(60 days)
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.
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Simulated Use Testing | Met all performance acceptance criteria |
| Dimensional Specifications | Met all performance acceptance criteria |
| Balloon Burst Pressure | Met all performance acceptance criteria |
| Joint Separation Force | Met all performance acceptance criteria |
| Deflation Time | Met all performance acceptance criteria |
| Balloon Cycle Fatigue | Met all performance acceptance criteria |
| Shelf Life | Established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-11 requirements. |
| Biocompatibility | Biocompatible per ISO 10993-1. |
| Sterilization Assurance Level (SAL) | 10^-6, validated per AAMI/ANSI/ISO 11135:2014 (overkill/half-cycle approach in a fixed chamber). |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements. |
| Packaging Shelf Life | Established per ASTM F1980-07. |
2. Sample Size for Test Set and Data Provenance
The document states, "Clinical data was not necessary for the RELIEVA ULTIRRA® Sinus Balloon Catheter." This indicates that no clinical test set was used, and therefore no sample size or data provenance for a clinical test set is applicable. The evaluation was based on non-clinical performance testing.
3. Number of Experts and Qualifications for Ground Truth
Since no clinical data or human-in-the-loop performance was performed for this 510(k) submission, the concept of "experts used to establish ground truth" is not applicable in the context of evaluating diagnostic accuracy or clinical decision-making. The ground truth for the non-clinical performance tests would be the established engineering and materials standards and specifications. Engineers and technicians with expertise in medical device testing would have established and verified these.
4. Adjudication Method for Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The submission explicitly states "Clinical data was not necessary."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a manual surgical instrument (catheter), not an algorithm or AI system. The performance studies conducted were non-clinical, evaluating the physical and mechanical properties of the device.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance data was based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM standards) for medical device performance (e.g., burst pressure, fatigue, biocompatibility, sterilization).
8. Sample Size for Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The device's design and manufacturing processes are developed and refined through engineering principles and iterative testing, not through data-driven training sets as understood in AI systems.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set in this context. The "ground truth" for the device's development and manufacturing would be its intended function, design specifications, and relevant industry standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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
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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)
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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 DriveIrvine, CA 92618 |
|---|---|
| Contact Person: | Leena SorathiaSr. Regulatory Affairs SpecialistEmail: lsorathi@its.jnj.comTel: 949-923-4118 |
Date Summary Prepared: May 3, 2019
[807.92(a)(2)] Name of Device
| Device TradeName: | RELIEVA ULTIRRA® Sinus Balloon Catheter |
|---|---|
| ClassificationName: | Ear, Nose, and Throat Manual Surgical Instrument |
| Common Name: | Sinus Balloon Catheter |
| DeviceClassification: | Class I |
| RegulationNumber: | 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 isintended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon andpermits the passage of an electromagnetic navigable sinus guidewire or sinusillumination 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 todilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic andtherapeutic procedures. It is also intended to irrigate from within a target sinus fortherapeutic procedures and to facilitate diagnostic procedures. |
|---|---|
| For children aged 17 and under, the balloon catheter system is intended to dilate sinusostia and spaces associated with the maxillary sinus for diagnostic and therapeuticprocedures. It is also intended to irrigate from within a target sinus for therapeuticprocedures and to facilitate diagnostic procedures. | |
| The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunctionwith TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasaland sinus spaces, and to confirm placement in the accessed anatomy. It is NOTintended to irrigate from within a target sinus for therapeutic procedures nor tofacilitate diagnostic procedures with TruDi™ NAV Wire. | |
| Difference inIndications fromPredicate Device | The indications for use statement of the subject device, RELIEVA ULTIRRA® SinusBalloon Catheter, is similar to predicate device, RELIEVA Solo Elite™ Sinus BalloonCatheter (K111254). The subject and predicate devices are both intended to access anddilate the sinus ostia and paranasal spaces using a balloon. |
| The proposed revised indications for use for the subject device are largely unchangedfrom the predicate device with the exception of the additional statement that thedevice may be used in conjunction with TruDi™ NAV Wire and TruDi™ NavigationSystem. In addition, the irrigation function of the subject device is not intended to beused in conjunction with the TruDi™ NAV Wire. | |
| The changes in indications for use of the subject device do not raise any significantissues of safety and effectivenessof the device when used as labeled, as demonstrated bperformance testing. | |
| The difference in indications for use between the subject device and thepredicate/reference devices is supported is presented in Table 1 of this summary. |
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Image /page/5/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 curved line above the "ent" portion of the word.
[807.92(a)(6)] Technical Characteristics
| TechnologicalCharacteristics: | The design and materials of the subject device, RELIEVA ULTIRRA® SinusBalloon Catheter, are identical to the predicate device RELIEVA Solo Elite™ SinusBalloon Catheter (K111254). The added capability of the subject device to be usedwith the TruDi™ NAV Wire and TruDi™ Navigation System did not require anydesign 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 notallow for the irrigation feature. | |
| The subject device is substantially equivalent in technological characteristics, asthere are no significant differences in design, fundamental scientific technology, orother features of the device as compared to the predicate device. | |
| See Table 1 for a comparison of the technological characteristics between thesubject 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 CodeClassificationSection | LRC21 CFR 874.4420 | LRC21 CFR 874.4420 | LRC21 CFR 874.4420 |
| Indications for Use | The RELIEVA Ultirra® Sinus BalloonCatheter is an instrument intended to dilatesinus ostia and spaces within the paranasalsinus cavities for diagnostic andtherapeutic procedures. It is also intendedto irrigate from within a target sinus fortherapeutic procedures and to facilitatediagnostic procedures.For children aged 17 and under, theballoon catheter system is intended todilate sinus ostia and spaces associatedwith the maxillary sinus for diagnostic andtherapeutic procedures. It is also intendedto irrigate from within a target sinus fortherapeutic procedures and to facilitatediagnostic procedures. | The RELIEVA ULTIRRA® Nav SinusBalloon Catheter is an instrument intendedto dilate the sinus ostia and spaces withinthe paranasal sinus cavities for diagnosticand therapeutic procedures.For children aged 17 and under, the ballooncatheter system is intended to dilate sinusostia and spaces associated with themaxillary sinus for diagnostic andtherapeutic procedures.The RELIEVA ULTIRRA® Sinus BalloonCatheter may be utilized in conjunctionwith the Acclarent NavWire™ SinusNavigation Guidewire and ACCLARENT®ENT Navigation System to provide access tonasal and sinus spaces, and to confirmplacement in the accessed anatomy. | The RELIEVA ULTIRRA® Sinus BalloonCatheter is an instrument intended to dilatesinus ostia and spaces within the paranasalsinus cavities for diagnostic and therapeuticprocedures. It is also intended to irrigate fromwithin a target sinus for therapeutic proceduresand to facilitate diagnostic procedures.For children aged 17 and under, the ballooncatheter system is intended to dilate sinus ostiaand spaces associated with the maxillary sinusfor diagnostic and therapeutic procedures. It isalso intended to irrigate from within a targetsinus for therapeutic procedures and tofacilitate diagnostic procedures.The RELIEVA ULTIRRA® Sinus BalloonCatheter may be utilized in conjunction withTruDi™ NAV Wire and TruDi™ NavigationSystem to provide access to nasal and sinusspaces, and to confirm placement in theaccessed anatomy. It is NOT intended toirrigate from within a target sinus fortherapeutic procedures nor to facilitatediagnostic procedures with TruDi™ NAV Wire. |
| Indicated forChildren | Yes, for children 17 years and under inmaxillary sinus only | Yes, for children 17 years and under inmaxillary sinus only | Yes, for children 17 years and under inmaxillary 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 PatientContact | Yes | Yes | Yes |
| Labeled as Non-Pyrogenic? | No | No | No |
| TechnologicalCharacteristics | Allows for dilation of sinus ostia with theadded capability to irrigate. | Allows for dilation of sinus ostia. | Allows for dilation of sinus ostia with theadded capability to irrigate when used with theRELIEVA LUMA SENTRY®. It is NOTintended to irrigate from within a target sinusfor therapeutic procedures nor to facilitatediagnostic procedures with TruDi™ NAV Wire. |
| Constructed ofMaterialsCommonly Usedin PatientContactingMedical Devices | Yes | Yes | Yes |
| Balloon Material | Nylon | Nylon | Nylon |
| Balloon Diameterand Length | 5x16mm, 6x16mm, 7x16mm and 7x24mm | 5x16mm | 5x16mm, 6x16mm, 7x16mm and 7x24mm |
| MaximumInflation Pressure | 12 ATM | 12 ATM | 12 ATM |
| Flexible Shaft | Yes | Yes | Yes |
| Deflation Time | < 5 seconds | < 3.6 seconds | < 5 seconds |
| Catheter Length | 250 ± 2 mm | 250 ± 2mm | 250 ± 2mm |
| Shaft Design | Dual Lumen | Dual Lumen | Dual Lumen |
| Used withGuidewire | Yes | Yes | Yes |
| GuidewireCompatibility | 0.035" | 0.035" | 0.035" |
| Attribute | Primary Predicate Device:RELIEVA Solo Elite™ Sinus GuideCatheter (K111254) | Reference Device:RELIEVA ULTIRRA® Nav SinusBalloon Catheter (K161698) | Subject Device:RELIEVA ULTIRRA® Sinus BalloonCatheter (K190525) |
| BalloonRadiopaqueMarker Bands | Yes | Yes | Yes |
| Balloon SlideMechanism | Yes | Yes | Yes |
| IrrigationCapability | Yes | No | Yes, if used with RELIEVA LUMA SENTRY®No, if used TruDi™ NAV Wire |
| IncorporatedSuction | No | No | No |
| Sinuses in whichdevice is intendedfor use: [Sphenoid,Maxillary, Frontal] | Sphenoid, Maxillary, Frontal | Sphenoid, Maxillary, Frontal | Sphenoid, Maxillary, Frontal |
| EtO Sterilized | Yes | Yes | Yes |
| Packaging | HDPE backer card in Tyvek/Nylon pouch | HDPE backer card in Tyvek/Nylon pouch | HDPE backer card in Tyvek/Nylon pouch |
| Accessory DevicesPacked withDevice | Stylet | Stylet | Stylet |
| Principles ofOperation | Manually operated device. Balloon inflatedwith sterile saline or water to mechanicallydilate sinus ostia. | Manually operated device. Balloon inflatedwith sterile saline or water to mechanicallydilate sinus ostia. | Manually operated device. Balloon inflatedwith sterile saline or water to mechanicallydilate sinus ostia. |
| Labeled forcompatibility withImage NavigationSystems | No | Yes | Yes |
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Image /page/7/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. To the right of the word is a purple design that looks like a swoosh.
Traditional 510(k) Premarket Notification
RELIEVA ULTIRRA® Sinus Balloon Catheter
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Traditional 510(k) Premarket Notification
RELIEVA ULTIRRA® Sinus Balloon Catheter
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Image /page/9/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font. The first part of the word, "Accla," is in black, while the "rent" portion is in purple. There is a curved line above the purple portion of the word.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical PerformanceData: | The RELIEVA ULTIRRA® Sinus Balloon Catheter met all performanceacceptance criteria including simulated use testing, dimensionalspecifications, balloon burst pressure, joint separation force, deflationtime, 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 BalloonCatheter is biocompatible per ISO 10993-1.The sterilization process has been validated per AAMI/ANSI/ISO11135:2014 and demonstrated a sterility assurance level of 10-6. Themethod used for sterilization validation was the overkill (half-cycleapproach) in a fixed chamber. Ethylene oxide residuals were tested andmet ISO 10993-7:2008 requirements. The subject device is not testednor labeled as “non-pyrogenic”.Packaging shelf life has been established per ASTM F1980-07.Clinical data was not necessary for the RELIEVA ULTIRRA® SinusBalloon Catheter. The performance data demonstrated that the deviceperforms as intended.The RELIEVA ULTIRRA® Sinus Balloon Catheter passed all intendedcriteria in accordance with appropriate test criteria and standards. |
|---|---|
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the RELIEVA ULTIRRA® SinusBalloon Catheter. The performance data demonstrated that the deviceperforms as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-Clinical and Clinical Tests | Based on the information provided in this premarket notification,Acclarent concludes that the RELIEVA ULTIRRA® SinusBalloon Catheter is as safe and effective and substantiallyequivalent to the predicate device. |
§ 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.