Entellus Medical Sinus Guidewire is a 0.035" – compatible guidewire with a flexible angled radiopaque distal tip. It is constructed of nickel titanium alloys, stainless steel, and features a polymer coating.

AI/ML Overview

The provided document is a 510(k) summary for the Entellus Medical Sinus Guidewire, a Class I manual surgical instrument. For such devices, the regulatory approval process often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive, detailed clinical trials with acceptance criteria and statistical performance measures typically seen with higher-risk devices or software.

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

Acceptance Criteria and Device Performance

A formal table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, etc.) is not explicitly provided in the 510(k) summary for clinical performance metrics. The submission focuses on demonstrating substantial equivalence through technological characteristics and design verification testing.

Instead of clinical performance metrics, the "Performance Data" section states: "Performance testing showed that the device meets design specifications and performed as intended."

The key evaluation for this device appears to be:

Acceptance Criteria (Implied)	Reported Device Performance
Device meets design specifications.	Device meets design specifications.
Device performs as intended (utility in sinus spaces).	Device performed as intended.
Device comparable in design, function, materials, biocompatibility, packaging, and sterilization to predicate devices.	Device is comparable in these aspects to predicate devices.

Study Details

The specific "study" that proves the device meets the (implied) acceptance criteria is described as:

Design Verification Testing: This included simulated use and compatibility testing.
Cadaver Study: This was conducted "to support the utility of this device in the sinus spaces."

Here's the breakdown of other requested information:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for either the design verification testing or the cadaver study. The cadaver study would involve a sample of human cadavers, but the number is not given.
Data Provenance: The cadaver study would be prospective in nature, as it involves active testing of the device. The geographical origin of the cadavers or the testing facility is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Given the nature of a manual surgical guidewire, ground truth in a cadaver study would likely involve direct observation by surgeons or anatomical experts during the procedure, but their number and qualifications are not detailed.

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

This information is not provided. Clinical adjudication methods are typically used for more subjective assessments or where a definitive "answer" needs to be established from multiple reviewers, which doesn't seem to be the primary evaluation method for a simple guidewire in a cadaver study.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/radiological imaging devices, not for a manual surgical guidewire.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or AI.

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

For the cadaver study, the ground truth for "utility in the sinus spaces" would implicitly be established through direct observation and assessment by surgical or anatomical experts during the cadaver procedures. There is no mention of pathology or outcomes data in this context.

8. The sample size for the training set:

This device is not an AI/ML device that requires a "training set." The concept of a training set is not applicable.

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

Not applicable, as there is no training set for this type of device.

In summary, the K110739 submission primarily relies on demonstrating substantial equivalence to predicate devices and verifying that the device meets its design specifications through engineering and cadaver testing, rather than extensive clinical efficacy studies with detailed performance metrics and ground truth establishment typically required for higher-risk devices or those with complex diagnostic/therapeutic functions.

Summary

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K110739

Entellus Medical

JUN 1 4 2011

Image /page/0/Picture/3 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made up of curved lines. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font.

510(k) Summary

Date Prepared: Submitter Information:

Establishment Registration:

Contact Information:

June 13, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311

3006345872

Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com

Device Information: Trade Name: Common Name: Classification Regulation: Classification Name: Classification Panel: Device Classification: Product Code:

Entellus Medical Sinus Guidewire Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC

Predicate Devices:

NeoMetrics Selectiva™ SB Guidewire [K033321, K013024] Relieva Vigor™ Sinus Guidewire

Device Description:

Indication for Use

To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over.

Contraindications:

None

Technological Characteristics:

The device has the same technological characteristics (i.e., design, function, materials, biocompatibility, packaging and sterilization) as the predicate device [K033321, K013024]. The device has the same technological characteristics (i.e., design, function, principle of operation, and biocompatibility) as the predicate device (Relieva Vigor Sinus Guidewire). The subject and

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predicate devices are all sterilized using Ethylene Oxide (EtO), validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10°. All devices are for single use only and are biocompatible per ISO 10993-1.

Substantial Equivalence:

The intended use and indications for use of the subject device is the same as the predicate device (Relieva Vigor Sinus Guidewire). The technological characteristics of the subject device are the same as the predicate devices, [K033321, K013024] and/or Relieva Vigor Sinus Guidewire, including: design, function, principle of operation, materials, biocompatibility, packaging and sterilization.

Performance Data:

Performance testing of the Entellus Medical Sinus Guidewire consisted of design verification testing and a cadaver study. Design verification testing included simulated use and compatibility testing. A cadaver study was conducted to support the utility of this device in the sinus spaces. Biocompatibility, sterilization, packaging, shelf life testing, animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performed as intended.

Conclusion

In conclusion, the device is substantially equivalent based on a comparison of intended use, indications for use, and technological characteristics. The device is safe and effective for its intended use.

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

JUN 1 4 2011

Entellus Medical, Inc. c/o Karen E. Peterson Vice President, Clinical, Regulatory and Quality 705 Wedgwood Court North Maple Grove, MN 55311 USA

Re: K110739

Trade/Device Name: Entellus Medical Sinus Guidewire Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose and Throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 16, 2011 Received: March 17, 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.

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.html 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,

Q.h.hm.b

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

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Indications for Use Statement

510(k) Number (if known): __ K110739

Device Name: Entellus Medical Sinus Guidewire

Indications for Use

To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use OR/AND

Susan Rudy CRNP
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KI10739 510(k) Number_

Over-the-Counter Use

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.