XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
Applicant
Olympus Optical Co., Ltd.
Product Code
EOB · Ear, Nose, Throat
Decision Date
Dec 26, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4760
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This instruments has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy accessories and other ancillary equipment for endoscpic diagnosis and treatment within the nasal and nasopharyngeal lumen. Do not use this instrument for any purpose other than its intended use.
Device Story
XENF-TP Rhino-Laryngofiberscope is a flexible endoscope for visualization and treatment of nasal and nasopharyngeal lumens. Device features an instrument channel for use with ancillary tools (biopsy forceps, retrieval baskets, injection needles, spray catheters). Operates with external Olympus light sources or detachable battery-powered miniature light source. Used by clinicians in clinical settings for diagnostic and therapeutic procedures. Provides direct visualization to the physician via display monitor or eyepiece; facilitates tissue sampling, foreign body removal, and localized drug delivery. Benefits include minimally invasive access to nasal/nasopharyngeal anatomy for diagnosis and intervention.
Clinical Evidence
No clinical data. Substantial equivalence is based on design, intended use, and established safety profile of predicate devices. Bench testing performed to verify compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18 standards.
Technological Characteristics
Flexible fiber-optic endoscope with instrument channel. Materials are identical to previously cleared devices (e.g., LF-TP/DP). Energy source: external light source or detachable battery-powered miniature light source. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18. Connectivity: optical/mechanical interface for light sources and imaging peripherals.
Indications for Use
Indicated for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen, including tissue collection, foreign body/calculi retrieval, vascular/submucosal injection, and medication spraying, using compatible Olympus endoscopes and ancillary accessories.
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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K013591
## 510(k) SUMMARY
# XENF-TP Rhino-Laryngo fiberscope, its accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in rnis Sammary of U.S. (1) in the requirements of SMDA 1990 and 21 CFR, Section 807.92.
> Japan 8010047
Japan
## A. Submitter's Name, Address, Phone and Fax Number
## 1. Manufacturer of the subject device
Name & Address of Manufacturer;
Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division
2 Name of Contact Person Name :
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416
Olympus Optical Co, Ltd.
2951 Ishikawa-cho
TEL 81-426-42-5177 FAX 81-426-46-5613
Shinjuku-ku, Tokyo, 163-0914
Hachioji-shi, Tokyo 192-8507
2-3-1 Shinjuku Monolis Nishi-shinjuku
Address, Phone and Fax :
#### B. Device Name, Common Name
1. Device Name :
2. Common/Usual Name :
accessories and ancillary equipment
XENF-TP Rhino-Laryngofiberscope, its
Fiber Scope for Rhino-Laryng Fiberscope
3. Classification Name :
21CFR 876.1500 21 CFR 868.5530 21 CFR 874.4760
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#### C. Predicate Devices:
| Model | Device Description &<br>510(k)#/ Date Cleared | Manufacturer |
|---------------------------------------------------------|-----------------------------------------------|-------------------------------------|
| Pentax Naso-Pharyngo-<br>Laryngoscope<br>FNL-15P2/15RP2 | #K921707<br>07/01/1992 | Pentax Precision<br>Instrument Corp |
| Laparoscope,<br>Hand Instruments | #K950103<br>03/06/1995 | Olympus America,Inc. |
| LF-TP/DP | #K981543<br>08/06/1998 | Olympus Optical Co., |
### D. Summary Description of the Device
#### 1. Summary
This subject device "XENF-TP Rhino-Laryngofiberscope" is an endoscope used for treatment and observation within the nasal and nasopharyngeal lumen. This endoscpe can be used with two types of light sources, detachable with an reusable battery powered and light cable source. This device is equipped instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.
#### 2. Design
"XENF-TP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601 -1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
#### 3. Materials
There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions such as LF-TP/DP.
#### E. Intended Use of the device
This instruments has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy accessories and other ancillary equipment for endoscpic diagnosis and treatment within the nasal and nasopharyngeal lumen. Do not use this instrument for any purpose other than its intended use.
#### F. Technological Characteristics
This endoscope does not have special technological characteristics compared to the predicate device.
#### G. Reason for not requiring clinical data
Compared to the predicate devices, "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of safety and efficacy.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is an emblem of three stylized lines that resemble an eagle or bird in flight. The logo is black and white.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# DEC 2 6 2001
Olympus Optical Co., Ltd. c/o Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, NY 11747
Re: K013591
Trade/Device Name: XENF-TP Rhino-Laryngofiberscope, its accessories and ancillary equipment
Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope Regulatory Class: Class II Product Code: EOB Dated: October 29, 2001 Received: October 30, 2001
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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# Indication for Use Statement
510(k) Number(if known): Not assigned yet. Device Name: XENF-TP Rhino-Larvngofiberscope, its accessories and ancillary equipment.
#### Indications for Use:
Fiberscope:
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, document, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.
Miniature Light Source:
MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP.
#### FB-56D-1
These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen.
#### FG-53SX-1
These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen.
#### BC-201C/ BC-8C/BC-10C
These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen.
#### NM-101C-0427 / NM-201L-0423 / NM-201L-0525
These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen.
#### PW-6C-1/MAJ-929
These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.
en. Analyst /qn
Division Sign-Off
(Division Sign-Oll
Division of Ophthalmic Ear,
Nose and Throat Devises
K0135
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C Prescription Use_
OR
Over-The-Counter Use
(Prescription 21 CFR 801.109)
(Optional Format 1-2-96)
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.
