The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

Device Description

The Relieva SpinPlus Balloon Sinuplasty System is an integrated device that incorporates an ergonomically designed Handle, an illuminated Guidewire, a Sinus Balloon Catheter, and a Guide Catheter. The Sinus Balloon Catheter enables sinus irrigation without instrument exchanges. The principles of operation of SpinPlus are similar to the predicate devices in allowing for access and enlargement of sinus ostia, and irrigation from within the target sinus.

AI/ML Overview

The provided document is a 510(k) summary for the Relieva SpinPlus Balloon Sinuplasty System. It describes the device, its indications for use, and performance data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/algorithm-based medical device performance evaluation.

The "Performance Data" section in the 510(k) summary (page 3) states:

"Bench testing met all acceptance criteria for attributes such as simulated use testing, dimensional attributes, cycle fatigue, balloon burst, bond separation, irrigation flow rate and wire light output. Testing also showed that the SpinPlus Balloon Sinuplasty System is biocompatible."
"The sterilization process has been validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as “non-pyrogenic”."
"Packaging shelf life has been established to be 3 months per ASTM F1980-07."
"Clinical data were not necessary for the SpinPlus Balloon Sinuplasty System. The performance data demonstrate that the device performs as intended."

This information pertains to engineering and safety performance of a physical medical device (balloon sinuplasty system), not the performance of an AI/algorithm. Therefore, I cannot extract the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and testing described in this document.

Summary

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

April 22, 2015

Acclarent, Inc. Pavan Sethi, Ph.D. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K143541

Trade/Device Name: Relieva SpinPlus Balloon Sinuplasty 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 20, 2015 Received: March 23, 2015

Dear Dr. Sethi:

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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Indications for Use

510(k) Number (if known) K143541

Device Name Relieva SpinPlus Balloon Sinuplasty System

Indications for Use (Describe)

The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target simus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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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 "A" in black and the rest of the letters in a dark purple color. There is a curved line above the "ent" in purple.

510(K) SUMMARY

Sponsor/Submitter:	Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025
Contact Person:	Pavan Sethi, Ph.D.Manager, Regulatory AffairsPhone: (650) 687-5413Fax: (650) 687-4847
Date of Submission:	December 12, 2014
Device Trade Name:	Relieva SpinPlus Balloon Sinuplasty System
Common Name:	Sinus Dilation System
Device Classification:	Class I
Regulation Number:	21 CFR 874.4420
Classification Name:	Ear, Nose, and Throat Manual Surgical Instrument
Product Code:	LRC
Predicate Devices:	Relieva Spin Sinus Dilation System (Primary Predicate, K111875)Relieva Solo Elite Sinus Balloon Catheter (K111254)Relieva Luma Sinus Illumination System (K071845)
Device Description:	The Relieva SpinPlus Balloon Sinuplasty System is an integrateddevice that incorporates an ergonomically designed Handle, anilluminated Guidewire, a Sinus Balloon Catheter, and a Guide Catheter.The Sinus Balloon Catheter enables sinus irrigation without instrumentexchanges. The principles of operation of SpinPlus are similar to thepredicate devices in allowing for access and enlargement of sinus ostia,and irrigation from within the target sinus.
Indications for Use:	The Relieva SpinPlus Balloon Sinuplasty System is intended to: providea means to access the sinus space and illuminate within andtransilluminate across nasal and sinus structures; dilate the sinus ostiaand spaces associated with the paranasal sinus cavities for diagnosticand therapeutic procedures; and irrigate from within a target sinus fortherapeutic procedures and to facilitate diagnostic procedures.
	For children aged 17 and under, the Relieva SpinPlus BalloonSinuplasty System is intended to: provide a means to access the sinus
	space and illuminate within and transilluminate across nasal and sinusstructures; dilate sinus ostia and spaces associated with the maxillarysinus for diagnostic and therapeutic procedures; and irrigate from withinthe maxillary sinus for therapeutic procedures and to facilitatediagnostic procedures.
TechnologicalCharacteristics:	The Relieva SpinPlus Balloon Sinuplasty System combines a SinusGuide Catheter and Handle Assembly (integrated with Sinus BalloonCatheter, Sinus Irrigation and Illuminated Sinus Guidewire) into asingle device.
Performance Data:	Bench testing met all acceptance criteria for attributes such as simulateduse testing, dimensional attributes, cycle fatigue, balloon burst, bondseparation, irrigation flow rate and wire light output. Testing alsoshowed that the SpinPlus Balloon Sinuplasty System is biocompatible.
	The sterilization process has been validated per AAMI/ANSI/ISO11135-1: 2007 and demonstrated a sterility assurance level of 10-6. Themethod used for sterilization validation is the overkill (half-cycleapproach) in a fixed chamber. Ethylene oxide residuals have beentested and meet ISO 10993-7:2008 requirements. The subject device isnot tested nor labeled as “non-pyrogenic”.
	Packaging shelf life has been established to be 3 months per ASTMF1980-07.
	Clinical data were not necessary for the SpinPlus Balloon SinuplastySystem. The performance data demonstrate that the device performs asintended.

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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. There is a purple curved line above the "rent" portion of the logo.

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.