(97 days)
No
The description focuses on standard RF energy delivery and temperature monitoring, with no mention of AI or ML for analysis, decision-making, or control.
Yes
The device is intended to treat a medical condition (nasal airway obstruction) by shrinking submucosal tissue using radiofrequency energy, which is a therapeutic intervention.
No
Explanation: The device is designed to treat nasal airway obstruction by shrinking submucosal tissue using radiofrequency energy, not to diagnose a condition.
No
The device description clearly outlines both a hardware component (InSeca ARC Stylus) and a hardware console (Aerin Console) that generate and deliver radiofrequency energy. While the console includes user interface software, the core function and components are hardware-based.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The InSeca ARC Stylus and Aerin Console are used directly on the patient's tissue (in vivo) to perform a therapeutic procedure (coagulation of soft tissue). They are not used to analyze samples taken from the patient.
- Intended Use: The intended use is for "coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue." This is a surgical/therapeutic intervention, not a diagnostic test performed on a sample.
The device is an electrosurgical system used for a therapeutic procedure within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
InSeca ARC Stylus
The InSeca 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.
Aerin Console
The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an ARC Stylus (e.g., InSeca ARC Stylus). The Aerin Console is indicated for use in small clinic, office or hospital environments.
Product codes
GEI
Device Description
InSeca ARC Stylus
The InSeca 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 InSeca ARC Stylus is used to treat patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the InSeca ARC 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 coagulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the dearee of obstruction.
Aerin Console
The Aerin Console is an RF generator designed to be used with the InSeca ARC Stylus to deliver bipolar RF energy to tissue. The Aerin Console consists of an RF generator, a power cord, and a foot switch. It incorporates user interface software to control, monitor and requlate RF power delivery to soft tissues via a cableconnected electrosurgical hand piece and electrode.
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
Clinician; small clinic, office or hospital environments
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
Bench testing, software validation and usability testing. Force load testing, 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. Additional performance testing was performed to verify substantial equivalence to the predicate devices in terms of thermal effects. Biocompatibility testing, sterilization and packaging validation activities, electrical safety testing and electromagnetic compatibility testing.
The subject devices met all the performance testing requirements. The testing showed that the InSeca ARC Stylus used with the Aerin Console creates thermal lesion volumes that are comparable to volumes created with the predicate device.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be formed by a continuous line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2017
Aerin Medical, Inc. Scott Wolf, M.D. President and Chief Medical Officer 690 W. Fremont Avenue, Unit 3 Sunnyvale, CA 94087
Re: K162810
Trade/Device Name: InSeca ARC Stylus, Aerin Console Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 9, 2016 Received: December 12, 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
InSeca ARC Stylus and Aerin Console
Indications for Use (Describe)
InSeca ARC Stylus
The InSeca 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.
Aerin Console
The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an ARC Stylus (e.g., InSeca ARC Stylus). The Aerin Console is indicated for use in small clinic, office or hospital environments.
| 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 logo features the word "Aerin" in a large, blue, sans-serif font, with the word "MEDICAL" in a smaller, gray, sans-serif font underneath. 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: | Scott Wolf, M.D. |
| President and Chief Medical Officer | |
| Phone: 650-434-3247 | |
| Fax: 408-716-2438 | |
| Establishment | |
| Registration Number | 3011625895 |
| Date Prepared: | December 9, 2016 |
| Name of the Device | |
| Proprietary Name: | InSeca ARC Stylus, Model FG256 |
| Aerin Console, Model FG226 | |
| Common Name: | Radiofrequency generator and 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: | Aerin Medical Stylus (K161994) |
| Reference Device: | Smith & Nephew ORA-50™ S Radiofrequency |
| Generator (K993854) |
Device Description
InSeca ARC Stylus
The InSeca 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
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. 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.
features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.
The InSeca ARC Stylus is used to treat patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the InSeca ARC 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 coagulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the dearee of obstruction.
Aerin Console
The Aerin Console is an RF generator designed to be used with the InSeca ARC Stylus to deliver bipolar RF energy to tissue. The Aerin Console consists of an RF generator, a power cord, and a foot switch. It incorporates user interface software to control, monitor and requlate RF power delivery to soft tissues via a cableconnected electrosurgical hand piece and electrode.
Indications for Use
InSeca ARC Stylus
The InSeca ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coaqulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue.
Aerin Console
The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an ARC Stylus (e.g., InSeca ARC Stylus). The Aerin Console is indicated for use in small clinic, office or hospital environments.
Summary of the technological characteristics of the device compared to the predicate device
The InSeca ARC Stylus and Aerin Console were found to be equivalent to the predicate device in design and intended use to generate and deliver bipolar RF energy to coagulate tissue in ENT procedures.
| Characteristic | InSeca ARC Stylus
(Model FG256) and Aerin
Console (Model FG226)
Subject Device | Aerin Medical Stylus
(Model FG174) - K161994
Predicate Device |
|----------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Design configuration | Same | Integrated cable, handle and
electrode |
| Energy type | Same | Bipolar radiofrequency |
| Tissue temperature | Same | 50 – 70 °C
(temperature controlled) |
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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, sans-serif font in blue. Below it, the word "MEDICAL" is in a smaller, sans-serif font, also in blue. To the right of the word "Aerin" are several green circles of varying sizes, arranged in a cluster.
| Stylus RF generator
compatibility | Aerin Console,
Model FG226 | Smith & Nephew
ORA-50 S |
|--------------------------------------|--------------------------------------------------|----------------------------------------------------------|
| Use limit feature | Yes | No |
| Characteristic | Aerin Console
(Model FG226)
Subject Device | Smith & Nephew ORA-50 S
(K993854)
Reference Device |
| Design configuration | Same | Generator, power cord, foot
switch |
| Energy type | Same | Bipolar radiofrequency |
| Operating frequency
(KHz) | Same | 460 |
| Treatment temperature
range | 50-70°C | 15-99°C |
| Output power | 3-5 watts | Up to 50 watts |
| Stylus validation feature | Yes | No |
Summary of non-clinical tests
Device performance testing included bench testing, software validation 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 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 devices 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 InSeca ARC Stylus used with the Aerin Console creates thermal 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 compatibility testing. Biocompatibility of the InSeca ARC Stylus was demonstrated through testing performed in accordance with AAMI/ANSI/ISO 10993-1 (2009/(R) The sterilization validation was performed in accordance with 2013). ANSI/AAMI/ISO 11135:2014 and ISO 10993-7:2008. Electrical safety of the Aerin Console and InSeca ARC Stylus 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 InSeca 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 F1980-07, ASTM F2096-11, and ASTM F88/F88M-15), and met all acceptance criteria.
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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 word "MEDICAL" in a smaller, red, sans-serif font below it. To the right of the word "Aerin" are a series of green circles that are arranged in a gradient pattern.
Summary of clinical tests
Not applicable. No clinical tests were necessary.
Conclusion
Testing demonstrates that the InSeca ARC Stylus and Aerin Console are 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.