(102 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "diagnostic and therapeutic procedures."
No
The device description clearly outlines physical components such as a Handle System, Sinus Guide Catheter Tip, and Sinus Balloon Catheter, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Relieva Spin Sinus Dilation System is a surgical tool used to physically access and dilate sinus passages. It is used in vivo (within the body) for therapeutic and diagnostic procedures, not for testing samples in vitro (outside the body).
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's sinus cavities.
- Device Description: The description details components like catheters, balloons, and a handle system, all designed for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other elements typically associated with IVD devices.
Therefore, based on the provided information, the Relieva Spin Sinus Dilation System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Relieva Spin Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
Product codes
LRC
Device Description
The Relieva Spins Sinus Dilation System is comprised of three components: Handle System, Sinus Guide Catheter Tip, and Sinus Balloon Catheter. The Handle System unites the various components into one device. A suction line is embedded in the Handle System which can be actuated by the user covering the suction port. The Sinu Guide Catheter Tip is a sinus guide catheter that is available in three shapes and attaches to the Handle System on the distal end. The Sinus Balloon Catheter is a flexible catheter with a balloon on the distal tip; one lumen is used for inflation of the sinus balloon and the second permits passage of a sinus guidewire. A hypotube is incorporated on the proximal end of the device to provide rigidity as the Sinus Balloon Catheter is advanced and retracted in the Handle System. There are several markers placed along the Sinus Balloon Catheter to aid in positioning under direct endoscopic visualization. A sinus guidewire is packaged with the Relieva Spin Sinus Dilation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
paranasal sinus cavities, maxillary sinus
Indicated Patient Age Range
For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
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)
Bench testing met all acceptance criteria for attributes such as dimensional, cycle fatigue, balloon burst, and joint separation. Testing also showed that Spin is biocompatible.
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".
Packaging shelf life was established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.
Clinical data was not necessary for Spin. The performance data demonstrates that the subject device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Relieva Acella Sinus Balloon Catheter (K073041), Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003)
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.
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Image /page/0/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top of the "l" to the right, partially enclosing the word. The font is black against a white background.
510(K) SUMMARY
KII1875
OCT | 1 2011
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen
Manager, Regulatory and Clinical
Phone: (650) 687-5874
Fax: (650) 687-4449 |
| Date of Submission: | August 30, 2011 |
| Device Trade Name: | Relieva Spin Sinus Dilation System |
| Common Name: | Sinus Dilation System |
| 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 Acella Sinus Balloon Catheter (K073041)
Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003) |
| Device Description: | The Relieva Spins Sinus Dilation System is comprised of three
components: Handle System, Sinus Guide Catheter Tip, and Sinus
Balloon Catheter. The Handle System unites the various components
into one device. A suction line is embedded in the Handle System
which can be actuated by the user covering the suction port. The Sinu
Guide Catheter Tip is a sinus guide catheter that is available in three
shapes and attaches to the Handle System on the distal end. The Sinus
Balloon Catheter is a flexible catheter with a balloon on the distal tip;
one lumen is used for inflation of the sinus balloon and the second
permits passage of a sinus guidewire. A hypotube is incorporated on
the proximal end of the device to provide rigidity as the Sinus Balloon
Catheter is advanced and retracted in the Handle System. There are
several markers placed along the Sinus Balloon Catheter to aid in
positioning under direct endoscopic visualization. A sinus guidewire is
packaged with the Relieva Spin Sinus Dilation System. |
1
- The Relieva Spin Sinus Dilation System is intended to provide a means Indications for Use: to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
The technological characteristics of the subject device are similar to its.
Technological
Characteristics:
predicate devices.
| Attribute | Predicate Device
(Relieva Acella Sinus
Balloon Catheter) | Predicate Device
(XprESS Multi-Sinus
Dilation Tool) | Subject Device
(Relieva Spin Sinus
Dilation System) |
|----------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) number | K073041 | K102003 | TBD |
| Manufacturer | Acclarent | Entellus Medical | Same, Acclarent |
| Balloon
Diameters | 6mm | 6mm | Same, 6mm |
| Balloon Length | 12mm | 18mm | 16mm |
| Maximum
Inflation
Pressure | 14 ATM | 12 ATM | Same, 12 ATM |
| Suction
Incorporated | No | Yes | Same, Yes |
| Balloon Slide
Mechanism | No | Yes | Same, Yes |
| Technological
Characteristics | Combines a sinus balloon
catheter and a sinus
guidewire to access and
dilate sinuses. | Combines features of a
curved suction tip and a
frontal ostium seeker
(access) with the tissue
expansion effect of balloon
dilation (treat). The distal
end of the device is re-
shapeable. | Combines a sinus balloon
catheter and a sinus guide
catheter to access and
dilate sinuses. |
| Packaged
Devices | None | Packaged with inflation
device and infusion line | Packaged with Relieva
Luma Sentry Sinus
Illumination System |
Performance Data:
Bench testing met all acceptance criteria for attributes such as dimensional, cycle fatigue, balloon burst, and joint separation. Testing also showed that Spin is biocompatible.
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".
Packaging shelf life was established per ASTM F1980-07, ASTM
2
F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements.
Clinical data was not necessary for Spin. The performance data demonstrates that the subject device performs as intended.
The Relieva Spin Sinus Dilation System is substantially equivalent to Summary of Substantial Equivalence: the predicate device as confirmed through relevant tests.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 1 2011
Acclarent, Inc. c/o Ms. Keri Yen Manager, Regulatory and Clinical 1525-B O'Brien Drive Menlo Park. CA 94025
Re: K111875
Trade/Device Name: Relieva Spin Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 30, 2011 Received: August 31, 2011
Dear Ms. Yen:
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.
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Page 2 - Ms. Keri Yen
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 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,
Signature
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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Acclarent )
APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K111875 |
|---|---|
| Trade Name: | Relieva Spin Sinus Dilation System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | The Relieva Spin Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic 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)
Daniel Coleman
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
(Posted November 13, 2003)
510(k) Number K111875
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