RhinAer® Stylus (FG1393)

K221907 · Aerin Medical, Inc. · GEI · Jul 29, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221907
• Device Name: RhinAer® Stylus (FG1393)
• Applicant: Aerin Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RhinAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

Device Story

RhinAer Stylus is a bipolar radiofrequency (RF) probe used in ENT surgery for soft tissue destruction. Operated by a physician, the device delivers RF energy to target tissue in the nasal airway to treat chronic rhinitis. The system consists of a handle, integrated cable, and a malleable shaft with a treatment tip. Compared to the predicate, the subject device features a reduced-diameter, more malleable shaft and a 10° tilted treatment tip to improve visualization, access, and tissue apposition. The device connects to the Aerin Console (Model FG226) to deliver 4W of power at a fixed 60°C temperature. The output is thermal energy for tissue coagulation/destruction. The device is single-use, sterile, and includes a use-limit and stylus validation feature to ensure safe operation. Clinical benefit is derived from the targeted destruction of nasal tissue to alleviate chronic rhinitis symptoms.

Clinical Evidence

No clinical testing was deemed necessary. Evidence is based on bench functional testing, usability testing, force load testing, and thermocouple accuracy/response time verification. Packaging and shelf-life (6 months) were validated via aging and transit testing.

Technological Characteristics

Bipolar radiofrequency electrosurgical probe. Energy source: Aerin Console (Model FG226). Fixed output: 4W power, 60°C temperature. Features a malleable shaft (proximal 0.120", distal 0.083") and 10° tilted treatment tip. Sterilization: EtO. Connectivity: Integrated cable to console. Includes use-limit and stylus validation features.

Indications for Use

Indicated for patients with chronic rhinitis requiring ENT surgery for soft tissue destruction in the nasal airway, including posterior nasal nerve regions.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• RHIN1 Stylus (K192471)

Submission Summary (Full Text)

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July 29, 2022

Aerin Medical Inc. Shannon Scott Sr. Director RA/QA 2565 Leghorn St. Mountain View, California 91043

Re: K221907

Trade/Device Name: RhinAer® Stylus (FG1393) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 28, 2022 Received: June 30, 2022

Dear Shannon Scott:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221907

Device Name

RhinAer® Stylus

Indications for Use (Describe)

The RhinAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

### General Information

| Submitter Information | | |
|--------------------------------------|----------------------------------------------------------------------------|--|
| Company: | Aerin Medical Inc. | |
| Submitter's Address: | 2565 Leghorn St. | |
| | Mountain View, CA 94043 | |
| Contact Person: | Shannon Scott | |
| | Sr Director, Regulatory Affairs & Quality Assurance<br>Phone: [phone] | |
| Establishment Registration<br>Number | 3011625895 | |
| Date Prepared: | 07/25/2022 | |
| Name of the Device | | |
| Proprietary Name: | RhinAer® Stylus, Model FG1393 | |
| Common Name: | Radiofrequency probe | |
| Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories | |
| Classification Panel: | General and Plastic Surgery | |
| Device Class: | Class II | |
| Product Code: | GEI | |
| CFR Section: | 21 CFR 878.4400 | |
| Predicate Device: | RHIN1 Stylus (K192471) | |

#### Device Description

The RhinAer Stylus is functionally unchanged from the predicate in design and intended use to generate and deliver bipolar RF energy to treat tissue in ENT procedures. The design of the Stylus shaft has been changed to improve physician visualization and access during the procedure. The Stylus shaft diameter has been reduced and is more malleable. The treatment tip shape has been re-designed to change its position relative to the shaft to facilitate tissue apposition. The subject and predicate devices have the same material composition. The device and packaging system has been tested and validated with shelf-life studies out to 6 months. The optional custom treatment parameters (power, temperature, time) have been removed.

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#### Indications for Use

The RhinAer Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

#### Summary of the technological characteristics of the device compared to the predicate device

The RhinAer Stylus was found to be equivalent to the predicate device in design and intended use to generate and deliver bipolar RF energy to treat tissue in ENT procedures.

| Characteristic | RhinAer Stylus<br>(Model FG1393) | RHIN1 Stylus<br>(Model FG815) |
|---------------------------------|-------------------------------------|-------------------------------------------|
| | Subject Device | Predicate Device K192471 |
| Design configuration | Same | Integrated cable, handle and<br>electrode |
| Energy type | Same | Bipolar radiofrequency |
| Tissue temperature | 60°C | 50 - 70 °C<br>(temperature controlled) |
| Power | 4 W | 3-5 W |
| RF generator<br>compatibility | Same | Aerin Console,<br>Model FG226 |
| Shaft shape | Straight with diameter step<br>down | Straight |
| Shaft Diameter, proximal | 0.120 inches | 0.148 inches* |
| Shaft Diameter, distal | 0.083 inches | *same diameter throughout proximal |
| (Dimension without shrink tube) | | and distal shaft |
| Treatment Tip | 10° tilt<br>Image: [Treatment Tip] | No tilt<br>Image: [Treatment Tip] |
| Sterilization | Same | EtO |
| Packaging System | Same | Tray |
| Use limit feature | Yes | Yes |
| Stylus validation feature | Yes | Yes |

#### Summary of non-clinical tests

Device performance testing included bench functional testing and usability testing. Force load testing was conducted to verify adequate stylus strength. The efficacy of the subject device is supported by thermocouple accuracy and response time testing. The subject devices met all the performance testing requirements.

The usability of the RhinAer Stylus, the Instructions for Use, and the Physician Training Materials were all evaluated to validate and confirm that there were no

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new use errors that could cause serious harm to the user or patient, that no further improvement to the device and its user interface is necessary, and the device is safe to use. All study objectives were met.

After reviewing the differences between the RhinAer and RHIN1 Styluses (changes to the shaft diameter and malleability, and treatment tip design), it was determined that the RHIN1 Stylus design verification testing is applicable to the RhinAer Stylus for biocompatibility, electrical safety, and sterility validation.

The packaging and devices passed all aging and transit testing acceptance criteria, thereby allowing all styluses to be labeled with a 6-month shelf life.

#### Summary of clinical tests

No clinical testing was deemed necessary for this device.

#### Conclusion

Verification testing demonstrates that the modified device RhinAer Stylus does not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.