(85 days)
For patients aged 18 and older, the Relieva Scout™ Multi-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 sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.
Here's a breakdown of the acceptance criteria and the study information for the Relieva Scout™ Multi-Sinus Dilation System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical (bench) testing. Therefore, much of the information typically found in clinical studies (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies) is not present because it was not required for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent based on non-clinical performance data. Specific numerical acceptance criteria are not detailed in this summary, but the general categories and outcomes are listed below:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Integrity | Met all acceptance criteria for dimensional attributes, cycle fatigue, balloon burst, and bond separation. |
| Biocompatibility | Demonstrated to be biocompatible in accordance with ISO 10993-1 and AAMI ANSI ISO 10993-1:2009/(R) 2013. |
| Sterilization | Sterilization process validated per AAMI/ANSI/ISO 11135-1:2007, demonstrating a sterility assurance level of 10^-6. Ethylene oxide residuals met ISO 10993-7:2008 requirements. |
| Non-Pyrogenicity | Not tested or labeled as "non-pyrogenic." |
| Packaging Shelf Life | Established per ASTM F1980-07. |
| Overall Performance | The performance data demonstrated that the device performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This documentation focuses on non-clinical (bench) testing, where specific "sample sizes" like those for patient data are not typically reported in this format. The testing would have involved multiple units of the device for each test (e.g., multiple balloons for burst testing).
- Data Provenance: The data is from non-clinical (bench) testing conducted by the manufacturer, Acclarent, Inc., based in Menlo Park, California, USA. It is inherently "prospective" in the sense that the tests were designed and conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to predefined engineering specifications, standardized test methods (e.g., ISO, AAMI, ASTM standards), and regulatory requirements. There are no "experts" establishing ground truth in the clinical interpretation sense.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies involving human interpretation or uncertain outcomes. For bench testing, results are typically objective measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary for the Relieva Scout™ Multi-Sinus Dilation System." This type of study would be for evaluating the effectiveness of the device in a clinical setting, often involving human readers/interpreters, which was not performed for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual surgical instrument, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was established by:
- Predefined Engineering Specifications: The device's design and manufacturing specifications.
- Standardized Test Methods: Adherence to international and national standards such as ISO 10993-1, AAMI ANSI ISO 10993-1:2009/(R) 2013 for biocompatibility; AAMI/ANSI/ISO 11135-1:2007 for sterilization; ISO 10993-7:2008 for ethylene oxide residuals; and ASTM F1980-07 for packaging shelf life.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Acclarent, Inc. James Patrick Garvey Senior Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, California 94025
Re: K153341
Trade/Device Name: Relieva Scout™ Multi-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: November 18, 2015 Received: November 19, 2015
Dear Mr. Garvey:
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
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
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Indications for Use
510(k) Number (if known) K153341
Device Name Relieva Scout™ Multi-Sinus Dilation System
Indications for Use (Describe)
For patients aged 18 and older, the Relieva Scout™ Multi-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 sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate across nasal and sinus structures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Relieva Scout™ Multi-Sinus Dilation System
APPENDIX A: 510(k) SUMMARY
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
| Contact Person: | Patrick GarveySr. Manager, Regulatory AffairsEmail: pgarvey@its.jnj.comTel: 650-687-5888 |
| Date Summary Prepared: | February 12, 2016 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | Relieva ScoutTM Multi-Sinus Dilation System |
| Common Name: | Sinus Balloon Catheter |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 874.4420) |
| Product Code: | LRC |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Devices: | RELIEVA SCOUT® Sinus Dilation System (K120280)XprESSTM Multi-Sinus Dilation Tool (K121174)RELIEVA® Spin Balloon Sinuplasty System (K111875) |
| [807.92(a)(4)] Device Description |
The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system Device Description: that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.
[807.92(a)(5)] Intended Use
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation Indications for Use: System is intended to provide a means to access the sinus space and to dilate
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Relieva Scout™ Multi-Sinus Dilation System
| the sinus ostia and spaces associated with the sphenoid, frontal, and maxillarysinus cavities for diagnostic and therapeutic procedures. In addition, thedevice is intended to illuminate within and transilluminate across nasal andsinus structures. | |||
|---|---|---|---|
| Difference inIndications fromPredicate Device | The difference in indications for use between the subject and predicate devicesis supported is presented in Table 1. |
[807.92(a)(6)] Technical Characteristics
The Relieva Scout™ Multi-Sinus Dilation System combines features of a rail-Technological Characteristics: based balloon catheter with the tissue expansion effect of balloon dilation. The distal end of the device may be shaped with the angle selection tool to optimize sinus access. Light from an extendable integrated illumination system can be seen via transillumination.
See Table 1 for a comparison of the technological characteristics between the Relieva Scout and the predicate devices.
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Relieva Scout™ Multi-Sinus Dilation System
| Attribute | Primary PredicateDevice:RELIEVA SCOUTⓇSinus Dilation System(K120280) | Secondary PredicateDevice:XprESS™ Multi-SinusDilation Tool (K121174) | Predicate Device:RELIEVA® Spin SinusDilation System(K111875) | Subject Device:Relieva Scout ™ Multi-Sinus (SMS) DilationSystem |
|---|---|---|---|---|
| Manufacturer | Acclarent, Inc. | Entellus Medical, Inc. | Acclarent, Inc. | Acclarent, Inc. |
| Common Name | Sinus Balloon DilationSystem | Sinus Balloon DilationSystem | Sinus Balloon DilationSystem | Sinus Balloon DilationSystem |
| Class | I | I | I | I |
| Product Code is LRC | LRC | LRC | LRC | LRC |
| Classification Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 |
| Indications for Use | For patients aged 18 andolder, the Relieva ScoutSinus Dilation System isintended to provide ameans to access the frontalsinus space and to dilatethe frontal recess, frontalsinus ostia and spaceswithin the frontal sinuscavity for diagnostic andtherapeutic procedures. Inaddition, the device isintended to illuminatewithin and transilluminateacross nasal and sinusstructures. | To access and treat thefrontal recesses, sphenoidsinus ostia and maxillaryostia/ethmoidinfundibula in adults usinga trans-nasal approach.The bony sinus outflowtracts are remodeled byballoon displacement ofadjacent bone andparanasal sinus structures. | Intended to provide ameans to access the sinusspace and to dilate thesinus ostia and spacesassociated with theparanasal sinus cavities fordiagnostic and therapeuticprocedures. For childrenaged 17 and under, thedevice is intended to dilatesinus ostia and spacesassociated with themaxillary sinus fordiagnostic and therapeuticprocedures. | For patients aged 18 andolder, the Relieva ScoutMulti-Sinus DilationSystem is intended toprovide a means to accessthe sinus space and todilate the sinus ostia andspaces associated with thesphenoid, frontal, andmaxillary sinus cavities fordiagnostic and therapeuticprocedures. In addition,the device is intended toilluminate within andtransilluminate acrossnasal and sinus structures. |
| Indicated for Children | No | No | Yes | No |
| Attribute | Primary PredicateDevice:RELIEVA SCOUT®Sinus Dilation System(K120280) | Secondary PredicateDevice:XprESS™ Multi-SinusDilation Tool (K121174) | Predicate Device:RELIEVA® Spin SinusDilation System(K111875) | Subject Device:Relieva Scout TM Multi-Sinus (SMS) DilationSystem |
| Single Patient Use | Yes | Yes | Yes | Yes |
| Direct Patient Contact | Yes | Yes | Yes | Yes |
| Labeled as Non-Pyrogenic? | No | No | No | No |
| TechnologicalCharacteristics | Combines features of afrontal ostium seeker withthe tissue expansion effectof balloon dilation. Thedistal end of the device ispermanently curved tooptimize frontal ostiumaccess. Light from thedistal tip of the integratedsinus illumination systemcan be seen viatransillumination. Thedevice is connected to anystandard light source via alight cable and an adapter. | 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 the sinusspace and dilate sinusostia.A Sinus IlluminationSystem comes packagedwith the device and is pre-loaded into the Spin SinusDilation System. | Combines a sinus ballooncatheter with rail-basedballoon guidance to accessthe sinus space and dilatethe sinus ostia. Thepackaged device containsan angle selection tool toenable angular bends formultiple sinus access.Light from the distal tip ofthe integrated sinusillumination system can beseen via transillumination. |
| Constructed of MaterialsCommonly Used in PatientContacting MedicalDevices | Yes | Yes | Yes | Yes |
| Balloon Diameter | 6mm | 5mm to 7mm | 6mm | 6mm |
| Balloon Length | 24mm | 8-20mm | 16mm | 24mm |
| Attribute | Primary PredicateDevice:RELIEVA SCOUT®Sinus Dilation System(K120280) | Secondary PredicateDevice:XprESSTM Multi-SinusDilation Tool (K121174) | Predicate Device:RELIEVA® Spin SinusDilation System(K111875) | Subject Device:Relieva Scout TM Multi-Sinus (SMS) DilationSystem |
| Maximum InflationPressure | 12 ATM | 12 ATM | 12 ATM | 12 ATM |
| Single-Handed Use | Yes | Yes | Yes | Yes |
| Balloon Slide Mechanism | Yes | Yes | Yes | Yes |
| Rail-Based Design | Yes, preset rail intendedfor frontal sinus accessonly | Yes, malleable rail | No | Yes, malleable rail |
| Handle and Slider Systemto Facilitate Advancementof a Balloon Catheter onthe Distal End | Yes | Yes | Yes | Yes |
| Uses a Bending Tool toAchieve Target Angles forAccess into TargetedAnatomy | No | Yes | No | Yes |
| Guidewire Capability(Sinus IlluminationSystem) | Yes | Yes | Yes | Yes |
| Sinuses in which device isintended for use:[Sphenoid, Maxillary,Frontal] | Frontal | Sphenoid, Maxillary,Frontal | Sphenoid, Maxillary,Frontal | Sphenoid, Maxillary,Frontal |
| EtO Sterilized | Yes | Yes | Yes | Yes |
| Attribute | Primary PredicateDevice:RELIEVA SCOUT®Sinus Dilation System(K120280) | Secondary PredicateDevice:XprESSTM Multi-SinusDilation Tool (K121174) | Predicate Device:RELIEVA® Spin SinusDilation System(K111875) | Subject Device:Relieva Scout TM Multi-Sinus (SMS) DilationSystem |
| Packaging | Thermoformed tray inpouch | Backer card in pouch | Backer card in pouch | Thermoformed tray inpouch |
| Principles of Operation | Manually operated device.Balloon inflated withsterile saline or water tomechanically dilate sinusostia. | Manually operated device.Balloon inflated withsterile saline or water tomechanically dilate sinusostia. | Manually operated device.Balloon inflated withsterile saline or water tomechanically dilate sinusostia. | Manually operated device.Balloon inflated withsterile saline or water tomechanically dilate sinusostia. |
Table 1: Comparison of Technological Characteristics between the Relieva Scout" "Multi-Sinus Dilation System and predicate devices.
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Relieva Scout™ Multi-Sinus Dilation System
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Relieva Scout™ Multi-Sinus Dilation System
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Relieva Scout™ Multi-Sinus Dilation System
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Relieva Scout™ Multi-Sinus Dilation System
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical PerformanceData: | Bench testing met all acceptance criteria for attributes such asdimensional attributes, cycle fatigue, balloon burst, and bondseparation. Testing in accordance with ISO 10993-1AAMI ANSI ISO 10993-1:2009/(R) 2013 also showed that theRelieva Scout™ Multi-Sinus Dilation System is biocompatible. |
|---|---|
| The sterilization process was validated per AAMI/ANSI/ISO 11135-1:2007 and demonstrated a sterility assurance level of 10-6. The methodused for sterilization validation was the overkill (half-cycle approach) ina fixed chamber. Ethylene oxide residuals were tested and met ISO10993-7:2008 requirements. The subject device is not tested norlabeled as "non-pyrogenic". | |
| Packaging shelf life was established per ASTM F1980-07. | |
| The performance data demonstrated that the device performs asintended. | |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the Relieva Scout™ Multi-SinusDilation System. The performance data demonstrated that the deviceperforms as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-Clinical and Clinical Tests | The Relieva Scout™ Multi-Sinus Dilation System is substantiallyequivalent to the predicate devices. |
§ 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.