(84 days)
Not Found
No
The description focuses on mechanical and electromagnetic navigation technology, with no mention of AI or ML for image processing, data analysis, or decision support.
Yes
The device is used to access and treat sinus issues by remodeling bone and paranasal sinus structures, which directly addresses a health condition.
No
The device is intended for treatment (remodeling bony sinus outflow tracts) and surgical guidance, not for diagnosing conditions.
No
The device description clearly details physical components like a balloon, suction tube, luer fitting, and a sensor carrier, indicating it is a hardware device with a software component for navigation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access and treat anatomical structures within the sinuses using a trans-nasal approach and balloon dilation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument designed for mechanical manipulation and dilation of tissue and bone.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological specimens.
The device is a surgical tool used in vivo (within the body) to perform a therapeutic procedure. The navigation system component aids in guiding the surgical tool, but the primary function of the VenSure™ Balloon Device itself is mechanical dilation within the patient's sinuses.
N/A
Intended Use / Indications for Use
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.
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
Fiagon's VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, singleuse devices designed to remodel the bony structures within the sinuses. The device comes in two versions a navigation ready version (VenSure™ Nav) that is compatible with the Fiagon electromagnetic navigation system, and a basic non-navigation ready version (VenSure™).
The VenSure™ and VenSure™ Nav devices, 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, and sphenoid sinuses 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 within the same patient.
Both versions enable a physician to track the device into the sinuses using endoscopic visualization; while the VenSure™ Nav allows for image-guided visualization when connected to the Fiagon Navigation System. The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "plug 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 sinus 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 inflator to expand the outflow track of the targeted sinus.
A suction tube may be connected directly to the proximal luer fitting of the basic VenSure™ balloon dilation device to provide active suction. Alternately, an Extension Line connected to a syringe may be connected directly to the proximal luer fitting to provide irrigation. Suction and irrigation are not possible on the VenSure™ Nav.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model of the anatomy
Anatomical Site
frontal recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, frontal, maxillary, and sphenoid sinuses
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to ensure that the VenSure™ and VenSure™ Nav met the predefined acceptance criteria to demonstrate safety and performance. Testing included the following:
- Balloon dimensional integrity
- Balloon pressure stability /Inflation/Deflation
- Inflation and Deflation Time
- Mechanical integrity
- Torsion strength
- Tensile force
- Dimensions
- Navigation compatibility (VenSure™ Nav only)
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.
Biocompatibility evaluation was conducted in accordance with FDA recognized consensus standard ISO 10993-1:2009. Testing included cytotoxicity, irritation, sensitization and acute systemic toxicity testing. All tests successfully met the required acceptance criteria.
Validation of the sterilization cycle has been conducted in accordance with ISO 11135:2014, ISO10993-7:2018, ISO 11737-1:2018.
Shelf life and packaging testing were performed to support the labeled shelf life:
- Accelerated aging study has been performed (ASTM F 1980) and in parallel a real-time aging study was started
- package integrity was determined by:(referenced standards: ISO11607-1, ASTM F1886, ASTM F88, ASTM F1140, ASTM F1929)
- packaging system performance testing was performed according to reference standard ISTA-2A.
All tests were successfully completed. Real time aging study has been started.
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 predicate, Medtronic EM Sinus Dilation System.
The device VenSure™ Nav is used in connection with the Fiagon Navigation system. Compliance to IEC 60601-1-2, 4th edition of the new device could be demonstrated by leveraging existing data of cleared navigation probes used with the Fiagon Navigation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
XprESS Multi-Sinus Dilation Tool (K142252), Medtronic EM Sinus Dilation System (K132297)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
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August 26, 2020
Fiagon GmbH Dirk Mucha Chief Technology Officer Neuendorfstrasse 23b 16761 Hennigsdorf Germany
Re: K201472
Trade/Device Name: VenSure Balloon Device, VenSure Nav Balloon Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I, reserved Product Code: LRC Dated: June 2, 2020 Received: June 3, 2020
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 Actinclude 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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-devices/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 (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,
Malvina B. Eydelman, M.D. Director 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) K201472
Device Name VenSure™ Balloon Device VenSure™ Nav Balloon Device
Indications for Use (Describe)
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.
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
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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Image /page/3/Picture/0 description: The image shows the logo for Fiagon. The logo consists of the word "fiagon" in a sans-serif font. The "f" is green and enclosed in a green circle. The rest of the letters are black, except for a green dot after the "n".
510(k) Summary
August 11, 2020
1. Submitter Information
Submitter: | Fiagon GmbH |
---|---|
Address: | Neuendorfstrasse 23b |
16761 Hennigsdorf, Germany | |
Telephone: | +49 3302 201 21 10 |
Telefax: | +49 3302 201 21 15 |
Contact: Dirk Mucha Chief Technology Officer
2. Device Information
| Trade Name: | VenSure™ Balloon Device
VenSure™ Nav Balloon Device |
|----------------------|--------------------------------------------------------|
| 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
The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are substantially equivalent to the following predicate devices:
- Primary predicate: XprESS Multi-Sinus Dilation Tool (K142252) ●
- Secondary predicate: Medtronic EM Sinus Dilation System (K132297) ●
4. Device Description
Fiagon's VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, singleuse devices designed to remodel the bony structures within the sinuses. The device comes in two versions a navigation ready version (VenSure™ Nav) that is compatible with the Fiagon electromagnetic navigation system, and a basic non-navigation ready version (VenSure™).
The VenSure™ and VenSure™ Nav devices, 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, and sphenoid sinuses 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 within the same patient.
4
Image /page/4/Picture/0 description: The image shows the logo for Fiagon. The logo consists of a green circle with a white "f" inside, followed by the word "fiagon" in black. There is a small green dot after the word "fiagon".
Both versions enable a physician to track the device into the sinuses using endoscopic visualization; while the VenSure™ Nav allows for image-guided visualization when connected to the Fiagon Navigation System. The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "plug 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 sinus 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 inflator to expand the outflow track of the targeted sinus.
A suction tube may be connected directly to the proximal luer fitting of the basic VenSure™ balloon dilation device to provide active suction. Alternately, an Extension Line connected to a syringe may be connected directly to the proximal luer fitting to provide irrigation. Suction and irrigation are not possible on the VenSure™ Nav.
5. Intended Use
The VenSure™ and VenSure™ Nav and the predicate devices have the same Intended Use, which is to access and treat the frontal, maxillary and sphenoid sinuses using a transnasal approach.
The Indications for Use for the VenSure™ and VenSure™ Nav Balloon Devices are the same as the XprESS Multi-Sinus Dilation Tube. Both, the VenSure™ Nav and the Medtronic EM Sinus Dilation System have an additional indication for use with a compatible image-guided navigation system (Fiagon Navigation System) as an aid for locating anatomical structures in either open or percutaneous procedures.
Device | Indications for Use |
---|---|
VenSure™ Balloon Device | 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. |
VenSure™ Nav Balloon Device | 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. |
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy. | |
Xpress Multi-Sinus Dilation Tool | |
(K142252) | 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. |
Indications for Use for VenSure™ / VenSure™ Nav and Predicate Devices | |||
---|---|---|---|
----------------------------------------------------------------------- | -- | -- | -- |
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Image /page/5/Picture/0 description: The image shows the logo for Fiagon. The logo consists of a green circle with a white "f" inside, followed by the word "fiagon" in black sans-serif font. A small green circle is located to the right of the word.
Device | Indications for Use |
---|---|
EM Sinus Dilation | |
System / | |
(K132297) | The EM Sinus Dilation System is intended for use in sinus procedures when surgical |
navigation or image-guided surgery may be necessary to locate and remove tissue, | |
bone or cartilaginous tissue surrounding the drainage pathways of the frontal, | |
maxillary, and sphenoid sinuses. | |
The EM Sinus Dilation system is used in conjunction with the Medtronic computer- | |
assisted surgery system. | |
The Medtronic computer-assisted surgery system and its associated applications are | |
intended as an aid for precisely locating anatomical structures in either open or | |
percutaneous procedures. Their use is indicated for any medical condition in which the | |
use of stereotactic surgery may be appropriate, and where reference to a rigid | |
anatomical structure, such as the skull, can be identified relative to a CT- or MR-based | |
model, or digitized landmarks of the anatomy. | |
The system and its associated applications should be used only as an adjunct for | |
surgical guidance. They do not replace the surgeon's knowledge, expertise or | |
judgment. |
6. Comparison of Technological Characteristics
The VenSure™ and VenSure™ Nav Balloon Devices have the same fundamental scientific technology as the predicate devices [K142252 and K132297]. The subject devices have the same technological characteristics; in particular, basic design, performance, and principle of operation.
| Feature | VenSure™ and
VenSure™ Nav
Balloon Device | Xpress Multi-Sinus
Dilation Tool
[K142252] | EM Sinus Dilation
System [K132297] | Equivalence |
|--------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Class | Class I
21 CFR 874.4420
Product code: LRC | Class I
21 CFR 874.4420
Product code: LRC | Class I
21 CFR 874.4420
Product code: LRC | Same |
| Indications for
Use | (see above) | (see above) | (see above) | Equivalent
For Dilation same as
Predicate 1
For image guidance
same as Predicate 2 |
| Balloon design | Fixed balloon | Sliding balloon
mechanism | Fixed balloon | Same as Predicate 1 |
| Balloon
Dimensions
[D x L (mm)] | 6 x 18 | 5 x 8, 5 x 18, 5 x 20, 6
x 8, 6 x 18, 6 x 20, 7 x
18 | 5 x 7, 6 x 7, 7 x 7
5 x 17, 6 x 17, 7 x
17 | Equivalent
Same size available
in Predicate 1
Less additional sizes
are available |
| Ability to access
multiple
locations with
single balloon? | Yes - tip angle is
reshapable using
bending tool | Yes - tip angle is
reshapable using
bending tool | N/A - Rigid tip.
Multiple versions of
device with fixed
balloon shapes
based on sinus. | Same as Predicate 1 |
| Inflation Device | Syringe barrel and
plunger | Syringe barrel and
plunger | Syringe barrel and
plunger | Same |
| Visualization | Endoscopy & Image
guided option
(VenSure™ Nav) | Endoscopy | Endoscopy & Image
guided option ( | Same as Predicate 2 |
| Image-guided
Tracking
Method | Electromagnetic
(VenSure™ Nav
only) | N/A (Compatible) | Electromagnetic | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Fiagon. The logo consists of the word "fiagon" in black letters, with a green circle containing a white "f" to the left of the word. There is also a green dot to the right of the word.
7. Performance Data
Bench Testing
Bench testing was conducted to ensure that the VenSure™ and VenSure™ Nav met the predefined acceptance criteria to demonstrate safety and performance. Testing included the following:
- Balloon dimensional integrity ●
- Balloon pressure stability /Inflation/Deflation ●
- Inflation and Deflation Time ●
- Mechanical integrity ●
- o Torsion strength
- Tensile force o
- o Dimensions
- Navigation compatibility (VenSure™ Nav only) .
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.
Biocompatibility
The biocompatibility evaluation for the VenSure™ and VenSure™ Nav balloon dilation devices was conducted in accordance with FDA recognized consensus standard ISO 10993-1:2009. 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 & Shelf Life
Validation of the sterilization cycle has been conducted in accordance with ISO 11135:2014, ISO10993-7:2018, ISO 11737-1:2018.
Shelf life and packaging testing were performed to support the labeled shelf life:
- Accelerated aging study has been performed (ASTM F 1980) and in parallel a real-● time aging study was started
- package integrity was determined by:(referenced standards: ISO11607-1, ASTM F1886, ASTM F88, ASTM F1140, ASTM F1929)
- packaging system performance testing was performed according to reference standard ● ISTA-2A.
All tests were successfully completed. Real time aging study has been started.
Navigation Compatibility (VenSure™ 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
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Image /page/7/Picture/0 description: The image shows the logo for Fiagon. The logo consists of a green circle with a white "f" inside, followed by the word "fiagon" in black lowercase letters. There is a green dot after the word "fiagon".
system and support the claim of substantial equivalence to the predicate, Medtronic EM Sinus Dilation System.
Electromagnetic Compatibility
The device VenSure™ Nav is used in connection with the Fiagon Navigation system. Compliance to IEC 60601-1-2, 4th edition of the new device could be demonstrated by leveraging existing data of cleared navigation probes used with the Fiagon Navigation System.
8. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, Fiagon GmbH demonstrated that the VenSure™ and VenSure™ Nav are substantially equivalent to the predicate devices identified in this submission, and they are as safe and perform in an equivalent manner to the stated predicate devices.