(60 days)
No
The summary describes a mechanical device (balloon catheter) and its intended uses. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on mechanical and material properties.
Yes
No
The text states the device is intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic procedures, and to facilitate diagnostic procedures. However, the device itself is a catheter used for dilation and irrigation, not for performing the diagnosis itself. It facilitates diagnostic procedures as a tool, but it doesn't make a diagnosis.
No
The device description clearly describes a physical catheter with a balloon, shaft, and hypotube, indicating it is a hardware device.
Based on the provided information, the RELIEVA ULTIRRA® Sinus Balloon Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as an instrument for dilating sinus ostia and spaces, irrigating from within a target sinus, and facilitating diagnostic procedures within the body. These are all procedures performed in vivo (within a living organism).
- Device Description: The description details a flexible catheter with a balloon for dilation, a shaft for inflation and passage of other instruments, and a hypotube for rigidity. This aligns with a device used for physical manipulation and access within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, tissue, or other bodily fluids, to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body. The RELIEVA ULTIRRA® Sinus Balloon Catheter is a surgical/interventional device used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic 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 RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.
Product codes
LRC
Device Description
The RELIEVA ULTIRRA® Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Paranasal sinus cavities (Sphenoid, Maxillary, Frontal)
Indicated Patient Age Range
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.
Not explicitly stated for adults, but the general indication applies to all ages above 17.
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 RELIEVA ULTIRRA® Sinus Balloon Catheter met all performance acceptance criteria including simulated use testing, dimensional specifications, balloon burst pressure, joint separation force, deflation time, and balloon cycle fatigue. Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-11 requirements. Testing also showed that the RELIEVA ULTIRRA® Sinus Balloon Catheter is biocompatible per ISO 10993-1. The sterilization process has been validated per AAMI/ANSI/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”. Packaging shelf life has been established per ASTM F1980-07. Clinical data was not necessary for the RELIEVA ULTIRRA® Sinus Balloon Catheter. The performance data demonstrated that the device performs as intended. The RELIEVA ULTIRRA® Sinus Balloon Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Clinical Performance Data: Clinical data was not necessary for the RELIEVA ULTIRRA® Sinus Balloon Catheter. The performance data demonstrated that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RELIEVA Solo Elite™ Sinus Balloon Catheter (K111254)
Reference Device(s)
RELIEVA UltirraNav® Sinus Balloon Catheter, (K161698)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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May 3, 2019
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K190525
Trade/Device Name: RELIEVA ULTIRRA Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 1, 2019 Received: March 4, 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.
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/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 Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K190525
Device Name RELIEVA ULTIRRA® Sinus Balloon Catheter
Indications for Use (Describe)
The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic 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 RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/0 description: The image shows the word "Acclarent" in a stylized font. The first part of the word, "Acclar" is in black, while the "ent" is in purple. There is a purple swoosh above the "ent" part of the word.
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: May 3, 2019
[807.92(a)(2)] Name of Device
| Device Trade
| Name: | RELIEVA ULTIRRA® Sinus Balloon Catheter |
|---|---|
| Classification | |
| Name: | Ear, Nose, and Throat Manual Surgical Instrument |
| Common Name: | Sinus Balloon Catheter |
| Device | |
| Classification: | Class I |
| Regulation | |
| Number: | 21 CFR 874.4420 |
| Review Panel: | Ear, Nose, and Throat |
| Product Code: | LRC |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | RELIEVA Solo Elite™ Sinus Balloon Catheter (K111254) |
| Reference Device: | RELIEVA UltirraNav® Sinus Balloon Catheter, (K161698) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The RELIEVA ULTIRRA® Sinus Balloon Catheter is a flexible catheter that is |
| intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and | |
| permits the passage of an electromagnetic navigable sinus guidewire or sinus | |
| illumination system to facilitate access to the target sinus ostia. A hypotube is |
incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "rent" portion in purple. Above the purple part of the word is a curved line, also in purple, that arches over the text.
[807.92(a)(5)] Intended Use
| Indications for Use: | 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 RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction
with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal
and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT
intended to irrigate from within a target sinus for therapeutic procedures nor to
facilitate diagnostic procedures with TruDi™ NAV Wire. |
| Difference in
Indications from
Predicate Device | The indications for use statement of the subject device, RELIEVA ULTIRRA® Sinus
Balloon Catheter, is similar to predicate device, RELIEVA Solo Elite™ Sinus Balloon
Catheter (K111254). The subject and predicate devices are both intended to access and
dilate the sinus ostia and paranasal spaces using a balloon. |
| | The proposed revised indications for use for the subject device are largely unchanged
from the predicate device with the exception of the additional statement that the
device may be used in conjunction with TruDi™ NAV Wire and TruDi™ Navigation
System. In addition, the irrigation function of the subject device is not intended to be
used in conjunction with the TruDi™ NAV Wire. |
| | The changes in indications for use of the subject device do not raise any significant
issues of safety and effectivenessof the device when used as labeled, as demonstrated b
performance testing. |
| | 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. |
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[807.92(a)(6)] Technical Characteristics
| Technological
Characteristics: | The design and materials of the subject device, RELIEVA ULTIRRA® Sinus
Balloon Catheter, are identical to the predicate device RELIEVA Solo Elite™ Sinus
Balloon Catheter (K111254). The added capability of the subject device to be used
with the TruDi™ NAV Wire and TruDi™ Navigation System did not require any
design changes from the predicate device. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Like the predicate device, the subject device has the same ballon dilation pressure,
material composition, and size specifications. However, the subject device does not
allow for the irrigation feature. |
| | The subject device is substantially equivalent in technological characteristics, as
there are no significant differences in design, fundamental scientific technology, or
other features of the device as compared to the predicate device. |
| | See Table 1 for a comparison of the technological characteristics between the
subject device and the predicate/reference devices. |
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Image /page/6/Picture/0 description: The image shows the logo for "Acclarent." The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "ent" portion in purple. There is a purple curved line above the "ent" portion of the word, and a trademark symbol to the right of the "t".
| Attribute | Primary Predicate Device: | Reference Device: | Subject Device: |
|---|---|---|---|
| RELIEVA Solo Elite™ Sinus Guide | RELIEVA ULTIRRA® Nav Sinus | RELIEVA ULTIRRA® Sinus Balloon | |
| Catheter (K111254) | Balloon Catheter (K161698) | Catheter (K190525) | |
| Manufacturer | Acclarent | Acclarent | Acclarent |
| Common Name | Sinus Balloon Dilation System | Sinus Balloon Dilation System | Sinus Balloon Dilation System |
| Class | I | I | I |
| Product Code | |||
| Classification | |||
| Section | LRC | ||
| 21 CFR 874.4420 | LRC | ||
| 21 CFR 874.4420 | LRC | ||
| 21 CFR 874.4420 | |||
| Indications for Use | 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 RELIEVA ULTIRRA® Nav Sinus | ||
| Balloon Catheter is an instrument intended | |||
| to dilate the sinus ostia and spaces within | |||
| the paranasal sinus cavities for diagnostic | |||
| and therapeutic 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. | |||
| The RELIEVA ULTIRRA® Sinus Balloon | |||
| Catheter may be utilized in conjunction | |||
| with the Acclarent NavWire™ Sinus | |||
| Navigation Guidewire and ACCLARENT® | |||
| ENT Navigation System to provide access to | |||
| nasal and sinus spaces, and to confirm | |||
| placement in the accessed anatomy. | 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 RELIEVA ULTIRRA® Sinus Balloon | |||
| Catheter may be utilized in conjunction with | |||
| TruDi™ NAV Wire and TruDi™ Navigation | |||
| System to provide access to nasal and sinus | |||
| spaces, and to confirm placement in the | |||
| accessed anatomy. It is NOT intended to | |||
| irrigate from within a target sinus for | |||
| therapeutic procedures nor to facilitate | |||
| diagnostic procedures with TruDi™ NAV Wire. | |||
| Indicated for | |||
| Children | Yes, for children 17 years and under in | ||
| maxillary sinus only | Yes, for children 17 years and under in | ||
| maxillary sinus only | Yes, for children 17 years and under in | ||
| maxillary sinus only | |||
| Attribute | Primary Predicate Device: | ||
| RELIEVA Solo Elite™ Sinus Guide | Reference Device: | ||
| RELIEVA ULTIRRA® Nav Sinus | Subject Device: | ||
| RELIEVA ULTIRRA® Sinus Balloon | |||
| Catheter (K111254) | Balloon Catheter (K161698) | Catheter (K190525) | |
| Single Patient Use | Yes | Yes | Yes |
| Direct Patient | |||
| Contact | Yes | Yes | Yes |
| Labeled as Non- | |||
| Pyrogenic? | No | No | No |
| Technological | |||
| Characteristics | Allows for dilation of sinus ostia with the | ||
| added capability to irrigate. | Allows for dilation of sinus ostia. | Allows for dilation of sinus ostia with the | |
| added capability to irrigate when used with the | |||
| RELIEVA LUMA SENTRY®. It is NOT | |||
| intended to irrigate from within a target sinus | |||
| for therapeutic procedures nor to facilitate | |||
| diagnostic procedures with TruDi™ NAV Wire. | |||
| Constructed of | |||
| Materials | |||
| Commonly Used | |||
| in Patient | |||
| Contacting | |||
| Medical Devices | Yes | Yes | Yes |
| Balloon Material | Nylon | Nylon | Nylon |
| Balloon Diameter | |||
| and Length | 5x16mm, 6x16mm, 7x16mm and 7x24mm | 5x16mm | 5x16mm, 6x16mm, 7x16mm and 7x24mm |
| Maximum | |||
| Inflation Pressure | 12 ATM | 12 ATM | 12 ATM |
| Flexible Shaft | Yes | Yes | Yes |
| Deflation Time |