(164 days)
The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 years or older.
The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, which is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is composed of:
- A RELIEVA TRACT™ Balloon Catheter, which consists of an integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
- A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.
This document is a 510(k) Summary for a medical device, the RELIEVA TRACT™ Balloon Dilation System. The request is to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data validation (e.g., test set, experts, ground truth).
However, this document does not contain information about the performance of a software or AI-based medical device, nor does it detail a study involving a test set, expert consensus for ground truth, or MRMC studies.
This 510(k) is for a physical medical device (a balloon dilation system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., sterilization validation, biocompatibility, simulated use testing on cadavers).
Therefore, many of the requested bullet points, which are typically relevant for the validation of AI/software medical devices, cannot be answered from the provided text. The document explicitly states:
- "Clinical data was not necessary for the RELIEVA TRACT™ Balloon Dilation System." (Page 6)
Below is an attempt to answer the questions based on the available information, highlighting where the requested details are not present in the document.
Acceptance Criteria and Device Performance Study (RELIEVA TRACT™ Balloon Dilation System)
This 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance and simulated use testing, rather than a clinical study or a study specifically validating a data-driven AI/software component with a test set and ground truth.
1. Table of acceptance criteria and the reported device performance:
The document broadly states that the device "met all performance acceptance criteria," and then lists types of testing performed. Specific numerical acceptance criteria for each test are not detailed in this summary.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Packaging Shelf Life | Met a shelf life of 24 months in accordance with ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements. |
| Sterilization | Validated per ISO 11135:2014, demonstrating a sterility assurance level of 10^-6 (overkill, half-cycle approach). Ethylene oxide residuals met ISO 10993-7:2008 requirements. |
| Biocompatibility | Successfully completed testing to determine the device is biocompatible per ISO 10993-1. |
| Simulated Use Testing | Successfully conducted on cadavers, verifying function according to intended use and design specifications in a simulated clinical setting. Packaging and instructions for use were also assessed. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "simulated use testing on cadavers." The number of cadavers or specific test instances is not provided.
- Data Provenance: "Cadavers" are mentioned for simulated use testing. No information on country of origin or whether the testing was retrospective or prospective. Given it's simulated use, it would typically be prospective for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The simulated use testing included "evaluators" who assessed the packaging and instructions for use, but their number and qualifications (e.g., medical professionals, engineers) are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No, this type of study was not performed. This device is a physical medical instrument, not an AI/software. The document explicitly states "Clinical data was not necessary."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the simulated use testing, the "ground truth" would implicitly be the successful navigation, deployment, and dilation of the device as per its design specifications and intended use in the cadaveric model. This would likely be assessed by professional evaluators (e.g., engineers, medical device specialists, or potentially clinicians), but the specific method (e.g., visual inspection, measurement, functional assessment against a defined standard) is not detailed, nor is it based on expert consensus in the sense of diagnostic image interpretation.
8. The sample size for the training set:
- Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
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Image /page/0/Picture/1 description: The image displays the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "RELIEVA TRACT™ Balloon Dilation System" is written in bold. The text describes a medical device or system related to balloon dilation.
K183090: 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: | April 16, 2019 |
| [807.92(a)(2)] Name of Device | |
| Device TradeName: | RELIEVA TRACT™ Balloon Dilation System |
| ClassificationName: | Ear, nose, and throat manual surgical instrument |
| Common Name: | Balloon, Nasal Airway |
| DeviceClassification: | Class I |
| RegulationNumber: | 21 CFR 874.4420 |
| Review Panel: | Ear, Nose, and Throat |
| Product Code: | QGK |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | ENT manual surgical instruments (21 CFR 874.4420) |
| Reference Device: | RELIEVA Solo Elite™ Sinus Guide Catheter (K111254)(trade name is RELIEVA ULTIRRA® Sinus Balloon Catheter)Airway Balloon Catheter and Accessories (K090660)(trade name is INSPIRA AIR® Balloon Dilation System) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device,which is intended to provide increased intranasal space to facilitate access forendonasal and transnasal procedures and/or temporarily address nasal obstructionby displacing the inferior turbinate and lower nasal septum. It is intended for usein ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System iscomposed of: |
| Indications forUse: | The RELIEVA TRACT™ Balloon Dilation System is an instrument intended toprovide increased intranasal space to facilitate access for endonasal and transnasalprocedures and/or temporarily address nasal obstruction by displacing the inferiorturbinate and lower nasal septum. |
| The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17years or older. | |
| Difference inIndications fromPredicate Device | The difference in indications for use between the subject device and thepredicate/reference devices is supported is presented in Table 1 of this summary. |
| [807.92(a)(6)] Technical Characteristics |
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Image /page/1/Picture/1 description: The image shows the Acclarent logo. The word "Acclarent" is written in bold, black letters, with a purple swoosh above the "ent". Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters.
- A RELIEVA TRACT™ Balloon Catheter, which consists of an . integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
- . A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.
[807.92(a)(5)] Intended Use
Technological See Table 1 for a comparison of the technological characteristics between the Characteristics: subject device and the predicate/reference devices.
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Image /page/2/Picture/1 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the "rent" is a purple arch. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
Table 1: Comparison of Technological Characteristics between RELIEVA TRACT™ Balloon Dilation System and Predicate and Reference devices.
| Attribute | Predicate DeviceENT Manual SurgicalInstrument(21 CFR 874.4420) | Reference DeviceRELIEVA Solo Elite™ SinusGuide Catheter (Ultirra)(K111254) | Reference DeviceAirway Balloon Catheterand Accessories(Inspira Air)(K090660) | Subject DeviceRELIEVA TRACT™ BalloonDilation System |
|---|---|---|---|---|
| 510(k) number | 510(k) exempt | K111254 | K090660 | K183090 |
| Manufacturer | N/A | Acclarent, Inc. | Acclarent, Inc. | Acclarent, Inc |
| Trade Name | N/A | RELIEVA ULTIRRA® SinusBalloon Catheter | INSPIRA AIR® Balloon DilationSystem | RELIEVA TRACT™ BalloonDilation System |
| Classification Name | Ear, nose, and throat manual surgicalinstrument | Ear, nose, and throat manualsurgical instrument | Bronchoscope (flexible or rigid)and accessories | Ear, nose, and throat manualsurgical instrument |
| Class | I | I | II | I |
| Product Code | LRC | LRC | KTI | QGK |
| ClassificationSection | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4680 | 21 CFR 874.4420 |
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Image /page/3/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the "ent" in purple and the rest in black. Below the logo, the words "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" are written in a smaller font.
| Attribute | Predicate DeviceENT Manual SurgicalInstrument(21 CFR 874.4420) | Reference DeviceRELIEVA Solo Elite™ SinusGuide Catheter (Ultirra)(K111254) | Reference DeviceAirway Balloon Catheterand Accessories(Inspira Air)(K090660) | Subject DeviceRELIEVA TRACT™BalloonDilation System |
|---|---|---|---|---|
| Indications for Use | An ear, nose, and throat manualsurgical instrument is one of a varietyof devices intended for use in surgicalprocedures to examine or treat thebronchus, esophagus, trachea, larynx,pharynx, nasal and paranasal sinus, orear. This generic type of deviceincludes the esophageal dilator;tracheal bistour (a long, narrowsurgical knife); tracheal dilator;tracheal hook; laryngeal injection set;laryngeal knife; laryngeal saw;laryngeal trocar; laryngectomy tube;adenoid curette; adenotome; metaltongue depressor; mouth gag; oralscrew; salpingeal curette;tonsillectome; tonsil guillotine; tonsilscrew; tonsil snare; tonsil suctiontube; tonsil suturing hook; antomreforator; ethmoid curette; frontalsinus-rasp; nasal curette; nasal rasp;nasal rongeur; nasal saw; nasalscissors; nasal snare; sinus irrigator;sinus trephine; ear curette; earexcavator; ear rasp; ear scissor, earsnare; ear spoon; ear suction tube;malleous ripper; mastoid gauge;microsurgical ear chisel;myringotomy tube inserter; ossiciholding clamp; sacculotomy tackinserter; vein press; wire ear loop;microrule; mirror; mobilizer; ear,nose, and throat punch; ear, nose andthroat knife; and ear, nose, and throattrocar. | The RELIEVA ULTIRRA® SinusBalloon Catheter is an instrumentintended to dilate sinus ostia andspaces within the paranasal sinuscavities for diagnostic andtherapeutic procedures. It is alsointended to irrigate from within atarget sinus for therapeuticprocedures and to facilitatediagnostic procedures.For children aged 17 and under, theballoon catheter system is intendedto dilate sinus ostia and spacesassociated with the maxillary sinusfor diagnostic and therapeuticprocedures. It is also intended toirrigate from within a target sinusfor therapeutic procedures and tofacilitate diagnostic procedures. | The Airway Balloon Catheter isan instrument intended to dilatestrictures of the airway tree. | The RELIEVA TRACT™ BalloonDilation System is an instrumentintended to provide increasedintranasal space to facilitate accessfor endonasal and transnasalprocedures and/or temporarilyaddress nasal obstruction bydisplacing the inferior turbinate andlower nasal septum.The RELIEVA TRACT™ BalloonDilation System is intended for usein ages 17 years or older. |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the first part of the word in black and the last part in purple. Below the company name, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller font.
| Attribute | Predicate DeviceENT Manual SurgicalInstrument(21 CFR 874.4420) | Reference DeviceRELIEVA Solo Elite™ SinusGuide Catheter (Ultirra)(K111254) | Reference DeviceAirway Balloon Catheterand Accessories(Inspira Air)(K090660) | Subject DeviceRELIEVA TRACT™ BalloonDilation System |
|---|---|---|---|---|
| Intended Use | An ear, nose, and throat manualsurgical instrument is one of a varietyof devices intended for use in surgicalprocedures to examine or treat thebronchus, esophagus, trachea, larynx,pharynx, nasal and paranasal sinus, orear. This generic type of deviceincludes the esophageal dilator;tracheal bistour (a long, narrowsurgical knife); tracheal dilator;tracheal hook; laryngeal injection set;laryngeal knife; laryngeal saw;laryngeal trocar; laryngectomy tube;adenoid curette; adenotome; metaltongue depressor; mouth gag; oralscrew; salpingeal curette;tonsillectome; tonsil guillotine; tonsilscrew; tonsil snare; tonsil suctiontube; tonsil suturing hook; antomreforator; ethmoid curette; frontalsinus-rasp; nasal curette; nasal rasp;nasal rongeur; nasal saw; nasalscissors; nasal snare; sinus irrigator;sinus trephine; ear curette; earexcavator; ear rasp; ear scissor, earsnare; ear spoon; ear suction tube;malleous ripper; mastoid gauge;microsurgical ear chisel;myringotomy tube inserter; ossiciholding clamp; sacculotomy tackinserter; vein press; wire ear loop;microrule; mirror; mobilizer; ear,nose, and throat punch; ear, nose andthroat knife; and ear, nose, and throattrocar. | The RELIEVA ULTIRRA® SinusBalloon Catheter is intended todilate nasal anatomy, such as sinusostia and spaces within theparanasal sinus cavities fordiagnostic and therapeuticprocedures. | The Airway Balloon Catheter isan instrument intended to dilatestrictures of the airway tree. | The RELIEVA TRACT™ BalloonDilation System is an instrumentintended to provide increasedintranasal space to facilitate accessfor endonasal and transnasalprocedures and/or temporarilyaddress nasal obstruction. |
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Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the "Ac" in black and the rest of the word in purple. Below the name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
| Attribute | Predicate DeviceENT Manual SurgicalInstrument(21 CFR 874.4420) | Reference DeviceRELIEVA Solo Elite™ SinusGuide Catheter (Ultirra)(K111254) | Reference DeviceAirway Balloon Catheterand Accessories(Inspira Air)(K090660) | Subject DeviceRELIEVA TRACT™ BalloonDilation System |
|---|---|---|---|---|
| TechnologicalCharacteristics | Intended for use in surgicalprocedures to examine or treat ENTspaces | Allows for dilation of sinus ostiawith the added capability to irrigate | To dilate strictures of airway tree | Allows for dilation of nasal passagewithout irrigation |
| Single Patient Use | N/A | Yes | Yes | Yes |
| Direct PatientContact | N/A | Yes | Yes | Yes |
| Balloon Diameterand Length | Not applicable | 5mm x 16mm6mm x 16mm7mm x 16mm7mm x 24mm | 5mm x 24mm7mm x 24mm8.5mm x 24mm10mm x 40mm12mm x 40mm14mm x 40mm16mm x 40mm | 5mm x 24mm7mm x 24mm8.5mm x 24mm10mm x 40mm12mm x 40mm14mm x 40mm16mm x 40mm |
| Maximum InflationPressure | Not applicable | 12 ATM | 8-16 ATM | 8-16 ATM |
| Flexible Shaft | Not applicable | Yes | Yes | Yes |
| Deflation Time | Not applicable | < 5 seconds | ≤ 15 sec | ≤ 15 sec |
| Catheter Length | Not applicable | 250mm | 450mm | 450mm |
| Balloon SlideMechanism | Not applicable | No | No | No |
| Irrigation Capability | Not applicable | Yes | No | No |
| Incorporated Suction | Not applicable | No | No | No |
| Accessory DevicesPacked with Device | Varies | Stylet | Stylet | Stylet |
| Principles ofOperation | ENT manual surgical instrumentintended for use in surgicalprocedures to examine or treat ENTspaces. | Manually operated device. Ballooninflated with sterile saline or waterto mechanically dilate sinus ostia. | Manually operated device.Balloon inflated with sterile salineor sterile water to mechanically todilate strictures of the airway tree. | ENT manual surgical instrument.Balloon inflated with sterile salineor sterile water to mechanicallydilate nasal passage. |
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Image /page/6/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a bold, sans-serif font, with the "ent" portion of the word in purple. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
| Traditional 510(k) |
|---|
| CONFIDENTIAL |
| [807.92(b) (1)] Determination of Substantial Equivalence | |
|---|---|
| Non-Clinical PerformanceData: | The subject device, RELIEVA TRACT™ Balloon Dilation System, metall performance acceptance criteria. |
| Packaging shelf life was evaluated in accordance with ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements andconfirmed to meet a shelf life of 24 months. | |
| The sterilization process has been validated per ISO 11135:2014 anddemonstrated a sterility assurance level of 10-6. The method used forsterilization validation was the overkill (half-cycle approach) in a fixedchamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as"non-pyrogenic". | |
| Biocompatibility testing was successfully completed to determine thatthe RELIEVA TRACT™ Balloon Dilation System is biocompatible perISO 10993-1. | |
| Simulated use testing on cadavers was successfully conducted to verifythat the RELIEVA TRACT™ Balloon Dilation System functions inaccordance with its intended use and design specifications in asimulated clinical setting. The packaging and instructions for use werealso successfully assessed by evaluators as part of the study. | |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the RELIEVA TRACT™ BalloonDilation System. 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 TRACT™ Balloon DilationSystem is as safe and as effective as and substantially equivalent to thepredicate device. |
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Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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.
April 19, 2019
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K183090
Trade/Device Name: Relieva Tract Balloon Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: QGK Dated: March 19, 2019 Received: March 20, 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.
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
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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 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
§ 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.