(106 days)
Not Found
No
The summary describes a radiofrequency probe with a temperature sensor for tissue coagulation, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to treat nasal airway obstruction by shrinking submucosal tissue, which directly addresses a medical condition to improve patient health.
No
The device is indicated for surgical coagulation of soft tissue to treat nasal airway obstruction by shrinking submucosal tissue, not for diagnosis.
No
The device description clearly states it is a handheld bipolar radiofrequency (RF) probe with a handle, shaft, treatment tip, electrodes, and temperature sensor, which are all hardware components.
Based on the provided information, the Vivaer ARC Stylus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Vivaer ARC Stylus Function: The Vivaer ARC Stylus is a surgical tool used directly on the patient's tissue within the nasal airway. It uses radiofrequency energy to coagulate and shrink tissue. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue." This is a therapeutic procedure performed in vivo (within the living body).
Therefore, the Vivaer ARC Stylus is a surgical device used for treatment, not an IVD device used for diagnosis or analysis of specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal airway, internal nasal valve area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Otorhinolaryngology (ENT) surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 efficacy endpoints of the study were met and demonstrated significant and clinically meaningful improvement in the nasal 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
§ 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.
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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)
Device Name
Vivaer ARC Stylus
Indications for Use (Describe)
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.
| 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)
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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 Drive | |
| Sunnyvale, CA 94089 | ||
| Contact Person: | Shannon Scott | |
| Director, Regulatory Affairs | ||
| Phone: 512-221-9956 | ||
| Establishment | ||
| Registration 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 and | |
| accessories | ||
| 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
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.
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
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, including cartilage in the internal nasal valve area.
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 and
electrode |
| Energy type | Same | Bipolar radiofrequency |
| Tissue temperature | Same | 50 - 70 °C
(temperature controlled) |
| RF generator
compatibility | 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
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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