The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.

The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

Device Description

The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.

The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.

AI/ML Overview

The provided text describes a 510(k) submission for the ENTrigue® Sinus Dilation System, focusing on its substantial equivalence to a predicate device. The information available pertains to the device's technical characteristics and the claim of equivalence, rather than a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the ENTrigue® Sinus Dilation System in a typical clinical study format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool.

The primary "acceptance criterion" in this context is that the ENTrigue® Sinus Dilation System is "as safe and effective" as the predicate device. The performance data presented are qualitative and based on comparing technological characteristics and intended use.

Acceptance Criteria (Implicit for Substantial Equivalence):

Acceptance Criteria Category	Description	Reported Device Performance
Intended Use	The ENTrigue® Sinus Dilation System has the same intended uses as the predicate device (access, examine, or treat nasal and paranasal tissues leading to ostia).	The ENTrigue® Sinus Dilation System's intended use is consistent with the predicate.
Indications for Use	The ENTrigue® Sinus Dilation System has similar indications for use as the predicate device (access and treat frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach).	The ENTrigue® Sinus Dilation System's indications for use are similar to the predicate.
Technological Characteristics	The ENTrigue® Sinus Dilation System has similar design, materials, and principles of operation to the predicate device. Minor technological differences do not constitute differences in fundamental scientific technology.	The ENTrigue® Sinus Dilation System consists of a disposable balloon mounted on a reusable delivery instrument for dilation, similar to the predicate's description. The document states "The ENTrigue® Sinus Dilation System has the same intended uses and similar indications, technological characteristics (design, materials), principles of operation, packaging and sterilization (EtO) as the predicate device."
Performance Data (Functional Equivalence)	Bench and cadaveric testing, featuring multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantially equivalent to the legally marketed predicate device. This implies the device functions reliably and safely for its intended purpose.	"Bench and cadaveric testing, featuring multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantial equivalent to the legally marketed predicate device..." "In all instances, the ENTrigue® Sinus Dilation System functioned as intended and the results observed were as expected."
Biocompatibility, Sterilization, Packaging, Distribution, Shelf Life	These aspects were tested to ensure the device is safe and effective in these areas, comparable to the predicate.	Biocompatibility, sterilization, packaging, distribution, and shelf life testing were submitted. "In all instances... the results observed were as expected."

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

Sample Size: The document mentions "Bench and cadaveric testing, featuring multiple users." It does not specify the exact number of cadavers or the number of components tested for bench testing. It also doesn't specify the number of "users" (presumably surgeons) involved.
Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not specified. It is likely prospective testing specifically conducted for this 510(k) submission, given the nature of bench and cadaveric studies.

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

The document refers to "multiple users" for the cadaveric testing. It does not specify the number or qualifications of these users/experts. It can be inferred that these would be medical professionals (e.g., ENT surgeons) experienced in sinus dilation procedures, as the testing was to validate "user requirements."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method. The testing appears to be functional validation and comparison, rather than a scenario requiring multiple expert opinions for ground truth establishment. The focus is on the device's operational performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on substantial equivalence through bench and cadaveric testing, not a clinical trial comparing human reader performance with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.

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

This question is not applicable as the ENTrigue® Sinus Dilation System is a physical surgical instrument, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is the device itself being evaluated for its physical function, guided by a human surgeon.

7. The Type of Ground Truth Used:

For the bench testing, the "ground truth" would be engineering specifications and expected functional performance.
For the cadaveric testing, the "ground truth" would be the successful and safe execution of the intended surgical procedures (e.g., successful dilation of ostia as observed by the "multiple users" for meeting "user requirements"), demonstrating physical interaction with anatomical structures. This is essentially expert observation and assessment of procedural success and device functionality in a simulated environment.

8. The Sample Size for the Training Set:

This question is not applicable. The ENTrigue® Sinus Dilation System is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models. This type of device is developed and validated through engineering design, material science, and functional testing, not through data-driven training.

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

This question is not applicable for the same reason as point 8.

Summary

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K 12135|

AUG 2 9 2012

510(k) Number

510(k) SUMMARY

ENTrigue Surgical's Sinus Dilation System

Date Prepared:

May 3, 2012

Trade Name:

Sponsor:

ENTrigue® Sinus Dilation System

ENTrigue Surgical, Inc. 12672 Silicon Drive, Suite 150 San Antonio, Texas 78249 USA Telephone: 1-877-300-5010 Fax: 1-210-298-6399 Contact Person: Gabriele G. Niederauer, Ph.D.

Product Code and
Device Classification Name:

Classification:

Predicate Device:

Intended Use:

Indications for Use:

Technological: Characteristics LRC Sinus Dilation System (21 C.F.R. § 874.4420)

Class I (exempt from 510(k) requirements)

Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool [K102003]

The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.

The Sinus Dilation Balloon System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

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recommended and validated cleaning and sterilizing procedures.

Performance Data:

Substantial Equivalence:

Bench and cadaveric testing,fea turing multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantial equivalent to the legally marketed predicate device; the XprESS™ Multi-Sinus Dilation Tool. Biocompatibility, sterilization, packaging, distribution, and shelf life testing were also submitted. In all instances, the ENTrigue® Sinus Dilation System functioned as intended and the results observed were as expected.

The ENTrique® Sinus Dilation System is as safe and effective as the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool. The ENTrigue® Sinus Dilation System has the same intended uses and similar indications, technological characteristics (design, materials), principles of operation, packaging and sterilization (EtO) as the predicate device. The minor technological differences between the ENTrigue® Sinus Dilation System and its predicate device do not constitute differences in fundamental scientific technology. Performance data demonstrate that the ENTrigue® Sinus Dilation System is as safe and effective as the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool. Thus, the ENTrigue® Sinus Dilation System is substantially equivalent to the XprESS™ Multi-Sinus Dilation Tool.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

ENTrigue Surgical, Inc. c/o Gabriele G. Niederauer, Ph.D. Senior Vice President, Technology and Development 12672 Silicon Drive, Suite 150 San Antonio, TX 78249

Re: K121351

Trade/Device Name: ENTrigue® Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 31, 2012 Received: August 9, 2012

Dear Dr. Niederauer:

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.

AUG 29 2012

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Page 2 - Gabriele G. Niederauer, Ph.D.

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,

Erica Newman, MD

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

Enclosure

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K 12 135|

Indications for Use Statement

510(k) Number (if known): _

Device Name: ENTrigue® Sinus Dilation System

Intended Use:

The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.

Indications for Use:

The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amalolal

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
The Course of Devices (Division Sign-Off) Division of Open of Open of Orices
Nose and Throat Devices

Number |<12135|

Page of

510(k) Number

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.