(122 days)
No
The summary describes a mechanical balloon dilation system with optional navigation and illumination features, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as dilating sinus ostia and spaces for "therapeutic procedures" in children, and dilating the cartilaginous Eustachian tube for "treatment of persistent Eustachian tube dysfunction" in adults. These directly indicate a therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic procedures" and to "facilitate diagnostic procedures" in relation to accessing the sinus space and dilating sinus ostia and spaces.
No
The device description clearly outlines a physical system including a handle, guide tip, knobs, sliders, and a balloon, indicating it is a hardware device. While it can be used with navigation software, the core device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for therapeutic and diagnostic procedures performed directly on the patient's body (accessing, dilating, irrigating, suctioning, and facilitating procedures within the sinuses and Eustachian tube). IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical device with mechanical components (handle, guide tip, sliders, balloon) designed for direct interaction with anatomical structures. This is consistent with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies described are bench testing and simulated use testing, which are relevant for evaluating the mechanical and functional performance of a medical device used in vivo, not the analytical or clinical performance of an IVD.
In summary, the NGB Balloon Dilation System is a medical device used for interventional procedures within the nasal and sinus cavities and the Eustachian tube. It does not perform diagnostic testing on specimens outside the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.
The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.
Product codes (comma separated list FDA assigned to the subject device)
PNZ, PGW, LRC
Device Description
The Next Generation Balloon Dilation System (NGB) is an integrated balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that will be available in light fiber and navigation guidewire configurations for compatibility with illumination and navigation technology. The system includes a handle with several integrated features to allow for single-handed use. The adjustable gripping feature allows for ergonomic handling. The directable guide tip enables access (i.e. manipulating/separating/dividing tissue) and placement near the targeted anatomy. There are four preset approximate positions: Sphenoid (straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The directable guide knob allows for positioning of the balloon tip towards the target anatomy. The wire slider and spinner are used to advance, retract, and rotate the guidewire. The balloon slider is used advance and retract the balloon. The Next Generation Balloon Dilation System also allows for suction and irrigation in and around the target anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus space within and across nasal and sinus structures; sinus ostia and spaces associated with the paranasal sinus cavities; maxillary sinus; cartilaginous Eustachian tube.
Indicated Patient Age Range
The NGB Balloon System is intended for children aged 17 and under for maxillary sinus procedures, and for patients ages 18 and older for Eustachian tube dilation.
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)
Non-clinical Performance Data:
- Bench testing has been performed and met all acceptance criteria for attributes such as simulated use testing, dimensional attributes, cycle fatigue, balloon burst, bond separation, irrigation flow rate and device accuracy. Moreover, testing also showed that the Next Generation Balloon Dilation System is biocompatible.
- The sterilization process has been validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as “non-pyrogenic”.
- Packaging shelf life has been established to be 3 months per ASTM F1980-07.
- Mechanical testing was performed, including tensile and flexural testing of catheter joints and materials.
- Durability testing was performed, including fatigue and burst pressure testing of the balloon materials and components.
- Inflation and deflation characterization testing was performed, including time and pressure measurements, and leak testing of the balloon.
- Verification testing of safety features built into the device was performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
- Simulated use testing in a clinically relevant model demonstrated the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and that the design features limit access to only the cartilaginous portion of the Eustachian tube.
- The Next Generation Balloon Dilation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Clinical Data:
Clinical data was not necessary to determine that the subject Next Generation Balloon Dilation System performs as intended.
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.
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
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
0
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August 27, 2020
Acclarent Inc. David Locke Manager, Regulatory Affairs 31 Technology Dr., Suite 200 Irvine, California 92618
Re: K201115
Trade/Device Name: Next Generation Balloon Dilation System Regulation Number: 21 CFR 874.4180 Regulation Name: Eustachian Tube Balloon Dilation System Regulatory Class: Class II Product Code: PNZ, PGW, LRC Dated: July 25, 2020 Received: July 28, 2020
Dear David Locke:
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.
1
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 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 (OS) 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 medical devices and radiation-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.
for Malvina B. Eydelman, M.D. Director 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) K201115
Device Name Next Generation Balloon Dilation System
Indications for Use (Describe)
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.
The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.
| 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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Image /page/3/Picture/0 description: The image displays the Acclarent logo, with the company name in bold, followed by a curved line above the 'ent'. Below the logo, the text "Next Generation Balloon Dilation System" is present. The text is in a smaller font size compared to the logo.
K201115 - 510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Applicant: | Acclarent Inc.
31 Technology Drive, Suite 200
Irvine, CA 92618, USA
Tel.: 419-233-2611
Fax: 949-450-6886 |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Locke
Manager, Regulatory Affairs
Acclarent Inc.
Phone: 419-233-2611
Dlocke1 @its.jnj.com |
| Authored by: | David Locke
Manager, Regulatory Affairs
Acclarent Inc.
Phone: 419-233-2611 |
| Date Summary Prepared: | Aug 26, 2020 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name:
Device Common Name:
Classification Name: | Next Generation Balloon - Balloon Dilation System
Next Generation Balloon Dilation System
Eustachian tube balloon dilation system (21 CFR 874.4180) |
| Device Classification: | Class II |
| Product Code:
Secondary Codes:
Review Panel: | PNZ
PGW, LRC
Ear, Nose and Throat |
| [807.92(a)(3)] Legally Marketed Devices | |
| Primary Predicate Device: | Acclarent AERA® Eustachian Tube Balloon Dilation System
(K171761) |
| Secondary Predicate
Devices: | Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687)
Relieva SpinPlus® Balloon Sinuplasty System (K143541) |
| Reference Device: | Acclarent TruDi NAV Wire (K190532) |
| Device Description: | The Next Generation Balloon Dilation System (NGB) is an integrated
balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that
will be available in light fiber and navigation guidewire configurations for
compatibility with illumination and navigation technology. The system
includes a handle with several integrated features to allow for single-
handed use. The adjustable gripping feature allows for ergonomic
handling. The directable guide tip enables access (i.e.
manipulating/separating/dividing tissue) and placement near the targeted
anatomy. There are four preset approximate positions: Sphenoid
(straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The
directable guide knob allows for positioning of the balloon tip towards the
target anatomy. The wire slider and spinner are used to advance, retract,
and rotate the guidewire. The balloon slider is used advance and retract
the balloon. The Next Generation Balloon Dilation System also allows for
suction and irrigation in and around the target anatomy. |
4
[807.92(a)(4)] Device Description
[807.92(a)(5)] Intended Use and Predicate Device Comparison
| Indications for Use: |
|---|
| The NGB Balloon Dilation System is intended to provide a means to |
| access the sinus space within and across nasal and sinus structures; dilate |
| the sinus ostia and spaces associated with the paranasal sinus cavities for |
| diagnostic and therapeutic procedures; irrigate from within a target sinus; |
| suction throughout therapeutic procedures and to facilitate diagnostic |
| procedures. |
| For children aged 17 and under, the NGB Balloon Dilation System is |
| intended to provide a means to access the sinus space within and across |
| nasal and sinus structures; dilate sinus ostia and spaces associated with the |
| maxillary sinus for diagnostic and therapeutic procedures; irrigate from |
| within the maxillary sinus; suction throughout therapeutic procedures and |
| to facilitate diagnostic procedures. |
| The NGB Balloon Dilation System is intended to dilate the cartilaginous |
| Eustachian tube for treatment of persistent Eustachian tube dysfunction in |
| patients ages 18 and older. |
| The NGB Balloon Dilation System with the navigation guidewire may be |
| utilized in conjunction with the TruDiTM Navigation System, to help direct |
| access to nasal and paranasal spaces, and to confirm placement in the |
| targeted anatomy. NGB may be utilized in conjunction with the TruDiTM |
| NAV Wire to confirm placement of the balloon in the Eustachian tube. |
| The NGB Balloon Dilation System with the illumination guidewire may |
| be utilized to illuminate within and provide transcutaneous illumination |
| across nasal and sinus structures. |
5
Image /page/5/Picture/0 description: The image shows the word "Acclarent" in bold, with a purple arc over the last few letters. Below that, the text "Next Generation Balloon Dilation System" is written in a smaller font. The word "Next" is capitalized, and the rest of the words are in lowercase.
[807.92(a)(6)] Technical Characteristics
| Technological
Characteristics: | The Next Generation Balloon Dilation System combines Sinuplasty and
Eustachian Tube Dilation into a single handheld device. The device also
allows for the use of the Acclarent TruDiTM NAV Wire for real-time
tracking within nasal and Eustachian tube anatomy as well as an
illumination wire for transcutaneous illumination across, nasal and sinus
structures. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Performance
Data: | The Next Generation Balloon was tested to ensure that it functions in
accordance with the device design specifications related to substantial
equivalence in terms of device safety and effectiveness.
The following nonclinical tests were performed:
-
Bench testing has been performed and met all acceptance criteria for
attributes such as simulated use testing, dimensional attributes, cycle
fatigue, balloon burst, bond separation, irrigation flow rate and device
accuracy. Moreover, testing also showed that the Next Generation
Balloon Dilation System is biocompatible. -
The sterilization process has been validated per AAMI/ANSI/ISO
11135-1: 2007 and demonstrated a sterility assurance level of 10-6.
The method used for sterilization validation is the overkill (half-cycle
approach) in a fixed chamber. Ethylene oxide residuals have been
tested and meet ISO 10993-7:2008 requirements. The subject device
is not tested nor labeled as “non-pyrogenic”. -
Packaging shelf life has been established to be 3 months per ASTM
F1980-07. -
Mechanical testing was performed, including tensile and flexural
testing of catheter joints and materials. -
Durability testing was performed, including fatigue and burst pressure
testing of the balloon materials and components. -
Inflation and deflation characterization testing was performed,
including time and pressure measurements, and leak testing of the
balloon. -
Verification testing of safety features built into the device was
performed, including the characterization of catheter geometries and
distal tip insertion limitation mechanisms. -
Simulated use testing in a clinically relevant model demonstrated the
reliability of the device to remain mechanically functional throughout
the anticipated conditions of use, and that the design features limit
access to only the cartilaginous portion of the Eustachian tube. -
The Next Generation Balloon Dilation System passed all tests in
accordance with appropriate test criteria and standards, and the
modified device did not raise new questions of safety or effectiveness. |
6
Image /page/6/Picture/0 description: The image shows the Acclarent logo, with the company name in bold black letters and a purple curved line above the "ent" portion of the name. Below the logo, the text "Next Generation Balloon Dilation System" is displayed in a smaller, non-bold font. The text is left-aligned and positioned directly beneath the Acclarent logo.
| Clinical Data: | Clinical data was not necessary to determine that the subject Next
Generation Balloon Dilation System performs as intended. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The modified Next Generation Balloon Dilation System device is
substantially equivalent to the currently cleared Acclarent AERA®
Eustachian Tube Balloon Dilation System and the secondary predicate
devices based on the completion of non-clinical bench testing as well as
similar principles of design, operation and indications for use. |
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Image /page/7/Picture/0 description: The image shows the word "Acclarent" in black font. The "ent" portion of the word is in purple font. There is a purple arc above the "ent" portion of the word.
Substantial Equivalence Table
| Attribute | Primary Predicate
Device:
ACCLARENT
AERA®
Eustachian Tube
Balloon Dilation
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
NAV Balloon
Sinuplasty
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
Balloon
Sinuplasty
System | Reference
Device:
TruDi™ NAV
Wire® | Subject
Device:
Next
Generation
Balloon
Dilation
System | Substantial
Equivalence
Rationale |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | K171761 | K171687 | K143541 | K190532 | K201115 | N/A |
| Manufacturer | Acclarent | Acclarent | Acclarent | Acclarent | Acclarent | N/A |
| Trade Name | ACCLARENT
AERA®
Eustachian
Balloon
Dilation
System | RELIEVA
SPINPLUS®
NAV
Balloon
Sinuplasty
System | Relieva
SpinPlus
Balloon
Sinuplasty
System | TruDi™ NAV Wire | Next
Generation
Balloon
Dilation
System | N/A |
| Common
Name | Eustachian
Tube Balloon
Dilation
Device | Sinus
Dilation
System | Sinus
Dilation
System | Image Guided
Surgery
System | Eustachian
Tube
Balloon
Dilation
Device | N/A |
| Class | II | I | I | II | II | Same as the
higher
classification
devices |
| Attribute | Primary Predicate
Device:
ACCLARENT
AERA®
Eustachian Tube
Balloon Dilation
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
NAV Balloon
Sinuplasty
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
Balloon
Sinuplasty
System | Reference
Device:
TruDi™ NAV
Wire® | Subject
Device:
Next
Generation
Balloon
Dilation
System | Substantial
Equivalence
Rationale |
| Classification
Product Code | PNZ | LRC | LRC | PGW | PNZ | Same as
primary
predicate
device |
| Subsequent
Product Code | N/A | PGW | N/A | N/A | PGW,
LRC | N/A |
| Classification
Section | 874.4180 | 874.4420 | 874.4420 | 882.4560 | 874.4180 | Same as
primary
predicate
device |
| Indications
for Use | The ACCLARENT
AERA® Eustachian
Tube Balloon Dilation
System is intended to
dilate the Eustachian
tube for treatment of
persistent Eustachian
tube dysfunction in
patients ages 18 and
older. | The RELIEVA
SPINPLUS® NAV
Balloon Sinuplasty
System is intended to
provide a means to
access the sinus space,
within and across
nasal and sinus
structures; dilate the
sinus ostia and spaces
associated with the
paranasal sinus
cavities for diagnostic
and therapeutic
procedures; and
irrigate from within a
target sinus for
therapeutic procedures
and to facilitate
diagnostic procedures.
For children aged 17
and under, the
RELIEVA
SPINPLUS® NAV
Balloon Sinuplasty
System is intended to
provide a means to
access the sinus space,
within and across
nasal and sinus
structures; dilate sinus
ostia and spaces
associated with the
maxillary sinus for
diagnostic and
therapeutic
procedures; and
irrigate from within
the maxillary sinus for
therapeutic procedures
and to facilitate
diagnostic procedures.
The RELIEVA
SPINPLUS® NAV
Balloon Sinuplasty | The RELIEVA
SPINPLUS™
Balloon Sinuplasty
System is intended
to: provide a means
to access the
sinus space and
illuminate within
and transilluminate
across nasal and
sinus structures;
dilate the sinus
ostia and spaces
associated with the
paranasal sinus
cavities for
diagnostic and
therapeutic
procedures;
and irrigate from
within a target sinus
for therapeutic
procedures and to
facilitate diagnostic
procedures.
For children aged 17
and under, the
RELIEVA
SPINPLUS™
Balloon Sinuplasty
System is intended
to:
provide a means to
access the sinus
space and illuminate
within and
transilluminate
across nasal and
sinus structures;
dilate sinus ostia and
spaces associated
with the maxillary
sinus for diagnostic
and therapeutic
procedures; and
irrigate from within
the maxillary sinus | The TruDi™ NAV
Wire is intended
for use as an
electromagnetically
navigable
guidewire to
provide access and
confirmation of
placement in the
patient anatomy.
The device is
intended for use
during ENT
procedures where
reference to a rigid
anatomical
structure can be
identified relative
to a CT-based
model of the
anatomy. | The NGB Balloon
Dilation System is
intended to provide
a means to access
the sinus space
within and across
nasal and sinus
structures; dilate
the sinus ostia and
spaces associated
with the paranasal
sinus cavities;
irrigate from
within a target
sinus; suction
throughout
therapeutic
procedures and to
facilitate diagnostic
procedures.
For children aged
17 and under, the
NGB Balloon
Dilation System is
intended to provide
a means to access
the sinus space
within and across
nasal and sinus
structures; dilate
sinus ostia and
spaces associated
with the maxillary
sinus for diagnostic
and therapeutic
procedures; irrigate
from within the
maxillary sinus;
suction throughout
therapeutic
procedures and to
facilitate diagnostic
procedures.
The NGB Balloon
Dilation System is
intended to dilate | The IFU and
Indications of the
subject Next
Generation
Balloon Dilation
System is aligned
with the
predicate devices.
The merging of
technologies
within the
indications does
not bring about
any new concerns
with respect to
substantial
equivalence, and
the safety and
effectiveness of
the subject device
is supported by
completed device
testing. |
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Image /page/8/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc above the word that starts at the end of the word and curves to the right. The font is sans-serif and the word is left-aligned.
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Image /page/9/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc above the last few letters of the word. The arc starts above the letter "r" and ends above the letter "t".
Traditional 510(k) Premarket Notification
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Image /page/10/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple arc over the last few letters of the word. The arc starts above the "r" and ends above the "t".
| | utilized in conjunction
with the
ACCLARENT® ENT
Navigation System, to
provide access to
nasal and sinus
spaces, and to confirm
placement in the
accessed anatomy." | for therapeutic
procedures and to
facilitate diagnostic
procedures. | the cartilaginous
Eustachian tube for
treatment of
persistent
Eustachian tube
dysfunction in
patients ages 18
and older.
The NGB Balloon
Dilation System
with the navigation
guidewire may be
utilized in
conjunction with
the TruDi™
Navigation
System, to help
direct access to
nasal and paranasal
spaces, and to
confirm placement
in the targeted
anatomy. NGB
may be utilized in
conjunction with
the TruDi™ NAV
Wire to confirm
placement of the
balloon in the
Eustachian tube.
The NGB Balloon
Dilation System
with the
illumination
guidewire may be
utilized to
illuminate within
and provide
transcutaneous
illumination across
nasal and sinus
structures. | |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
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| Attribute | Primary
Predicate
Device:
ACCLARENT
AERA®
Eustachian Tube
Balloon Dilation
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
NAV
Balloon
Sinuplasty
System | Secondary
Predicate
Device:
RELIEVA
SPINPLUS®
Balloon
Sinuplasty
System | Reference
Device:
TruDi™ NAV
Wire®
Sinus Navigation
Guidewire | Subject
Device:
Next Generation
Balloon Dilation
System | Substantial
Equivalence
Rationale |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | EtO | EtO | EtO | EtO | EtO | Same |
| Packaging | PETG
thermoformed
tray in
Tyvek/Nylon
pouch | PETG
thermoformed
d tray in
Tyvek/Nylon
pouch | PETG
thermoformed
tray in
Tyvek/Nylon
pouch | Backer-card in
Tyvek/Nylon
pouch | PETG
thermoformed
tray in
Tyvek/Nylon
pouch | Same |
| Single Use | Yes | Yes | Yes | Yes | Yes | Same |
| Patient Contact | Direct | Direct | Direct | Direct | Direct | Same |
| Labeled as Non-
Pyrogenic? | No | No | No | No | No | Same |
| Technological
Characteristics | The ACCLARENT
AERA® Eustachian
Tube Balloon
Dilation System is
a device that
allows for dilation
of the cartilaginous | The
RELIEVA
SPINPLUS®
NAV Balloon
Sinuplasty
System
combines a | The RELIEVA
SPINPLUS®
Balloon
Sinuplasty
System combines
a Sinus Guide | The TruDi™
NAV Wire
utilizes
electromagnetic
image-guided
sinus surgery | The NEXT
GENERATION
BALLOON
DILATION
SYSTEM
combines | The technological
characteristics
have been tested
through non-
clinical testing
and they do not |
| | portion of the
Eustachian tube.
Eustachian tube
dilation is achieved
via a noncompliant
balloon located on
the distal end of
the device. | Sinus Guide
Catheter and
Handle
Assembly
(integrated
with Sinus
Balloon
Catheter,
Sinus
Irrigation and
Sinus
Navigation
System) into a
single device.
The device is
connected to
the Acclarent
ENT
Navigation
System to
provide
location
information
via EM
navigation
relative to a
pre-loaded
scan. | Catheter and
Handle Assembly
(integrated with
Sinus Balloon
Catheter, Sinus
Irrigation and
Sinus
Illumination
System) into a
single device.
The device is
connected to any
standard light
source via
accessory light
cable and adapter. | and is used in
conjunction
with a
compatible
surgical
navigation
system which
consists of
computer-aided
software, CT-
imaging, patient
tracker,
registration
probe, and
various
instruments
used in sinus
surgery.
TruDi® NAV
Wire provides
real-time
tracking at the
distal tip of the
guidewire in the
nasal anatomy. | Sinuplasty and
Eustachian Tube
Dilation into a
single handheld
device. The
device also allows
for the use of the
Acclarent TruDi
Nav Wire for
real-time tracking
within nasal and
Eustachian tube
anatomy as well
as an illumination
wire for
transcutaneous
illumination
across, nasal and
sinus structures. | impact substantial
equivalence.
Moreover, the
minor
technological
differences do not
raise any new
concerns with
respect to safety
and effectiveness. |
| Material | PTFE,
Polycarbonate,
Nylon, Pebax,
Grilamid Ely,
Barium, Pebax, Blue
Nylon, Barium,
Marabu TPU ink,
Stainless Steel. | Pebax, PET,
Loctite, Pad
printing,
Stainless steel,
PEEK,
Polycarbonate,
Nylon, PTFE,
Polyester. | Pebax, PET,
Loctite, Pad
printing, Stainless
steel, PEEK,
Polycarbonate,
Nylon, PTFE,
Polyester, Silicone
rubber. | Polycarbonate
Pebax
Ethyl
Cyanoacrylate
Adhesive, Silver
Plated Copper,
PTFE, Silver | Pebax, PET,
Loctite, Pad
printing, Stainless
steel, PEEK,
Polycarbonate,
Nylon, PTFE,
Polyester, Silicone | The materials
used are those
commonly used in
medical devices
and have been
tested via |
| | | | | | | |
| | Polyolefin, Loctite
4014, Loctite 4011,
Dymax 204CTH,
Loctite 745,
Platinum, 10%
Iridium, Loctite 408,
Loctite 7451,
Dymax 1191 | Silicone rubber,
Polypropylene,
Silicone, Tygon,
Parylene,
Polyurethane,
Silver Plated
Copper,
Antioxidant
Nickel-Iron-
Molybdenum
Alloy, fiberglass
insulation,
RoHS-compliant
PCB Assembly,
Adhesive Silver
Plated Copper | Polypropylene,
Silicone, Tygon,
Parylene.
Polyurethane | Filled
Polycarbonate/A
BS
RoHS-compliant
PCB Assembly
Polypropylene,
Hydrocarbon
Resin, Styrene-
Butadiene
Polymer, Paraffin
Wax.
Polyethylene,
Antioxidant.
Nickel-Iron-
Molybdenum
Alloy, Stainless
Steel, Silicone | rubber,
Polypropylene,
Silicone, Tygon,
Parylene,
Polyurethane,
Silver Plated
Copper.
Antioxidant
Nickel-Iron-
Molybdenum
Alloy, fiberglass
insulation, RoHS-
compliant PCB
Assembly,
Adhesive Silver
Plated Copper
SE508 Nitinol | biocompatibility.
The materials use
in the subject
device are the
same as the
predicate devices.
There are no new
concerns with
respect to safety
and effectiveness
and the materials
used in the subject
device are
substantially
equivalent to the
predicate devices. |
| Balloon
Material | PET | Nylon | PET | N/A | Nylon | The balloon
material is
equivalent to that
of the currently
marketed primary
predicate device. |
| Balloon Length | 16 mm | 16 mm | 16 mm | N/A | 16 mm | Same |
| Guidewire
Diameter | N/A | 0.035 inches | N/A | 0.035 inches | 0.035 inches | Same as compared
to applicable
devices |
| Deflation Time |