The Vivaer ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, in the internal nasal valve area.

Device Description

The Vivaer ARC Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft and treatment tip. The treatment tip consists of an array of bipolar electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Device Performance (Non-Clinical)	System responsiveness	Met all performance testing requirements.
	Effectiveness for clinical use	Met all performance testing requirements.
	Adequate shaft strength (Force load testing)	Verified.
	Thermocouple accuracy and response time (water bath immersion)	Efficacy supported.
	Tissue heating time (using representative soft tissues of the nasal airway)	Efficacy supported.
	Comparable thermal lesion volumes to predicate device	Showed that the Vivaer ARC Stylus creates thermal lesion volumes comparable to the predicate device.
Device Safety (Non-Clinical)	Biocompatibility (AAMI/ANSI/ISO 10993-1 (2009/(R) 2013))	Demonstrated through testing.
	Sterilization validation (ANSI/AAMI/ISO 11135:2014 and ISO 10993-7:2008)	Performed in accordance with standards.
	Electrical safety (IEC 60601-1:2005/A1:2012 and IEC 60601-2-2:2009)	Demonstrated through testing.
	Electromagnetic compatibility (IEC 60601-1-2:2007/AC:2010)	Performed according to standard.
	Packaging validation (Transit testing, visual inspection, accelerated aging, gross leak detection, seal strength testing in accordance with ASTM D4169-14, D4332-14, F1980-07(2011), F2096-11, F88/F88M-15)	Met all acceptance criteria.
	Long-term safety and healing in nasal tissue (in vivo canine study)	Treatment resulted in durable change of submucosal gland population, no significant fibrosis, tissue contraction, or cartilage degeneration after 6 months. Healing process complete or near-complete at 6 months. Supports long-term safety.
Clinical Efficacy	Primary Efficacy Endpoint: Statistically significantly greater than 15-point improvement in mean NOSE score from baseline to 26 weeks post-procedure.	Met. Mean NOSE score decreased 55 points (SD 21) from baseline to 26 weeks (paired t-test, p<0.0001, lower 95% confidence bound=50).
	Secondary Efficacy Endpoint: Treatment responder rate of 55% or greater, where a responder is defined as achieving a 15-point or greater improvement (decrease) in the NOSE score from baseline to 26 weeks.	Met. Responder rate was 94% (95% CI [84, 98]).
Clinical Safety	Adverse events: Type and frequency characterized, no device-related or unanticipated adverse events.	Two serious adverse events reported (unrelated to device/procedure). No device-related adverse events. No unanticipated adverse events. Procedure-associated adverse events were mild, transient, and expected. Risks are minimal.
	Favorable recovery process (Physical and endoscopic nasal assessment)	Assessed with improvement from baseline condition and favorable recovery.
	High patient satisfaction (Patient Satisfaction Survey)	Patient-reported opinion and satisfaction with tolerability, recovery, and effect was high.

The studies collectively support the safety and efficacy of the Vivaer ARC Stylus for its intended use and its substantial equivalence to the predicate device.

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

Clinical Study (Test Set):
- Sample Size: 50 subjects
- Data Provenance: Prospective, multi-center, non-randomized, non-significant risk clinical study conducted in the United States.
In Vivo Study (Non-Clinical Test Set):
- Sample Size: Canines (specific number not provided, but refers to "canines" implying multiple animals).
- Data Provenance: In vivo testing.

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

Clinical Study: Not explicitly stated that experts established the primary ground truth for the test set by independently reviewing images or data for the NOSE score. The NOSE score is a patient-reported outcome.
- However, for physical and endoscopic nasal assessment, the assessments would have been performed by clinicians/physicians at the 8 study sites, who are presumed to be qualified in ENT surgery, given the context of the study. Specific expert qualifications (e.g., years of experience, board certification) are not detailed in the provided text.
In Vivo Study:
- Expert: A veterinary pathologist was used to evaluate the treated tissue histologically.
- Qualifications: "veterinary pathologist" is mentioned. Specific years of experience or other detailed qualifications are not provided.

4. Adjudication Method for the Test Set

The text does not explicitly mention an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either the clinical or in vivo studies.
For the clinical study, the primary efficacy endpoint (NOSE score) is a patient-reported outcome, not typically subject to expert adjudication of results, though it would be collected and managed by clinical study staff. The physical/endoscopic assessments would be performed by individual clinicians, and any discrepancies across sites or with baseline would likely be managed through standard clinical trial protocols (e.g., central review if severe discrepancies arose, but not detailed here).
For the in vivo study, the veterinary pathologist evaluated histology. This implies a single expert assessment for the histological ground truth, with no multi-reader adjudication method 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

No MRMC comparative effectiveness study was mentioned or performed. This device is a surgical tool (radiofrequency probe), not an AI-powered diagnostic or assistive tool for human readers/interpreters of medical images. Therefore, the concept of human readers improving with AI assistance does not apply to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The Vivaer ARC Stylus is a medical device, a handheld radiofrequency probe used for surgical procedures, it is not an algorithm or AI system. Its performance is directly tied to the physical action of the device and the clinician's use of it, not independent algorithmic performance.

7. The Type of Ground Truth Used

Clinical Study:
- Efficacy: Patient-reported outcome (Nasal Obstruction Symptom Evaluation - NOSE score) from subjects treated in a prospective study.
- Safety: Characterization of adverse events reported by subjects and clinicians, physical/endoscopic nasal assessments performed by clinicians, and patient satisfaction surveys.
In Vivo Study (Non-Clinical):
- Safety/Healing: Histological evaluation by a veterinary pathologist, endoscopic evaluation, and observation of healing and long-term effects in canines.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense. The "training" for the device's development would be through engineering design, material science, and iterative testing, not data-driven machine learning.

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

Not applicable. As stated above, there is no "training set" for an AI/ML algorithm associated with this device. Device development relies on established engineering principles, biocompatibility standards, electrical safety standards, and pre-clinical and clinical testing to validate its design and performance against its intended use.

Summary

{0}------------------------------------------------

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, with the letters FDA in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

December 5, 2017

Aerin Medical, Inc. Shannon Scott Director, Regulatory Affairs 232 E. Caribbean Drive Sunnyvale, CA 94089

Re: K172529

Trade/Device Name: Vivaer ARC Stylus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 2, 2017 Received: November 6, 2017

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. 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.

{1}------------------------------------------------

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 (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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 yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K172529

Device Name

Vivaer ARC Stylus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font, with the "A" stylized to look like a triangle. Below "Aerin" is the word "MEDICAL" in a smaller, red, sans-serif font. To the right of "Aerin" is a cluster of green circles that fade from dark green to light green.

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:	232 E. Caribbean DriveSunnyvale, CA 94089
Contact Person:	Shannon ScottDirector, Regulatory AffairsPhone: 512-221-9956
EstablishmentRegistration Number	3011625895
Date Prepared:	November 2, 2017
Name of the Device
Proprietary Name:	Vivaer ARC Stylus, Model FG257
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:	InSeca ARC Stylus (K162810)

Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font, with the "A" stylized to have a pointed top. To the right of the "n" are several green circles of varying sizes, arranged in a gradient pattern. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font, also in blue.

The Vivaer ARC Stylus is used to treat patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the Vivaer ARC Stylus into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, allowing the tissue to be repositioned by applying lateral pressure, and creates a coagulation lesion. As the lesion heals, the tissue retracts and stiffens. The treatment shrinks and reshapes the tissue to lessen the degree of obstruction.

Indications for Use

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

The Vivaer ARC 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	Vivaer ARC Stylus(Model FG257)Subject Device	InSeca ARC Stylus(Model FG256)Predicate Device K162810
Design configuration	Same	Integrated cable, handle andelectrode
Energy type	Same	Bipolar radiofrequency
Tissue temperature	Same	50 - 70 °C(temperature controlled)
RF generatorcompatibility	Same	Aerin Console,Model FG226
Use limit feature	Yes	Yes
Stylus validation feature	Yes	Yes

Summary of non-clinical tests

Device performance testing included system responsiveness and effectiveness for use in a clinical setting. Force load testing was conducted to verify adequate shaft strength. The efficacy of the subject device is supported by thermocouple accuracy and response time testing via water bath immersion and tissue heating time testing. Tissue heating time testing was performed using tissues representative of the soft tissues of the nasal airway. The subject device met all the performance testing requirements. Additional performance testing was performed to verify substantial equivalence to the predicate devices in terms of thermal effects. The testing showed that the Vivaer ARC Stylus creates thermal

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font, with the "A" stylized to look like a triangle. Below "Aerin" is the word "MEDICAL" in a smaller, red, sans-serif font. To the right of "Aerin" are several green circles of varying sizes, arranged in a cluster.

lesion volumes that are comparable to volumes created with the predicate device.

Device safety is supported through biocompatibility testing, sterilization and packaging validation activities, electrical safety testing and electromagnetic Biocompatibility of the Vivaer ARC Stylus was compatibility testing. demonstrated through testing performed in accordance with AAMI/ANSI/ISO 10993-1 (2009/(R) 2013). The sterilization was performed in accordance with ANSI/AAMI/ISO 11135:2014 and ISO 10993-7:2008. Electrical safety was demonstrated through testing to IEC 60601-1:2005/A1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility testing was performed according to IEC 60601-1-2:2007/AC:2010. The Vivaer ARC Stylus packaging system was subjected to transit testing, visual inspection, accelerated aging, gross leak detection and seal strength testing in accordance with the applicable ASTM standards (ASTM D4169-14, ASTM D4332-14, ASTM F1980-07(2011), ASTM F2096-11, and ASTM F88/F88M-15), and met all acceptance criteria. In vivo testing was conducted in canines to evaluate the healing and long-term effects of temperature-controlled bipolar RF energy delivered to nasal tissue. The treatment sites were evaluated endoscopically post-procedure and at several timepoints out to 24 weeks (6 months). The treated tissue was evaluated histologically by a veterinary pathologist after 1. 4 and 24 weeks of healing. The study results at the end of the 6-month follow-up period support the long-term safety of the Vivaer ARC Stylus to treat the submucosal tissue including cartilage. Treatment with the Stylus resulted in a durable change of the submucosal gland population and did not result in significant fibrosis, tissue contraction, or cartilage degeneration after 6 months of healing. At 6 months, the healing process was complete or near-complete.

Summary of clinical tests

A prospective, multi-center, non-randomized, non-significant risk clinical study was conducted in the United States to confirm safety and effectiveness in a population presenting with a history of poor nasal breathing or chronic nasal obstruction. The primary efficacy endpoint was defined as a statistically significantly greater than 15-point improvement in the mean Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-procedure. The secondary efficacy endpoint was defined as a treatment responder rate of 55% or greater, where a responder is defined as achieving a 15 point or greater improvement (decrease) in the NOSE score from baseline to 26 weeks. Safety was assessed by characterizing the type and frequency of adverse events reported throughout the study. Additional evaluations included physical and endoscopic nasal assessment and Patient Satisfaction Survey.

Fifty (50) subjects from 8 study sites were treated in the study. The subjects received bilateral treatment of the internal nasal valve with the Vivaer Stylus. The primary and secondary efficacv endpoints of the study were met and demonstrated significant and clinically meaningful improvement in the nasal

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font, with the "A" being significantly larger than the other letters. Below "Aerin" is the word "MEDICAL" in a smaller, gray, sans-serif font. To the right of "Aerin" are several green circles of varying sizes, arranged in a cluster.

obstructions symptoms reported by the subjects.

Significant clinical improvement in symptoms was demonstrated by marked improvement in the NOSE score of nearly all subjects and across the multiple study centers. The mean NOSE score at the 26-week endpoint decreased 55 points (SD 21) from baseline (paired t-test. p<0.0001. lower 95% confidence bound=50). The responder rate, defined as at least a 15-point improvement in the NOSE Score, was 94% (95% CI [84, 98]). Three subjects were nonresponders at the 26-week evaluation. Each of these non-responders had external circumstances that likely contributed to their status at the final evaluation. One subject was lost-to-follow-up for the evaluation at 26 weeks; at previous evaluations up through 18 weeks the subject had significant improvement and was a responder.

Patient-reported opinion and satisfaction with the tolerability, recovery process, and effect of the procedure was high. Physical and endoscopic nasal status assessments showed improvement from baseline condition and a favorable recovery process following the procedure.

Two serious adverse events in 2 subjects were reported. Neither of the events was related to the device or procedure. Both subjects continued to participate in the study and were treatment responders. There were no device-related adverse events and no unanticipated adverse events. The adverse events associated with the procedure were relatively mild, transient, and not unexpected for this type of procedure, demonstrating that the risks associated with the Vivaer ARC Stylus and procedure are minimal.

The results from this study support the safety and efficacy of the proposed indication expansion to include treatment the internal nasal valve area.

Conclusion

Testing demonstrates that the Vivaer ARC Stylus is substantially equivalent to the predicate in terms of both intended use and delivered RF treatment and is as safe and effective for its intended use.

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.