← Product Code [PNZ](/submissions/EN/subpart-e%E2%80%94surgical-devices/PNZ) · K230065 # VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (K230065) _Fiagon GmbH · PNZ · May 26, 2023 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/PNZ/K230065 ## Device Facts - **Applicant:** Fiagon GmbH - **Product Code:** [PNZ](/submissions/EN/subpart-e%E2%80%94surgical-devices/PNZ.md) - **Decision Date:** May 26, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4180 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## 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). ## 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. ## Regulatory 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. ## Predicate Devices - XprESS ENT Dilation System ([K163509](/device/K163509.md)) - VenSure and VenSure Nav Balloon Devices ([K201472](/device/K201472.md)) - VenSure LightGuide ([K212774](/device/K212774.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |---------------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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™,
VenSure™ Light,
VenSure™ Nav,
and VenSure™ ET
Balloon Dilation
System | The VenSure™ Balloon Dilation System is used to access and treat the frontal
ostia/recesses, 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.
The balloon devices are used to dilate portions of the Eustachian tube for treating
persistent Eustachian tube dysfunction in adult patients using a transnasal approach. | | | The VenSure™ Nav Balloon Dilation System is 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 pathways of frontal,
maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia. | | | The VenSure™ Light Balloon Dilation System is used to locate, illuminate within, and
transilluminate across, nasal and sinus structures in adults. | | VenSure™,
VenSure™ Nav
Balloon Device
(K201472) | The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access
and treat the frontal recesses, 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. | | | The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon
Navigation System during sinus procedures when surgical navigation or image-
guided surgery may be necessary to locate and move tissue, bone or cartilaginous
tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses
to facilitate dilation of the sinus ostia. | | VenSure™
LightGuide
(K212774) | The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate
across, nasal and sinus structures in adults. | | Xpress ENT
Dilation System
(K163509) | To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and
older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and
older using a transnasal 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 tube dysfunction in patients 18 years and older using a transnasal
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
Dilation System
(VenSure, VenSure
Light, VenSure Nav,
VenSure ET) | Xpress ENT Dilation
System
(Entellus/Stryker)
[K163509] | VenSure Balloon
Dilation Device
(VenSure, VenSure
Nav) [K201472] with
VenSure LightGuide
[K212774] | Equivalence | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate | Secondary Predicate | | | Class | Class II
21 CFR 874.4420
21 CFR 874.4180
Product code: PNZ, LRC | Class II
21 CFR 874.4420
21 CFR 874.4180
Product code: PNZ, LRC | Class I
21 CFR 874.4420
Product code: LRC | Equivalent,
Same as primary
predicate for PNZ
Same as secondary
predicate for LRC | | Indications for
Use | (see above) | (see above) | (see above) | Equivalent,
Same as primary
predicate for PNZ
Same as secondary
predicate for LRC | | Balloon design | Fixed balloon over
malleable shaft | Sliding balloon mechanism
over malleable shaft | Fixed balloon over
malleable shaft | Equivalent, Same | | Balloon
Dimensions
[D x L (mm)] | 6 x 18 | 5 x 8, 5 x 20
6 x 8, 6 x 18, 6 x 20
7 x 18, 7 x 20 | 6 x 18 | Equivalent, Same | | Balloon Tip
(mm) | Polymer coated ball-tip
diameter (dimensions):
1.81 | Stainless steel ball-tip
diameter (dimensions):
Standard: 2
LoProfile: 1.75
Ultra: 1.5 | Polymer coated ball-tip
diameter (dimensions):
1.63 | Equivalent, both
subject and
predicate devices
have a round ball-
tip | | Endoscopic
Visual
Distance
Indicator | 10 mm and 20 mm depth
indicator marks printed on
balloon shaft | 10 mm and 20 mm depth
indicator marks printed on
balloon shaft | 10 mm and 20 mm depth
indicator marks printed
on balloon shaft | Same | | Ability to access
multiple
locations with
single balloon | Yes - tip angle is
reshapable using bending
tool | Yes - tip angle is
reshapable using bending
tool | Yes - tip angle is
reshapable using
bending tool | Same | | Inflation Device | Syringe barrel and plunger | Syringe barrel and plunger | Syringe barrel and
plunger | Same | | Visualization | -Endoscopy
-Navigation option
(VenSure™ Nav)
-Light illumination option
(VenSure™ Light) | -Endoscopy
-Navigation option (TGS
Guidewire)
-Light illumination option
(PathAssist) | -Endoscopy
-Navigation option
(VenSure™ Nav)
-Light illumination
option
(VenSure LightGuide) | Equivalent, Same | | Image-guided
Tracking
Method | Electromagnetic
(VenSure™ Nav only) | Electromagnetic
(optional TGS Guidewire) | Electromagnetic
(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
and in accordance with the properties of the
predicates. | | Balloon pressure stability/ Balloon fatigue
conditioning test | The burst pressure at end of lifetime is above the
rated in use pressure and within the
specifications of the predicates. | | Balloon Inflation/Deflation times | The balloon inflates and deflates at end of
lifetime of the device within the specifications of
the predicates. | | Balloon burst pressure | The burst pressure is well above the rated in use
pressure and within the specifications of the
predicates. | | Mechanical integrity | Mechanical properties all met predefined
acceptance criteria. It can be demonstrated that
the minor differences in dimensions to the
secondary predicate do not raise new concerns of
safety and effectiveness and can be rated as
substantial equivalent. | | Catheter and distal tip geometries characterization | The specified catheter and distal tip geometries
are within the range of the primary predicate
devices. | | Simulated use testing in clinical model | Same design safety features and mechanically
functionality as primary predicate device can be
demonstrated. | | Navigation compatibility (VenSure™ Nav only) | Navigation accuracy is within the rating of the
secondary predicate. | | LightGuide compatibility and performance | Dimensions and light output performance are
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. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/PNZ/K230065](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/PNZ/K230065) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com