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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VenSure™ Balloon Device and VenSure™ Nav Balloon Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as might be seen for novel devices or PMAs.

Therefore, the information requested, particularly regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and detailed ground truth establishment, is largely not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.

However, I can extract the information that is available:

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the predefined acceptance criteria." and "All tests successfully met the required acceptance criteria". However, the specific quantitative acceptance criteria values themselves are not provided in the text. Only the categories of tests performed are mentioned.

Acceptance Criteria Category	Reported Device Performance
Balloon dimensional integrity	Met predefined acceptance criteria
Balloon pressure stability /Inflation/Deflation	Met predefined acceptance criteria
Inflation and Deflation Time	Met predefined acceptance criteria
Mechanical integrity (Torsion strength, Tensile force, Dimensions)	Met predefined acceptance criteria
Navigation compatibility (VenSure™ Nav only)	Met predefined acceptance criteria; demonstrated functionality and compatibility with Fiagon Navigation System
Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity)	Met required acceptance criteria
Sterilization Cycle Validation	Conducted in accordance with ISO 11135:2014, ISO10993-7:2018, ISO 11737-1:2018; All tests successfully completed
Shelf Life (Accelerated aging, Real-time aging, Package integrity, Packaging system performance)	Accelerated aging study performed, real-time aging started; All tests successfully completed
Electromagnetic Compatibility	Demonstrated compliance to IEC 60601-1-2, 4th edition

2. Sample size used for the test set and the data provenance

The document specifies "Bench testing" and "Biocompatibility testing" were conducted. It does not provide specific sample sizes for these tests (e.g., number of balloons tested for dimensional integrity).

Data Provenance: Bench testing would be conducted in a laboratory setting. Biocompatibility testing involved laboratory assays. The document does not specify a country of origin for the test data, but the submitter (Fiagon GmbH) is based in Germany. The tests are described as prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The tests described are largely objective laboratory and engineering tests (e.g., measuring balloon dimensions, pressure). For biocompatibility, the ground truth would be established by the results of standardized biological assays, not expert consensus in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the types of bench and biocompatibility tests described.

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

No, an MRMC comparative effectiveness study was not done. The devices described are physical surgical instruments (balloon dilation devices and their navigation-compatible versions), not AI/software intended for diagnostic interpretation or aiding human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. These are physical medical devices, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For bench testing, the ground truth would be engineering specifications, material properties, and functionality requirements (e.g., specific dimensions, pressure resistance, inflation/deflation times).
For biocompatibility testing, the ground truth would be the defined acceptable limits and criteria for cytotoxicity, irritation, sensitization, and acute systemic toxicity as per ISO 10993-1 and related sub-standards.
For sterilization and shelf-life, the ground truth is established by the specified standards (e.g., ISO 11135 for sterilization, ASTM F1980 for accelerated aging, ISO 11607-1 for packaging).

8. The sample size for the training set

Not applicable. These are physical medical devices, not machine learning algorithms that require training sets. The document describes pre-market testing for device safety and performance, not AI model development.

9. How the ground truth for the training set was established

Not applicable. As above, this concept refers to AI/ML development and is not relevant to this device submission.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K201472

Device Name VenSure™ Balloon Device VenSure™ Nav Balloon Device

Indications for Use (Describe)

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 23b16761 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 DeviceVenSure™ 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

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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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Device	Indications for Use
EM Sinus DilationSystem /(K132297)	The EM Sinus Dilation System is intended for use in sinus procedures when surgicalnavigation 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 areintended as an aid for precisely locating anatomical structures in either open orpercutaneous procedures. Their use is indicated for any medical condition in which theuse of stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, can be identified relative to a CT- or MR-basedmodel, or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct forsurgical guidance. They do not replace the surgeon's knowledge, expertise orjudgment.

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™ andVenSure™ NavBalloon Device	Xpress Multi-SinusDilation Tool[K142252]	EM Sinus DilationSystem [K132297]	Equivalence
Class	Class I21 CFR 874.4420Product code: LRC	Class I21 CFR 874.4420Product code: LRC	Class I21 CFR 874.4420Product code: LRC	Same
Indications forUse	(see above)	(see above)	(see above)	EquivalentFor Dilation same asPredicate 1For image guidancesame as Predicate 2
Balloon design	Fixed balloon	Sliding balloonmechanism	Fixed balloon	Same as Predicate 1
BalloonDimensions[D x L (mm)]	6 x 18	5 x 8, 5 x 18, 5 x 20, 6x 8, 6 x 18, 6 x 20, 7 x18	5 x 7, 6 x 7, 7 x 75 x 17, 6 x 17, 7 x17	EquivalentSame size availablein Predicate 1Less additional sizesare available
Ability to accessmultiplelocations withsingle balloon?	Yes - tip angle isreshapable usingbending tool	Yes - tip angle isreshapable usingbending tool	N/A - Rigid tip.Multiple versions ofdevice with fixedballoon shapesbased on sinus.	Same as Predicate 1
Inflation Device	Syringe barrel andplunger	Syringe barrel andplunger	Syringe barrel andplunger	Same
Visualization	Endoscopy & Imageguided option(VenSure™ Nav)	Endoscopy	Endoscopy & Imageguided option (	Same as Predicate 2
Image-guidedTrackingMethod	Electromagnetic(VenSure™ Navonly)	N/A (Compatible)	Electromagnetic	Same

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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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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.

Regulation Number and Section

§ 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.