(101 days)
Not Found
No
The device description and performance studies focus on the physical characteristics of the RF probe, temperature monitoring, and clinical outcomes related to tissue destruction. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
Yes
The device is designed to treat chronic rhinitis by destroying soft tissue in the nasal airway using radiofrequency energy, which directly addresses a medical condition and aims to improve patient health outcomes.
No
Explanation: The device is used to treat chronic rhinitis by destroying soft tissue with radiofrequency energy, not to diagnose a condition.
No
The device description clearly outlines a physical, handheld bipolar radiofrequency (RF) probe with a handle, shaft, treatment tip, electrodes, and a temperature sensor. It connects to a console via a cable and delivers RF energy to tissue. This is a hardware device, not software-only.
Based on the provided information, the RHIN1 Stylus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RHIN1 Stylus Function: The RHIN1 Stylus is a surgical instrument used directly on the patient's tissue within the nasal airway to destroy soft tissue using radiofrequency energy. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "destruction of soft tissue in the nasal airway," which is a treatment procedure, not a diagnostic test.
- Device Description: The description details a handheld probe for delivering energy to tissue, not for analyzing biological samples.
Therefore, the RHIN1 Stylus falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RHIN I 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.
Product codes
GEI
Device Description
The RHIN1 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 electric es and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The shaft is malleable to allow the user to bend the shaft in order to more easily access the desired treatment area(s). 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 RHIN1 Stylus is used to treat patients experiencing chronic rhinitis. During a treatment procedure, the clinician inserts the shaft of the RHIN1 Stylus into a patient's nostril to position the treatment tip and deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, causing destruction of the unwanted soft tissue. The shaft of the RHIN1 Stylus is then removed from the nostril.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal airway, posterior nasal nerve regions
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
Device performance testing included ex-vivo functional testing and usability testing. 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. The subject devices met all the performance testing requirements.
The usability of the RHIN1 Stylus and System, the Instructions for Use, and the Physician Training Materials were all evaluated to validate and confirm that there were no 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.
The primary efficacy endpoint was defined as a statistically significantly greater than 1-point improvement in the mean 12-hour reflective 4-item Total Nasal Symptom Scale (rTNSS) from baseline to 12 weeks. The secondary efficacy endpoint was defined as a treatment responder rate of 55% or greater, where a responder is defined as achieving a 1 point or greater improvement (decrease) from baseline to 12 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 Survev.
Fifty (50) subjects from 5 study sites were treated in the study. The subjects received bilateral treatment of the nasal airway in the area of the posterior nasal nerve with the RHIN1 Stylus. Twelve (12) week rTNSS scores were obtained from 49 subjects with one patient's score failed to be taken at their 12-week visit. The primary and secondary efficacy endpoints of the study were met and demor. Trreted significant and clinically meaningful improvement in the rhinitis symptoms as reported in the rTNSS at 12 weeks of follow up.
Significant clinical improvement in symptoms was demonstrate by marked improvement in the Total Nasal Symptom Scale (rTNSS) in nearly all subjects and across all centers. The mean rTNSS at baseline was 8.5 (SD 1.8), which improved to 3.4 (SD 2.3) at the 12-week primary endpoint with a mean decrease of 5.1 points (SD 2.6) from baseline (59.2% improvement) (paired t-test, p= 1-point improvement in rTNSS): 94%
Predicate Device(s)
InSeca ARC Stylus (K162810)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
December 20, 2019
Aerin Medical Inc. Matthew Hull Director, US Regulatory Affairs 232 E Caribbean Dr. Sunnyvale, California 94089
Re: K192471
Trade/Device Name: RHIN1 Stylus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 9, 2019 Received: September 10, 2019
Dear Matthew Hull:
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.
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 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 (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 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 Advice (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.
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name RHIN1 Stylus
Indications for Use (Describe)
The RHIN I Stylus is indicated for use in otothing of 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)
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 written in a large, blue, sans-serif font. Below the word "Aerin" is the word "MEDICAL" written in a smaller, red, sans-serif font. To the right of the word "Aerin" are several green circles of varying sizes.
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: | Matthew M Hull | |
| Director, Regulatory Affairs | ||
| Phone: 916-642-3554 | ||
| Establishment Registration | ||
| Number | 3011625895 | |
| Date Prepared: | 09/09/2019 | |
| Name of the Device | ||
| Proprietary Name: | RHIN1 Stylus, Model FG815 | |
| 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 RHIN1 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 electric es and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The shaft is malleable to allow the user to bend the shaft in order to more easily access the desired treatment area(s). The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and
4
Image /page/4/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is written in a large, stylized font, with the "A" in a darker blue and the rest of the letters in a lighter blue. Below "Aerin" is the word "MEDICAL" in smaller, gray letters. To the right of "Aerin" are some small, light blue circles.
authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.
The RHIN1 Stylus is used to treat patients experiencing chronic rhinitis. During a treatment procedure, the clinician inserts the shaft of the RHIN1 Stylus into a patient's nostril to position the treatment tip and deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, causing destruction of the unwanted soft tissue. The shaft of the RHIN1 Stylus is then removed from the nostril.
Indications for Use
The RHIN1Stylus 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 RHIN1 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 | RHIN1 Stylus
(Model FG815)
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) |
| Power | Same | 3-5 W |
| RF generator
compatibility | Same | Aerin Console,
Model FG226 |
| Sterilization | Same | EtO |
| Packaging System | Tray | Pouch |
| Use limit feature | Yes | Yes |
| Stylus validation feature | Yes | Yes |
| Summary of non-clinical tests | | |
Device performance testing included ex-vivo functional testing and usability testing. Force load testing was conducted to verify adequate shaft strength. The efficacy of
5
Image /page/5/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a blue serif font, with the "A" being larger than the other letters. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font. To the right of "Aerin" is a small circle with the "®" symbol inside. Above and to the right of "Aerin" are several small green circles of varying sizes.
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 RHIN1 Stylus and System, the Instructions for Use, and the Physician Training Materials were all evaluated to validate and confirm that there were no 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 RHIN1 and InSeca Styluses (change in shaft component and change in functional use to enable shaft bending for rhinitis), it was determined that the InSeca design verification testing is applicable to the RHIN1 device for biocompatibility, transit, and aging testing.
A packaging system change from pouch to lidded tray was previously documented through internal change control. The change from the originally cleared InSeca ARC Stylus packaging (polyethylene/nylon mix-Tyvek pouch) to a thermoformed polyethylene-Tyvek tray was fully validated for sterilization and evaluated for shelflife (accelerated aging), usability, and biocompatibility risk. The results and conclusions from sterilization testing demonstrated the ability of Ethylene Oxide (EO) gas sterilization to effectively sterilize the ARC Stylus family of products to a Sterility Assurance Level (SAL) of 10-6 using the overkill half-cycle method approach and establishing the sterilization process parameters for routine sterilization. The packaging and devices passed all aging and transit testing acceptance criteria, thereby allowing all styluses to be labeled with a two-year shelf life. A tray usability study was conducted; user ratings and comments received were positive, demonstrating the overall satisfaction of polled users with the tray packaging configuration. All packaging biocompatibility test acceptance criteria were met.
Summary of clinical tests
The primary efficacy endpoint was defined as a statistically significantly greater than 1-point improvement in the mean 12-hour reflective 4-item Total Nasal Symptom Scale (rTNSS) from baseline to 12 weeks. The secondary efficacy endpoint was defined as a treatment responder rate of 55% or greater, where a responder is defined as achieving a 1 point or greater improvement (decrease) from baseline to 12 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 Survev.
Fifty (50) subjects from 5 study sites were treated in the study. The subjects received bilateral treatment of the nasal airway in the area of the posterior nasal nerve with the RHIN1 Stylus. Twelve (12) week rTNSS scores were obtained from
6
Image /page/6/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a blue sans-serif font, with the "A" being 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.
49 subjects with one patient's score failed to be taken at their 12-week visit. The primary and secondary efficacy endpoints of the study were met and demor. Trreted significant and clinically meaningful improvement in the rhinitis symptoms as reported in the rTNSS at 12 weeks of follow up.
Significant clinical improvement in symptoms was demonstrate by marked improvement in the Total Nasal Symptom Scale (rTNSS) in nearly all subjects and across all centers. The mean rTNSS at baseline was 8.5 (SD 1.8), which improved to 3.4 (SD 2.3) at the 12-week primary endpoint with a mean decrease of 5.1 points (SD 2.6) from baseline (59.2% improvement) (paired t-test, p