(98 days)
No
The summary describes a standard RF generator with user interface software for controlling power delivery. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on electrical safety, EMC, software validation, and device security, not AI/ML performance metrics.
Yes
The device is an electrosurgical system that generates radiofrequency electrical current to deliver bipolar RF energy to tissue, which is a therapeutic action.
No
The device is an electrosurgical system that generates radiofrequency electrical current to deliver energy to tissue. It is described as a treatment device, not one that detects or identifies a disease or condition.
No
The device description explicitly states that the Aerin Console consists of an RF generator, a power cord, and a foot switch, which are hardware components. While it incorporates user interface software, it is not solely software.
Based on the provided information, the Aerin Console is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to generate radiofrequency electrical current for use with a stylus to deliver energy to tissue. This is a therapeutic/surgical application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details an RF generator and its components used for delivering energy to tissue. This aligns with a surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing diagnostic tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aerin Console's function is to directly interact with and modify tissue using energy, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Aerin Console is an electrosurgical system intended to generate radiofrequency (RF) electrical current for the use of an Aerin Medical Stylus. The Aerin Console is indicated for use in small clinic, office or hospital environments.
Product codes
GEI
Device Description
The Aerin Console is a radio-frequency (RF) generator designed to be used with an Aerin Medical Stylus (RhinAer Stylus, K221907 and VivAer, K200300) 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 regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test:
Device Performance was tested to comply to:
Electrical Safety and EMC:
- ISO 60601-1
- ISO 60601-1-2
- IEC 60601-4-2
- 47 CFR Part 15 Subpart B
- 47 CFR Part 27
Software validation: - IEC 62304
Device Security: - IEC 81001-5-1
Clinical testing was not necessary for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aerin Console (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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
December 10, 2024
Aerin Medical, Inc. Teri Feeley Regulatory Affairs Manager 2565 Leghorn St. Mountain View, California 94043
Re: K242630
Trade/Device Name: 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: November 13, 2024 Received: November 13, 2024
Dear Teri Feeley:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Digitally signed by Long H. Long H. Chen -Chen -S Date: 2024.12.10 13:21:08 S -05'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Aerin Console
Indications for Use (Describe)
The Aerin Console is an electrosurgical system intended to generate radiofrequency (RF) electrical current for the use of an Aerin Medical Stylus. The Aerin Console is indicated for use in small clinic, office or hospital environments.
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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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 that are arranged in a gradient pattern.
510(k) Summary K242630
General Information
| Submitter Information | |
|---|---|
| Company: | Aerin Medical Inc. |
| Submitter address: | 2565 Leghorn St. |
| Mountain View, CA 94043 | |
| Contact Person: | Teri Feeley |
| Regulatory Affairs Manger | |
| Phone: 210-827-1618 | |
| Establishment Registration Number: | 3011625895 |
| Date Prepared: | 30 Aug 2024 |
| Name of Device | |
| Brand Name: | Aerin Console |
| Common Name: | Radiofrequency generator |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification Panel | General and Plastic Surgery |
| Device Class: | Class II |
| Product Code: | GEI |
| CFR Regulation: | 21 CFR 878.4400 |
| Predicate Device: | Aerin Console (K162810) |
| Device Description |
The Aerin Console is a radio-frequency (RF) generator designed to be used with an Aerin Medical Stylus (RhinAer Stylus, K221907 and VivAer, K200300) 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 regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Indications for Use
The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an Aerin Medical Stylus. The Aerin Console is indicated for use in small clinic, office or hospital environments.
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, arranged in a gradient pattern.
510(k) Summary K242630
Summary of Technological characteristics compared to the predicate device
The subject device has the same technological characteristics as the predicate including the principle of operation, performance, and design features.
| Characteristic | Subject Device | Predicate Device
(K162810) |
|--------------------------------|----------------|-------------------------------------------------------------|
| Design Configuration | Same | Generator, power cord, foot
switch |
| Energy type | Same | Bipolar radiofrequency |
| Treatment temperature
range | Same | 50-70°C |
| Output Power | Same | 3-5 Watts |
| Stylus compatibility | Same | Aerin Medical Stylus
(RhinAer Stylus &
VivAer Stylus) |
Summary of non-clinical test
Device Performance was tested to comply to:
Electrical Safety and EMC:
- ISO 60601-1 ●
- ISO 60601-1-2 ●
- IEC 60601-4-2 ●
- 47 CFR Part 15 Subpart B ●
- 47 CFR Part 27 ●
Software validation
-
. IEC 62304
Device Security -
IEC 81001-5-1 .
Summary of clinical test
Clinical testing was not necessary for this device.
Conclusion
The subject device is substantially equivalent to the predicate device based on a comparison of the intended use, indications for use, and technological characteristics and the minor differences do not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.