 2 7 2012

entellus
MEDICAL™

510(k) Summary

Date Prepared: Submitter Information:

January 23, 2012 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

Establishment Registration:

Contact Information:

3006345872

Garrett P. Ahlborg 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 I, 21 CFR 874.4420

Predicate Device: PathAssist™ Light Seeker™ [K110158]

Device Description:

Image /page/0/Figure/16 description: The image shows a diagram of a medical instrument. The instrument has a curved, tapered probe with a 1.5 mm lighted ball tip. The instrument also has a handle and a light post.

PathAssist™ Light Seeker™

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Entellus Medical

Indications for Use:

Contraindications:

None

Technological Characteristics:

The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device [K110158]. The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, and biocompatibility per ISO 10993-1) as the predicate device. The reprocessing methods for the subject device have been modified to include the option of high level disinfection, in addition to the previously cleared validated methods for cleaning and sterilization.

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 testing after repetitive reprocessing cycling consisting of manual cleaning and manual high level disinfection. Design verification testing included functional testing to support the useful life of the device. High level disinfection validation results obtained from device [K102366] were submitted. Cleaning validation results obtained from device [K102366] and sterilization validation data were submitted and cleared for the subject device in [K110158]. Biocompatibility, packaging testing, animal and clinical data was not submitted. Performance testing showed 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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

JAN 2 7 2012

Entellus Medical, Inc. c/o Garrett P. Ahlborg Regulatory Affairs Specialist 6705 Wedgwood Court North Maple Grove, MN 55311

Re: K113522

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: December 28, 2011 Received: December 29, 2011

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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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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Edithrim

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

Enclosure

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Page 3 - Garrett P. Ahlborg

Indications for Use

510(k) Number (if known): K113522

PathAssist™ Light Seeker™ Device Name:

Indications For Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rudy, CRWP

Page 1 of

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

510(k) Number K113522

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.