Relieva UltirraNav Sinus Balloon Catheter

K161698 · Acclarent, Inc. · LRC · Oct 24, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161698
• Device Name: Relieva UltirraNav Sinus Balloon Catheter
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Oct 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Relieva Ultirra® Nav 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 Ultirra® Nav Sinus Balloon Catheter may be utilized in conjunction with the Acclarent NavWire™ Sinus Navigation Guidewire and CARTO® ENT System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy.

Device Story

Flexible sinus balloon catheter; used for mechanical dilation of sinus ostia. Features hypotube on proximal end for rigidity during insertion through guide catheter. Operates by manual inflation of noncompliant balloon with sterile saline or water. Designed for use in conjunction with electromagnetic navigation guidewire and CARTO® ENT System to facilitate access and confirm placement relative to pre-acquired CT images. Used by ENT surgeons in clinical settings. Provides visual confirmation of device location within anatomy; aids in precise navigation to target sinus ostia. Benefits patient by enabling minimally invasive sinus dilation procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including dimensional verification, balloon burst pressure, joint separation force, deflation time, cycle fatigue, biocompatibility, and sterilization validation. Simulated use testing with ENT surgeons confirmed effective access to paranasal sinuses using the navigation system.

Technological Characteristics

Noncompliant balloon catheter; hypotube proximal shaft. Materials biocompatible per ISO 10993. Sterilization via Ethylene Oxide (EtO) per AAMI/ANSI/ISO 11135:2014. Compatible with 0.035" guidewires. Manual operation; balloon inflation via sterile saline/water. Integrated with electromagnetic navigation systems.

Indications for Use

Indicated for dilation of sinus ostia and spaces in maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, indicated for dilation of sinus ostia and spaces associated with the maxillary sinus.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

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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.<br>33 Technology Drive<br>Irvine, CA 92618 |
| Contact Person: | Patrick Garvey<br>Associate Director, Regulatory Affairs<br>Email: [e-mail]<br>Tel: [phone] |
| 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)<br>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.

Relieva Ultirra® Nav Sinus Balloon Catheter

# [807.92(a)(5)] Intended Use The Relieva Ultirra® Nav Sinus Balloon Catheter is an instrument intended to Indications for Use: 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 Ultirra® Nav Sinus Balloon Catheter may be utilized in conjunction with the Acclarent NavWire™ Sinus Navigation Guidewire and CARTO® ENT System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. Difference in The difference in indications for use between the subject and predicate devices Indications from is supported is presented in Table 1 of this summary. Predicate Device [807.92(a)(6)] Technical Characteristics Technological The Relieva Ultirra® Nav Sinus Balloon Catheter is a device that allows for Characteristics: dilation of sinus ostia with the added capability to be utilized with the

CARTO®ENT Navigation System. Sinus dilation is achieved via a noncompliant balloon located on the distal end of the device. See Table 1 for a comparison of the technological characteristics between the

Relieva Ultirra® Nav Sinus Balloon Catheter and the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black, with the "ent" portion of the word in purple. There is a purple curved line above the "ent" portion of the word, and a trademark symbol is visible.

Relieva Ultirra® Nav Sinus Balloon Catheter

| Attribute | Primary Predicate Device: | Secondary Predicate Device: | Subject Device: |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Relieva Solo Elite™ Sinus<br>Balloon Catheter | Medtronic EM Dilation Tool | Relieva Ultirra® Nav Sinus<br>Balloon Catheter |
| 510(k) Number | K11254 | K132297 | K161698 |
| Manufacturer | Acclarent. Inc. | Medtronic Xomed, Inc. | Acclarent, Inc. |
| Common Name | Sinus Balloon Dilation System | EM Sinus Dilation System | Sinus Balloon Dilation System |
| Class | I | I | I |
| Product Code | LRC | LRC | LRC |
| Classification Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 |
| Indicated for Children | Yes | No | Yes |
| Single Patient Use | Yes | Yes | Yes |
| Direct Patient Contact | Yes | Yes | Yes |
| Labeled as Non-<br>Pyrogenic? | No | No | No |
| Balloon Diameter | 3.5mm, 6mm, 7mm | 5mm, 6mm, 7mm | 5mm |
| Balloon Length | 16mm | Frontal = 17mm<br>Maxillary = 7mm<br>Sphenoid = 17mm | 16mm |
| Working Length | 245 mm | Unknown | 245 mm |
| Maximum Inflation<br>Pressure | 12 ATM | Unknown | 12 ATM |
| Flexible Shaft | Yes | No | Yes |
| Attribute | Primary Predicate Device: | Secondary Predicate Device: | Subject Device: |
| | Relieva Solo Elite™ Sinus<br>Balloon Catheter | Medtronic EM Dilation Tool | Relieva Ultirra® Nav Sinus<br>Balloon Catheter |
| Indications for Use | The Relieva Ultirra® Sinus<br>Balloon Catheter is an instrument<br>intended to dilate sinus ostia and<br>spaces within the paranasal sinus<br>cavities for diagnostic and<br>therapeutic procedures. It is also<br>intended to irrigate from within a<br>target sinus for therapeutic<br>procedures and to facilitate<br>diagnostic procedures.<br>For children aged 17 and under,<br>the balloon catheter system is<br>intended to dilate sinus ostia and<br> | The EM Sinus Dilation System is<br>intended for use in sinus<br>procedures when surgical<br>navigation or image-guided<br>surgery may be necessary to locate<br>and move tissue, bone, or<br>cartilaginous tissue surrounding<br>the drainage pathways of the<br>frontal, maxillary, sphenoid<br>sinuses.<br>The EM Dilation system is used in<br>conjunction with the Medtronic<br>Computer-assisted surgery system.<br>The Medtronic computer-assisted<br>surgery system and its associated<br>applications are intended as an aid<br>for precisely locating anatomical<br>structures in either open or<br>percutaneous procedures. Their<br>use is indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where reference<br>to a rigid anatomical structure,<br>such as the skull, can be identified<br>relative to a CT or MR based<br>model, or digitized landmarks of<br>the anatomy.<br>The system and its associated<br>applications should be used only as<br>an adjunct for surgical guidance.<br>They do not replace the surgeon's<br>knowledge, expertise, or judgment. | The Relieva Ultirra® Nav Sinus<br>Balloon Catheter is an instrument<br>intended to dilate the sinus ostia<br>and spaces within the paranasal<br>sinus cavities for diagnostic and<br>therapeutic procedures.<br>For children aged 17 and under,<br>the balloon catheter system is<br>intended to dilate sinus ostia and<br>spaces associated with the<br>maxillary sinus for diagnostic and<br>therapeutic procedures.<br>The Relieva Ultirra® Nav Sinus<br>Balloon Catheter may be utilized<br>in conjunction with the Acclarent<br>NavWire™ Sinus Navigation<br>Guidewire and CARTO® ENT<br>System to provide access to nasal<br>and sinus spaces, and to confirm<br>placement in the accessed<br>anatomy. |
| Attribute | Primary Predicate Device: | Secondary Predicate Device: | Subject Device: |
| | Relieva Solo Elite™ Sinus<br>Balloon Catheter | Medtronic EM Dilation Tool | Relieva Ultirra® Nav Sinus<br>Balloon Catheter |
| Technological<br>Characteristics | Enables dilation of sinus ostia<br>with added capability of<br>irrigating the sinuses. | Allows for dilation of sinus<br>ostia and EM Navigation | Allows for dilation of sinus<br>ostia and EM Navigation |
| Constructed of Materials<br>Commonly Used in<br>Patient Contacting<br>Medical Devices | Yes | Unknown | Yes |
| Use a Sinus Guide for<br>Access into Targeted<br>Anatomy | Yes | No | Yes |
| Guidewire Compatibility<br>with (NavWire or Sinus<br>Illumination System) | Yes<br>0.035" | No | Yes<br>0.035" |
| EtO Sterilized | Yes | Unknown | Yes |
| Sinuses in which device<br>is intended for use:<br>[Sphenoid, Maxillary,<br>Frontal] | Frontal, Maxillary, Sphenoid | Frontal, Maxillary, Sphenoid | Sphenoid, Maxillary, Frontal |
| Packaging | Thermoformed tray in pouch…