← Product Code [LRC](/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC) · K131709 # SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (K131709) _Arthrocare Corp. · LRC · Oct 4, 2013 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K131709 ## Device Facts - **Applicant:** Arthrocare Corp. - **Product Code:** [LRC](/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC.md) - **Decision Date:** Oct 4, 2013 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 874.4420 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia. ## Device Story System comprises disposable balloon sleeve, connecting collar, and inflation line mounted on reusable cannulated delivery instrument. Used by physicians in surgical settings to access/treat nasal and paranasal tissues. Physician guides device to sinus ostium under endoscopic visualization; instrument cannulation provides working channel for suction/irrigation. Balloon is inflated to dilate sinus ostia. Reusable instrument requires sterilization; balloon and inflation device are single-use. Facilitates minimally invasive sinus dilation; improves access to paranasal cavities. ## Clinical Evidence Bench testing only. Validated instrument design against user requirements, including fatigue life, human factors, articulation/locking, and cleaning/sterilization protocols. No clinical data presented. ## Technological Characteristics Disposable balloon sleeve, connecting collar, inflation line; reusable cannulated delivery instrument. Endoscopic guidance. Manual operation. Sterilization required for reusable components. ## Regulatory 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 - ENTrigue® Sinus Dilation System ([K121351](/device/K121351.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K131709 . • # 510(k) SUMMARY ﺎ # Sinus Dilation System with Cannulated Instrument | Sponsor: | ArthroCare Corporation
12672 Silicon Drive, Suite 150
San Antonio, Texas 78249 USA
Telephone: 1-877-300-5010
Fax: 1-210-298-6399
Contact Person: Gabriele G. Niederauer, Ph.D.
| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | OCT 0 4 2013 | | Date Prepared: | September 17, 2013 | | Trade Name: | Sinus Dilation System with Cannulated Instrument | | Product Code and
Device Classification Name: | LRC
Sinus Dilation System (21 C.F.R. § 874.4420) | | Classification:
Predicate Device(s): | Class I (exempt from 510(k) requirements)
ENTrigue Surgical, Inc. ENTrigue® Sinus Dilation System
[K121351] | | Purpose of the
Special 510(k) notice: | The Sinus Dilation System with Cannulated Instrument is a
modification to ENTrigue® Sinus Dilation System. | | Intended Use: | The Sinus Dilation System with Cannulated Instrument is
intended for use in surgical procedures to access, examine or
treat the nasal and paranasal tissues leading to ostia. | | Indications for Use: | The Sinus Dilation System with Cannulated Instrument is
indicated to access and treat the frontal recesses, sphenoid
sinus ostia, and maxillary ostia/ethmoid infundibula in adults
using a trans-nasal approach. | | Technological:
Characteristics | The Sinus Dilation System with Cannulated Instrument
consists of a disposable balloon which is mounted on a
reusable cannulated delivery instrument to allow for dilation of
sinus ostia in the paranasal cavity under endoscopic guidance.
The Sinus Balloon components include a balloon sleeve to
slide over the tip of the delivery instrument, a connecting collar
to latch the balloon sleeve to the delivery instrument, and an
inflation line to connect to the balloon inflation device. The
features of this device enable a physician to guide the device | {1}------------------------------------------------ to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc. The Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The cannulated delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures. Performance Data: Bench testing was conducted to validate that the instrument design met user requirements and test results confirmed that the Sinus Dilation System with Cannulated Instrument is substantially equivalent to the legally marketed predicate device the ENTrique® Sinus Dilation System. Instrument testing included fatigue life, human factors verification, ability to articulate and lock, cleaning and sterilization validations. In all instances, the Sinus Dilation System with Cannulated Instrument functioned as intended and the results observed were as expected. The Sinus Dilation System with Cannulated Instrument has the same intended use and similar indications, principles of operation, and technological characteristics as ENTrigue® Sinus Dilation System. The minor difference in handle design and cannulation of the reusable delivery instrument does not alter the fundamental scientific technology. Verification and validation testing confirms that the modifications do not raise any new risks. Thus, the Sinus Dilation System with Cannulated Instrument is substantially equivalent to its predicate devices. ### Substantial Equivalence: {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image. Public Health Service October 4, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-002 ArthroCare, Inc. % Gabrielle G. Niederauer, Ph.D. Senior Director, R & D 7000 W. William Cannon Dr., Bldg. 1 Austin. TX 78735 Re: K131709 Trade/Device Name: Sinus dilation system with cannulated instrument Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 5, 2013 Received: September 6, 2013 Dear Dr. Niederauer: 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 enacunent 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. Iisting 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. {3}------------------------------------------------ Page 2 - Gabrielle G. Niederauer, Ph.D. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Eric Ayman -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 {4}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): K131709 Device Name: Sinus Dilation System with Cannulated Instrument ### Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia. Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostialethmoid infundibula in adults using a transnasal approach. Prescription Use _ × (Per 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Sunny Par 2013.10.03 14:00 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K131709](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K131709) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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