To access and treat the frontal recesses and sphenoid sinus ostia in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Device Description

The Entellus Medical Balloon Device is shaped like a sinus ostium seeker, or a curved suction tube, with a dilatation balloon. It is placed trans-nasally under endoscopic guidance. The position of the device may be verified with fluoroscopy. The size of the device lumen is similar to a 5F suction tube and can be used to aspirate thin liquids from the sinus. The device is provided sterile and is available either in the standard model or the shapeable model.

AI/ML Overview

The provided text describes a medical device, the Entellus Medical Balloon Device, and its 510(k) submission to the FDA. However, it does not include information about acceptance criteria, a detailed study proving device performance against those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with performance evaluation of diagnostic or AI-driven medical devices.

The information provided focuses on the substantial equivalence to predicate devices, safety, biocompatibility, and functional testing. Therefore, I cannot fully answer all aspects of your request based on the given text.

Here's what I can extract and address:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it mentions that the device "meets design specification" and "performed as intended" based on bench testing.

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in terms of quantitative metrics suitable for AI/diagnostic device performance like sensitivity/specificity)	- Biocompatible
	- Sterility assured through sterilization validation
	- Meets design specification
	- Performed as intended (functional tests)
	- Can be safely positioned within sinus structures (cadaver studies)
	- Easily visible using fluoroscopy (fluoroscopy imaging)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing" and "Cadaver studies." It does not specify the sample size for these tests, nor does it provide information about the country of origin or whether the data was retrospective or prospective.

3. 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)

This information is not provided in the document. The "ground truth" here seems to be inherent in the engineering and medical testing (e.g., successful balloon inflation, correct positioning in cadavers), rather than expert interpretation of medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or conducted for this device based on the provided text. This type of study is typically relevant for diagnostic devices, especially those incorporating AI, where human interpretation is a key component. The Entellus Medical Balloon Device is a surgical instrument.

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

This concept is not applicable to the Entellus Medical Balloon Device, as it is a manual surgical instrument. There is no AI algorithm or standalone performance. The "human-in-the-loop" is the surgeon using the instrument.

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

For the specific tests mentioned:

Bench testing: Ground truth would be engineered specifications and direct measurement/observation of physical properties (e.g., burst pressure, inflation time, material strength).
Biocompatibility: Ground truth is established through adherence to ISO standards or similar guidelines for material interactions with biological systems.
Sterilization validation: Ground truth is the absence of microbial contamination, validated by standard microbiological tests.
Cadaver studies: Ground truth is the physical observation of the device's ability to be safely and correctly positioned within anatomical structures (e.g., successful navigation, absence of trauma).

8. The sample size for the training set

This is not applicable as the device is a manual surgical instrument and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

510(K) SUMMARY 1.

1.1 ADMINISTRATIVE INFORMATION

Company Name and address

Entellus Medical, Inc. Deborah Neymark VP Regulatory, Clinical and QA 6705 Wedgwood Court N, Maple Grove, MN 55311 Tel: 1-763-463-7056 Fax: 1-763-463-1599

FDA Est. Reg #: 3006345872

DATE : FEBRUARY 4, 2010

Device Name

Trade Name	Entellus Medical Balloon Device
Common Name	Sinus Balloon Dilation System
Classification Name	ENT Manual Surgical Instrument
Classification	21CFR 874.4420Class I
Product Code	LRC

1.2 SUBSTANTIAL EQUIVALENT PREDICATES

The Entellus Medical is substantially equivalent to:

K081542 - FinESS Sinus Treatment System K061903- Relieva Sinus Balloon Dilatation Catheter 510(k) exempt - Karl Storz Frontal Sinus Ostium Seeker 510(k) exempt - Karl Storz Sphenoid Punch 510(k) exempt - 5F Ferguson or Frazier Suction Tube

The intended use of the device is similar to the predicates. The device, like the predicates is intended to treat sinus diseases with endoscopic visualization.

FEB - 5 2010

{1}------------------------------------------------

The basic features and principle of operations of the device are similar to the predicate devices. Any minor differences do not raise new issues of safety, effectiveness, performance, or function.

1.3 INDICATION FOR USE

1.4 DEVICE DESCRIPTION

1.5 PERFORMANCE DATA

The device performance bench test data is provided in the 510(k) submission. Testing showed that the device is biocompatible. Sterilization of the device was achieved via ethylene oxide and sterility of the device assured through sterilization validation.

Bench testing showed that the device meets design specification. The device functional tests showed that it performed as intended. Cadayer studies showed that the device can be safely positioned within the sinus structures as intended. Fluoroscopy imaging showed that the device is easily visible using fluoroscopy.

{2}------------------------------------------------

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

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

Entellus Medical, Inc. c/o See-Wah Tay, PhD. Regulatory Consultant Libra Medical, LLC 18555 37" Ave. N. Plymouth, MN 55446

FEB - 5 2010

Re: K093007

Trade/Device Name: Entellus Medical Sinus Balloon Device (Model MSB) Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: January 11, 2010 Received: January 14, 2010

Dear Dr. Tay:

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

{3}------------------------------------------------

Page 2 - See-Wah Tay, PhD.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

A. m. h

· 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

{4}------------------------------------------------

INDICATION FOR USE STATEMENT

510(k) Number (if known): K093007

Device Name: Entellus Medical Balloon Device

Indications for Use

Prescription Use X (Part 21 CFR 801 Subpart D)

Prescription Use (Per 21 CFR 801.109) 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)

S. Ludy CRNP

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

510(k) Number K093007

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.