The Relieva UltirraNav TM Sinus Balloon Catheter is an instrument intended to dilate the sinus ostia and spaces within the maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic procedures.

For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The Relieva UltirraNav™ Sinus Balloon Catheter may be utilized in conjunction with the Navigation Guidewire and CARTO® ENT System to to confirm placement in the accessed anatomy relative to pre-acquired CT images.

Device Description

The Relieva Ultirra® Nav Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study demonstrating device effectiveness from scratch. Therefore, many of the typical acceptance criteria and study details for a novel AI/software device may not be explicitly present or directly applicable. This document primarily describes non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Dimensional Specifications	(Implicit: Device dimensions meet pre-defined requirements)	The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications.
Balloon Performance	- Balloon burst pressure- Deflation time- Balloon cycle fatigue	The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including... balloon burst pressure, joint separation force, deflation time, and balloon cycle fatigue.
Joint Integrity	- Joint separation force	The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including... joint separation force...
Shelf Life	- Per ASTM F1980-07- Per ASTM F88/F88M-09- Per ISTA 2A- Per ASTM F2096-04	Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-04 requirements.
Biocompatibility	(Implicit: Meets biocompatibility standards for patient contact)	Testing also showed that the Relieva Ultirra® Nav Sinus Balloon Catheter is biocompatible.
Sterilization	- Sterility Assurance Level (SAL) of 10^-6 per AAMI/ANSI/ISO 11135:2014 (overkill/half-cycle approach)- Ethylene oxide residuals meet ISO 10993-7:2008	The sterilization process has been validated per AAMI/ANSI/ISO 11135:2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements.
Packaging Shelf Life	- Per ASTM F1980-07	Packaging shelf life has been established per ASTM F1980-07.
Simulated Use Performance	- Effectiveness in accessing paranasal sinuses when used with Acclarent NavWire Sinus Navigation Guidewire and CARTO ENT System (performed by ENT surgeons)	Simulated use testing was performed with ENT surgeons performing balloon dilation of the paranasal sinuses utilizing the UltirraNav Sinus Balloon Catheter, Acclarent NavWire Sinus Navigation Guidewire and the CARTO ENT System. The testing demonstrated that the UltirraNav Sinus Balloon used with the Acclarent NavWire and the CARTO ENT System could effectively access the paranasal sinuses.

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

Sample Size for Test Set: Not explicitly stated in terms of a numerical count of devices or cases for each test. The document refers to "testing" that was performed and "simulated use testing."
Data Provenance: The tests described (dimensional, burst pressure, fatigue, biocompatibility, sterilization, simulated use) are non-clinical studies conducted by the manufacturer, Acclarent, Inc. There is no mention of country of origin of data or whether it's retrospective or prospective, as these are non-clinical lab/bench tests.

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

For non-clinical performance tests (e.g., balloon burst, sterilization), "ground truth" is typically established by engineering specifications, material science, and validated test methods rather than expert consensus on interpretation.
For the simulated use testing, "ENT surgeons" were used. The specific number and qualifications (e.g., years of experience) of these surgeons are not provided in this summary. Their role was to perform surgical tasks, effectively acting as "experts" validating the device's functional performance in a simulated environment.

4. Adjudication Method for the Test Set

For the non-clinical tests, adjudication methods like 2+1 or 3+1 typically apply to subjective expert reviews of images or cases. These are not applicable here as the criteria are objective measurements against specifications.
For the simulated use testing, the document states it "demonstrated that the UltirraNav Sinus Balloon used with the Acclarent NavWire and the CARTO ENT System could effectively access the paranasal sinuses." It does not specify an adjudication method among multiple surgeons, implying it was a functional demonstration and evaluation.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a balloon catheter), not an AI or imaging-based diagnostic/screening tool that would typically involve MRMC studies. The device is a manual surgical instrument intended for dilation.
Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as AI assistance is not the primary function or innovation being evaluated here. The "Nav" in the device name refers to its compatibility with an existing navigation system (CARTO® ENT System), which is an aid for surgeons, not an AI interpreting clinical data in the way an AI diagnostic tool would.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not done. This is a hardware medical device (catheter) that is manually operated by a surgeon. It is not an algorithm that can perform standalone without human intervention. Its "navigation" feature is a human-in-the-loop system where the device provides information to the surgeon for guidance.

7. Type of Ground Truth Used

For the non-clinical tests: Objective specifications and validated test methods/standards (e.g., ISO, ASTM standards, internal engineering specifications for burst pressure, dimensions, etc.).
For the simulated use testing: Performance by ENT surgeons in a simulated environment, demonstrating "effective access" to paranasal sinuses. This is a form of functional performance validation.

8. Sample Size for the Training Set

Not applicable. This summary describes the validation of a physical medical device (balloon catheter), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment relevant to machine learning.

Summary

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

October 24, 2016

Acclarent, Inc. Mr. James Patrick Garvey II Associate Director, Regulatory Affairs 33 Technology Drive Irvine, CA 92618

Re: K161698

Trade/Device Name: Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 21, 2016 Received: September 22, 2016

Dear Mr. Garvey:

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 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR 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 Industry and Consumer Education 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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161698

Device Name

Relieva UltirraNav TM Sinus Balloon Catheter

Indications for Use (Describe)

The Relieva UltirraNaving Sinus Balloon Catheter is an instrument intended to dilate the sinus ostia and spaces within the maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic procedures.

For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740 F

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Image /page/3/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "rent" portion in purple. There is a purple curved line above the "rent" portion of the word, which is likely part of the company's branding.

Traditional 510(k) Summary – Relieva Ultirra® Nav Sinus Balloon Catheter

[807.92(a)(1)] Submitter Information
Sponsor/Submitter:	Acclarent, Inc.33 Technology DriveIrvine, CA 92618
Contact Person:	Patrick GarveyAssociate Director, Regulatory AffairsEmail: pgarvey@its.jnj.comTel: 949-789-8505
Date Summary Prepared:	September 21, 2016
[807.92(a)(2)] Name of Device
Device Trade Name:	Relieva Ultirra® Nav Sinus Balloon Catheter
Common Name:	Sinus Balloon Catheter
Device Classification:	Class I
Regulation Number:	21 CFR 874.4420
Classification Name:	Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 874.4420)
Product Code:	LRC
[807.92(a)(3)] Legally Marketed Devices
Predicate Devices:	Relieva Solo Elite™ Sinus Balloon Catheter (K111254)Medtronic EM Dilation Tool (K132297)

[807.92(a)(4)] Device Description

The Relieva Ultirra® Nav Sinus Balloon Catheter is a flexible catheter that is Device Description: intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.

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Image /page/4/Picture/0 description: The image shows the word "Acclarent" in a stylized font. The first part of the word, "Accla" is in black, while the second part, "rent" is in purple. There is a purple curved line above the word "rent" that extends to the right.