(251 days)
None
No
The summary describes a mechanical balloon dilatation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat a medical condition (persistent obstructive Eustachian tube dysfunction) by dilating the Eustachian tube.
No
Explanation: The device is intended to dilate the Eustachian tube for treatment of a medical condition, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components: a balloon catheter, an insertion device, and an inflation device. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TubaVent balloon dilatation system is a surgical device used to physically dilate the Eustachian tube within the patient's body. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to treat a condition by physically modifying a part of the body, not to diagnose or monitor a condition through laboratory analysis.
Therefore, based on the provided information, the TubaVent balloon dilatation system is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
PNZ
Device Description
The TubaVent balloon dilatation system is an Eustachian Tube Balloon Dilation 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eustachian tube
Indicated Patient Age Range
18 years and older.
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
Non-clinical Tests: Bench
Biocompatibility: All tests (ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10: 2010 (Sensitization & Irritation), ISO 10993-11: 2017 (acute systemic toxicity), ISO 10993-23: 2021 (sensitization)) were passed. The TubaVent balloon dilatation system fulfils all applicable biocompatibility requirements. The material used for this device is not cytotoxic. It does not cause sensitization, irritation or intracutaneous reactivity nor does it cause acute systemic toxicity.
Performance: All performance tests have demonstrated that the TubaVent balloon dilatation system performs as intended. Tests include dimensional verification, deflation time, balloon burst pressure, tensile strength, torque and fatigue tests. Simulation studies in a head model and in an animal cadaver model (sheep head) have ensured that the TubaVent balloon dilatation system functions in accordance with its design specifications and intended use. A human cadaver study was executed in order to fulfil the special control of 874.4180(b)(iv)(6). TubaVent balloon dilatation system. This human factors validation testing demonstrated that the device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. The results confirm that the TubaVent balloon dilatation system is safe and performs as intended.
Shelf life: Accelerated aging tests as well as real time aging tests have demonstrated that the TubaVent has a shelf life of 3 years, if stored under the recommended conditions. The insertion device Tubalnsert, has a shelf life of 5 years, the Tuba inflation devices a shelf life of 3 years.
Sterilization: Validation of the sterilization procedure and parameters has demonstrated that the TubaVent, Tubalnsert and the Inflation device reach the sterility assurance level (SAL) of 10-6.
Design validation: Design validation was performed in a human cadaver study.
Non-clinical Tests: Animal: No animal study was conducted.
Clinical Performance Data: No clinical performance study was conducted for the TubaVent balloon dilatation system.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
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
2
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
Burghof 4
51491 Overath / Germany |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number | 3002858762 |
| Phone / Fax number | +49 2206 9081-65 / +49 2206 9081-13 |
| Contact Person for 510(k) | Claudia Winterschladen
Head of Regulatory Affairs International
Email: 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 Balloon
Dilation 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. |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| How it functions | The balloon is located at the distal end of the TubaVent and is inflated using
sterile isotonic saline solution NaCl 0.9 % to 10 bar. The inflation is
controlled with help of the pressure gauge on the inflation device. The
balloon pressure is then hold for 2 minutes. Insertion of the TubaVent into
the Eustachian tube (ET) is done with the Tubalnsert via a patient's nostril.
The procedure is usually carried out under general anesthesia. Evidence is
emerging in the scientific literature that the procedure can be done under
local anesthesia, sedation, and analgesia. Real-world clinical data collected
in a pilot feasibility study from 10 patients (5 received bilateral BET)
supports the use of the TubaVent short device under local anesthesia. The
use of local anesthesia for this procedure is evident with appropriate
patient preparation, which may include supplemental medication for
patient management.1 |
| Scientific concept | Eustachian tube dysfunction (ETD) is a common condition resulting from
inadequate opening of the Eustachian tube or the inability to
appropriately equalize pressure between the middle ear and the
environment, respectively. This may lead to hearing loss, chronic otitis
media, tinnitus, and vertigo. The principle of dilatation to open an
obstructed tube has been successfully applied for many years for example
in blood vessels. The marketing of the first Eustachian balloon dilation
catheter was permitted by the FDA in September 2016. The decision was
based on a randomized clinical trial in which 52 % of treated patients had
tympanogram results within a normal functioning range six weeks after
the procedure compared to 14 % of the patients, who were treated with
conventional medical management (nasal spray). |
| Significant physical and
performance | The TubaVent balloon dilatation system is offered with two different
balloon 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 working
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 | |||
| Total Length [mm] | 270 | 327 | Different: The TubaVent |
| balloon dilatation | |||
| system is shorter thus | |||
| perfectly adapted to the | |||
| insertion instrument | |||
| TubaInsert, which | |||
| prevents the catheter | |||
| from being pushed too | |||
| far into the Tuba | |||
| Eustachii. | |||
| Catheter | |||
| Working Length [mm] | 236 | Not known | See explanation in |
| previous line. | |||
| Distal shaft end | |||
| (balloon) | flexible | flexible | Identical |
| Proximal shaft end | Hypotube made of | ||
| stainless steel | Hypotube, rigid | Identical: In both | |
| devices the proximal | |||
| shaft is a rigid hypotube | |||
| Insertion / Shaft marker | No, because the | ||
| protruding length of the | |||
| TubaVent Balloon out of | |||
| the TubaInsert is fixed by | |||
| design features. | Yes | Different: The length of | |
| the TubaVent | |||
| protruding from the | |||
| TubaInsert is fixed. After | |||
| the proximal end of the | |||
| TubaVent has come into | |||
| contact with the | |||
| Characteristics | New device | Predicate device | Correspondence |
| proximal end of the | |||
| Tubalnsert, further | |||
| advancement out of the | |||
| Tubalnsert is not | |||
| possible and therefore | |||
| no shaft marker is | |||
| required. Therefore, this | |||
| difference does not | |||
| cause any new issue of | |||
| safety or effectiveness | |||
| of the new device. | |||
| Actuator | No | Yes | Different: The function |
| of the actuator of the | |||
| predicate device is to | |||
| facilitate single-handed | |||
| advancement and | |||
| retraction of balloon | |||
| catheter, if required. | |||
| The balloon catheter of | |||
| the predicate device can | |||
| also be moved forward | |||
| with two hands. | |||
| Furthermore, the | |||
| usability study | |||
| confirmed that the two | |||
| hand procedure of the | |||
| new device does not | |||
| cause new safety issues | |||
| as the movement of the | |||
| catheter is done under | |||
| endoscopic control. | |||
| Balloon catheter design | Dual lumen tubing: outer | ||
| lumen is used to expand | |||
| the balloon | Dual lumen tubing | Identical | |
| Inflation connection | Luer connector | Luer connector | Identical |
| Balloon | |||
| Length x Diameter | |||
| [mm] at working | |||
| pressure | - Short: 3.28 x 20.0 |
- Short wide: 4.94 x 20.0 | 6.0 x 16.0 | Similar: The TubaVent
balloon has a smaller
diameter and is 4 mm
longer than the |
| Characteristics | New device | Predicate device | Correspondence |
| | | | diameter is less
traumatic and a longer
balloon ensures that a
longer part of the
cartilaginous part of the
ET (approx. 24 mm long)
is dilated. |
| Type | Semi-compliant | Non-compliant | Different: Semi-
compliant balloons
provide more
compliance than a non-
compliant balloon and
more flexibility to ease
delivery than a non-
compliant balloon.
Schubert et al.
published a comparison
of the balloons in 20182,
which shows that the
Acclarent Aera balloon
also behaves like a
semi-compliant balloon.
Thus, both balloons are
equivalent, although
Acclarent describes its
balloon as non-
compliant. |
| Material | PA (Polylauryllactam;
nylon) | PET (Polyethylene
terephthalate;
polyester) | Similar, as both
materials are
thermoplastic and
chemically inert or
chemically resistant,
respectively. |
| Catheter tip | | | |
| Characteristics | New device | Predicate device | Correspondence |
| Design | Olive-shaped; 1.2 mm in diameter; atraumatic
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
extended) | 34.9 cm | 11.3" [ $\triangleq$ 28.702
cm] | Different due to the
greater volume of the
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)
- 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 fulfils
all applicable biocompatibility requirements. The material used for
this device is not cytotoxic. It does not cause sensitization, irritation
or intracutaneous reactivity nor does it cause acute systemic
toxicity. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | All performance tests have demonstrated that the TubaVent balloon
dilatation system performs as intended. Tests include dimensional
verification, deflation time, balloon burst pressure, tensile strength,
torque and fatigue tests. Simulation studies in a head model and in
an animal cadaver model (sheep head) have ensured that the
TubaVent balloon dilatation system functions in accordance with its
design specifications and intended use.
A human cadaver study was executed in order to fulfil the special
control of 874.4180(b)(iv)(6).
TubaVent balloon dilatation system. This human factors validation
testing demonstrated that the device can be used by the intended
users without serious use errors or problems, for the intended uses
and under the expected use conditions. The results confirm that the
TubaVent balloon dilatation system is safe and performs as
intended. |
| Shelf life | Accelerated aging tests as well as real time aging tests have
demonstrated that the TubaVent has a shelf life of 3 years, if stored
under the recommended conditions. The insertion device
Tubalnsert, has a shelf life of 5 years, the Tuba inflation devices a
shelf life of 3 years. |
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| Sterilization | Validation of the sterilization procedure and parameters has
demonstrated that the TubaVent, Tubalnsert and the Inflation
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.
No
o animal study
WAS
conditioner
| 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
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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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.