ACCLARENT SE Inflation Device

K150172 · Acclarent, Inc. · LRC · Apr 7, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K150172
• Device Name: ACCLARENT SE Inflation Device
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Apr 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Manual inflation device used during sinus balloon catheter procedures; enables clinician to inflate/deflate balloon and monitor pressure. Device consists of high-pressure syringe barrel, piston with locking mechanism, ergonomic handle, pressure gauge, and high-pressure tubing. Clinician operates device manually to deliver fluid to balloon catheter; pressure gauge provides visual feedback on inflation pressure. Used in clinical settings by physicians; output informs clinician of balloon inflation status and pressure levels, facilitating safe and effective sinus dilation. Benefits patient by enabling controlled, monitored sinus opening.

Clinical Evidence

Bench testing only. Evaluated dimensional attributes, cycle fatigue, and reliability after three years of simulated accelerated aging (ASTM F 1980-07). Biocompatibility testing performed per EN ISO 10993-1:2009 (intracutaneous reactivity, sensitization, cytotoxicity, systemic toxicity) with passing results. Sterilization validated per AAMI/ANSI/ISO 11135-1:2007; ethylene oxide residuals met ISO 10993-7:2008. No clinical data required.

Technological Characteristics

Manual, rigid inflation device. Features: 7cc syringe capacity, pressure gauge (atm), ergonomic piston handle, high-pressure tubing. Biocompatibility per ISO 10993 series. Sterilization: Ethylene oxide (AAMI/ANSI/ISO 11135-1:2007). Shelf life: 3 years (ASTM F 1980-07). No software or electronic components.

Indications for Use

Indicated for use as an instrument to inflate, deflate, and monitor pressure in balloon catheters during sinus procedures. No specific patient population age or gender restrictions provided.

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

• Acclarent Balloon Inflation Device (K052198)

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

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 [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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# 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)

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Acclarent SE Inflation Device

Special 510(k) Premarket Notification -

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II<br>Sr. Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| 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,<br>deflate and monitor pressure in balloon catheters used during sinus procedures. |
| | When used in a Balloon Sinuplasty dilation procedure, the inflation device<br>enables the user to inflate the sinus balloon catheter, monitor the pressure<br>within the balloon, and deflate the balloon. |
| | The device has a pressure gauge that indicates the atmospheric pressure at<br>which the attached balloon is inflated, a high pressure syringe barrel that<br>indicates the amount of fluid in the chamber, a mechanism to lock/unlock the<br>piston, an ergonomic piston handle, and high pressure tubing used to attach the<br>inflation device to the balloon catheters. The ACCLARENT SE Inflation<br>Device should only be used with Acclarent Sinus Balloon Catheters with<br>balloon sizes less than or equal to 7mmx24mm. Consult the individual<br>Acclarent sinus balloon catheter carton labels for balloon size information. |
| Indications for Use: | The Acclarent® SE Inflation Device is an instrument intended to inflate, deflate<br>and monitor pressure in balloon catheters used sinus procedures. |

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## Acclarent SE Inflation Device

### Technological Characteristics:

| Attribute | Predicate Device<br>Acclarent Balloon<br>Inflation Device | Subject Device<br>ACCLARENT SE<br>Inflation Device |
|---------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------|
| 510(k) number | K052198 | This Application |
| Model Number | BID30 | SE Inflation Device |
| Rigidity | Rigid | Same |
| Pressure Gauge | Values Displayed in<br>atmospheres (atm) &<br>Pounds per Square in<br>(PSI) | Values Displayed in<br>atmospheres (atm) only |
| Length<br>(Plunger not extended) | 8.1" | 8.8" |
| Length<br>(Plunger extended) | 11.3" | 11.1" |
| Device Diameter (at<br>hand position) | 1.0 inch | 1.3 inches |
| Flexible reinforced<br>high 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 |
|------------------------------|-------------------|---------|
| Intracutaneous<br>Reactivity | 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.