RELIENT NAVIGATION DEVICE

{0}------------------------------------------------ K0600974 Image /page/0/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the "t" in "Acclarent". The word and curved line are black against a white background. : 上一篇: Sinus Guide Adapter and Calibration Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special 510(k): Device Modification CONFIDENTIAL | | | 5/5/06 | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | | APPENDIX A: 510(k) SUMMARY | | | Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 | | | Contact Person: | Su-Mien Chong<br>Vice President, Clinical/Quality/Regulatory<br>Phone: (650) 704-1632<br>Fax: (650) 687-5889 | | | Date of Submission: | April 6, 2006 | | | Device Trade Name: | <i>ReliENT</i> TM Navigation Device | | | Common Name: | Sinus Guide Adapter and Calibration Device | | | Device Classification: | Class 1 | | | Regulation Number: | 21 CFR 874.4420 | | | Classification Name: | ENT Manual Surgical Instrument | | | Product Code: | KAM | | | Predicate Device: | Sinus Guide Catheter (K043445) | | | Device Description: | The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the<br><i>InstaTrak</i> Receiver. | | | | The Sinus Guide Adapter is used in conjunction with a Calibration Device that<br>is compatible with the <i>InstaTrak</i> Navigation system. The Calibration Device is<br>used to calibrate the tip position and the trajectory line of the Sinus Guide<br>Catheter. Once calibrated, the Calibration Device is removed. | | | Indications for Use: | The Sinus Guide Adapter and Calibration Device are intended to provide a<br>means to access the sinus space for diagnostic and therapeutic procedures. | | | Technological<br>Characteristics | The Sinus Guide Adapter and Calibration Device are accessory devices to the<br>Sinus Guide Catheter. The accessory devices enable navigation capability for<br>the Sinus Guide Catheter, if desired. | | | Performance Data | The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and<br>Calibration Device met all performance testing acceptance criteria. | | | Summary of<br>Substantial<br>Equivalence: | The Sinus Guide Adapter and Calibration Device are substantially equivalent to<br>the predicate device as confirmed through relevant performance tests. | | {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center resembles a stylized eagle or bird with outstretched wings. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 5 2006 Acclarent, Inc. c/o Ms. Su-Mien Chong 1525-B O'Brien Drive Menlo Park, CA 94025 Re: K060974 Trade/Device Name: ReliENT™ Navigation Device Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: KAM Dated: April 19, 2006 Received: April 20, 2006 Dear Ms. Chong: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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. {2}------------------------------------------------ Page 2 - Ms. Su-Mien Chong This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance al its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.himi. Sincerely yours, M.B. Egelston - M.D. 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 {3}------------------------------------------------ Acclarént / Special 510(k): Device Modification CONFIDENTIAL APPENDIX B: INDICATIONS FOR USE STATEMENT KO 60974 510(k) Number (if known): Sinus Guide Adapter and Calibration Device Trade Name: ReliENT™ Navigation Device Sinus Guide Adapter and Calibration Device Common Name: The Sinus Guide Adapter and Calibration Device are intended to Indications For Use: provide a means to access the sinus space for diagnostic and therapeutic procedures. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page of of *(Posted November 13, 2003)* insion Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices Rose and Throat Devices :10(k) Number K060924