← Product Code [LRC](/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC) · K110158 # ILLUMINATING SINUS SEEKER (K110158) _Entellus Medical, Inc. · LRC · Jun 7, 2011 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K110158 ## Device Facts - **Applicant:** Entellus Medical, Inc. - **Product Code:** [LRC](/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC.md) - **Decision Date:** Jun 7, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4420 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat ## Intended Use The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in adults aged 18 and over. ## Device Story PathAssist Light Seeker is a fiber optic, manually operated, reusable sinus seeker. Device connects to external light source via standard light guides/adapters to emit light from distal ball tip. Used by clinicians during sinus procedures; advanced under endoscopic visualization into nasal/sinus cavities. Light transmission enables transillumination of sinus structures, assisting surgeon in locating and navigating anatomy. Device is non-sterile; requires cleaning and sterilization between uses. Benefits include improved visualization and navigation of sinus structures during surgery. ## Clinical Evidence Bench testing only. Evidence includes biocompatibility testing, design verification (dimensional/functional), simulated use validation in cadaver model, steam sterilization validation, compatibility testing, and storage/transportation testing. No animal or clinical data submitted. ## Technological Characteristics Fiber optic sinus seeker; stainless steel construction; biocompatible per ISO 10993-1. Features 1.5 mm lighted ball tip, curved tapered probe, handle, and light post. Connects to standard 2.5mm light guides. Reusable; requires steam sterilization. Manual operation; no electronic or software 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 - Sinus Seekers (510(k) exempt) - Relieva Luma™ Sinus Illumination System ([K071845](/device/K071845.md)) ## Reference Devices - Relieva Luma Sinus Illumination System ([K093007](/device/K093007.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}------------------------------------------------ Entellus Medical K110158 Image /page/0/Picture/2 description: The image shows the logo for "entellus MEDICAL". To the left of the text is a circular graphic made up of curved lines. The text "entellus" is in a sans-serif font, and below it is the word "MEDICAL" in a smaller font size. JUN - 7 2011 #### 510(k) Summary Date Prepared: Submitter Information: Establishment Registration: Contact Information: May 10, 2011 Entellus Medical, Inc. 6705 Wedgwood Court, North Maple Grove, MN 55311 3006345872 Karen E. Peterson Vice President Clinical, Regulatory and Quality (763) 463-7066 kpeterson@entellusmedical.com Device Information: Trade Name: Common Name: Classification Name: Product Code: Regulation Number: PathAssist Light Seeker Sinus Seeker ENT Manual Surgical Instrument LRC Class I, 21 CFR 874.4420 #### Predicate Devices: Sinus Seekers - Surgical Instrument - [510(k) exempt] Relieva Luma™ Sinus Illumination System [K071845] #### Device Description: The PathAssist Light Seeker is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables). Image /page/0/Figure/17 description: The image shows a diagram of a PathAssist Light Seeker. The diagram labels the different parts of the device, including the 1.5 mm Lighted Ball Tip, Curved Tapered Probe, Handle, and Light Post. The PathAssist Light Seeker appears to be a medical device with a curved, tapered probe and a lighted ball tip. {1}------------------------------------------------ ## Indication for Use: The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in adults aged 18 and over. ## Contraindications: None # Technological Characteristics: The subject device has the same technological characteristics (i.e., principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods) as the predicate devices: [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K0930071. Both the subject device and predicate device [Sinus Seekers, 510(k) exempt] are shaped like a sinus seeker and are advanced under endoscopic visualization into the sinus, are made of stainless steel, are provided non-sterile, are reusable, and must be cleaned and sterilized between each use. Both devices are biocompatible per ISO 10993-1. Both the subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] transmit light from the proximal to distal tip of the device via light fibers that can be seen via transillumination. Both devices can be connected to a standard light source via a light cable and an adapter. Both devices are biocompatible per ISO 10993-1. # Substantial Equivalence: The intended use and indications for use of the subject device is the same as the intended use and indications for use of the predicate device [Relieva Luma Sinus Illumination System, K093007]. The technological characteristics of the subject device are the same as the predicate devices. [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System. K093007], including: principle of operation, design, function, materials, biocompatibility, reusability and reprocessing methods. #### Performance Data: Performance testing of the device consisted of biocompatibility testing, design verification testing, simulated use design validation testing in a cadaver model, steam sterilization, compatibility testing, and storage and transportation testing. Design verification testing included dimensional and functional testing to support the useful life of the device. Cleaning validation testing performed on device [K102366] was submitted. Animal and clinical data were not submitted. Performance testing showed that the device meets design specifications and performs as intended. # Conclusion: In conclusion, the device is substantially equivalent based on a comparison of intended use, indications for use, and technological characteristics. The device is safe and effective for its intended use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Entellus Medical, Inc. c/o Karen E. Peterson Vice President, Clinical, Regulatory and Quality 705 Wedgwood Court North Maple Grove, MN 55311 USA JUN - 7 2011 Re: K110158 Trade/Device Name: PathAssist Light Seeker Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: May 12, 2011 Received: May 13, 2011 Dear Ms. Peterson: 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. 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 {3}------------------------------------------------ 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/ycm115809.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. Signature Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use Statement KI10158 510(k) Number (if known): Device Name: PathAssist Light Seeker # Indications for Use The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in adults aged 18 and over. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use X OR/AND Over-the-Counter Use Susan Rudy CRNP (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K110158 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K110158](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LRC/K110158) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com