(29 days)
Not Found
No
The summary describes a device that delivers bipolar RF energy and focuses on mechanical design changes and performance testing. There is no mention of AI or ML.
Yes.
The device is indicated for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis, which constitutes a therapeutic intervention.
No
The device is indicated for the destruction of soft tissue in the nasal airway, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components (Stylus shaft, treatment tip) and mentions bench functional testing, force load testing, and thermocouple accuracy testing, indicating it is a hardware device that delivers RF energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "destruction of soft tissue in the nasal airway... in patients with chronic rhinitis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device generates and delivers bipolar RF energy to treat tissue. This is a therapeutic function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's condition. The device is used for treatment.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
GEI
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 packaging and devices passed all aging and transit testing acceptance criteria, thereby allowing all styluses to be labeled with a 6-month shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RHIN1 Stylus (K192471)
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
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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
1
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)
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) | |
|---|---|
| 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 Assurance | ||
| Phone: 512-221-9956 | ||
| Establishment Registration | ||
| 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 | |
| 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
(Model FG1393) | RHIN1 Stylus
(Model FG815) |
|---------------------------------|-------------------------------------|-------------------------------------------|
| | Subject Device | Predicate Device K192471 |
| Design configuration | Same | Integrated cable, handle and
electrode |
| Energy type | Same | Bipolar radiofrequency |
| Tissue temperature | 60°C | 50 - 70 °C
(temperature controlled) |
| Power | 4 W | 3-5 W |
| RF generator
compatibility | Same | Aerin Console,
Model FG226 |
| Shaft shape | Straight with diameter step
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
Image: [Treatment Tip] | No tilt
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
5
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.