(65 days)
No
The description focuses on the physical device, RF energy delivery, and temperature control, with no mention of AI or ML capabilities.
Yes
The device is intended to treat a medical condition (nasal airway obstruction) by shrinking submucosal tissue, which is a therapeutic action.
No
The device is indicated for use in ENT surgery for "coagulation of soft tissue" and "shrinking submucosal tissue," which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is a handheld bipolar radiofrequency (RF) probe with a handle, shaft, and treatment tip, indicating it is a physical hardware device.
Based on the provided information, the Aerin Medical Stylus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the coagulation of soft tissue in the nasal airway during ENT surgery to treat nasal airway obstruction. This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a handheld probe that delivers radiofrequency energy to tissue. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Aerin Medical Stylus is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Aerin Medical 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.
Product codes
GEI
Device Description
The Aerin Medical 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 radiofrequency energy delivery. The stylus is connected, via a flexible cable, to a commercially-available RF generator (the ORA-50 S, cleared under K993854) meeting the following requirements: RF operating frequency of 460 kHz (± 5 kHz); bipolar low power (3 watts to 5 watts) RF energy delivery; and sensitive temperature control with low overshoot (50°C to 70°C).
The Aerin Medical Stylus is used in the treatment of patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the Aerin Medical Stylus into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. Radiofrequency treatment of tissue creates a coaqulative lesion which fibroses and retracts as it heals, thereby shrinking 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
otorhinolaryngology (ENT) surgery Setting
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 safety is supported through biocompatibility testing, sterilization and packaging validation activities, electrical safety testing and electromagnetic Biocompatibility of the Aerin Medical Stylus was compatibility testing. demonstrated through testing performed in accordance with AAMI / ANSI / ISO standards 10993-1 (2009/(R) 2013). Radiation sterilization was validated per AAMI / ANSI / ISO 11137-1 (2006/(R) 2010) and 11137-2 (2013). Electrical safety was demonstrated through testing to IEC 60601-1 (2005/(R) 2012) and 60601-2-2 (2009) and electromagnetic compatibility testing was performed according to IEC 60601-1-2 (2007). The packaging systems were 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 F1980-07, ASTM F2096-11, and ASTM F88/F88M-15), and met all acceptance criteria.
Device performance testing included usability factors as well as factors related to system responsiveness and effectiveness for use in a clinical setting. Usability factors, such as ergonomics, visualization, orientation and force application, were evaluated as part of a cadaver study, Additionally, 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 submucosal tissues of the nasal airway. The subject device met all performance testing requirements, thereby supporting its equivalency to the predicate device in terms of delivery of RF energy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Scott Wolf, M.D. President and Chief Medical Officer Aerin Medical, Inc. 690 W. Fremont Avenue, Unit 3 Sunnyvale, CA 94087
Re: K161994
Trade/Device Name: Aerin Medical Stylus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 19, 2016 Received: August 23, 2016
Dear Dr. Wolf:
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
Page 2 - Scott Wolf, M.D.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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 Aerin Medical Stylus
Indications for Use (Describe)
The Aerin Medical 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.
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 word "MEDICAL" in a smaller, gray, sans-serif font below it. To the right of the word "Aerin" are several green circles that are arranged in a gradient pattern.
This 510(k) Summary is being submitted in accordance with the requirements of 21CFR 807.92.
General Information
| Submitter Information | |
|---|---|
| Company: | Aerin Medical, Inc. |
| Submitter's Address: | 690 W. Fremont Avenue, Unit 3 |
| Sunnyvale, CA 94087 | |
| Contact Person: | Scott Wolf, M.D. |
| President and Chief Medical Officer | |
| Phone: 650-434-3247 | |
| Fax: 408-716-2438 | |
| Establishment | |
| Registration Number | 3011625895 |
| Date Prepared: | September 21, 2016 |
| Name of the Device | |
| Proprietary Name: | Aerin Medical Stylus |
| Common Name: | Radiofrequency wand |
| 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: | Aerin Medical Wand (K150637) |
Device Description
The Aerin Medical 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 radiofrequency energy delivery. The stylus is connected, via a flexible cable, to a commercially-available RF generator (the ORA-50 S, cleared under K993854) meeting the following requirements: RF operating frequency of 460 kHz (± 5 kHz); bipolar low power (3 watts to 5 watts) RF energy delivery; and sensitive temperature control with low overshoot (50°C to 70°C).
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. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font. To the right of "Aerin" are several green circles of varying sizes, arranged in a pattern.
The Aerin Medical Stylus is used in the treatment of patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the Aerin Medical Stylus into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. Radiofrequency treatment of tissue creates a coaqulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the degree of obstruction.
Indications for Use
The Aerin Medical 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.
Summary of the technological characteristics of the device compared to the predicate device
The Aerin Medical Stylus was found to be equivalent to the predicate device in design and intended use to deliver bipolar RF energy to coagulate tissue in otorhinolaryngology procedures.
| Characteristic | Aerin Medical Stylus
(Models FG011 & FG174)
Subject Device | Aerin Medical Wand
(Model FG011)
Predicate Device
K150637 |
|----------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Same | 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. |
| Design configuration | Same | Integrated cable, handle
and electrode |
| Energy type | Same | Bipolar radiofrequency |
| Tissue temperature | Same | 50 — 70 °C
(temperature controlled) |
Summary of non-clinical tests
Device safety is supported through biocompatibility testing, sterilization and packaging validation activities, electrical safety testing and electromagnetic Biocompatibility of the Aerin Medical Stylus was compatibility testing. demonstrated through testing performed in accordance with AAMI / ANSI / ISO standards 10993-1 (2009/(R) 2013). Radiation sterilization was validated per AAMI / ANSI / ISO 11137-1 (2006/(R) 2010) and 11137-2 (2013). Electrical safety was demonstrated through testing to IEC 60601-1 (2005/(R) 2012) and
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. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font. To the right of "Aerin" are several green circles of varying sizes.
60601-2-2 (2009) and electromagnetic compatibility testing was performed according to IEC 60601-1-2 (2007). The packaging systems were 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 F1980-07, ASTM F2096-11, and ASTM F88/F88M-15), and met all acceptance criteria.
Device performance testing included usability factors as well as factors related to system responsiveness and effectiveness for use in a clinical setting. Usability factors, such as ergonomics, visualization, orientation and force application, were evaluated as part of a cadaver study, Additionally, 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 submucosal tissues of the nasal airway. The subject device met all performance testing requirements, thereby supporting its equivalency to the predicate device in terms of delivery of RF energy.
Summary of clinical tests
Not applicable. No clinical tests were necessary.
Conclusion
Testing demonstrates that the Aerin Medical Stylus is substantially equivalent to the predicate in terms of both indications for use and delivered RF treatment and is as safe and effective for its intended use.