(110 days)
No
The document describes a mechanical device (catheter with balloon) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for "therapeutic procedures" such as dilating sinus ostia and spaces within the paranasal sinus cavities, and irrigating from within a target sinus.
No
The device is intended for diagnostic and therapeutic procedures, but it facilitates diagnostic procedures rather than directly performing diagnostic functions itself. It is a tool for dilating access and irrigating, which can aid in the diagnostic process, but it does not analyze or interpret data to provide a diagnosis.
No
The device description clearly outlines a physical catheter with a balloon, hypotube, and irrigation capabilities, indicating it is a hardware device, not software-only.
Based on the provided information, the Relieva Solo Elite Sinus Balloon Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for diagnostic and therapeutic procedures related to the sinuses. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a flexible catheter with a balloon, guidewire passage, and irrigation capabilities, all designed for direct interaction with the patient's sinus anatomy. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Relieva Solo Elite Sinus Balloon Catheter is an in vivo medical device used for procedures within the paranasal sinuses.
N/A
Intended Use / Indications for Use
The Relieva Solo Elite 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 Relieva Solo Elite Sinus Balloon Catheter 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.
Product codes
LRC
Device Description
The Relieva Solo Elite 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 a 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. The subject device also has the capability to irrigate the sinus through the distal tip and three side holes on the distal end.
The Relieva Solo Elite Sinus Balloon Catheter is a device that allows for dilation of sinus ostia with the added capability to irrigate. Dilation is achieved via a non-compliant balloon located on the distal end of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus ostia, paranasal sinus cavities, maxillary sinus
Indicated Patient Age Range
For children aged 17 and under.
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
The Relieva Solo Elite Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications; balloon burst pressure, joint separation force, deflation time, irrigation flow rate, and balloon cycle fatigue.
The sterilization process is validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and meet ISO 10993-7:2008 requirements. The subject device is not tested or labeled as "non-pyrogenic".
Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
111254
Image /page/0/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top right of the "t" to above the "A", creating a semi-circular shape over the word. The text is black against a white background.
:
AUG 2 2 2011
510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kim Ky
Sr. Regulatory Affairs Specialist
Phone: (650) 687-4473
Fax: (650) 687-4449 |
| Date of Submission: | August 11, 2011 |
| Device Trade Name: | Relieva Solo Elite Sinus Balloon Catheter |
| Common Name: | Sinus Balloon Catheter |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, nose, and throat manual surgical instrument |
| Product Code: | LRC |
| Predicate Devices: | Relieva Sinus Balloon Catheter (K073041)
Xpress Multi-Sinus Dilation Tool (K102003) |
| Device Description: | The Relieva Solo Elite 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 a
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. The subject device also has the capability
to irrigate the sinus through the distal tip and three side holes
on the distal end. |
| Indications for Use: | The Relieva Solo Elite 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 procedure and to facilitate diagnostic
procedures.
For children aged 17 and under, the Relieva Solo Elite Sinus
Balloon Catheter 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 |
1
Image /page/1/Picture/0 description: The image contains the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top of the "t", creating a visual element above the word. The overall impression is that of a company logo or brand name.
์ไ
Technological Characteristics:
Performance Data:
Summary of Substantial Equivalence:
facilitate diagnostic procedures.
The Relieva Solo Elite Sinus Balloon Catheter is a device that allows for dilation of sinus ostia with the added capability to irrigate. Dilation is achieved via a non-compliant balloon located on the distal end of the device.
The Relieva Solo Elite Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications; balloon burst pressure, joint separation force, deflation time, irrigation flow rate, and balloon cycle fatigue.
The sterilization process is validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10 . The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and meet ISO 10993-7:2008 requirements. The subject device is not tested or labeled as "non-pyrogenic".
Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.
The Relieva Solo Elite Sinus Balloon Catheter is substantially equivalent to predicate device as confirmed through relevant tests.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Acclarent, Inc. Ms. Kim Ky Manager, Regulatory & Clinical 1525-B O'Brien Dr Menlo Park, CA 94025
AUG 2 2 2011
Re: K111254
Trade/Device Name: Relieva Solo Elite Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: I Product Code: LRC Dated: July 18, 2011 Received: July 19, 2011
Dear Ms. Ky,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Evelin Mz. Jr.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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III 25̄4
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K111254 |
|---|---|
| Trade Name: | Relieva Solo Elite Sinus Balloon Catheter |
| Common Name: | Sinus Balloon Catheter |
| Indications For Use: | The Relieva Solo Elite 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 Relieva Solo Elite Sinus
Balloon Catheter 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. |
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anatolur
(Division Sign-Off) (Division Sign-Orr)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111254.
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(Posted November 13, 2003)