(102 days)
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.
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.
This document describes the Relieva Spin Sinus Dilation System, a medical device, and its acceptance criteria as presented in a 510(k) summary. The information provided is for a device submission, not an AI or algorithm-based product. Therefore, several of the requested categories related to AI performance, such as MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for AI, are not applicable.
Here's an analysis based on the provided text for the medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|---|
| Dimensional | Met established specifications for dimensions. | Bench testing met all acceptance criteria. |
| Cycle Fatigue | Met established specifications for durability under simulated use. | Bench testing met all acceptance criteria. |
| Balloon Burst | Withstood specified inflation pressures without bursting. (e.g., > 12 ATM for maximum inflation pressure) | Bench testing met all acceptance criteria (implicitly > 12 ATM). |
| Joint Separation | Maintained integrity of device components during use. | Bench testing met all acceptance criteria. |
| Biocompatibility | Met biocompatibility standards for medical devices. | Testing showed that Spin is biocompatible. |
| Sterilization | Achieved a Sterility Assurance Level (SAL) of 10⁻⁶. | Sterilization process is validated per AAMI/ANSI/ISO 11135-1:2007 and demonstrated a sterility assurance level of 10⁻⁶. |
| Ethylene Oxide (EtO) Residuals | Met ISO 10993-7:2008 requirements. | EtO residuals were tested and meet ISO 10993-7:2008 requirements. |
| Packaging Shelf Life | Met relevant ASTM and ISTA standards for packaging integrity and shelf life. | Packaging shelf life was established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing, meaning the "test set" refers to the manufactured device units subjected to various physical and chemical tests. The sample sizes for these specific bench tests are not explicitly stated in the provided text.
- Data Provenance: The tests are conducted on manufactured devices in a laboratory setting, not patient data. The country of origin of the data is implicitly where Acclarent, Inc. conducts its testing, which is likely the USA given their address. All data is prospective as it's generated through controlled testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the "ground truth" for a physical medical device in bench testing is defined by engineering specifications, material science standards, and established regulatory guidelines (e.g., ISO, ASTM standards). It does not involve expert clinicians establishing ground truth on medical images or patient outcomes. The "experts" would be the engineers and scientists conducting and interpreting the tests, ensuring compliance with the defined standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving discrepancies in expert interpretations of clinical data, especially in AI studies. For bench testing of a physical device, results are objectively measured against predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable. This device is a physical medical instrument (sinus dilation system), not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This device is a physical medical instrument; there is no algorithm for standalone performance.
7. The Type of Ground Truth Used
For this physical medical device, the "ground truth" is based on:
- Engineering Specifications: Pre-defined design parameters for dimensions, material properties, and performance limits.
- International and National Standards: Adherence to established standards like AAMI/ANSI/ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for EtO residuals, and ASTM/ISTA standards for packaging.
- Bench Testing Results: Objective measurements from physical tests (e.g., burst pressure, fatigue cycles, dimensional measurements).
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI system that requires a "training set" of data. Its performance is verified through physical bench testing on manufactured units.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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510(K) SUMMARY
KII1875
OCT | 1 2011
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | Keri YenManager, Regulatory and ClinicalPhone: (650) 687-5874Fax: (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 threecomponents: Handle System, Sinus Guide Catheter Tip, and SinusBalloon Catheter. The Handle System unites the various componentsinto one device. A suction line is embedded in the Handle Systemwhich can be actuated by the user covering the suction port. The SinuGuide Catheter Tip is a sinus guide catheter that is available in threeshapes and attaches to the Handle System on the distal end. The SinusBalloon Catheter is a flexible catheter with a balloon on the distal tip;one lumen is used for inflation of the sinus balloon and the secondpermits passage of a sinus guidewire. A hypotube is incorporated onthe proximal end of the device to provide rigidity as the Sinus BalloonCatheter is advanced and retracted in the Handle System. There areseveral markers placed along the Sinus Balloon Catheter to aid inpositioning under direct endoscopic visualization. A sinus guidewire ispackaged with the Relieva Spin Sinus Dilation System. |
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- 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 SinusBalloon Catheter) | Predicate Device(XprESS Multi-SinusDilation Tool) | Subject Device(Relieva Spin SinusDilation System) |
|---|---|---|---|
| 510(k) number | K073041 | K102003 | TBD |
| Manufacturer | Acclarent | Entellus Medical | Same, Acclarent |
| BalloonDiameters | 6mm | 6mm | Same, 6mm |
| Balloon Length | 12mm | 18mm | 16mm |
| MaximumInflationPressure | 14 ATM | 12 ATM | Same, 12 ATM |
| SuctionIncorporated | No | Yes | Same, Yes |
| Balloon SlideMechanism | No | Yes | Same, Yes |
| TechnologicalCharacteristics | Combines a sinus ballooncatheter and a sinusguidewire to access anddilate sinuses. | Combines features of acurved suction tip and afrontal ostium seeker(access) with the tissueexpansion effect of balloondilation (treat). The distalend of the device is re-shapeable. | Combines a sinus ballooncatheter and a sinus guidecatheter to access anddilate sinuses. |
| PackagedDevices | None | Packaged with inflationdevice and infusion line | Packaged with RelievaLuma Sentry SinusIllumination 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
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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
Page
§ 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.