The ACCLARENT SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used during sinus procedures. When used in a Balloon Sinuplasty dilation procedure, the inflation device enables the user to inflate the sinus balloon catheter, monitor the pressure within the balloon, and deflate the balloon. The device has a pressure gauge that indicates the atmospheric pressure at which the attached balloon is inflated, a high pressure syringe barrel that indicates the amount of fluid in the chamber, a mechanism to lock/unlock the piston, an ergonomic piston handle, and high pressure tubing used to attach the inflation device to the balloon catheters. The ACCLARENT SE Inflation Device should only be used with Acclarent Sinus Balloon Catheters with balloon sizes less than or equal to 7mmx24mm. Consult the individual Acclarent sinus balloon catheter carton labels for balloon size information.

AI/ML Overview

The Acclarent SE Inflation Device is an instrument designed to inflate, deflate, and monitor pressure in balloon catheters used in sinus procedures.

Here is an analysis of its acceptance criteria and the supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, and reliability following three years of simulated accelerated aging." Specific numerical acceptance criteria are not detailed in the provided text. However, the performance is reported as meeting these criteria.

Acceptance Criteria Category	Reported Device Performance
Dimensional Attributes	Met acceptance criteria
Cycle Fatigue	Met acceptance criteria
Reliability (after 3 years simulated accelerated aging)	Met acceptance criteria
Intracutaneous Reactivity	Pass
Sensitization	Pass
In Vitro Cytotoxicity	Pass
Systemic Toxicity	Pass
Sterility Assurance Level	Demonstrated 10⁻⁶
Ethylene Oxide Residuals	Met ISO 10993-7:2008 requirements
Packaging Shelf Life	Established at three years

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

The provided document does not specify the sample sizes for the "bench testing" that evaluated dimensional attributes, cycle fatigue, and reliability. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective). Given that this is a premarket notification for a Class I device and clinical data was deemed "not necessary," it is highly likely that the testing was conducted in a laboratory setting.

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

The document does not describe the use of experts to establish a "ground truth" for the test set. Given that the performance data mainly involves bench testing (physical and chemical properties), expert consensus, as typically understood in clinical or image-based studies, would not be applicable here.

4. Adjudication Method for the Test Set

Not applicable. The reported studies are focused on bench testing and biocompatibility, not expert review or adjudication of data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to establish the safety and efficacy of the ACCLARENT SE Inflation Device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This question is not applicable as the device is a manual surgical instrument (an inflation device), not an AI algorithm. Its performance is inherent to its physical and material properties.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" would be established by engineering specifications, material standards, and validated testing protocols. For biocompatibility, the ground truth is established by the accepted standards (e.g., ISO 10993 series) which define acceptable biological responses. For sterility, the ground truth is a sterility assurance level of 10⁻⁶ validated per AAMI/ANSI/ISO 11135-1: 2007.

8. The Sample Size for the Training Set

Not applicable. The device is a physical instrument, not an AI or machine learning model that requires a training set.

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

Not applicable, for the same reason as point 8.

Summary

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

April 7, 2015

Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K150172

Trade/Device Name: Acclarent SE Inflation Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: March 12, 2015 Received: March 13, 2015

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 (reporting of medical devicerelated 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) K150172

Device Name ACCLARENT SE Inflation Device

Indications for Use (Describe)

The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus 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)

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Acclarent SE Inflation Device

Special 510(k) Premarket Notification -

Sponsor/Submitter:	Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025
Contact Person:	James Patrick Garvey IISr. Manager, Regulatory AffairsPhone: (650) 687-4807Fax: (650) 687-4847
Date of Submission:	March 12, 2015
Device Trade Name:	ACCLARENT SE Inflation Device
Common Name:	Balloon Inflation Device
Device Classification:	Class I
Regulation Number:	21 CFR 874.4420
Classification Name:	Ear, nose, and throat manual surgical instrument
Product Code:	LRC
Predicate Devices:	Acclarent Balloon Inflation Device (K052198)
Device Description:	The ACCLARENT SE Inflation Device is an instrument intended to inflate,deflate and monitor pressure in balloon catheters used during sinus procedures.
	When used in a Balloon Sinuplasty dilation procedure, the inflation deviceenables the user to inflate the sinus balloon catheter, monitor the pressurewithin the balloon, and deflate the balloon.
	The device has a pressure gauge that indicates the atmospheric pressure atwhich the attached balloon is inflated, a high pressure syringe barrel thatindicates the amount of fluid in the chamber, a mechanism to lock/unlock thepiston, an ergonomic piston handle, and high pressure tubing used to attach theinflation device to the balloon catheters. The ACCLARENT SE InflationDevice should only be used with Acclarent Sinus Balloon Catheters withballoon sizes less than or equal to 7mmx24mm. Consult the individualAcclarent sinus balloon catheter carton labels for balloon size information.
Indications for Use:	The Acclarent® SE Inflation Device is an instrument intended to inflate, deflateand monitor pressure in balloon catheters used sinus procedures.

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Acclarent SE Inflation Device

Technological Characteristics:

Attribute	Predicate DeviceAcclarent BalloonInflation Device	Subject DeviceACCLARENT SEInflation Device
510(k) number	K052198	This Application
Model Number	BID30	SE Inflation Device
Rigidity	Rigid	Same
Pressure Gauge	Values Displayed inatmospheres (atm) &Pounds per Square in(PSI)	Values Displayed inatmospheres (atm) only
Length(Plunger not extended)	8.1"	8.8"
Length(Plunger extended)	11.3"	11.1"
Device Diameter (athand position)	1.0 inch	1.3 inches
Flexible reinforcedhigh pressure tubing	Yes	Same
Syringe capacity	20cc	7cc
Luminescent dial	Yes	Yes

Performance Data:

Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, and reliability following three years of simulated accelerated aging.

Biocompatibility testing was performed for the ACCLARENT SE Inflation Device in accordance with EN ISO 10993-1: 2009. Biocompatibility testing for the SE Inflation Device included:

Test	Test Standard	Results
IntracutaneousReactivity	ISO 10993-10:2013	Pass
Sensitization	ISO 10993-10:2013	Pass
In Vitro Cytotoxicity	ISO 10993-5:2009	Pass
Systemic Toxicity	ISO 10993-11:2009	Pass

Biocompatibility data indicates that the likelihood of a toxic biologic effect from the SE Inflation Device is negligible. Additionally, the ACCLARENT SE Inflation Device is determined to have met the requirements of EN ISO 10993-1 and FDA General Program Memorandum #G95-1, and is therefore considered safe from a biocompatibility perspective.

The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 100. Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.

The subject device is not tested nor labeled as "non-pyrogenic". Packaging shelf life was established at three years via accelerated aging per ASTM F 1980-07. Clinical data was not necessary to establish the safety and efficacy

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Acclarent SE Inflation Device

Special 510(k) Premarket Notification

of the ACCLARENT SE Inflation Device. The performance data demonstrates that the subject device performs as intended. The performance data demonstrate that the device performs as intended.

Summary of Substantial Equivalence:

The ACCLARENT SE Inflation Device is substantially equivalent to the predicate device.

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.