(30 days)
Not Found
No
The description mentions a "computerized system" with "integral temperature and impedance feedback mechanism" that "automatically adjust[s] energy delivery." While this involves automation and feedback loops, it does not explicitly describe or imply the use of AI or ML algorithms for learning or complex pattern recognition beyond basic control systems. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
Yes
The device is used in dermatological and general surgical procedures for coagulation/contraction of soft tissue or hemostasis, which are therapeutic actions aiming to treat or alleviate a medical condition or symptom.
No
The device is described as an RF System for coagulation/contraction of soft tissue and hemostasis in dermatological and general surgical procedures, controlling energy delivery based on temperature and impedance feedback. There is no mention of diagnostic functions such as disease detection, diagnosis, or monitoring.
No
The device description explicitly lists hardware components such as an AC/DC power supply unit, RF generator, controller, user interface with touch screen, RF handpiece, cable, and foot switch. This indicates it is a hardware-based system, not software-only.
Based on the provided information, the Inbella RF System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device generates RF energy to heat tissue for coagulation and hemostasis. This is a physical process applied to the patient.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The Inbella RF System does not perform any such analysis of specimens.
The device is clearly intended for direct application to the patient's soft tissue during surgical procedures, which falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Inbella RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Inbella RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Inbella RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The Inbella RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and return (external) electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No new bench performance data is submitted to support this submission.
No new animal performance data is submitted to support this submission.
Not Applicable (Clinical Performance Data)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
January 3, 2024
Inbella Medical Ltd. Michael Kreindel CTO 100 Leek Crescent, unit 13 Richmond Hill, ON L4B 3E6 Canada
Re: K243737
Trade/Device Name: Inbella RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 19, 2024 Received: December 19, 2024
Dear Michael Kreindel:
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/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.
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 820.70) 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 (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 Rue"). The UDI Rule requires, among other things, that a device bear a unique 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-advice-comprehensiveregulatory-assistance/unique-device-identification-system-udi-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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-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-devices/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).
2
Sincerely,
Digitally signed by James H. James H. Jang -S Jang -S Date: 2025.01.03 18:03:15 -05'00'
For 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
510(k) Number (if known) K243737
Device Name Inbella RF System
Indications for Use (Describe)
The Inbella RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Inbella Medical Inc.'s Inbella RF System
Applicant Name:
| Company Name: | Inbella Medical Inc. |
|---|---|
| Address: | 100 Leek Crescent, unit 13, |
| Richmond Hill, Ontario, | |
| Canada | |
| Contact Person: | Jodi K. Scott |
| Partner | |
| jodi.scott@hoganlovells.com | |
| T +1 303 454 2463 | |
| F +1 303 899 7333 | |
| Date Prepared: | December 4, 2024 |
| Name of Device: | Inbella RF System |
| Common or Usual Name: Radiofrequency-based electrosurgical coagulation device |
Classification Name: CFR 878.4400
Regulatory Class: Class II Medical Device
Product Code: GEI
Predicate Device:
The Inbella RF System manufactured by Inbella Medical is substantially equivalent to the InMode RF System manufactured by InMode Ltd. (K240780).
Purpose of the 510(k) notice:
The Inbella RF System manufactured by Inbella Medical in all aspects to the InMode RF System manufactured by InMode Ltd. (K240780). The only difference is the manufacturer and 510(k) holder.
Intended Use:
The Inbella RF System is indicated for use in dermatological and general surgical procedures where coaqulation/contraction of soft tissue or hemostasis is needed.
Device Description:
The Inbella RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Inbella RF System constantly monitors the temperature and impedance of the
5
target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The Inbella RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.
Performance Standards:
The Inbella RF System has been tested and complies with the following voluntary recognized standards:
- -ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- -IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
Non-Clinical (Bench) Performance Data:
No new bench performance data is submitted to support this submission.
Animal Performance Data / Histology Data:
No new animal performance data is submitted to support this submission.
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use and technological characteristics of the Inbella RF System manufactured by Inbella Medical are the same as those of the InMode RF System manufactured by InMode Ltd. (K240780). The only difference is the manufacturer and 510(k) holder.
Thus, the Inbella RF System is substantially equivalent to the cleared predicate and may, therefore, be legally marketed in the USA.