K102366 · Entellus Medical, Inc. · EOB · Feb 15, 2011 · Ear, Nose, Throat
Device Facts
Record ID
K102366
Device Name
FINESS ENDOSCOPE
Applicant
Entellus Medical, Inc.
Product Code
EOB · Ear, Nose, Throat
Decision Date
Feb 15, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4760
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
Device Story
The FinESS Endoscope is a fiber optic, manually operated, reusable rigid antroscope; used for visualization of the maxillary sinus cavity and delivery of a balloon dilation catheter. The device features a working channel for catheter delivery; compatible with standard 'B' mount camera couplers and light guides. It is used in a clinical setting by physicians as part of the FinESS Sinus Treatment procedure; inserted via a sterile access sheath through the canine fossa. The device provides direct visualization to assist the physician in navigating the sinus anatomy and positioning the dilation catheter, facilitating minimally invasive treatment of the maxillary ostium and ethmoid infundibulum.
Clinical Evidence
Bench testing only. No clinical or animal data submitted. Performance testing included biocompatibility, dimensional verification, cadaver studies, manual cleaning validation (TOC endpoint), high-level disinfection validation, and sterilization validation (STERRAD NX per ISO 14937).
Technological Characteristics
Fiber optic, rigid, all-metal, fully immersible antroscope. Features a working channel for balloon catheter delivery. Compatible with 'B' mount camera couplers and standard light guides. Sterilization via STERRAD NX system (ISO 14937).
Indications for Use
Indicated for visualization of the maxillary sinus cavity and delivery of a balloon dilation catheter to treat the maxillary sinus ostium and ethmoid infundibulum in adults via a trans-antral approach.
Regulatory Classification
Identification
A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
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Image /page/0/Picture/0 description: The image shows the logo for "entellus MEDICAL". To the left of the company name is a circular graphic made up of several curved lines. The company name is in all lowercase letters, and below it is the word "MEDICAL" in all caps with a trademark symbol.
FEB 1 5 2011
#### K102366 510(k) Summary
### Submitter's Name, Address, and Date of Submission
Karen E. Peterson Vice President Clinical, Regulatory and Quality 6705 Wedgwood Court North Maple Grove, MN 55311 Tel: 1-763-463-7056 Fax: 1-763-463-1599
Submitted:
February 15, 2011
#### Device Name
Trade Name: Common Name: Classification Name: Product Code:
FinESS Endoscope Endoscope or Antroscope or Sinuscope Nasopharyngoscope (flexible or rigid), 21CFR 874.4760 EOB
### Predicate Device
Entellus Medical Flexible Endoscope [K082569] used with Entellus Sinus Cannula [K072302]
#### Device Description
The FinESS Endoscope is a fiber optic based, manually operated, reusable rigid antroscope designed for performing the FinESS Sinus Treatment procedure. It is short, all metal and fully immersible. It is labeled non-sterile and must be cleaned and disinfected or sterilized prior to use. The endoscope is compatible with standard "B" mount camera couplers, and comes with two light post adapters, which allows the endoscope to be compatible with most commonly used light guides. The endoscope also has a working channel that allows for delivery of the FinESS balloon dilation catheter to treat the maxillary ostium and ethmoid infundibulum.
Image /page/0/Picture/14 description: The image shows a diagram of a medical device. The device has a syringe-like component attached to a rectangular piece with the word "AnESS" printed on it. Two tubes are connected to the rectangular piece on either side.
The FinESS Endoscope is part of and used with the FinESS Sinus Treatment [K081542] and insertion of the endoscope is performed using a sterile access sheath [K091681].
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#### Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
#### Substantial Equivalence
The FinESS Endoscope has the same intended use, principal of operation, biocompatibility, device and accessory compatibility, reusability, and reprocessing methods as the predicate device.
The FinESS Endoscope has some different technological features compared to the predicate device, however. these differences present the same type of questions about safety or effectiveness, accepted scientific methods exist for evaluating the features, and data are provided to demonstrate that the features have not diminished safety or effectiveness.
#### Performance Data
The device performance test data is provided in the 510(k) submission. Performance tests included biocompatibility testing, dimensional verification, cadaver studies, manual cleaning validation utilizing total organic carbon as study endpoint, manual high level disinfection validation, sterilization validation of STERRAD NX system (per ISO 14937), compatibility testing, and storage and transportation testing. Animal and clinical data were not submitted. The testing showed that the device meets design specifications and performs as intended.
#### Conclusion
FinESS Endoscope is substantially equivalent to the predicate device. FinESS Endoscope is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Entellus Medical, Inc. c/o Ms. Karen Peterson Vice President, Clinical, Regulatory and Quality 6705 Wedgewood Court North Maple Grove, MN 55311
FEB 15 201
Re: K102366
Trade/Device Name: Entellus FinESS Endoscope (Model ES300) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: February 11, 2011 Received: February 14, 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.
:
. ・
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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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R.C. Turner
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
Enclosure
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# Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FinESS Endoscope
# Indications for Use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use X X OR/AND
Over-the-Counter Use
Susan Rudy CRWP
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) FinESS Endoscope
K102366 510(k) Number_
Page 6-1
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.
