(147 days)
Not Found
No
The device description and performance testing focus on mechanical and material properties of a balloon dilation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the treatment of persistent Eustachian tube dysfunction in patients 18 years and older, which is a medical condition, making it a therapeutic device. It directly treats the condition by dilating the Eustachian tube.
No.
The device is a treatment device, specifically a balloon used to dilate the Eustachian tube, not for diagnosis.
No
The device description clearly outlines physical components such as a balloon handpiece, stopcock valve, inflator, extension tubing, and a balloon, indicating it is a hardware-based medical device.
Based on the provided information, the Nu Vent Eustachian Tube Dilation Balloon is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of persistent Eustachian tube dysfunction in patients. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a balloon catheter designed to be inserted into the Eustachian tube and inflated to dilate it. This is a physical manipulation of tissue within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The Nu Vent Eustachian Tube Dilation Balloon is an in vivo (within the body) therapeutic device.
N/A
Intended Use / Indications for Use
The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.
Product codes (comma separated list FDA assigned to the subject device)
PNZ
Device Description
The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.
A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing consisted of testing to support the substantial equivalence of the NuVent™ device to the predicate Aera® and XprESS™ devices, and to support the safety and effectiveness of the NuVent™ device. All testing was conducted on the sterile final product, and followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non-aged) and aged products.
Testing included:
- Wire dislodgement
- . Balloon inflation
- . Balloon deflation
- Stopcock holding pressure without leaking
- . Pressure indicator button functionality
- System does not leak or burst under use conditions in cyclic testing
- Handpiece does not leak at the rated burst pressure in cyclic testing
- . Tensile strength of balloon, balloon bonds and tip
- Torsional testing of balloon system
- Usability testing, including simulated use
- Flexibility testing comparing the flexibility and rigidity of the subject and predicate devices under the conditions of axial, angular, and torsional loading of the balloon sections.
All samples passed testing and met acceptance criteria. This testing demonstrates that the subject NuVent™ device is as safe, as effective, and performs as well as the predicate Aera® and XprESS™ devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4180 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2021
Medtronic Xomed, Inc. Matthew Harmon Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K210841
Trade/Device Name: NuVent Eustachian Tube Dilation Balloon Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ Dated: July 20, 2021 Received: July 21, 2021
Dear Matthew Harmon:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,
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) K210841
Device Name NuVent Eustachian Tube Dilation Balloon
Indications for Use (Describe)
The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.
| 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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510(k) Summary
K210841
- Company: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone Number: 904-332-8186 Fax Number: 904-296-2386
- Contact: Matthew Harmon Principal Regulatory Affairs Specialist Phone: (904) 332-6704 E-mail: matthew.harmon@medtronic.com
Date Prepared: August 12, 2021
Device Trade name: NuVent Eustachian Tube Dilation Balloon
Common Name: Eustachian Tube Balloon Dilation System
Classification Name: Eustachian Tube Balloon Device (21 CFR 874.4180)
Classification: Class II (21 CFR 874.4180)
Product Code: PNZ
Primary Predicate Device: XprESS ENT Dilation System K163509
Secondary Predicate Device: Aera®Eustachian Tube Balloon Dilation System K171761
Device Description:
The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.
A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.
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Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.
Indications for Use:
The NuVent™ Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.
Technological Characteristics:
The NuVent™ device has the same intended use, same indications for use, same principle of operation, function, biocompatibility, and sterilization as well as similar design and materials to the primary predicate XprESS™ device and the secondary predicate Aera® device.
Please find a comparison of the subject NuVent™and the primary predicate XprESS™ device in Table 1, and a comparison of the subject NuVent™ and secondary predicate Aera® device in Table 2, below.
| Feature/
Attribute | NuVent™ Eustachian
Tube Dilation Balloon
Subject Device | XprESS™ ENT Dilation
System
K163509
Primary Predicate Device | Comparison | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PNZ | PNZ, LRC | Both have PNZ product code. | | | | |
| Regulations | 21 CFR 874.4180 | 21 CFR 874.4180
21 CFR 874.4420 | Both are subject to 21 CFR
874.4180. | | | | |
| Common Name | Eustachian Tube Balloon
Dilation Device | Balloon Sinus Dilation System ;
Eustachian Tube Balloon Dilation
System | Both are Eustachian Tube Balloon
Dilation Systems. | | | | |
| Handpiece | The NuVent™ Eustachian
Tube Dilation Balloon
consists of an integrated
polymer handle, stainless
steel shaft, and flexible
polymer balloon section
with atraumatic polymer tip. | The XprESS ENT Dilation Balloons
consist of an integrated polymer handle,
stainless steel shaft and balloon section
with a polymer balloon mounted on a
polymer that slides over a stainless steel
tube with a rounded metal tip. | Both provide an area for the
surgeon to grip and manipulate the
handpiece for delivery of the
balloon into the nasal passage and
Eustachian Tube canal. | | | | |
| Rigid Shaft | Stainless steel
2.76 mm diameter x 95 mm
long | Stainless steel
3.17 mm dia x ~100 mm long | Both contain rigid shafts to support
manipulation of the devices for
directing the tips to the entrance of
the Eustachian Tube canal. | | | | |
| Balloon | Non-compliant polymeric
balloon, 6 mm diameter 16 mm
long | Non-compliant polymeric balloon,
5 mm diameter x 8 mm long
5 x 20 mm
6 x 8 mm
6 x 20 mm
7 x 20 (LoProfile) | Both offer balloons that are 6 mm
in diameter. | | | | |
| Description | Balloon
Section | Flexible polymer tube with
internal shaping wire | Stainless steel tube | Both have a balloon section that is
bent at an angle meant to support
insertion of the balloon into the
Eustachian Tube canal. The
Stryker device balloon sections are
rigid and do not have flexibility | | | |
| | Feature/
Attribute | NuVent™ Eustachian
Tube Dilation Balloon
Subject Device | XprESS™ ENT Dilation
System
K163509
Primary Predicate Device | Comparison | | | |
| | Balloon Tip | Rounded 2.6 mm diameter
polymer | Rounded 1.75mm diameter stainless
steel (LoProfile)
Rounded 1.50 mm diameter stainless
steel (Ultra) | Both systems have rounded tips.
The Medtronic balloon system is
larger and polymeric. | | | |
| | Insertion
Method | The flexible polymer balloon
section is angled to promote
insertion of the polymer
balloon section into the ET
canal and the balloon section is
inserted into the ET canal. | The rigid stainless steel balloon section
is bent to the ET angle with a provided
bending tool angled to promote insertion
into the ET canal and the balloon section
is inserted into the ET canal and the
polymeric balloon is advanced into the
ET canal over the top of the inserted SS
balloon section. | Both devices provide a means for
inserting the flexible balloon
sections into the Eustachian Tube
canal by including an angle that
mimics the Eustachian Tube canal
and both systems are inserted
manually as a unitized handpiece. | | | |
| | Insertion
Marker | Blue band at the proximal end
of the balloon 30mm from the
tip visible under direct
endoscopic visualization
provides recognition of the
depth of balloon insertion in
the ET canal aiding in
positioning the handpiece. | Markings on SS balloon section at 10
and 20 mm from tip. | Both balloon sections have
markings on the balloon section to
provide visual recognition of the
depth of insertion. | | | |
| | Inflator | The balloon handpiece is
meant to be used in
conjunction only with the
Medtronic NuVent™ inflator
to provide the pressure for the
handpiece balloon. The
inflator limits the pressure
delivered. | The balloon handpiece is meant to be
used in conjunction only with the
Entellus Inflation Syringe which limits
inflation pressure. | Both systems have inflators that
readily connect to the handpiece
with Luer fittings and provide
pressure during the procedure. | | | |
| | Intended Use | To dilate the Eustachian tube
canal. | To remodel or recreate the sinus outflow
tract and dilate the Eustachian tube by
transnasal balloon dilation. | Both devices are intended to dilate
the Eustachian Tube canal. | | | |
| | Indications for
Use | The NuVent Eustachian Tube
Dilation Balloon is indicated
for use in patients 18 years and
older who need treatment for
persistent Eustachian tube
dysfunction. | To dilate the cartilaginous portion of the
Eustachian tube for treating persistent
Eustachian tube dysfunction in patients
18 years and older using a transnasal
approach. | Both devices are indicated to treat
persistent Eustachian Tube
dysfunction in patients 18 years
and older. | | | |
| | Predicate Device | Acclarent Aera® - K171761
XprESS ENT Dilation System
- K163509 | XprESS Multi-Sinus Dilation System
(K152434)
Acclarent Aera® (DEN150056) | N/A | | | |
| | Contraindications | The NuVent™ Eustachian
Tube Dilation Balloon is
contraindicated for use in a
Eustachian tube with an
ipsilateral carotid artery that is
dehiscent into the Eustachian
Tube lumen or history or
ipsilateral patulous Eustachian
tube. | The XprESS device does include
warnings against using XprESS to dilate
Eustachian tubes in patients with a
history of patulous Eustachian tubes, to
review appropriate radiographic imaging
prior to treatment, and not to use the
device to treat patients with evidence of
internal carotid artery dehiscence. | Both devices are not intended to be
used in patients who have patulous
Eustachian Tubes or in patients
with evidence of internal carotid
artery dehiscence. | | | |
| | Contact Time | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical | | | |
| | Sterility | Ethylene Oxide | Ethylene Oxide | Identical | | | |
| | Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical | | | |
| Feature/
Attribute | | NuVentTM Eustachian
Tube Dilation Balloon
Subject Device | Aera® Eustachian Tube
Balloon Dilation System
K171761
Secondary Predicate Device | Comparison | | | |
| Product Code | | PNZ | PNZ | Identical | | | |
| | Regulations
Common Name | 21 CFR 874.4180
Eustachian Tube Balloon
Dilation Device | 21 CFR 874.4180
Eustachian Tube Balloon Dilation
Device | Identical
Identical | | | |
| | | Handpiece | The NuVentTM Eustachian
Tube Dilation Balloon consists
of an integrated polymer
handle, stainless steel shaft,
and flexible polymer balloon
section with an atraumatic
polymer tip. | The ACCLARENT AERA® Eustachian
Tube Dilation Balloon consists of a rigid
Guide Catheter and a flexible polymer
Balloon Catheter with an atraumatic
polymer tip. | Both consist of a rigid shaft and
flexible balloon section with an
atraumatic polymer tip. They differ
in that the NuVentTM device is a
single handpiece, while the AeraTM
device uses as separate guide
catheter and balloon catheter. | | |
| | | Rigid
Shaft | Stainless steel
2.76 mm diameter x 95 mm
long | Stainless steel & rigid polymer end
3.83 mm dia x 83 mm long SS and 17
mm long polymer = ~100 mm | Both contain rigid shafts to support
manipulation of the devices for
directing the tips to the entrance of
the Eustachian Tube canal. | | |
| | | | Balloon | Non-compliant polymeric
balloon, 6 mm diameter 16 mm
long | Non-compliant polymeric balloon, 6 mm
diameter x 16 mm long | Identical | |
| | | | Balloon
Section | Flexible polymer tube with
internal shaping wire | Flexible polymer tube | Both have flexible balloon sections
with adequate stiffness to support
insertion of the balloon into the
Eustachian Tube canal. | |
| | | | Balloon
Tip | Rounded 2.6 mm diameter
polymer | Rounded 2.4 mm diameter polymer | Both devices have bulbous,
atraumatic, and polymeric tips. | |
| | | | | Insertion
Method | The flexible polymer balloon
section is angled to promote
insertion of the polymer
balloon section into the ET
canal and the balloon section is
inserted into the ET canal. | The flexible polymer balloon catheter is
advanced through the angled tip of the
guide catheter, inserting the balloon into
the ET canal. | Both devices provide a means for
inserting the flexible balloon
sections into the Eustachian Tube
canal by including an angle that
mimics the Eustachian Tube canal.
The Aera device does so by
following the guide catheter and
the Medtronic device by inclusion
of an angled balloon section of a
unitized handpiece. |
| | | Insertion
Marker | | Blue band at the proximal end
of the balloon 30mm from the
tip visible under direct
endoscopic visualization
provides recognition of the
depth of balloon insertion in
the ET canal aiding in
positioning the handpiece. | No visual markers present to estimate
depth of Eustachian tube insertion. The
device has a marker on the balloon
catheter to indicate when the balloon
section of the balloon catheter is
extended past the distal end of the guide
catheter. | Both balloon sections are 30 mm
long.
The NuVentTM balloon includes a
visual marker to provide easy
recognition of the end of the
flexible balloon and recognition of
the depth of insertion. The Aera
device also has a visual marker, but
it does not indicate the depth of
balloon insertion. | |
| | | Inflator | | The balloon handpiece is
meant to be used in
conjunction only with the
Medtronic NuVentTM inflator
to provide the pressure for the
handpiece balloon. The
inflator limits the pressure
delivered. | The balloon handpiece is compatible
with either the Acclarent® Balloon
Inflation Device or Acclarent® SE
Inflation Device and is instructed to not
exceed 12 atm pressure. | Both systems have inflators that
readily connect to the handpiece
with Luer fittings and provide
pressure and a way to maintain the
pressure during the procedure. | |
| | | | | Intended Use | To dilate the Eustachian tube
canal. | To dilate the Eustachian tube canal. | Identical |
| | | Description | | Indications for
Use | The NuVent Eustachian Tube
Dilation Balloon is indicated | The Acclarent Aera® Eustachian Tube | Identical |
| | | Feature/
Attribute | NuVent™ Eustachian
Tube Dilation Balloon
Subject Device | Aera® Eustachian Tube
Balloon Dilation System
K171761
Secondary Predicate Device | Comparison | | |
| | | | for use in patients 18 years and
older who need treatment for
persistent Eustachian tube
dysfunction. | dilate the Eustachian tube for treatment
of persistent Eustachian tube dysfunction
in patients 18 years and older. | | | |
| Predicate Device | | Acclarent Aera® - K171761
XprESS ENT Dilation System - K163509 | Acclarent Aera® (DEN150056)
Entellus XprESS ENT Dilation System
(K163509) | N/A | | | |
| Contraindications | The NuVent™ Eustachian
Tube Dilation Balloon is
contraindicated for use in a
Eustachian tube with an
ipsilateral carotid artery that is
dehiscent into the Eustachian
Tube lumen or history or
ipsilateral patulous Eustachian
tube. | The Acclarent Aera® Eustachian Tube
Balloon Dilation System is
contraindicated for use in a Eustachian
tube with an ipsilateral carotid artery that
is dehiscent into the ET lumen or history
of ipsilateral patulous Eustachian tube. | Identical | | | | |
| Contact Time | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical | | | | |
| Sterility | Ethylene Oxide | Ethylene Oxide | Identical | | | | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical | | | | |
Table 1: Device Comparison - NuVent™ and XprESS™ Devices
5
6
Table 2: Device Comparison – NuVent™ and Aera® Devices
7
Substantial Equivalence:
The NuVent™ Eustachian Tube Dilation Balloon has the same intended use, indications for use, and similar scientific technology as the primary predicate XprESS device (K163509) and the secondary predicate Aera® device (K171761). In support of this determination Medtronic conducted non-clinical tests to demonstrate compliance with the special controls applicable to this device, as set out in 21 CFR 874.4180, including tensile and flexural testing, durability testing, inflation and deflation testing, verification testing of the safety features on both the NuVent device and the NuVent inflator, biocompatibility testing, and sterility testing. The NuVent device met all acceptance criteria for this testing.
Medtronic conducted usability and validation testing on the NuVent device. In addition, to show equivalence to the predicate devices, Medtronic conducted comparison testing between the subject NuVent, primary predicate XprESS, and secondary predicate Aera to assess balloon characteristics by performing flexibility, torsional, and axial rigidity tests to demonstrate the NuVent device is as safe and effective as the primary and secondary predicates.
A comparison of the devices' dimensions, materials, design, power source, insertion methods, and instructions for use, as shown in Table 1 and Table 2, above, does not indicate any differences in the potential risks for each device and does not raise different questions of safety or effectiveness than the predicate Aera and XprESS devices. Therefore, the NuVent™ Eustachian Tube Dilation Balloon is substantially equivalent to the primary predicate XprESS device and the secondary predicate Aera device.
Biocompatibility:
Biocompatibility testing was performed using ISO 10993 Biological Evaluation of Medical Devices and FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," issued June 16, 2016. The
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NuVent™ Eustachian Tube Dilation Balloon complies with the biocompatibility requirements for its intended use.
Sterilization:
Sterilization is accomplished via ethylene oxide to deliver a minimum sterility assurance level (SAL) of 10 6. The sterilization method was validated in compliance to:
- . ISO 11135:2014 – Sterilization of Health Care Products – Ethylene Oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices.
- ISO 11138-2: 2017 - Sterilization of health care products: Biological Indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11737-1:2018 – Sterilization of Health Care Products - Microbiological Methods – Part 1: Determination of the Population of Microorganisms on Product
- ISO 11737-2: 2019 - Sterilization of Health Care Products - Microbiological Methods – Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process.
Performance Testing:
Performance testing consisted of testing to support the substantial equivalence of the NuVent™ device to the predicate Aera® and XprESS™ devices, and to support the safety and effectiveness of the NuVent™ device. All testing was conducted on the sterile final product, and followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non-aged) and aged products.
Testing included:
- Wire dislodgement
- . Balloon inflation
- . Balloon deflation
- Stopcock holding pressure without leaking
- . Pressure indicator button functionality
- System does not leak or burst under use conditions in cyclic testing
- Handpiece does not leak at the rated burst pressure in cyclic testing
- . Tensile strength of balloon, balloon bonds and tip
- Torsional testing of balloon system
- Usability testing, including simulated use
- Flexibility testing comparing the flexibility and rigidity of the subject and predicate devices under the conditions of axial, angular, and torsional loading of the balloon sections.
All samples passed testing and met acceptance criteria. This testing demonstrates that the subject NuVent™ device is as safe, as effective, and performs as well as the predicate Aera® and XprESS™ devices.
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Shelf Life Testing:
Shelf life testing was performed on the sterile final product and its packaging according to the applicable standards and guidance documents. The sterile final product and packaging were subjected to accelerated aging per ASTM F1980 – 2016. Real-time aging for the accelerated aging equivalent time is ongoing.
All samples passed testing and met the acceptance criteria of the design inputs for the device and packaging system following accelerated aging.
Conclusion:
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" issued on September 13, 2019, a comparison of key characteristics demonstrates that the proposed device NuVent™ Eustachian Tube Dilation Balloon is substantially equivalent to the predicate device(s) in terms of performance characteristics. The NuVent™ Eustachian Tube Dilation Balloon is as safe, as effective, and performs as well as the predicate device(s).