VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
K102733 · Vision-Sciences, Inc. · EOB · May 18, 2011 · Ear, Nose, Throat
Device Facts
Record ID
K102733
Device Name
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
Applicant
Vision-Sciences, Inc.
Product Code
EOB · Ear, Nose, Throat
Decision Date
May 18, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4760
Device Class
Class 2
Indications for Use
The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The digital video processor is intended for use with the VSI flexible video scope.
Device Story
Flexible ENT-5000 video endoscope system; includes digital video processor, display monitor, and optional sterile, single-use EndoSheath® technology. EndoSheath covers insertion tube to provide barrier protection. System captures and displays real-time video images of internal body cavities. Used by clinicians in clinical settings for diagnostic endoscopic and arthroscopic procedures. Provides illumination and visualization of upper airway, vocal cords, nasal passages, and other body cavities. Output viewed on monitor to assist physician in diagnostic assessment. Benefits include enhanced visualization and reduced cross-contamination risk via disposable sheath.
Clinical Evidence
Bench testing only. No clinical data provided. Device passed electrical safety, thermal, and EMC testing requirements. Patient contact materials verified as identical to predicate device (K072073).
Technological Characteristics
Flexible video endoscope with digital video processor and disposable sheath. Materials identical to K072073. Illumination and visualization via fiber optics/digital sensor. Connectivity to external display monitor. System includes optional sterile, single-use protective sheath (with or without working channel).
Indications for Use
Indicated for flexible endoscopic examination of upper airway, vocal cords, and nasal passages; and diagnostic arthroscopic and endoscopic procedures requiring illumination and visualization of body cavities via natural or surgical openings. No specific age or gender restrictions stated.
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.
Predicate Devices
Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology (K072073)
Avis Surgical Technologies, Inc.: C-MOR Visualization System (K093717)
Biomet InnerVue™ Diagnostic Scope System (K072879)
SpineView SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope (K081051)
Submission Summary (Full Text)
{0}------------------------------------------------
Vision-Sciences, Inc. September 16, 2010
Kbiา
ditional Indication 510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology
# 510(k) Summary
# Date Prepared (21 CFR 807.92(a)(1): September 8, 2010
1 8 2011 MAY
Owner's Name (21 CFR 807.92(a)(1):
| | Vision-Sciences, Inc. |
|-------------------|----------------------------------|
| Address: | 40 Ramland Road South |
| | Orangeburg, NY 10962 |
| Telephone Number: | (845) 365-0600 |
| Fax Number: | (845) 365-0620 |
| Contact Person: | Lillian Quintero; Director QA/RA |
# Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))
| Subject Device Name: | Flexible ENT-5000 Scopes with Digital Video Processor and<br>Disposable EndoSheath® Technology |
|------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible Video Endoscope with Sheath and Video Processor |
| Product Codes: | EOB, HRX |
| FDA Regulations: | 21CFR874.4760, 21CFR888.1100 |
| Device Classification: | Class II |
# Predicate Device Names (21 CFR 807.92(a)(3))
Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology (K072073)
Avis Surgical Technologies, Inc .: C-MOR Visualization System (K093717)
Biomet InnerVue™ Diagnostic Scope System (K072879)
Smith & Nephew Arthroscope (K043395)
SpineView SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope (K081051)
| Common/Usual Name: | Flexible video endoscopes with sheaths and accessories |
|-------------------------|--------------------------------------------------------|
| Product Codes: | EOB, HRX |
| FDA Regulations: | 21CFR874.4760, 21CFR888.1100 |
| Device Classification: | Class II |
| Premarket Notification: | K072073/K093717/K072879/K043395/K081051 |
### Device Description
The VSI endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Techology for the ENT-5000 are optional, sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
#### Intended Use
The flexible ENT Videoscope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
26
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Vision-Sciences, Inc. September 16, 2010
510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology
# Technological Characteristics
Vision Sciences believes that the subject device is substantially equivalent to both the Vision Sciences' predicate device, as well as those of other manufacturers, as outlined in this submission. The subject device has very similar functionality and indications as the predicate devices.
# Performance Testing
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The patient contact materials in the endoscope are identical to the materials used in predicate device Vision Sciences' ENT-5000 (K072073).
### Conclusion
Based on this request for additional indications for use, and the comparison to predicate devices, the VSI flexible video endoscopes with digital video processor and disposable EndoSheath® Technology have been shown to be safe and effective for their intended use.
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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 eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vision-Sciences, Inc. % Ms. Lillian Quintero 40 Ramland Road, South Orangeburg, New York 10962
MAY 18 2011
Re: K102733
Trade/Device Name: Flexible ENT-5000 Video ENT Scope with Video Processor and EndoSheath® Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HRX, EOB Dated: April 27, 2011 Received: April 29, 2011
Dear Ms. Quintero:
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
{3}------------------------------------------------
Page 2 - Ms. Lillian Quintero
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A.g B. nk
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Vision-Sciences, Inc. September 16, 2010
Additional Indications - 510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology
510(k) Number (if known):
Flexible ENT-5000 Video ENT Scope with Video Processor and EndoSheath® Device Name: Technology
Indications for Use: The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The digital video processor is intended for use with the VSI flexible video scope.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Net RP Ogden for mkm
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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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.
