(251 days)
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.
The TubaVent balloon dilatation system is an Eustachian Tube Balloon Dilatation System consisting of the balloon catheter, the Tubalnsert insertion device and the inflation device. It is used for dilation of the cartilaginous portion of the Eustachian tube in persistent obstructive Eustachian tube dysfunction. The balloon catheter TubaVent is available in two versions where the balloon diameter is different: 3 and 4.5 mm. The insertion device Tubalnsert has an angle of 45° at the distal end.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TubaVent Balloon Dilatation System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details performance tests that were conducted and states that the device "met all acceptance criteria." However, it does not provide a specific table outlining the acceptance criteria values themselves (e.g., "burst pressure > X bar") alongside the measured performance. Instead, it describes the types of tests performed and a general statement of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | - All tests passed (ISO 10993-5, -10, -11, -23). |
| - Not cytotoxic, does not cause sensitization, irritation, or acute systemic toxicity. | |
| Performance | - All performance tests demonstrated device performs as intended. |
| - Tests included dimensional verification, deflation time, balloon burst pressure, tensile strength, torque, and fatigue. | |
| - Simulation studies (head model, animal cadaver - sheep) ensured function per design specs and intended use. | |
| - Human factors validation testing showed safe use by intended users without serious errors. | |
| Shelf Life | - TubaVent balloon dilatation system: 3 years |
| - TubaInsert insertion device: 5 years | |
| - Tuba inflation devices: 3 years | |
| Sterilization | - Achieves Sterility Assurance Level (SAL) of 10-6. |
| Design Validation | - Performed in a human cadaver study. |
2. Sample Size Used for the Test Set and Data Provenance
- Human Cadaver Study (Design Validation): The text mentions a "human cadaver study" was executed for design validation and to fulfill a special control requirement (874.4180(b)(iv)(6)). It does not specify the sample size (number of cadavers or Eustachian tubes tested) or the provenance (country of origin, retrospective/prospective).
- Simulation Studies: Acknowledges "simulation studies in a head model and in an animal cadaver model (sheep head)" but does not specify sample sizes for these.
- Human Factors Validation Testing: No sample size or details about the participants are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" for a test set in the context of expert consensus, pathology, or outcomes data. The studies mentioned (biocompatibility, performance, shelf life, human cadaver, human factors) are primarily engineering and safety evaluations rather than diagnostic accuracy or clinical effectiveness studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the clinical study type requiring such adjudication (e.g., diagnostic accuracy where experts review cases) was not performed or detailed.
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
Not applicable. This device is a medical instrument (balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document primarily relies on engineering specifications, biological safety testing (biocompatibility), and functional performance data. For the human cadaver study, the "ground truth" would likely be the physical integrity and proper function of the device within the anatomical context, assessed through direct observation and measurements, rather than an expert consensus on a pathological finding or clinical outcome.
8. The Sample Size for the Training Set
Not applicable, as this device does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not involve machine learning or AI models with training sets.
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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 (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 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 GmbHBurghof 451491 Overath / Germany |
|---|---|
| Establishment Registration Number | 3002858762 |
| Phone / Fax number | +49 2206 9081-65 / +49 2206 9081-13 |
| Contact Person for 510(k) | Claudia WinterschladenHead of Regulatory Affairs InternationalEmail: c.winterschladen@spiggle-theis.com |
| 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 BalloonDilation System consisting of the balloon catheter, the Tubalnsertinsertion device and the inflation device. It is used for dilation of thecartilaginous portion of the Eustachian tube in persistent obstructiveEustachian tube dysfunction. The balloon catheter TubaVent is available intwo versions where the balloon diameter is different: 3 and 4.5 mm. Theinsertion 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 usingsterile isotonic saline solution NaCl 0.9 % to 10 bar. The inflation iscontrolled with help of the pressure gauge on the inflation device. Theballoon pressure is then hold for 2 minutes. Insertion of the TubaVent intothe Eustachian tube (ET) is done with the Tubalnsert via a patient's nostril.The procedure is usually carried out under general anesthesia. Evidence isemerging in the scientific literature that the procedure can be done underlocal anesthesia, sedation, and analgesia. Real-world clinical data collectedin a pilot feasibility study from 10 patients (5 received bilateral BET)supports the use of the TubaVent short device under local anesthesia. Theuse of local anesthesia for this procedure is evident with appropriatepatient preparation, which may include supplemental medication forpatient management.1 |
| Scientific concept | Eustachian tube dysfunction (ETD) is a common condition resulting frominadequate opening of the Eustachian tube or the inability toappropriately equalize pressure between the middle ear and theenvironment, respectively. This may lead to hearing loss, chronic otitismedia, tinnitus, and vertigo. The principle of dilatation to open anobstructed tube has been successfully applied for many years for examplein blood vessels. The marketing of the first Eustachian balloon dilationcatheter was permitted by the FDA in September 2016. The decision wasbased on a randomized clinical trial in which 52 % of treated patients hadtympanogram results within a normal functioning range six weeks afterthe procedure compared to 14 % of the patients, who were treated withconventional medical management (nasal spray). |
| Significant physical andperformance | The TubaVent balloon dilatation system is offered with two differentballoon diameters, 3.0 and 4.5 mm. The balloons are both 20 mm long |
| characteristics (design,material etc.) | and are made of polyamide. The balloon is semi-compliant. The workinglength 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 | |||
| CatheterTotal Length [mm] | 270 | 327 | Different: The TubaVentballoon dilatationsystem is shorter thusperfectly adapted to theinsertion instrumentTubaInsert, whichprevents the catheterfrom being pushed toofar into the TubaEustachii. |
| CatheterWorking Length [mm] | 236 | Not known | See explanation inprevious line. |
| Distal shaft end(balloon) | flexible | flexible | Identical |
| Proximal shaft end | Hypotube made ofstainless steel | Hypotube, rigid | Identical: In bothdevices the proximalshaft is a rigid hypotube |
| Insertion / Shaft marker | No, because theprotruding length of theTubaVent Balloon out ofthe TubaInsert is fixed bydesign features. | Yes | Different: The length ofthe TubaVentprotruding from theTubaInsert is fixed. Afterthe proximal end of theTubaVent has come intocontact with the |
| Characteristics | New device | Predicate device | Correspondence |
| proximal end of theTubalnsert, furtheradvancement out of theTubalnsert is notpossible and thereforeno shaft marker isrequired. Therefore, thisdifference does notcause any new issue ofsafety or effectivenessof the new device. | |||
| Actuator | No | Yes | Different: The functionof the actuator of thepredicate device is tofacilitate single-handedadvancement andretraction of ballooncatheter, if required.The balloon catheter ofthe predicate device canalso be moved forwardwith two hands.Furthermore, theusability studyconfirmed that the twohand procedure of thenew device does notcause new safety issuesas the movement of thecatheter is done underendoscopic control. |
| Balloon catheter design | Dual lumen tubing: outerlumen is used to expandthe balloon | Dual lumen tubing | Identical |
| Inflation connection | Luer connector | Luer connector | Identical |
| Balloon | |||
| Length x Diameter[mm] at workingpressure | - Short: 3.28 x 20.0- Short wide: 4.94 x 20.0 | 6.0 x 16.0 | Similar: The TubaVentballoon has a smallerdiameter and is 4 mmlonger than the |
| Characteristics | New device | Predicate device | Correspondence |
| diameter is lesstraumatic and a longerballoon ensures that alonger part of thecartilaginous part of theET (approx. 24 mm long)is dilated. | |||
| Type | Semi-compliant | Non-compliant | Different: Semi-compliant balloonsprovide morecompliance than a non-compliant balloon andmore flexibility to easedelivery than a non-compliant balloon.Schubert et al.published a comparisonof the balloons in 20182,which shows that theAcclarent Aera balloonalso behaves like asemi-compliant balloon.Thus, both balloons areequivalent, althoughAcclarent describes itsballoon as non-compliant. |
| Material | PA (Polylauryllactam;nylon) | PET (Polyethyleneterephthalate;polyester) | Similar, as bothmaterials arethermoplastic andchemically inert orchemically resistant,respectively. |
| Catheter tip | |||
| Characteristics | New device | Predicate device | Correspondence |
| Design | Olive-shaped; 1.2 mm in diameter; atraumaticImage: 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 (Plungerextended) | 34.9 cm | 11.3" [ $\triangleq$ 28.702cm] | Different due to thegreater volume of thesubject 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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Image /page/9/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, which contains a stylized blue profile of a face. To the right of the square, the text "SPIGGLE & THEIS" is written in white, with the word "Medizintechnik" written in a smaller font size below it, also in white. The background of the logo is blue.
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7. Non-clinical Tests: Bench [807.92(b)(1)]
| Biocompatibility | - ISO 10993-5:2009 (Cytotoxicity)- ISO 10993-10: 2010 (Sensitization & Irritation)- ISO 10993-11: 2017 (acute systemic toxicity)- ISO 10993-23: 2021 (sensitization)All tests were passed. The TubaVent balloon dilatation system fulfilsall applicable biocompatibility requirements. The material used forthis device is not cytotoxic. It does not cause sensitization, irritationor intracutaneous reactivity nor does it cause acute systemictoxicity. |
|---|---|
| Performance | All performance tests have demonstrated that the TubaVent balloondilatation system performs as intended. Tests include dimensionalverification, deflation time, balloon burst pressure, tensile strength,torque and fatigue tests. Simulation studies in a head model and inan animal cadaver model (sheep head) have ensured that theTubaVent balloon dilatation system functions in accordance with itsdesign specifications and intended use.A human cadaver study was executed in order to fulfil the specialcontrol of 874.4180(b)(iv)(6).TubaVent balloon dilatation system. This human factors validationtesting demonstrated that the device can be used by the intendedusers without serious use errors or problems, for the intended usesand under the expected use conditions. The results confirm that theTubaVent balloon dilatation system is safe and performs asintended. |
| Shelf life | Accelerated aging tests as well as real time aging tests havedemonstrated that the TubaVent has a shelf life of 3 years, if storedunder the recommended conditions. The insertion deviceTubalnsert, has a shelf life of 5 years, the Tuba inflation devices ashelf life of 3 years. |
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| Sterilization | Validation of the sterilization procedure and parameters hasdemonstrated that the TubaVent, Tubalnsert and the Inflationdevice 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.Noo animal studyWASconditionern 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 TubaVentballoon 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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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.
§ 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.