K Number

Device Name

Relieva UltirraNav Sinus Balloon Catheter

Manufacturer

ACCLARENT, INC.

Date Cleared

2016-10-24

(126 days)

Product Code

LRC

Regulation Number

874.4420

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K111254, K132297

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (balloon catheter) used for dilation and mentions its use with a navigation system, but there is no indication of AI or ML being used for image processing, analysis, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to dilate the sinus ostia and spaces within the maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic procedures." The term "therapeutic procedures" indicates its use in treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and therapeutic procedures."

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter with a balloon, shaft, and hypotube, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Relieva UltirraNav TM Sinus Balloon Catheter is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device 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." This describes a surgical or interventional procedure performed directly on the patient's body.
Device Description: The description details a flexible catheter with a balloon for dilation, designed for insertion into the sinus cavities. This is consistent with a surgical tool.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for testing biological samples in a laboratory or clinical setting.
Clinical Performance Data: The performance data focuses on the device's physical properties (burst pressure, fatigue, etc.) and its ability to effectively access and dilate the sinuses during simulated use. This is typical for a surgical device, not an IVD which would focus on analytical and clinical performance related to diagnostic accuracy.

In summary, the Relieva UltirraNav TM Sinus Balloon Catheter is a surgical device used for direct intervention within the patient's body, not for testing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LRC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

pre-acquired CT images.

Anatomical Site

maxillary, frontal, and sphenoid paranasal sinus cavities

Indicated Patient Age Range

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.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data: The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications; balloon burst pressure, joint separation force, deflation time, and balloon cycle fatigue.
Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-04 requirements.
Testing also showed that the Relieva Ultirra® Nav Sinus Balloon Catheter is biocompatible.
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. The subject device is not tested nor labeled as “non-pyrogenic”.
Packaging shelf life has been established per ASTM F1980-07.
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.
Clinical data was not necessary for the Relieva Ultirra® Nav Sinus Balloon Catheter. The performance data demonstrated that the device performs as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Relieva Solo Elite™ Sinus Balloon Catheter (K111254), Medtronic EM Dilation Tool (K132297)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on health and well-being. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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.

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

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.

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.

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

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 Drive
Irvine, CA 92618
Contact Person:	Patrick Garvey
Associate Director, Regulatory Affairs
Email: pgarvey@its.jnj.com
Tel: 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.

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.