(164 days)
Not Found
No
The device description and performance studies focus on mechanical components and standard medical device testing, with no mention of AI/ML algorithms, data processing, or training/test sets.
Yes
The device is intended to temporarily address nasal obstruction by displacing anatomical structures, which is a therapeutic action.
No
The device is described as an instrument intended to provide increased intranasal space and address nasal obstruction by displacing tissue, which implies a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components (balloon catheter, stylet) and mentions inflation with sterile water or saline, indicating a hardware-based medical device.
Based on the provided information, the RELIEVA TRACT™ Balloon Dilation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide increased intranasal space and temporarily address nasal obstruction by physically displacing tissue. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a physical instrument (balloon catheter and stylet) used for mechanical manipulation within the body. It does not involve testing samples of human origin (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic results.
- Predicate Device: The predicate device is listed as "ENT manual surgical instruments," which are also not IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RELIEVA TRACT™ Balloon Dilation System does not fit this definition.
N/A
Intended Use / Indications for Use
The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 years or older.
Product codes
QGK
Device Description
The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, which is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is composed of:
- A RELIEVA TRACT™ Balloon Catheter, which consists of an . integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
- A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intranasal space, inferior turbinate and lower nasal septum, nasal passage
Indicated Patient Age Range
17 years or 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)
Non-Clinical Performance Data: The subject device, RELIEVA TRACT™ Balloon Dilation System, met all performance acceptance criteria.
Packaging shelf life was evaluated in accordance with ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements and confirmed to meet a shelf life of 24 months.
The sterilization process has been validated per ISO 11135:2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Biocompatibility testing was successfully completed to determine that the RELIEVA TRACT™ Balloon Dilation System is biocompatible per ISO 10993-1.
Simulated use testing on cadavers was successfully conducted to verify that the RELIEVA TRACT™ Balloon Dilation System functions in accordance with its intended use and design specifications in a simulated clinical setting. The packaging and instructions for use were also successfully assessed by evaluators as part of the study.
Clinical Performance Data: Clinical data was not necessary for the RELIEVA TRACT™ Balloon Dilation System. The performance data demonstrated that the device 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.
Not Found
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
Image /page/0/Picture/1 description: The image displays the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "RELIEVA TRACT™ Balloon Dilation System" is written in bold. The text describes a medical device or system related to balloon dilation.
K183090: 510(K) SUMMARY
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc. |
| 33 Technology Drive | |
| Irvine, CA 92618 | |
| Contact Person: | Leena Sorathia |
| Sr. Regulatory Affairs Specialist | |
| Email: lsorathi@its.jnj.com | |
| Tel: 949-923-4118 | |
| Date Summary Prepared: | April 16, 2019 |
| [807.92(a)(2)] Name of Device | |
| Device Trade | |
| Name: | RELIEVA TRACT™ Balloon Dilation System |
| Classification | |
| Name: | Ear, nose, and throat manual surgical instrument |
| Common Name: | Balloon, Nasal Airway |
| Device | |
| Classification: | Class I |
| Regulation | |
| Number: | 21 CFR 874.4420 |
| Review Panel: | Ear, Nose, and Throat |
| Product Code: | QGK |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | ENT manual surgical instruments (21 CFR 874.4420) |
| Reference Device: | RELIEVA Solo Elite™ Sinus Guide Catheter (K111254) |
| (trade name is RELIEVA ULTIRRA® Sinus Balloon Catheter) | |
| Airway Balloon Catheter and Accessories (K090660) | |
| (trade name is INSPIRA AIR® Balloon Dilation System) | |
| [807.92(a)(4)] Device Description | |
| Device Description: | The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, |
| which is intended to provide increased intranasal space to facilitate access for | |
| endonasal and transnasal procedures and/or temporarily address nasal obstruction | |
| by displacing the inferior turbinate and lower nasal septum. It is intended for use | |
| in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is | |
| composed of: | |
| Indications for | |
| Use: | The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to |
| provide increased intranasal space to facilitate access for endonasal and transnasal | |
| procedures and/or temporarily address nasal obstruction by displacing the inferior | |
| turbinate and lower nasal septum. | |
| The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 | |
| years or older. | |
| Difference in | |
| Indications from | |
| Predicate Device | The difference in indications for use between the subject device and the |
| predicate/reference devices is supported is presented in Table 1 of this summary. | |
| [807.92(a)(6)] Technical Characteristics |
1
Image /page/1/Picture/1 description: The image shows the Acclarent logo. The word "Acclarent" is written in bold, black letters, with a purple swoosh above the "ent". Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters.
- A RELIEVA TRACT™ Balloon Catheter, which consists of an . integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
- . A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.
[807.92(a)(5)] Intended Use
Technological See Table 1 for a comparison of the technological characteristics between the Characteristics: subject device and the predicate/reference devices.
2
Image /page/2/Picture/1 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the "rent" is a purple arch. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
Table 1: Comparison of Technological Characteristics between RELIEVA TRACT™ Balloon Dilation System and Predicate and Reference devices.
| Attribute | Predicate Device
ENT Manual Surgical
Instrument
(21 CFR 874.4420) | Reference Device
RELIEVA Solo Elite™ Sinus
Guide Catheter (Ultirra)
(K111254) | Reference Device
Airway Balloon Catheter
and Accessories
(Inspira Air)
(K090660) | Subject Device
RELIEVA TRACT™ Balloon
Dilation System |
|---------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(k) number | 510(k) exempt | K111254 | K090660 | K183090 |
| Manufacturer | N/A | Acclarent, Inc. | Acclarent, Inc. | Acclarent, Inc |
| Trade Name | N/A | RELIEVA ULTIRRA® Sinus
Balloon Catheter | INSPIRA AIR® Balloon Dilation
System | RELIEVA TRACT™ Balloon
Dilation System |
| Classification Name | Ear, nose, and throat manual surgical
instrument | Ear, nose, and throat manual
surgical instrument | Bronchoscope (flexible or rigid)
and accessories | Ear, nose, and throat manual
surgical instrument |
| Class | I | I | II | I |
| Product Code | LRC | LRC | KTI | QGK |
| Classification
Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4680 | 21 CFR 874.4420 |
3
Image /page/3/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the "ent" in purple and the rest in black. Below the logo, the words "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" are written in a smaller font.
| Attribute | Predicate Device
ENT Manual Surgical
Instrument
(21 CFR 874.4420) | Reference Device
RELIEVA Solo Elite™ Sinus
Guide Catheter (Ultirra)
(K111254) | Reference Device
Airway Balloon Catheter
and Accessories
(Inspira Air)
(K090660) | Subject Device
RELIEVA TRACT™Balloon
Dilation System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | The RELIEVA ULTIRRA® Sinus
Balloon Catheter is an instrument
intended to dilate sinus ostia and
spaces within the paranasal sinus
cavities for diagnostic and
therapeutic procedures. It is also
intended to irrigate from within a
target sinus for therapeutic
procedures and to facilitate
diagnostic procedures.
For children aged 17 and under, the
balloon catheter system is intended
to dilate sinus ostia and spaces
associated with the maxillary sinus
for diagnostic and therapeutic
procedures. It is also intended to
irrigate from within a target sinus
for therapeutic procedures and to
facilitate diagnostic procedures. | The Airway Balloon Catheter is
an instrument intended to dilate
strictures of the airway tree. | The RELIEVA TRACT™ Balloon
Dilation System is an instrument
intended to provide increased
intranasal space to facilitate access
for endonasal and transnasal
procedures and/or temporarily
address nasal obstruction by
displacing the inferior turbinate and
lower nasal septum.
The RELIEVA TRACT™ Balloon
Dilation System is intended for use
in ages 17 years or older. |
4
Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the first part of the word in black and the last part in purple. Below the company name, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller font.
| Attribute | Predicate Device
ENT Manual Surgical
Instrument
(21 CFR 874.4420) | Reference Device
RELIEVA Solo Elite™ Sinus
Guide Catheter (Ultirra)
(K111254) | Reference Device
Airway Balloon Catheter
and Accessories
(Inspira Air)
(K090660) | Subject Device
RELIEVA TRACT™ Balloon
Dilation System |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The RELIEVA ULTIRRA® Sinus
Balloon Catheter is intended to
dilate nasal anatomy, such as sinus
ostia and spaces within the
paranasal sinus cavities for
diagnostic and therapeutic
procedures. | The Airway Balloon Catheter is
an instrument intended to dilate
strictures of the airway tree. | The RELIEVA TRACT™ Balloon
Dilation System is an instrument
intended to provide increased
intranasal space to facilitate access
for endonasal and transnasal
procedures and/or temporarily
address nasal obstruction. |
5
Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the "Ac" in black and the rest of the word in purple. Below the name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
| Attribute | Predicate Device
ENT Manual Surgical
Instrument
(21 CFR 874.4420) | Reference Device
RELIEVA Solo Elite™ Sinus
Guide Catheter (Ultirra)
(K111254) | Reference Device
Airway Balloon Catheter
and Accessories
(Inspira Air)
(K090660) | Subject Device
RELIEVA TRACT™ Balloon
Dilation System |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Technological
Characteristics | Intended for use in surgical
procedures to examine or treat ENT
spaces | Allows for dilation of sinus ostia
with the added capability to irrigate | To dilate strictures of airway tree | Allows for dilation of nasal passage
without irrigation |
| Single Patient Use | N/A | Yes | Yes | Yes |
| Direct Patient
Contact | N/A | Yes | Yes | Yes |
| Balloon Diameter
and Length | Not applicable | 5mm x 16mm
6mm x 16mm
7mm x 16mm
7mm x 24mm | 5mm x 24mm
7mm x 24mm
8.5mm x 24mm
10mm x 40mm
12mm x 40mm
14mm x 40mm
16mm x 40mm | 5mm x 24mm
7mm x 24mm
8.5mm x 24mm
10mm x 40mm
12mm x 40mm
14mm x 40mm
16mm x 40mm |
| Maximum Inflation
Pressure | Not applicable | 12 ATM | 8-16 ATM | 8-16 ATM |
| Flexible Shaft | Not applicable | Yes | Yes | Yes |
| Deflation Time | Not applicable |