To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Device Description

The Entellus Medical RS Series system allows for trans-mucocutaneous access of the sinus, placement of the balloon catheter with endoscopic guidance and the displacement of the tissue and bony structures by balloon catheter dilation.

AI/ML Overview

This 510(k) submission (K072302) for the Entellus Medical RS Series System primarily focuses on demonstrating substantial equivalence to predicate devices and provides general statements about performance testing. It does not contain the type of detailed acceptance criteria and study information typically associated with AI/ML device evaluations. The device described is a physical medical device (a trans-antral sinus access and dilation catheter system), not an AI-powered diagnostic or therapeutic tool.

Therefore, many of the requested fields cannot be directly extracted from the provided text because the study design and reporting requirements for this type of device are different than for AI/ML devices.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

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

Acceptance Criteria	Reported Device Performance
No explicit quantitative acceptance criteria for clinical performance are listed. The submission states the device "meets specification" and "performed as intended."	Safety and Performance: "The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification and performed as intended."
Biocompatibility	Met
Sterility Standards	Met
Design Specification	Met
Intent to Perform	Performed as intended

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

Not Applicable / Not Provided: The submission describes performance data from "bench testing and simulated use testing," but does not mention a clinical test set in the context of human data or AI model evaluation. It's for a physical medical device, not an AI artifact.
The data provenance, if human clinical data were used, is not specified.

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)

Not Applicable / Not Provided: This information is not relevant to the type of device and testing described. Ground truth in the context of AI/ML evaluation is not applicable here.

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

Not Applicable / Not Provided: No adjudication method is mentioned as this is not a study involving expert review of diagnostic outputs.

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: No MRMC study was conducted or mentioned. This is a physical surgical device, not an AI assistance tool for human readers.

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

Not Applicable / No: This is not an algorithm, but a physical device. Standalone performance as described for AI is not relevant.

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

Not Applicable: For this physical device, "ground truth" would relate to its physical properties (e.g., balloon pressure, material strength, dimensional accuracy) and the ability to perform its intended mechanical function, rather than diagnostic accuracy against a clinical reference standard. The text mentions meeting "design specification" as the standard.

8. The sample size for the training set

Not Applicable / Not Provided: This is not an AI/ML device, so there is no "training set."

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

Not Applicable / Not Provided: This is not an AI/ML device, so there is no "training set" or ground truth establishment for an algorithm.

Summary

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K072302

510(k) Summary

APR - 8 2008

Administrative Information

Name and address

Sponsor: Entellus Medical, Inc. 10200 73rd Ave. N., Suite 122, Maple Grove, MN 55369 Tel: 1-763-463-1595 Fax: 1-763-463-1599

FDA Est. Reg #: 9097639

Submitted on behalf of sponsor by: Sew-Wah Tay, Ph.D. (Regulatory Consultant) 18555 37th Ave North Plymouth, MN 55446 Cell: 612-801-6782 Fax: 763-208-4465 Email: swtay@libramed.com

Date Prepared: March 13. 2007

Device Name

Trade Name Entellus Medical RS Series System Common Name Trans-antral Sinus Access and Dilation Catheter System Classification Name Ear, nose, and throat electric or pneumatic surgical drill Classification 21 CFR 874.4250 Class II Product Code ERL

Indication for use

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Device Description

Substantial Equivalence

The Entellus Medical Series Device System is substantially equivalent to the previously cleared Kyphx Inflatable Bone Tamp (K981251), Diego RF Dissector and Drill System (K034004) and the Acclarent Relieva Sinus Balloon Catheter (K043527).

The Entellus Medical RS Series System (RS Series) has the same Intended Use as its predicate. The RS Series System, like the Kyphx Inflatable Bone Tamp, allows the use of a minimally invasive procedure to displace bony structure via balloon dilation. Like the Relieva Balloon catheter, it uses balloon to dilate inflamed tissue to produce the equivalent outcomes in the sinuses as the Diego RF Dissector and Drill System.

Performance Data

The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification and performed as intended.

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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 stripes representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2008

Entellus Medical, Inc c/o Sew-Wah Tay, PhD. Regulatory Consultant 18555 37th Ave. n Plymouth, MN 55446

Re: K072302

Trade/Device Name: Entellus Medical RS Series Balloon System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 10, 2008 Received: March 13, 2008

Dear Dr. Wah:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, und

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Entellus Medical RS Series System

Indications for Use

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

Concurrence of CDRH Office of Device Evaluation (ODE)

OR/AND Prescription Use X

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Karent Boker

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

510(k) Number K072302

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.