Relieva Tract Balloon Dilation System
Device Facts
| Record ID | K183090 |
|---|---|
| Device Name | Relieva Tract Balloon Dilation System |
| Applicant | Acclarent, Inc. |
| Product Code | QGK · Ear, Nose, Throat |
| Decision Date | Apr 19, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4420 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended 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.
Device Story
The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile, manually operated ENT surgical instrument. It consists of a coaxial balloon catheter and an optional stylet. The device is used by clinicians to mechanically dilate nasal passages. The clinician advances the catheter to the target site (inferior turbinate/nasal septum) using the stylet for guidance. The balloon is inflated with sterile water or saline using an external inflation device (ACCLARENT® Balloon Inflation Device). The resulting mechanical displacement increases intranasal space, facilitating surgical access or temporarily relieving nasal obstruction. The device is intended for use in a clinical setting by trained healthcare professionals. It provides a non-surgical or minimally invasive mechanical method to address nasal obstruction, potentially improving patient comfort and procedural access.
Clinical Evidence
No clinical data was necessary. Performance was verified through non-clinical bench testing, including packaging shelf-life (ASTM F1980-07, F88/F88M-09, F2096-04), sterilization validation (ISO 11135:2014), ethylene oxide residuals (ISO 10993-7:2008), and biocompatibility (ISO 10993-1). Simulated use testing on cadavers confirmed the device functions according to design specifications in a simulated clinical setting.
Technological Characteristics
Manual surgical instrument; coaxial catheter design with high-pressure balloon. Materials biocompatible per ISO 10993-1. Inflation via sterile water/saline; pressure range 8-16 ATM. Dimensions: 5mm-16mm diameter, 450mm length. Single-use, sterile (Ethylene Oxide, ISO 11135:2014). No electronic components, software, or connectivity.
Indications for Use
Indicated for patients aged 17 years or older requiring increased intranasal space to facilitate endonasal/transnasal procedures or temporary relief of nasal obstruction via displacement of the inferior turbinate and lower nasal septum.
Regulatory Classification
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.
Predicate Devices
- ENT manual surgical instruments (21 CFR 874.4420)
Reference Devices
- RELIEVA Solo Elite™ Sinus Guide Catheter (K111254)
- Airway Balloon Catheter and Accessories (K090660)
Related Devices
- K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER · Acclarent, Inc. · Mar 11, 2008
- K043527 — RELIEVA SINUS BALLOON DILATION CATHETER · Exploramed Nc1, Inc. · Apr 5, 2005
- K153341 — Relieva Scout Multi-Sinus Dilation System · Acclarent, Inc. · Feb 12, 2016
- K111875 — RELIEVA SPIN SINUS DILATION SYSTEM · Acclarent, Inc. · Oct 11, 2011
- K163509 — XprESS ENT Dilation System · Entellus Medical, Inc. · Apr 5, 2017
Submission Summary (Full Text)
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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.<br>33 Technology Drive<br>Irvine, CA 92618 |
| Contact Person: | Leena Sorathia<br>Sr. Regulatory Affairs Specialist<br>Email: lsorathi@its.jnj.com<br>Tel: 949-923-4118 |
| Date Summary Prepared: | April 16, 2019 |
| [807.92(a)(2)] Name of Device | |
| Device Trade<br>Name: | RELIEVA TRACT™ Balloon Dilation System |
| Classification<br>Name: | Ear, nose, and throat manual surgical instrument |
| Common Name: | Balloon, Nasal Airway |
| Device<br>Classification: | Class I |
| Regulation<br>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)<br>(trade name is RELIEVA ULTIRRA® Sinus Balloon Catheter)<br>Airway Balloon Catheter and Accessories (K090660)<br>(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,<br>which is intended to provide increased intranasal space to facilitate access for<br>endonasal and transnasal procedures and/or temporarily address nasal obstruction<br>by displacing the inferior turbinate and lower nasal septum. It is intended for use<br>in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is<br>composed of: |
| Indications for<br>Use: | The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to<br>provide increased intranasal space to facilitate access for endonasal and transnasal<br>procedures and/or temporarily address nasal obstruction by displacing the inferior<br>turbinate and lower nasal septum. |
| | The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17<br>years or older. |
| Difference in<br>Indications from<br>Predicate Device | The difference in indications for use between the subject device and the<br>predicate/reference devices is supported is presented in Table 1 of this summary. |
| [807.92(a)(6)] Technical Characteristics | |
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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.
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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<br>ENT Manual Surgical<br>Instrument<br>(21 CFR 874.4420) | Reference Device<br>RELIEVA Solo Elite™ Sinus<br>Guide Catheter (Ultirra)<br>(K111254) | Reference Device<br>Airway Balloon Catheter<br>and Accessories<br>(Inspira Air)<br>(K090660) | Subject Device<br>RELIEVA TRACT™ Balloon<br>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<br>Balloon Catheter | INSPIRA AIR® Balloon Dilation<br>System | RELIEVA TRACT™ Balloon<br>Dilation System |
| Classification Name | Ear, nose, and throat manual surgical<br>instrument | Ear, nose, and throat manual<br>surgical instrument | Bronchoscope (flexible or rigid)<br>and accessories | Ear, nose, and throat manual<br>surgical instrument |
| Class | I | I | II | I |
| Product Code | LRC | LRC | KTI | QGK |
| Classification<br>Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4680 | 21 CFR 874.4420 |
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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<br>ENT Manual Surgical<br>Instrument<br>(21 CFR 874.4420) | Reference Device<br>RELIEVA Solo Elite™ Sinus<br>Guide Catheter (Ultirra)<br>(K111254) | Reference Device<br>Airway Balloon Catheter<br>and Accessories<br>(Inspira Air)<br>(K090660) | Subject Device<br>RELIEVA TRACT™Balloon<br>Dilation System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | An ear, nose, and throat manual<br>surgical instrument is one of a variety<br>of devices intended for use in surgical<br>procedures to examine or treat the<br>bronchus, esophagus, trachea, larynx,<br>pharynx, nasal and paranasal sinus, or<br>ear. This generic type of device<br>includes the esophageal dilator;<br>tracheal bistour (a long, narrow<br>surgical knife); tracheal dilator;<br>tracheal hook; laryngeal injection set;<br>laryngeal knife; laryngeal saw;<br>laryngeal trocar; laryngectomy tube;<br>adenoid curette; adenotome; metal<br>tongue depressor; mouth gag; oral<br>screw; salpingeal curette;<br>tonsillectome; tonsil guillotine; tonsil<br>screw; tonsil snare; tonsil suction<br>tube; tonsil suturing hook; antom<br>reforator; ethmoid curette; frontal<br>sinus-rasp; nasal curette; nasal rasp;<br>nasal rongeur; nasal saw; nasal<br>scissors; nasal snare; sinus irrigator;<br>sinus trephine; ear curette; ear<br>excavator; ear rasp; ear scissor, ear<br>snare; ear spoon; ear suction tube;<br>malleous ripper; mastoid gauge;<br>microsurgical ear chisel;<br>myringotomy tube inserter; ossici<br>holding clamp; sacculotomy tack<br>inserter; vein press; wire ear loop;<br>microrule; mirror; mobilizer; ear,<br>nose, and throat punch; ear, nose and<br>throat knife; and ear, nose, and throat<br>trocar. | The RELIEVA ULTIRRA® Sinus<br>Balloon Catheter is an instrument<br>intended to dilate sinus ostia and<br>spaces within the paranasal sinus<br>cavities for diagnostic and<br>therapeutic procedures. It is also<br>intended to irrigate from within a<br>target sinus for therapeutic<br>procedures and to facilitate<br>diagnostic procedures.<br>For children aged 17 and under, the<br>balloon catheter system is intended<br>to dilate sinus ostia and spaces<br>associated with the maxillary sinus<br>for diagnostic and therapeutic<br>procedures. It is also intended to<br>irrigate from within a target sinus<br>for therapeutic procedures and to<br>facilitate diagnostic procedures. | The Airway Balloon Catheter is<br>an instrument intended to dilate<br>strictures of the airway tree. | The RELIEVA TRACT™ Balloon<br>Dilation System is an instrument<br>intended to provide increased<br>intranasal space to facilitate access<br>for endonasal and transnasal<br>procedures and/or temporarily<br>address nasal obstruction by<br>displacing the inferior turbinate and<br>lower nasal septum.<br>The RELIEVA TRACT™ Balloon<br>Dilation System is intended for use<br>in ages 17 years or older. |
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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<br>ENT Manual Surgical<br>Instrument<br>(21 CFR 874.4420) | Reference Device<br>RELIEVA Solo Elite™ Sinus<br>Guide Catheter (Ultirra)<br>(K111254) | Reference Device<br>Airway Balloon Catheter<br>and Accessories<br>(Inspira Air)<br>(K090660) | Subject Device<br>RELIEVA TRACT™ Balloon<br>Dilation System |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | An ear, nose, and throat manual<br>surgical instrument is one of a variety<br>of devices intended for use in surgical<br>procedures to examine or treat the<br>bronchus, esophagus, trachea, larynx,<br>pharynx, nasal and paranasal sinus, or<br>ear. This generic type of device<br>includes the esophageal dilator;<br>tracheal bistour (a long, narrow<br>surgical knife); tracheal dilator;<br>tracheal hook; laryngeal injection set;<br>laryngeal knife; laryngeal saw;<br>laryngeal trocar; laryngectomy tube;<br>adenoid curette; adenotome; metal<br>tongue depressor; mouth gag; oral<br>screw; salpingeal curette;<br>tonsillectome; tonsil guillotine; tonsil<br>screw; tonsil snare; tonsil suction<br>tube; tonsil suturing hook; antom<br>reforator; ethmoid curette; frontal<br>sinus-rasp; nasal curette; nasal rasp;<br>nasal rongeur; nasal saw; nasal<br>scissors; nasal snare; sinus irrigator;<br>sinus trephine; ear curette; ear<br>excavator; ear rasp; ear scissor, ear<br>snare; ear spoon; ear suction tube;<br>malleous ripper; mastoid gauge;<br>microsurgical ear chisel;<br>myringotomy tube inserter; ossici<br>holding clamp; sacculotomy tack<br>inserter; vein press; wire ear loop;<br>microrule; mirror; mobilizer; ear,<br>nose, and throat punch; ear, nose and<br>throat knife; and ear, nose, and throat<br>trocar. | The RELIEVA ULTIRRA® Sinus<br>Balloon Catheter is intended to<br>dilate nasal anatomy, such as sinus<br>ostia and spaces within the<br>paranasal sinus cavities for<br>diagnostic and therapeutic<br>procedures. | The Airway Balloon Catheter is<br>an instrument intended to dilate<br>strictures of the airway tree. | The RELIEVA TRACT™ Balloon<br>Dilation System is an instrument<br>intended to provide increased<br>intranasal space to facilitate access<br>for endonasal and transnasal<br>procedures and/or temporarily<br>address nasal obstruction. |
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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<br>ENT Manual Surgical<br>Instrument<br>(21 CFR 874.4420) | Reference Device<br>RELIEVA Solo Elite™ Sinus<br>Guide Catheter (Ultirra)<br>(K111254) | Reference Device<br>Airway Balloon Catheter<br>and Accessories<br>(Inspira Air)<br>(K090660) | Subject Device<br>RELIEVA TRACT™ Balloon<br>Dilation System |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Technological<br>Characteristics | Intended for use in surgical<br>procedures to examine or treat ENT<br>spaces | Allows for dilation of sinus ostia<br>with the added capability to irrigate | To dilate strictures of airway tree | Allows for dilation of nasal passage<br>without irrigation |
| Single Patient Use | N/A | Yes | Yes | Yes |
| Direct Patient<br>Contact | N/A | Yes | Yes | Yes |
| Balloon Diameter<br>and Length | Not applicable | 5mm x 16mm<br>6mm x 16mm<br>7mm x 16mm<br>7mm x 24mm | 5mm x 24mm<br>7mm x 24mm<br>8.5mm x 24mm<br>10mm x 40mm<br>12mm x 40mm<br>14mm x 40mm<br>16mm x 40mm | 5mm x 24mm<br>7mm x 24mm<br>8.5mm x 24mm<br>10mm x 40mm<br>12mm x 40mm<br>14mm x 40mm<br>16mm x 40mm |
| Maximum Inflation<br>Pressure | Not applicable | 12 ATM | 8-16 ATM | 8-16 ATM |
| Flexible Shaft | Not applicable | Yes | Yes | Yes |
| Deflation Time | Not applicable | < 5 seconds | ≤ 15 sec | ≤ 15 sec |
| Catheter Length | Not applicable | 250mm | 450mm | 450mm |
| Balloon Slide<br>Mechanism | Not applicable | No | No | No |
| Irrigation Capability | Not applicable | Yes | No | No |
| Incorporated Suction | Not applicable | No | No | No |
| Accessory Devices<br>Packed with Device | Varies | Stylet | Stylet | Stylet |
| Principles of<br>Operation | ENT manual surgical instrument<br>intended for use in surgical<br>procedures to examine or treat ENT<br>spaces. | Manually operated device. Balloon<br>inflated with sterile saline or water<br>to mechanically dilate sinus ostia. | Manually operated device.<br>Balloon inflated with sterile saline<br>or sterile water to mechanically to<br>dilate strictures of the airway tree. | ENT manual surgical instrument.<br>Balloon inflated with sterile saline<br>or sterile water to mechanically<br>dilate nasal passage. |
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Image /page/6/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 "ent" portion of the word in purple. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
| Traditional 510(k) |
|--------------------|
| CONFIDENTIAL |
| [807.92(b) (1)] Determination of Substantial Equivalence | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Performance<br>Data: | The subject device, RELIEVA TRACT™ Balloon Dilation System, met<br>all performance acceptance criteria. |
| | Packaging shelf life was evaluated in accordance with ASTM F1980-<br>07, ASTM F88/F88M-09, and ASTM F2096-04 requirements and<br>confirmed to meet a shelf life of 24 months. |
| | The sterilization process has been validated per ISO 11135:2014 and<br>demonstrated a sterility assurance level of 10-6. The method used for<br>sterilization validation was the overkill (half-cycle approach) in a fixed<br>chamber. Ethylene oxide residuals were tested and met ISO 10993-<br>7:2008 requirements. The subject device is not tested nor labeled as<br>"non-pyrogenic". |
| | Biocompatibility testing was successfully completed to determine that<br>the RELIEVA TRACT™ Balloon Dilation System is biocompatible per<br>ISO 10993-1. |
| | Simulated use testing on cadavers was successfully conducted to verify<br>that the RELIEVA TRACT™ Balloon Dilation System functions in<br>accordance with its intended use and design specifications in a<br>simulated clinical setting. The packaging and instructions for use were<br>also successfully assessed by evaluators as part of the study. |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the RELIEVA TRACT™ Balloon<br>Dilation System. The performance data demonstrated that the device<br>performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-<br>Clinical and Clinical Tests | Based on the information provided in this premarket notification,<br>Acclarent concludes that the RELIEVA TRACT™ Balloon Dilation<br>System is as safe and as effective as and substantially equivalent to the<br>predicate device. |
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Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2019
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K183090
Trade/Device Name: Relieva Tract Balloon Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: QGK Dated: March 19, 2019 Received: March 20, 2019
Dear Leena Sorathia:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
