The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.

Device Description

The FinESS Endoscope is a fiber optic based, manually operated, reusable rigid antroscope designed for performing the FinESS Sinus Treatment procedure. It is short, all metal and fully immersible. It is labeled non-sterile and must be cleaned and disinfected or sterilized prior to use. The endoscope is compatible with standard "B" mount camera couplers, and comes with two light post adapters, which allows the endoscope to be compatible with most commonly used light guides. The endoscope also has a working channel that allows for delivery of the FinESS balloon dilation catheter to treat the maxillary ostium and ethmoid infundibulum. The FinESS Endoscope is part of and used with the FinESS Sinus Treatment [K081542] and insertion of the endoscope is performed using a sterile access sheath [K091681].

AI/ML Overview

Based on the provided text, the FinESS Endoscope is a medical device that received 510(k) clearance. This means it demonstrated substantial equivalence to a legally marketed predicate device, rather than undergoing a de novo approval process that would typically involve establishing novel acceptance criteria and extensive standalone performance studies for an entirely new device.

Therefore, the structure of the provided content focuses on showing equivalence rather than proving a device meets predefined acceptance criteria for novel performance claims.

Here's an analysis of the provided information, noting what is present and what is absent regarding acceptance criteria and study details for AI/ML devices:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) that an AI/ML device would typically be evaluated against. Since this is a traditional medical device (an endoscope) and not an AI/ML device, its performance is assessed against design specifications and intended function rather than diagnostic or analytical performance metrics.

The "Performance Data" section states: "The testing showed that the device meets design specifications and performs as intended." This is the highest level of detail provided regarding performance.

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

Test Set Sample Size: Not applicable in the context of an AI/ML diagnostic or predictive model. The performance tests mentioned are related to engineering and usability aspects of the endoscope itself.
Data Provenance: Not applicable. The "cadaver studies" mentioned are for testing physical performance and usability, not for training or testing an AI model on patient data.

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

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on image labels) is not relevant for this type of traditional device submission. The verification of design specifications would involve engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of adjudication (e.g., 2+1, 3+1) as there are no diagnostic or interpretive outputs being evaluated from the device that would require human expert consensus.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This type of study is not mentioned because it is designed to evaluate human reader performance with and without AI assistance, which is irrelevant for a rigid endoscope.

6. Standalone Performance Study

Yes, in a sense, a "standalone" assessment of the device's physical and functional performance was conducted. The "Performance Data" section details various tests that were performed on the device itself to ensure it functions as designed and intended. These include:

Biocompatibility testing
Dimensional verification
Cadaver studies (for physical use and visualization)
Manual cleaning validation (utilizing total organic carbon as study endpoint)
Manual high level disinfection validation
Sterilization validation of STERRAD NX system (per ISO 14937)
Compatibility testing
Storage and transportation testing

7. Type of Ground Truth Used

The ground truth for this device's performance is its adherence to design specifications, industry standards, and regulatory requirements for medical devices (e.g., biocompatibility standards, sterilization efficacy, dimensional accuracy).

8. Sample Size for the Training Set

Not applicable. As a traditional medical device, there is no "training set" in the context of machine learning. The device's design is based on engineering principles and predicate device experience, not iterative learning from data.

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

Not applicable.

Summary of Device Performance Study as Described:

The study conducted for the FinESS Endoscope was a series of engineering and validation tests demonstrating that the device meets its design specifications and performs its mechanical and functional tasks as intended, particularly in terms of visualization, accessory delivery, and reprocessing. It showed substantial equivalence to its predicate device based on these performance characteristics, ensuring it maintains the same safety and effectiveness profile. No AI/ML components are involved, and thus, typical AI/ML evaluation metrics, studies, and data provenance requirements are not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "entellus MEDICAL". To the left of the company name is a circular graphic made up of several curved lines. The company name is in all lowercase letters, and below it is the word "MEDICAL" in all caps with a trademark symbol.

FEB 1 5 2011

K102366 510(k) Summary

Submitter's Name, Address, and Date of Submission

Karen E. Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgwood Court North Maple Grove, MN 55311 Tel: 1-763-463-7056 Fax: 1-763-463-1599

Submitted:

February 15, 2011

Device Name

Trade Name: Common Name: Classification Name: Product Code:

FinESS Endoscope Endoscope or Antroscope or Sinuscope Nasopharyngoscope (flexible or rigid), 21CFR 874.4760 EOB

Predicate Device

Entellus Medical Flexible Endoscope [K082569] used with Entellus Sinus Cannula [K072302]

Device Description

Image /page/0/Picture/14 description: The image shows a diagram of a medical device. The device has a syringe-like component attached to a rectangular piece with the word "AnESS" printed on it. Two tubes are connected to the rectangular piece on either side.

The FinESS Endoscope is part of and used with the FinESS Sinus Treatment [K081542] and insertion of the endoscope is performed using a sterile access sheath [K091681].

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Indications for Use

Substantial Equivalence

The FinESS Endoscope has the same intended use, principal of operation, biocompatibility, device and accessory compatibility, reusability, and reprocessing methods as the predicate device.

The FinESS Endoscope has some different technological features compared to the predicate device, however. these differences present the same type of questions about safety or effectiveness, accepted scientific methods exist for evaluating the features, and data are provided to demonstrate that the features have not diminished safety or effectiveness.

Performance Data

The device performance test data is provided in the 510(k) submission. Performance tests included biocompatibility testing, dimensional verification, cadaver studies, manual cleaning validation utilizing total organic carbon as study endpoint, manual high level disinfection validation, sterilization validation of STERRAD NX system (per ISO 14937), compatibility testing, and storage and transportation testing. Animal and clinical data were not submitted. The testing showed that the device meets design specifications and performs as intended.

Conclusion

FinESS Endoscope is substantially equivalent to the predicate device. FinESS Endoscope is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles an eagle or bird-like figure.

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

Entellus Medical, Inc. c/o Ms. Karen Peterson Vice President, Clinical, Regulatory and Quality 6705 Wedgewood Court North Maple Grove, MN 55311

FEB 15 201

Re: K102366

Trade/Device Name: Entellus FinESS Endoscope (Model ES300) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: February 11, 2011 Received: February 14, 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.

. ・

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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,

R.C. Turner

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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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: FinESS Endoscope

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 X OR/AND

Over-the-Counter Use

Susan Rudy CRWP

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

510(k) FinESS Endoscope

K102366 510(k) Number_

Page 6-1

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.