K110158 · Entellus Medical, Inc. · LRC · Jun 7, 2011 · Ear, Nose, Throat
Device Facts
Record ID
K110158
Device Name
ILLUMINATING SINUS SEEKER
Applicant
Entellus Medical, Inc.
Product Code
LRC · Ear, Nose, Throat
Decision Date
Jun 7, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4420
Device Class
Class 1
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.
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.
Indications for Use
Indicated for locating, illuminating, and transilluminating nasal and sinus structures (frontal, ethmoid, maxillary) in adults aged 18 and over.
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.
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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.
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## 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.
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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
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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
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# 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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
