(137 days)
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.
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.
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.
The provided text describes the VenSure™ Balloon Dilation System, including the VenSure™ Light, VenSure™ Nav, and VenSure™ ET variants. These devices are used for balloon dilation of frontal ostial recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, and the Eustachian tube in adults.
Here's an analysis of the acceptance criteria and the study information as requested:
1. A table of acceptance criteria and the reported device performance
| Performance Testing | Acceptance Criteria (Criteria for SE justification) | Reported Device Performance |
|---|---|---|
| Balloon dimensional integrity | The dimensions of the balloon are as specified and in accordance with the properties of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon pressure stability / Balloon fatigue conditioning | The burst pressure at end of lifetime is above the rated in use pressure and within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon Inflation/Deflation times | The balloon inflates and deflates at end of lifetime of the device within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon burst pressure | The burst pressure is well above the rated in use pressure and within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| 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. | All tests met the predefined acceptance criteria. |
| Catheter and distal tip geometries characterization | The specified catheter and distal tip geometries are within the range of the primary predicate devices. | All tests met the predefined acceptance criteria. |
| Simulated use testing in clinical model | Same design safety features and mechanically functionality as primary predicate device can be demonstrated. | All tests met the predefined acceptance criteria. |
| Navigation compatibility (VenSure™ Nav only) | Navigation accuracy is within the rating of the secondary predicate. | Test results demonstrate functionality and compatibility. |
| LightGuide compatibility and performance | Dimensions and light output performance are within the ratings of the secondary predicate. | All tests met the predefined acceptance criteria. |
| Biocompatibility | Compliance with FDA recognized consensus standard ISO 10993-1:2018 (cytotoxicity, irritation, sensitization, acute systemic toxicity testing). | All tests successfully met the required acceptance criteria. |
| Sterilization & Stability | Compliance with ISO 11135-1 for sterilization validation. Shelf life and packaging testing to support labeled shelf life. | All tests were successfully completed. |
| Electromagnetic compatibility and Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2. | Testing was conducted per standards (implied successful). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Simulated use testing in clinical model." However, it does not specify sample sizes for the test sets used in performance data. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The reference to "clinical model" suggests a simulated environment rather than actual patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The studies described are primarily bench testing and simulated use, not those requiring expert interpretation of medical images or patient outcomes for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as the described studies do not involve expert adjudication of results in a clinical context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device in question is a physical medical device (balloon dilation system) and not an AI/software product requiring human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an AI/software device. The VenSure™ Balloon Dilation System is a physical medical device. While the VenSure™ Nav includes "image-guided visualization" and "navigation software," the document does not describe "standalone" algorithm-only performance in the context of an FDA-cleared AI/software device. The navigation functionality is an aid for the physician using the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" implicitly refers to engineering specifications and established physical properties (e.g., "dimensions of the balloon are as specified," "burst pressure at end of lifetime is above the rated in use pressure"). For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-1:2018). For sterilization, the ground truth is sterilization validation standards (ISO 11135-1). For navigation compatibility, it's about functionality and compatibility with the Fiagon Navigation system meeting accuracy ratings of the predicate. This is based on objective, measurable physical and engineering endpoints rather than clinical ground truth (like pathology or expert consensus on a diagnosis).
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a training set for an AI/machine learning model.
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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
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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
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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) |
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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)
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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).
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Indications for Use for VenSure™ Balloon Dilation System and Predicate Devices
| Device | Indications for Use |
|---|---|
| VenSure™,VenSure™ Light,VenSure™ Nav,and VenSure™ ETBalloon DilationSystem | The VenSure™ Balloon Dilation System is used to access and treat the frontalostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula inadults using a trans-nasal approach. The bony sinus outflow tracts are remodeled byballoon displacement of adjacent bone and paranasal sinus structures.The balloon devices are used to dilate portions of the Eustachian tube for treatingpersistent Eustachian tube dysfunction in adult patients using a transnasal approach. |
| The VenSure™ Nav Balloon Dilation System is intended for use in conjunction withthe Cube Navigation System during ENT procedures when surgical navigation orimage-guided surgery may be necessary to locate the Eustachian tube or to locatetissue, 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, andtransilluminate across, nasal and sinus structures in adults. | |
| VenSure™,VenSure™ NavBalloon Device(K201472) | The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to accessand treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoidinfundibula in adults using a trans-nasal approach. The bony sinus outflow tracts areremodeled by balloon displacement of adjacent bone and paranasal sinus structures. |
| The VenSure™ Nav Balloon Device is intended for use in conjunction with the FiagonNavigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginoustissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinusesto facilitate dilation of the sinus ostia. | |
| VenSure™LightGuide(K212774) | The VenSure™ LightGuide is used to locate, illuminate within, and transilluminateacross, nasal and sinus structures in adults. |
| Xpress ENTDilation System(K163509) | To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years andolder, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years andolder using a transnasal approach. The bony sinus outflow tracts are remodeled byballoon displacement of adjacent bone and paranasal sinus structures.To dilate the cartilaginous portion of the Eustachian tube for treating persistentEustachian tube dysfunction in patients 18 years and older using a transnasalapproach. |
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.
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| Feature | VenSure™ BalloonDilation System(VenSure, VenSureLight, VenSure Nav,VenSure ET) | Xpress ENT DilationSystem(Entellus/Stryker)[K163509] | VenSure BalloonDilation Device(VenSure, VenSureNav) [K201472] withVenSure LightGuide[K212774] | Equivalence |
|---|---|---|---|---|
| Subject Device | Primary Predicate | Secondary Predicate | ||
| Class | Class II21 CFR 874.442021 CFR 874.4180Product code: PNZ, LRC | Class II21 CFR 874.442021 CFR 874.4180Product code: PNZ, LRC | Class I21 CFR 874.4420Product code: LRC | Equivalent,Same as primarypredicate for PNZSame as secondarypredicate for LRC |
| Indications forUse | (see above) | (see above) | (see above) | Equivalent,Same as primarypredicate for PNZSame as secondarypredicate for LRC |
| Balloon design | Fixed balloon overmalleable shaft | Sliding balloon mechanismover malleable shaft | Fixed balloon overmalleable shaft | Equivalent, Same |
| BalloonDimensions[D x L (mm)] | 6 x 18 | 5 x 8, 5 x 206 x 8, 6 x 18, 6 x 207 x 18, 7 x 20 | 6 x 18 | Equivalent, Same |
| Balloon Tip(mm) | Polymer coated ball-tipdiameter (dimensions):1.81 | Stainless steel ball-tipdiameter (dimensions):Standard: 2LoProfile: 1.75Ultra: 1.5 | Polymer coated ball-tipdiameter (dimensions):1.63 | Equivalent, bothsubject andpredicate deviceshave a round ball-tip |
| EndoscopicVisualDistanceIndicator | 10 mm and 20 mm depthindicator marks printed onballoon shaft | 10 mm and 20 mm depthindicator marks printed onballoon shaft | 10 mm and 20 mm depthindicator marks printedon balloon shaft | Same |
| Ability to accessmultiplelocations withsingle balloon | Yes - tip angle isreshapable using bendingtool | Yes - tip angle isreshapable using bendingtool | Yes - tip angle isreshapable usingbending tool | Same |
| Inflation Device | Syringe barrel and plunger | Syringe barrel and plunger | Syringe barrel andplunger | Same |
| Visualization | -Endoscopy-Navigation option(VenSure™ Nav)-Light illumination option(VenSure™ Light) | -Endoscopy-Navigation option (TGSGuidewire)-Light illumination option(PathAssist) | -Endoscopy-Navigation option(VenSure™ Nav)-Light illuminationoption(VenSure LightGuide) | Equivalent, Same |
| Image-guidedTrackingMethod | Electromagnetic(VenSure™ Nav only) | Electromagnetic(optional TGS Guidewire) | Electromagnetic(VenSure™ Nav only) | Equivalent, Same |
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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 specifiedand in accordance with the properties of thepredicates. |
| Balloon pressure stability/ Balloon fatigueconditioning test | The burst pressure at end of lifetime is above therated in use pressure and within thespecifications of the predicates. |
| Balloon Inflation/Deflation times | The balloon inflates and deflates at end oflifetime of the device within the specifications ofthe predicates. |
| Balloon burst pressure | The burst pressure is well above the rated in usepressure and within the specifications of thepredicates. |
| Mechanical integrity | Mechanical properties all met predefinedacceptance criteria. It can be demonstrated thatthe minor differences in dimensions to thesecondary predicate do not raise new concerns ofsafety and effectiveness and can be rated assubstantial equivalent. |
| Catheter and distal tip geometries characterization | The specified catheter and distal tip geometriesare within the range of the primary predicatedevices. |
| Simulated use testing in clinical model | Same design safety features and mechanicallyfunctionality as primary predicate device can bedemonstrated. |
| Navigation compatibility (VenSure™ Nav only) | Navigation accuracy is within the rating of thesecondary predicate. |
| LightGuide compatibility and performance | Dimensions and light output performance arewithin 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.
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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.
§ 874.4180 Eustachian tube balloon dilation system.
(a)
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.(b)
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.