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April 7, Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA PDF
April 7, Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD April 7, 2015 Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA Re: K Trade/Device Name: Acclarent SE Inflation Device Regulation Number: 21 CFR 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.
2 Page 2 - Mr. James Patrick Garvey 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 of the Act); 21 CFR 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) or (301) or at its Internet address Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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) or (301) or at its Internet address Enclosure 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
3 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K 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) This section applies only to requirements of the Paperwork Reduction Act of *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF 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 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) Page 1 of 1 PSC Publishing Services (301) EF
4 Acclarent SE Inflation Device Special 510(k) Premarket Notification CONFIDENTIAL Sponsor/Submitter: Contact Person: Acclarent, Inc B O Brien Drive Menlo Park, California James Patrick Garvey II Sr. Manager, Regulatory Affairs Phone: (650) Fax: (650) Date of Submission: March 12, 2015 Device Trade Name: Common Name: Device Classification: ACCLARENT SE Inflation Device Balloon Inflation Device Class I Regulation Number: 21 CFR Classification Name: Product Code: Predicate Devices: Device Description: Ear, nose, and throat manual surgical instrument LRC Acclarent Balloon Inflation Device (K052198) 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. Indications for Use: The Acclarent SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used sinus procedures. 31 1
5 Acclarent SE Inflation Device Special 510(k) Premarket Notification CONFIDENTIAL Technological Characteristics: Attribute Predicate Device Acclarent Balloon Inflation Device Subject Device ACCLARENT SE Inflation Device 510(k) number K This Application Model Number BID30 SE Inflation Device Rigidity Rigid Same Pressure Gauge Values Displayed in atmospheres (atm) & Pounds per Square in (PSI ) Values Displayed in atmospheres (atm) only Length (Plunger not extended) Length (Plunger extended) Device Diameter (at hand position) 1.0 inch 1.3 inches Flexible reinforced 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 : Biocompatibility testing for the SE Inflation Device included: Test Test Standard Results Intracutaneous Reactivity ISO :2013 Pass Sensitization ISO :2013 Pass In Vitro Cytotoxicity ISO :2009 Pass Systemic Toxicity ISO :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 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 : 2007 and demonstrated a sterility assurance level of Testing of ethylene oxide residuals met ISO :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 Clinical data was not necessary to establish the safety and efficacy 322
6 Acclarent SE Inflation Device Special 510(k) Premarket Notification CONFIDENTIAL 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. 333