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 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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the RhinAer® Stylus (FG1393). This summary focuses on demonstrating substantial equivalence to a predicate device (RHIN1 Stylus, K192471) rather than presenting a study where specific acceptance criteria are defined for a performance outcome and then proven.

In the context of this 510(k) submission, "acceptance criteria" are generally related to demonstrating that the modified device maintains the safety and effectiveness of its predicate, and that changes to the device (shaft diameter, malleability, treatment tip design) do not introduce new safety or effectiveness concerns. The "study" here refers to the non-clinical tests performed to support this claim.

Given the information, here's how we can address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for a "device performance" in the sense of a clinical outcome, but rather for engineering and safety aspects to demonstrate substantial equivalence.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Functional Performance	Adequate stylus strength (force load testing)	Met all performance testing requirements.
	Thermocouple accuracy	Met all performance testing requirements.
	Thermocouple response time	Met all performance testing requirements.
Usability	No new use errors causing serious harm	All study objectives met; no new use errors causing serious harm identified.
	No further improvement to device/user interface necessary	All study objectives met; device safe to use.
Biocompatibility	Equivalent to predicate (due to similar material composition)	Predicate device's testing applicable.
Electrical Safety	Equivalent to predicate (due to similar design and intended use)	Predicate device's testing applicable.
Sterility Validation	Equivalent to predicate (due to similar design and intended use)	Predicate device's testing applicable.
Shelf-life	Maintaining integrity and functionality for 6 months	Passed all aging and transit testing acceptance criteria for 6-month shelf life.
Material Composition	Same as predicate device	Subject and predicate devices have the same material composition.
RF Generator Compatibility	Same as predicate (Aerin Console, Model FG226)	Same
Energy Type	Same as predicate (Bipolar radiofrequency)	Same
Tissue Temperature	Consistent with predicate's operating range (50-70°C)	60°C (within predicate's range)
Power	Consistent with predicate's operating range (3-5W)	4 W (within predicate's range)

2. Sample Size Used for the Test Set and Data Provenance

The document only references "non-clinical tests" and "bench functional testing" and "usability testing." It does not provide specific sample sizes for these tests beyond implying a sufficient number were performed to meet test objectives.

Sample Size (Test Set): Not specified beyond general statements about "bench functional testing," "usability testing," and "aging and transit testing."
Data Provenance: Not explicitly stated, but as these are non-clinical (bench and usability) tests conducted for a medical device submission, they would typically be performed in a controlled laboratory or simulated clinical environment. There is no indication of country of origin of patient data, as no clinical studies were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This section is not applicable (N/A) because the reported "studies" are non-clinical engineering and usability tests, not studies requiring expert-adjudicated ground truth for a clinical outcome (e.g., image interpretation or disease diagnosis).
Usability testing likely involved healthcare professionals or trained users, but their role was to evaluate the device interface and identify potential use errors, not to establish a clinical "ground truth."

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation (e.g., radiology reads). The non-clinical tests described (functional, usability, shelf-life) do not involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

N/A. This device is an electrosurgical cutting and coagulation device, not an AI or imaging diagnostic device. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a physical medical instrument, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

N/A for clinical ground truth. For the non-clinical tests, the "ground truth" was established by engineering specifications, safety standards, and validated test methods (e.g., force load measurements, thermocouple calibration, sterility validations, package integrity standards).

8. The Sample Size for the Training Set

N/A. Training sets are relevant for machine learning algorithms. This device is a physical medical instrument and does not involve a training set as understood in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established

N/A. This question is not applicable for the reasons mentioned in point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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 AssurancePhone: 512-221-9956
Establishment RegistrationNumber	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 andaccessories
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

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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(Model FG1393)	RHIN1 Stylus(Model FG815)
	Subject Device	Predicate Device K192471
Design configuration	Same	Integrated cable, handle andelectrode
Energy type	Same	Bipolar radiofrequency
Tissue temperature	60°C	50 - 70 °C(temperature controlled)
Power	4 W	3-5 W
RF generatorcompatibility	Same	Aerin Console,Model FG226
Shaft shape	Straight with diameter stepdown	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° tiltImage: [Treatment Tip]	No tiltImage: [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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.