TubaVent Balloon Dilatation System

K223542 · Spiggle & Theis Medizintechnik GmbH · PNZ · Aug 3, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K223542
• Device Name: TubaVent Balloon Dilatation System
• Applicant: Spiggle & Theis Medizintechnik GmbH
• Product Code: PNZ · Ear, Nose, Throat
• Decision Date: Aug 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4180
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K223542 · Aug 3, 2023	TubaVent Balloon Dilatation System	Spiggle & Theis Medizintechnik GmbH	Published clinical literature (pilot feasibility study)	The document cites a pilot feasibility study of 10 patients to support the clinical use of the TubaVent device under local anesthesia, sedation, and analgesia.	Eustachian tube dysfunction; Local anesthesia; Pilot feasibility study

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Balloon Eustachian tuboplasty under monitored anaesthesia care with different balloon dilation devices: A pilot feasibility study; Pilot feasibility study	10 patients (5 received bilateral BET); Sample Size: 10	Not applicable for this study	Feasibility of procedure under local anesthesia

Indications for Use

The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.

Device Story

TubaVent Balloon Dilatation System is a surgical device for treating persistent obstructive Eustachian tube dysfunction (ETD). The system comprises a balloon catheter (3.0 or 4.5 mm diameter), a Tubalnsert insertion device, and an inflation device. The physician inserts the Tubalnsert through the patient's nostril to access the Eustachian tube; the TubaVent catheter is then advanced through the insert. The balloon is inflated with sterile 0.9% NaCl solution to 10 bar, held for 2 minutes, and then deflated. The procedure is typically performed under general anesthesia, though literature suggests feasibility under local anesthesia/sedation. The device mechanically dilates the cartilaginous Eustachian tube to restore pressure equalization between the middle ear and the environment, potentially alleviating symptoms like hearing loss, tinnitus, and vertigo. The clinician monitors the procedure via endoscopy and the inflation device's pressure gauge.

Clinical Evidence

No clinical performance study was conducted for the TubaVent. Evidence consists of bench testing (dimensional verification, deflation time, burst pressure, tensile strength, torque, fatigue), biocompatibility (ISO 10993), and human factors validation in a human cadaver model. Simulation studies were performed in head and animal (sheep) models.

Technological Characteristics

System includes a dual-lumen polyamide balloon catheter, stainless steel hypotube, and Pebax tip. Balloon is semi-compliant. Inflation device uses 30 cc syringe with pressure gauge (Atm/PSI). Sterilization via validated process to SAL 10^-6. Biocompatibility per ISO 10993-5, -10, -11, -23. Shelf life 3-5 years. No software or electronic components.

Indications for Use

Indicated for patients 18 years and older with persistent obstructive Eustachian tube dysfunction requiring dilation of the cartilaginous portion of the Eustachian tube.

Regulatory Classification

Identification

A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Mechanical testing, including tensile and flexural testing of catheter joints and materials. (ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components. (iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon. (iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms. (2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life. (6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device. (7) Labeling must include: (i) Detailed instructions for use. (ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes. (iii) A shelf life.

In combination with the general controls of the FD&C Act, the Acclarent Aera™ Eustachian Tube Balloon Dilation System is subject to the following special controls: - 1. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: - a. Mechanical testing, including tensile and flexural testing of catheter joints and materials. - b. Durability testing, including fatigue and burst pressure testing of the balloon materials and components. - Inflation and deflation characterization testing, including time and pressure C. measurements, and leak testing of the balloon. - d. Verification testing of safety features built into the device must be performed. including the characterization of catheter geometries and distal tip insertion limitation mechanisms. - 2. Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube. - 3. The patient-contacting components of the device must be demonstrated to be biocompatible. - 4. Performance data must demonstrate the sterility of the device. - 5. Performance data must support shelf life by demonstrating continued sterility of the device, package integrity and device functionality over the identified shelf life. - 6. Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device. - 7. Labeling must include: - a. Detailed instructions for use. - b. A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes. - c. A shelf life.

Predicate Devices

• Acclarent Aera (K171761)

Submission Summary (Full Text)

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August 3, 2023

Spiggle & Theis Medizintechnik GmbH Claudia Winterschladen Head of Regulatory Affairs International Burghof 4 Overath, North Rhime-Westphalia 51491 Germany

Re: K223542

Trade/Device Name: TubaVent Balloon Dilatation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ Dated: June 30, 2023 Received: July 3, 2023

Dear Claudia Winterschladen:

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 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

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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 mediation-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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223542

Device Name TubaVent Balloon Dilatation System

Indications for Use (Describe)

The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachiant of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5 - 510(k) Summary

as required by 21 CFR 807.92(c)

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#### 1. Owner of the 510(k) [807.92(a)(1)]

| Manufacturer / 510(k) Submitter | Spiggle & Theis Medizintechnik GmbH<br>Burghof 4<br>51491 Overath / Germany |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number | 3002858762 |
| Phone / Fax number | [phone] / [phone] |
| Contact Person for 510(k) | Claudia Winterschladen<br>Head of Regulatory Affairs International<br>Email: [e-mail] |
| Date, 510(k) summary was prepared | 2022-11-10 |

#### 2. Device Identification [807.92(a)(2)]

| Device Trade Name | TubaVent Balloon Dilatation System |
|---------------------------------------------|-----------------------------------------|
| Device Common or Usual Name | N/A |
| Classification/Regulation Name | Eustachian Tube Balloon Dilation System |
| Device Regulation Number | 21 CFR 874.4180 |
| Device Classification Product Code | PNZ |
| Device Class | Class II |
| Regulation Medical Specialty / Review Panel | Ear, Nose & Throat |

#### 3. Predicate Device [807.92(a)(3)]

| Manufacturer / 510(k) Submitter | Acclarent Inc. |
|---------------------------------------------|-----------------------------------------|
| 510(k) No. | K171761 |
| Device Trade Name | Acclarent Aera® |
| Device Common or Usual Name | N/A |
| Classification / Regulation Name | Eustachian Tube Balloon Dilation System |
| Device Regulation Number | 21 CFR 874.4180 |
| Device Classification Product Code | PNZ |
| Device Class | Class II |
| Regulation Medical Specialty / Review Panel | Ear, Nose & Throat |

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#### 4. New Device Description [807.92(a)(4)]

| Description | The TubaVent balloon dilatation system is an Eustachian Tube Balloon<br>Dilation System consisting of the balloon catheter, the Tubalnsert<br>insertion device and the inflation device. It is used for dilation of the<br>cartilaginous portion of the Eustachian tube in persistent obstructive<br>Eustachian tube dysfunction. The balloon catheter TubaVent is available in<br>two versions where the balloon diameter is different: 3 and 4.5 mm. The<br>insertion device Tubalnsert has an angle of 45° at the distal end. |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| How it functions | The balloon is located at the distal end of the TubaVent and is inflated using<br>sterile isotonic saline solution NaCl 0.9 % to 10 bar. The inflation is<br>controlled with help of the pressure gauge on the inflation device. The<br>balloon pressure is then hold for 2 minutes. Insertion of the TubaVent into<br>the Eustachian tube (ET) is done with the Tubalnsert via a patient's nostril.<br>The procedure is usually carried out under general anesthesia. Evidence is<br>emerging in the scientific literature that the procedure can be done under<br>local anesthesia, sedation, and analgesia. Real-world clinical data collected<br>in a pilot feasibility study from 10 patients (5 received bilateral BET)<br>supports the use of the TubaVent short device under local anesthesia. The<br>use of local anesthesia for this procedure is evident with appropriate<br>patient preparation, which may include supplemental medication for<br>patient management.1 |
| Scientific concept | Eustachian tube dysfunction (ETD) is a common condition resulting from<br>inadequate opening of the Eustachian tube or the inability to<br>appropriately equalize pressure between the middle ear and the<br>environment, respectively. This may lead to hearing loss, chronic otitis<br>media, tinnitus, and vertigo. The principle of dilatation to open an<br>obstructed tube has been successfully applied for many years for example<br>in blood vessels. The marketing of the first Eustachian balloon dilation<br>catheter was permitted by the FDA in September 2016. The decision was<br>based on a randomized clinical trial in which 52 % of treated patients had<br>tympanogram results within a normal functioning range six weeks after<br>the procedure compared to 14 % of the patients, who were treated with<br>conventional medical management (nasal spray). |
| Significant physical and<br>performance | The TubaVent balloon dilatation system is offered with two different<br>balloon diameters, 3.0 and 4.5 mm. The balloons are both 20 mm long |
| characteristics (design,<br>material etc.) | and are made of polyamide. The balloon is semi-compliant. The working<br>length of the catheter is for both variants 236 mm. |

^– Luukkainen V, Jero J, Sinkkonen ST. Balloon Eustachian tuboplasty under monitored anaesthesia care with different balloon dilation devices: A pilot feasibility study with 18 patients. Clin Otolaryngol. 2019 Jan;44(1):87-90. doi: 10.11111/coa.13236. Epub 2018 Nov 4. PMID: 30281926.

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#### 5. Intended Use New Device [807.92(a)(5)]

| Intended use and | The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older. |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| patient population | |

#### 6. Summary technological characteristics compared to predicate [807.92(a)(6)]

| Characteristics | New device | Predicate device | Correspondence |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter | | | |
| Catheter<br>Total Length [mm] | 270 | 327 | Different: The TubaVent<br>balloon dilatation<br>system is shorter thus<br>perfectly adapted to the<br>insertion instrument<br>TubaInsert, which<br>prevents the catheter<br>from being pushed too<br>far into the Tuba<br>Eustachii. |
| Catheter<br>Working Length [mm] | 236 | Not known | See explanation in<br>previous line. |
| Distal shaft end<br>(balloon) | flexible | flexible | Identical |
| Proximal shaft end | Hypotube made of<br>stainless steel | Hypotube, rigid | Identical: In both<br>devices the proximal<br>shaft is a rigid hypotube |
| Insertion / Shaft marker | No, because the<br>protruding length of the<br>TubaVent Balloon out of<br>the TubaInsert is fixed by<br>design features. | Yes | Different: The length of<br>the TubaVent<br>protruding from the<br>TubaInsert is fixed. After<br>the proximal end of the<br>TubaVent has come into<br>contact with the |
| Characteristics | New device | Predicate device | Correspondence |
| | | | proximal end of the<br>Tubalnsert, further<br>advancement out of the<br>Tubalnsert is not<br>possible and therefore<br>no shaft marker is<br>required. Therefore, this<br>difference does not<br>cause any new issue of<br>safety or effectiveness<br>of the new device. |
| Actuator | No | Yes | Different: The function<br>of the actuator of the<br>predicate device is to<br>facilitate single-handed<br>advancement and<br>retraction of balloon<br>catheter, if required.<br>The balloon catheter of<br>the predicate device can<br>also be moved forward<br>with two hands.<br>Furthermore, the<br>usability study<br>confirmed that the two<br>hand procedure of the<br>new device does not<br>cause new safety issues<br>as the movement of the<br>catheter is done under<br>endoscopic control. |
| Balloon catheter design | Dual lumen tubing: outer<br>lumen is used to expand<br>the balloon | Dual lumen tubing | Identical |
| Inflation connection | Luer connector | Luer connector | Identical |
| Balloon | | | |
| Length x Diameter<br>[mm] at working<br>pressure | - Short: 3.28 x 20.0<br>- Short wide: 4.94 x 20.0 | 6.0 x 16.0 | Similar: The TubaVent<br>balloon has a smaller<br>diameter and is 4 mm<br>longer than the |
| Characteristics | New device | Predicate device | Correspondence |
| | | | diameter is less<br>traumatic and a longer<br>balloon ensures that a<br>longer part of the<br>cartilaginous part of the<br>ET (approx. 24 mm long)<br>is dilated. |
| Type | Semi-compliant | Non-compliant | Different: Semi-<br>compliant balloons<br>provide more<br>compliance than a non-<br>compliant balloon and<br>more flexibility to ease<br>delivery than a non-<br>compliant balloon.<br>Schubert et al.<br>published a comparison<br>of the balloons in 20182,<br>which shows that the<br>Acclarent Aera balloon<br>also behaves like a<br>semi-compliant balloon.<br>Thus, both balloons are<br>equivalent, although<br>Acclarent describes its<br>balloon as non-<br>compliant. |
| Material | PA (Polylauryllactam;<br>nylon) | PET (Polyethylene<br>terephthalate;<br>polyester) | Similar, as both<br>materials are<br>thermoplastic and<br>chemically inert or<br>chemically resistant,<br>respectively. |
| Catheter tip | | | |
| Characteristics | New device | Predicate device | Correspondence |
| Design | Olive-shaped; 1.2 mm in diameter; atraumatic<br>Image: Catheter | Ball-shaped; 2.4 mm in diameter; atraumatic | Similar: Both designs prevent catheter travel into the isthmus |
| Material | Pebax | Nylon | Similar: Both materials are soft and therefore atraumatic. |
| Insertion Device | | | |
| Separate | Yes: Tubalnsert | Yes | Identical |
| Rigid shaft | Yes, hypotube | Yes, hypotube | Identical |
| Angled tip | Yes | Yes | Identical |
| Atraumatic tip | Yes | Yes | Identical |
| Distal angled tip | Yes | Yes | Identical |
| Inflation device | | | |
| Name | Inflation device | Acclarent Balloon Inflation device | N/A |
| Photo | Image: Inflation device | Image: Acclarent Balloon Inflation device | Similar in design and shape |
| Indications for use | The inflation device (...) is intended to inflate, deflate and monitor pressure in the TubaVent. | The ACCLARENT® Balloon Inflation Device is used to inflate the balloon. | Similar wording with identical meaning |
| Syringe volume | 30 cc | 20 cc | Different |
| Pressure gauge | Atm and PSI | Atm and PSI | Identical |
| Length (Plunger not extended) | 23.9 cm | 8.1" [ $ ≤ $ 20.575 cm] | Different due to the greater volume of the subject device. |
| Characteristics | New device | Predicate device | Correspondence |
| Length (Plunger<br>extended) | 34.9 cm | 11.3" [ $\triangleq$ 28.702<br>cm] | Different due to the<br>greater volume of the<br>subject device. |

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² Schubert J, Wilfling T, Schümann K, Paasche G, Grabow N, Schmidt W. Investigation of balloon dilatation devices for treatment of Eustachian tube dysfunction. Current Directions in Biomedical Engineering 4(1): 529-533, 2018.

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#### 7. Non-clinical Tests: Bench [807.92(b)(1)]

| Biocompatibility | - ISO 10993-5:2009 (Cytotoxicity)<br>- ISO 10993-10: 2010 (Sensitization & Irritation)<br>- ISO 10993-11: 2017 (acute systemic toxicity)<br>- ISO 10993-23: 2021 (sensitization)<br>All tests were passed. The TubaVent balloon dilatation system fulfils<br>all applicable biocompatibility requirements. The material used for<br>this device is not cytotoxic. It does not cause sensitization, irritation<br>or intracutaneous reactivity nor does it cause acute systemic<br>toxicity. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | All performance tests have demonstrated that the TubaVent balloon<br>dilatation system performs as intended. Tests include dimensional<br>verification, deflation time, balloon burst pressure, tensile strength,<br>torque and fatigue tests. Simulation studies in a head model and in<br>an animal cadaver model (sheep head) have ensured that the<br>TubaVent balloon dilatation system functions in accordance with its<br>design specifications and intended use.<br>A human cadaver study was executed in order to fulfil the special<br>control of 874.4180(b)(iv)(6).<br>TubaVent balloon dilatation system. This human factors validation<br>testing demonstrated that the device can be used by the intended<br>users without serious use errors or problems, for the intended uses<br>and under the expected use conditions. The results confirm that the<br>TubaVent balloon dilatation system is safe and performs as<br>intended. |
| Shelf life | Accelerated aging tests as well as real time aging tests have<br>demonstrated that the TubaVent has a shelf life of 3 years, if stored<br>under the recommended conditions. The insertion device<br>Tubalnsert, has a shelf life of 5 years, the Tuba inflation devices a<br>shelf life of 3 years. |

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| Sterilization | Validation of the sterilization procedure and parameters has<br>demonstrated that the TubaVent, Tubalnsert and the Inflation<br>device reach the sterility assurance level (SAL) of 10-6. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design validation | Design validation was performed in a human cadaver study. |

#### 8. Non-clinical Tests: Animal

| NI.<br>No<br>o animal study<br>WAS<br>conditioner<br>n will would and the world and the world of the start of the start of the start of | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|--|--|
|-----------------------------------------------------------------------------------------------------------------------------------------|--|--|

#### 9. Clinical Performance Data [807.92(b)(2)]

| N/A | No clinical performance study was conducted for the TubaVent<br>balloon dilatation system. |
|-----|--------------------------------------------------------------------------------------------|
|-----|--------------------------------------------------------------------------------------------|

#### Summary non-clinical and clinical tests [807.92(b)(3)] 10.

The TubaVent balloon dilatation system has met all acceptance criteria for attributes like dimensions, balloon burst pressure etc. Biocompatibility testing was performed in accordance to applicable parts of the the ISO 10993 standard. The TubaVent and all components of the system are biocompatible and do not cause sensitization or irritations. The sterilization process and parameters were validated in accordance with ISO 11135:2014. A sterility assurance level (SAL) of 10 · is reached. Packaging shelf life has been proven for 3 years for the TubaVent and the inflation device (5 years for Tubalnsert) via accelerated and/or real time aging. Thus, the performance test results demonstrate, that the TubaVent balloon dilatation system is as safe as the predicate device.

#### 11. Conclusion

Based on the non-clinical performance data, it is concluded that the TubaVent balloon dilatation system is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.

Minor differences in design or material of the TubaVent balloon dilatation system compared to the predicate device do not raise any new questions with regard to the safety or performance or effectiveness of the medical device.

The TubaVent balloon dilatation system is identical to its predicate device with respect to the intended use and the indications for use. It uses the same fundamental scientific technology compared to the predicate device, as it has the same operating principle and the same basic design.

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Image /page/12/Picture/0 description: The image is a logo for Spiggle & Theis Medizintechnik. The logo consists of a white square with a blue outline on the left, containing a stylized blue profile of a face. To the right of the square are the words "SPIGGLE & THEIS" in white, with the word "Medizintechnik" in a smaller font size underneath. The background of the logo is blue.

SPIGGLE & THEIS therefore believes that the TubaVent balloon dilatation system is as safe and effective and performs as the predicate device when used as instructed by knowledgeable and trained surgeons.

TubaVent balloon dilatation system is substantial equivalent to the legally marketed predicate device.