VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
Applicant
Fiagon GmbH
Product Code
PNZ · Ear, Nose, Throat
Decision Date
May 26, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4180
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The VenSure™, VenSure™ Light, VenSure™ Nav and VenSure™ ET Balloon Dilation Systems are intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. They have the same intended use as the primary predicate XprESS (K163509) and similar intended use as the secondary predicate VenSure Balloon Devices (K201472) with VenSure LightGuide (K212774).
Device Story
VenSure™ Balloon Dilation System comprises malleable suction/probe devices with integrated balloons for remodeling sinus outflow tracts and dilating Eustachian tubes. Distal tips are re-shapeable using a bending tool to access multiple anatomical sites. Operation involves trans-nasal insertion under endoscopic visualization. VenSure™ Nav integrates a sensor carrier for electromagnetic tracking with the Fiagon Cube Navigation System, displaying tip location on patient image planes. VenSure™ Light includes an integrated flexible light fiber with a battery-powered LED for transillumination. Inflation is performed via a manual syringe/plunger inflation device using saline. Used in clinical settings by physicians to facilitate sinus ostia dilation or Eustachian tube treatment; benefits include minimally invasive remodeling of bony/cartilaginous structures to improve drainage/function.
Clinical Evidence
Bench testing only. Evaluated balloon dimensional integrity, pressure stability, fatigue, inflation/deflation times, burst pressure, mechanical integrity, and simulated use in clinical models. Navigation accuracy and light output performance verified against predicate ratings. Biocompatibility confirmed per ISO 10993-1:2018; sterilization validated per ISO 11135-1.
Technological Characteristics
Malleable shaft with fixed balloon; polymer-coated ball-tip. Electromagnetic tracking (Nav version) via integrated sensor carrier; LED transillumination (Light version). Manual saline inflation. EO sterilized. Compatible with Fiagon Cube Navigation System. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.
Indications for Use
Indicated for adults to access and treat frontal ostia/recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula via trans-nasal approach; also indicated for dilation of the cartilaginous portion of the Eustachian tube for persistent Eustachian tube dysfunction in adults. VenSure™ Nav is indicated for use with the Cube Navigation System for image-guided localization of the Eustachian tube or sinus drainage pathways. VenSure™ Light is indicated for locating, illuminating, and transilluminating nasal and sinus structures.
Regulatory Classification
Identification
A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Mechanical testing, including tensile and flexural testing of catheter joints and materials.
(ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
(iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon.
(iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
(2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life.
(6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
(7) Labeling must include:
(i) Detailed instructions for use.
(ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
(iii) A shelf life.
In combination with the general controls of the FD&C Act, the Acclarent Aera™ Eustachian Tube Balloon Dilation System is subject to the following special controls:
- 1. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
- a. Mechanical testing, including tensile and flexural testing of catheter joints and materials.
- b. Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
- Inflation and deflation characterization testing, including time and pressure C. measurements, and leak testing of the balloon.
- d. Verification testing of safety features built into the device must be performed. including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
- 2. Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
- 3. The patient-contacting components of the device must be demonstrated to be biocompatible.
- 4. Performance data must demonstrate the sterility of the device.
- 5. Performance data must support shelf life by demonstrating continued sterility of the device, package integrity and device functionality over the identified shelf life.
- 6. Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
- 7. Labeling must include:
- a. Detailed instructions for use.
- b. A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
- c. A shelf life.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2023
Fiagon GmbH Dirk Mucha CTO Neuendorfst. 23b Hennigsdorf, Brandenburg 16761 Germany
Re: K230065
Trade/Device Name: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation Svstem Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ, LRC Dated: April 25, 2023 Received: April 25, 2023
Dear Dirk Mucha:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K230065
#### Device Name
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
#### Indications for Use (Describe)
The VenSure™ Balloon Dilation System is used to access and treat the frontal ostialrecesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
Type of Use (Select one or both, as applicable)
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary
### May 25, 2023
#### 1. Submitter Information
| Submitter: | Fiagon GmbH |
|------------|----------------------------|
| Address: | Neuendorfst. 23b |
| | 16761 Hennigsdorf, Germany |
| Telephone: | +49 3302 201 21 10 |
- Telephone: +49 3302 201 21 10 Telefax: +49 3302 201 21 15
- Contact: Dirk Mucha Chief Technology Officer
#### 2. Device Information
| Trade Name: | VenSure™ |
|-------------|----------------|
| | VenSure™ Light |
| | VenSure™ Nav |
| | VenSure™ ET |
Collectively: VenSure™ Balloon Dilation System
Eustachian Tube Dilation
| Common Name: | Eustachian Tube Balloon Dilation Device |
|----------------------|--------------------------------------------------|
| Classification: | Class II per 21 CFR 874.4180 |
| Classification Name: | Eustachian Tube Balloon System (21 CFR 874.4180) |
| Product Code: | PNZ |
| Sinus Dilation | |
| Common Name: | Sinus Dilation Device |
| Classification: | Class I per 21 CFR 874.4420 |
| Classification Name: | Ear, nose and throat manual surgical instrument |
| Product Code: | LRC |
#### 3. Predicate Device Information
- Primary predicate: XprESS ENT Dilation System (K163509)
- . Secondary predicate: VenSure and VenSure Nav Balloon Devices (K201472) with VenSure LightGuide (K212774)
{4}------------------------------------------------
The primary predicate is the predicate device for the added Eustachian Tube indication with product code PNZ, CFR 874.4180. The secondary predicate is the predicate device for sinus balloon dilation with product code LRC, CFR 874.4420.
## 4. Device Description
The VenSure Balloon Dilation Systems combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the Frontal, Maxillary, Sphenoid sinuses, and Eustachian tube using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and the Eustachian tube within the same patient. The devices come in an EO sterilized tray sealed inside of a Tyvek pouch with the bending tool, inflation device, and extension line included in the trav.
All VenSure versions enable a physician to track the device into the sinuses and eustachian tube using endoscopic visualization.
The VenSure™ Nav allows additionally for image-guided visualization when connected to the Cube Navigation System (manufactured by Fiagon). The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "blug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflation device to expand the outflow track of the targeted structure.
The VenSure™ Light additionally allows for LED light confirmation of the VenSure balloon through transillumination across nasal and sinus structures. The VenSure™ Light has an integrated flexible light fiber with battery powered LED light source designed to emit red light from the distal end of the VenSure balloon.
The VenSure™ ET is a 45°- pre-bent configuration of the basic VenSure (with straight balloon tip). The pre-bend to 45°bemt of the VenSure ET facilitates the use of the device when only used for treatment in the eustachian tube. The device however can also be reshaped to fit to the sinuses using the Bending tool.
## 5. Intended Use
The VenSure™, VenSure™ Light, VenSure™ Nav and VenSure™ ET Balloon Dilation Systems are intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. They have the same intended use as the primary predicate XprESS (K163509) and similar intended use as the secondary predicate VenSure Balloon Devices (K201472) with VenSure LightGuide (K212774).
{5}------------------------------------------------
# Indications for Use for VenSure™ Balloon Dilation System and Predicate Devices
| Device | Indications for Use |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VenSure™,<br>VenSure™ Light,<br>VenSure™ Nav,<br>and VenSure™ ET<br>Balloon Dilation<br>System | The VenSure™ Balloon Dilation System is used to access and treat the frontal<br>ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in<br>adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by<br>balloon displacement of adjacent bone and paranasal sinus structures.<br>The balloon devices are used to dilate portions of the Eustachian tube for treating<br>persistent Eustachian tube dysfunction in adult patients using a transnasal approach. |
| | The VenSure™ Nav Balloon Dilation System is intended for use in conjunction with<br>the Cube Navigation System during ENT procedures when surgical navigation or<br>image-guided surgery may be necessary to locate the Eustachian tube or to locate<br>tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal,<br>maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia. |
| | The VenSure™ Light Balloon Dilation System is used to locate, illuminate within, and<br>transilluminate across, nasal and sinus structures in adults. |
| VenSure™,<br>VenSure™ Nav<br>Balloon Device<br>(K201472) | The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access<br>and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid<br>infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are<br>remodeled by balloon displacement of adjacent bone and paranasal sinus structures. |
| | The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon<br>Navigation System during sinus procedures when surgical navigation or image-<br>guided surgery may be necessary to locate and move tissue, bone or cartilaginous<br>tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses<br>to facilitate dilation of the sinus ostia. |
| VenSure™<br>LightGuide<br>(K212774) | The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate<br>across, nasal and sinus structures in adults. |
| Xpress ENT<br>Dilation System<br>(K163509) | To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and<br>older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and<br>older using a transnasal approach. The bony sinus outflow tracts are remodeled by<br>balloon displacement of adjacent bone and paranasal sinus structures.<br>To dilate the cartilaginous portion of the Eustachian tube for treating persistent<br>Eustachian tube dysfunction in patients 18 years and older using a transnasal<br>approach. |
## 6. Comparison of Technological Characteristics
The VenSure™, VenSure™ Light, VenSure™ Nav, and VenSure™ ET Balloon Dilation Systems have the same fundamental scientific technology as the predicate devices [K201472 with K212774 and K163509]. The subject devices have the same technological characteristics; in particular, basic design, performance, and principle of operation.
{6}------------------------------------------------
| Feature | VenSure™ Balloon<br>Dilation System<br>(VenSure, VenSure<br>Light, VenSure Nav,<br>VenSure ET) | Xpress ENT Dilation<br>System<br>(Entellus/Stryker)<br>[K163509] | VenSure Balloon<br>Dilation Device<br>(VenSure, VenSure<br>Nav) [K201472] with<br>VenSure LightGuide<br>[K212774] | Equivalence |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Class | Class II<br>21 CFR 874.4420<br>21 CFR 874.4180<br>Product code: PNZ, LRC | Class II<br>21 CFR 874.4420<br>21 CFR 874.4180<br>Product code: PNZ, LRC | Class I<br>21 CFR 874.4420<br>Product code: LRC | Equivalent,<br>Same as primary<br>predicate for PNZ<br>Same as secondary<br>predicate for LRC |
| Indications for<br>Use | (see above) | (see above) | (see above) | Equivalent,<br>Same as primary<br>predicate for PNZ<br>Same as secondary<br>predicate for LRC |
| Balloon design | Fixed balloon over<br>malleable shaft | Sliding balloon mechanism<br>over malleable shaft | Fixed balloon over<br>malleable shaft | Equivalent, Same |
| Balloon<br>Dimensions<br>[D x L (mm)] | 6 x 18 | 5 x 8, 5 x 20<br>6 x 8, 6 x 18, 6 x 20<br>7 x 18, 7 x 20 | 6 x 18 | Equivalent, Same |
| Balloon Tip<br>(mm) | Polymer coated ball-tip<br>diameter (dimensions):<br>1.81 | Stainless steel ball-tip<br>diameter (dimensions):<br>Standard: 2<br>LoProfile: 1.75<br>Ultra: 1.5 | Polymer coated ball-tip<br>diameter (dimensions):<br>1.63 | Equivalent, both<br>subject and<br>predicate devices<br>have a round ball-<br>tip |
| Endoscopic<br>Visual<br>Distance<br>Indicator | 10 mm and 20 mm depth<br>indicator marks printed on<br>balloon shaft | 10 mm and 20 mm depth<br>indicator marks printed on<br>balloon shaft | 10 mm and 20 mm depth<br>indicator marks printed<br>on balloon shaft | Same |
| Ability to access<br>multiple<br>locations with<br>single balloon | Yes - tip angle is<br>reshapable using bending<br>tool | Yes - tip angle is<br>reshapable using bending<br>tool | Yes - tip angle is<br>reshapable using<br>bending tool | Same |
| Inflation Device | Syringe barrel and plunger | Syringe barrel and plunger | Syringe barrel and<br>plunger | Same |
| Visualization | -Endoscopy<br>-Navigation option<br>(VenSure™ Nav)<br>-Light illumination option<br>(VenSure™ Light) | -Endoscopy<br>-Navigation option (TGS<br>Guidewire)<br>-Light illumination option<br>(PathAssist) | -Endoscopy<br>-Navigation option<br>(VenSure™ Nav)<br>-Light illumination<br>option<br>(VenSure LightGuide) | Equivalent, Same |
| Image-guided<br>Tracking<br>Method | Electromagnetic<br>(VenSure™ Nav only) | Electromagnetic<br>(optional TGS Guidewire) | Electromagnetic<br>(VenSure™ Nav only) | Equivalent, Same |
{7}------------------------------------------------
### 7. Performance Data
#### Bench Testing
Bench testing was conducted to ensure that the VenSure™ Balloon Dilation Systems met the predefined acceptance criteria to demonstrate safety and performance. Testing included the following:
| Performance testing | Criteria for SE justification |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon dimensional integrity | The dimensions of the balloon are as specified<br>and in accordance with the properties of the<br>predicates. |
| Balloon pressure stability/ Balloon fatigue<br>conditioning test | The burst pressure at end of lifetime is above the<br>rated in use pressure and within the<br>specifications of the predicates. |
| Balloon Inflation/Deflation times | The balloon inflates and deflates at end of<br>lifetime of the device within the specifications of<br>the predicates. |
| Balloon burst pressure | The burst pressure is well above the rated in use<br>pressure and within the specifications of the<br>predicates. |
| Mechanical integrity | Mechanical properties all met predefined<br>acceptance criteria. It can be demonstrated that<br>the minor differences in dimensions to the<br>secondary predicate do not raise new concerns of<br>safety and effectiveness and can be rated as<br>substantial equivalent. |
| Catheter and distal tip geometries characterization | The specified catheter and distal tip geometries<br>are within the range of the primary predicate<br>devices. |
| Simulated use testing in clinical model | Same design safety features and mechanically<br>functionality as primary predicate device can be<br>demonstrated. |
| Navigation compatibility (VenSure™ Nav only) | Navigation accuracy is within the rating of the<br>secondary predicate. |
| LightGuide compatibility and performance | Dimensions and light output performance are<br>within the ratings of the secondary predicate. |
All tests met the predefined acceptance criteria. The test results demonstrated that the minor differences in device characteristics between the subject device and predicate devices do not raise any new questions of safety or effectiveness.
{8}------------------------------------------------
#### Biocompatibility
The biocompatibility evaluation for the VenSure™ Balloon Dilation Systems was conducted in accordance with FDA recognized consensus standard ISO 10993-1:2018. Biocompatibility testing included cytotoxicity, irritation, sensitization and acute systemic toxicity testing. All tests successfully met the required acceptance criteria, demonstrating that the patient contacting materials used in the devices are biocompatible.
### Sterilization & Stability
Sterilization validation testing was performed to demonstrate compliance with ISO 11135-1. Shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
## Navigation Compatibility (VenSureTM Nav)
Bench testing was conducted to determine the imaging accuracy of the device (VenSure™ Nav). Test results demonstrate functionality and compatibility with the Fiagon Navigation system and support the claim of substantial equivalence to the secondary predicate.
## Electromagnetic compatibility and Electrical Safety
Electromagnetic Compatibility (EMC) and Electrical Safety testing was conducted per IEC 60601-1 and IEC 60601-1-2 for applicable devises.
## 8. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, it is concluded that the VenSure™ Balloon Dilation Systems are substantially equivalent to the predicate devices identified in this submission, and do not present any new issues of safety or effectiveness.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
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.
