The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The BellaTform Applicator in EMS mode is intended for:

Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
· Increasing local blood circulation
· Muscle re-education
· Maintaining or increasing range of motion
· Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The BellaTform Applicator in TENS mode is intended for:

· Symptomatic relief and management of chronic, intractable pain
· Post-surgical acute pain
· Post-trauma acute pain

Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for:

· Non-invasive lipolysis (breakdown of fat) of the abdomen.
· Reduction in circumference of the abdomen

Device Description

The InBellaBody System with BellaTform Applicator is deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The InBellaBody System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings.

The InBellaBody System System includes the following components:

LCD display touch screen,
Audio loudspeaker,
48V AC/DC power supply,
. Real time controller, distributor card and 2 RF generators,
Fans

The System operates while connected to the BellaTform Applicator.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA. It states that the InbellaBody System with BellaTform Applicator is substantially equivalent to a previously cleared predicate device (Evolve System with Transform Applicator, K231495) and can therefore be marketed.

Crucially, the document explicitly states "Clinical Performance Data: Not Applicable" and "Non-Clinical (Bench) Performance Data: Not Applicable" and "Animal Performance Data / Histology Data: Not Applicable."

Therefore, based solely on the provided text, there is no study described that proves the device meets specific acceptance criteria.

The claim of substantial equivalence is based on the device being identical to a predicate device, with the only difference being the manufacturer and 510(k) holder. This means that the acceptance criteria and performance data for the InbellaBody System would be those established for the predicate device, Evolve System with Transform Applicator (K231495). However, the details of those studies are not present in this document.

Here's a breakdown of the requested information based on the provided text, highlighting where data is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Predicate Device)	Reported Device Performance (InbellaBody System)
Not specified in this document for the predicate.	Substantially Equivalent to Predicate Device
(Likely involved meeting safety and effectiveness standards for RF, EMS, and TENS technologies for the stated indications)	"The indications for use and technological characteristics of InBellaBody System with BellaTform Applicator manufactured by Inbella Medical are the same as those of the Evolve System with Transform Applicator manufactured by InMode Ltd. (K231495). The only difference is the manufacturer and 510(k) holder."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The document states "Clinical Performance Data: Not Applicable" for the InbellaBody System. Any clinical data would have been for the predicate device, which is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical or non-clinical performance data for the InbellaBody System is provided, nor for its substantial equivalence comparison, beyond the devices being identical in design and function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical or non-clinical performance data for the InbellaBody System is provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is an electrosurgical cutting and coagulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No performance studies (clinical or non-clinical) for the InbellaBody System are described in this document. Substantial equivalence is based on technical and intended use identity with a predicate.

8. The sample size for the training set

Not Applicable. The device is not an AI/machine learning product that would have a "training set."

9. How the ground truth for the training set was established

Not Applicable. The device is not an AI/machine learning product.

Summary of what the document does state regarding acceptance and study:

The acceptance of the InbellaBody System for marketing is based on its substantial equivalence to a previously cleared predicate device, the Evolve System with Transform Applicator (K231495). The study for this determination was essentially a comparison of the design, technological characteristics, and intended uses of the InbellaBody System against the predicate device. Since the InbellaBody System was found to be identical to the predicate device in all aspects except the manufacturer, no new clinical or non-clinical performance data was required or submitted for this specific 510(k) submission. The regulatory body (FDA) therefore accepted that the InbellaBody System meets the same safety and effectiveness standards that were established for the predicate device.

Summary

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February 11, 2025

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Inbella Medical Ltd. % Jodi K. Scott Partner Hogan Lovells US LLP 1601 Wewatta Street, Suite 900 Denver, CO 80202 n.s.

Re: K250200

Trade/Device Name: InbellaBody System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 23, 2025 Received: January 23, 2025

Dear Jodi K. 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 (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"

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(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).

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Sincerely,

Image /page/2/Figure/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2025.02.11, and the time is 09:57:14 -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

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Indications for Use

510(k) Number (if known) K250200

Device Name

InbellaBody System with BellaTform Applicator

Indications for Use (Describe)

The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.

The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The BellaTform Applicator in EMS mode is intended for:

Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
· Increasing local blood circulation
· Muscle re-education
· Maintaining or increasing range of motion
· Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The BellaTform Applicator in TENS mode is intended for:

· Symptomatic relief and management of chronic, intractable pain
· Post-surgical acute pain
· Post-trauma acute pain

Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for:

· Non-invasive lipolysis (breakdown of fat) of the abdomen.
· Reduction in circumference of the abdomen

Type of Use (Select one or both, as applicable)

☒ Registration Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart G)
-------------------------------------------------------------------------------------------------	-----------------------------------------------

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 INBELLABODY SYSTEM WITH BELLATFORM APPLICATOR

Applicant Name:

Company Name:	Inbella Medical Inc.
Address:	100 Leek Crescent, unit 13,Richmond Hill,Ontario, Canada
Contact Person:	Jodi K. ScottPartnerjodi.scott@hoganlovells.comT +1 303 899 7300454 2463F +1 303 899 7333
Date Prepared:	January 23, 2025
Name of Device:	InBellaBody System with BellaTform Applicator
Common or Usual Name:	Radiofrequency-based electrosurgical coagulation device
Classification Name:	CFR Classification section 878.4400
Classification:	Class II Medical Device

GEI Product code:

Predicate Device:

The InBellaBody System with BellaTform Applicator manufactured by Inbella Medical is substantially equivalent to the Evolve System with Transform Applicator manufactured by InMode Ltd. (K231495).

Purpose of the 510(k) notice:

The InBellaBody System with BellaTform Applicator manufactured by Inbella Medical in all aspects to the Evolve System with Transform Applicator manufactured by InMode Ltd. (K231495). The only difference is the manufacturer and 510(k) holder.

Intended Use:

The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.

The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

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The BellaTform Applicator in EMS mode is intended for:

. Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
. Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion ●
. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The BellaTform Applicator in TENS mode is intended for:

. Symptomatic relief and management of chronic, intractable pain
Post-surgical acute pain
Post-trauma acute pain

Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for:

. Non-invasive lipolysis (breakdown of fat) of the abdomen.
. Reduction in circumference of the abdomen

Device Description:

The InBellaBody System System includes the following components:

LCD display touch screen,
Audio loudspeaker,
48V AC/DC power supply,
. Real time controller, distributor card and 2 RF generators,
Fans

The System operates while connected to the BellaTform Applicator.

Performance Standards:

The InBellaBody System with BellaTform Applicator 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 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

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IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General i 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:

Not Applicable

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use and technological characteristics of InBellaBody System with BellaTform Applicator manufactured by Inbella Medical are the same as those of the Evolve System with Transform Applicator manufactured by InMode Ltd. (K231495). The only difference is the manufacturer and 510(k) holder.

Thus, the InBellaBody System with BellaTform Applicator is substantially equivalent to the cleared predicate and may, therefore, be legally marketed in the USA.

Regulation Number and Section

§ 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.